Sinu-Rite

Generic Name: glycyrrhiza glabra, sambucus nigra flowering top, sodium chloride, passiflora incarnata top and potassium dichromate

Dosage Form: tablet
Sinu-Rite

Relieves blocked sinus, nose and chest

Indications: Homeopathic remedy for sinusitis in dogs and cats

Dosage:  Tablets may be crushed and sprinkled on the tongue or taken whole. Cats and dogs under 20 lbs: 1 tablet 3-5 times daily.  Dogs 20-50 lbs: 2 tablets 3-5 times daily.  Dogs over 50 lbs: 3 tablets 3-5 times daily. 

Caution: Consult your vet if symptoms persist or worsen.  Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Glycorrhiza (3X) (HPUS), Sambucus nig (3X) (HPUS), Nat mur (6X) (HPUS), Wind flower (30C) (HPUS), Kali bich (30C) (HPUS)

Lactose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Sinu-Rite   glycyrrhiza, sambucus nig, nat mur, pulsatilla,, kali bich  tablet

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-139 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCYRRHIZA GLABRA (GLYCYRRHIZA GLABRA) GLYCYRRHIZA GLABRA 3 [hp_X] SAMBUCUS NIGRA FLOWERING TOP (SAMBUCUS NIGRA FLOWERING TOP) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6 [hp_X] PASSIFLORA INCARNATA TOP (PASSIFLORA INCARNATA TOP) PASSIFLORA INCARNATA TOP 30 [hp_C] POTASSIUM DICHROMATE (POTASSIUM CATION) POTASSIUM DICHROMATE 30 [hp_C]

Inactive Ingredients Ingredient Name Strength LACTOSE 100 mg

Product Characteristics Color white (white lactose tablet) Score no score Shape ROUND (round white lactose tablet) Size 5mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68647-139-10 125 TABLET In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2010

Labeler - Feelgood Health (538418296)

Establishment
Name	Address	ID/FEI	Operations
W Last		567284153	manufacture

Revised: 06/2010Feelgood Health

Minipress

prazosin hydrochloride

Dosage Form: capsule
Minipress®

Capsules

(prazosin hydrochloride)

For Oral Use

Minipress Description

Minipress® (prazosin hydrochloride), a quinazoline derivative, is the first of a new chemical class of antihypertensives. It is the hydrochloride salt of 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:

Molecular formula C19H21N5O4•HCl

It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each 1 mg capsule of Minipress for oral use contains drug equivalent to 1 mg free base.

Inert ingredients in the formulations are: hard gelatin capsules (which may contain Blue 1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.

Minipress - Clinical Pharmacology

The exact mechanism of the hypotensive action of prazosin is unknown. Prazosin causes a decrease in total peripheral resistance and was originally thought to have a direct relaxant action on vascular smooth muscle. Recent animal studies, however, have suggested that the vasodilator effect of prazosin is also related to blockade of postsynaptic alpha-adrenoceptors. The results of dog forelimb experiments demonstrate that the peripheral vasodilator effect of prazosin is confined mainly to the level of the resistance vessels (arterioles). Unlike conventional alpha-blockers, the antihypertensive action of prazosin is usually not accompanied by a reflex tachycardia. Tolerance has not been observed to develop in long term therapy.

Hemodynamic studies have been carried out in man following acute single dose administration and during the course of long term maintenance therapy. The results confirm that the therapeutic effect is a fall in blood pressure unaccompanied by a clinically significant change in cardiac output, heart rate, renal blood flow and glomerular filtration rate. There is no measurable negative chronotropic effect.

In clinical studies to date, prazosin hydrochloride has not increased plasma renin activity.

In man, blood pressure is lowered in both the supine and standing positions. This effect is most pronounced on the diastolic blood pressure.

Following oral administration, human plasma concentrations reach a peak at about three hours with a plasma half-life of two to three hours. The drug is highly bound to plasma protein. Bioavailability studies have demonstrated that the total absorption relative to the drug in a 20% alcoholic solution is 90%, resulting in peak levels approximately 65% of that of the drug in solution. Animal studies indicate that prazosin hydrochloride is extensively metabolized, primarily by demethylation and conjugation, and excreted mainly via bile and feces. Less extensive human studies suggest similar metabolism and excretion in man.

In clinical studies in which lipid profiles were followed, there were generally no adverse changes noted between pre- and post-treatment lipid levels.

Indications and Usage for Minipress

Minipress is indicated in the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents.

Contraindications

Minipress is contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.

Warnings

As with all alpha-blockers, Minipress may cause syncope with sudden loss of consciousness. In most cases, this is believed to be due to an excessive postural hypotensive effect, although occasionally the syncopal episode has been preceded by a bout of severe tachycardia with heart rates of 120–160 beats per minute. Syncopal episodes have usually occurred within 30 to 90 minutes of the initial dose of the drug; occasionally, they have been reported in association with rapid dosage increases or the introduction of another antihypertensive drug into the regimen of a patient taking high doses of Minipress. The incidence of syncopal episodes is approximately 1% in patients given an initial dose of 2 mg or greater. Clinical trials conducted during the investigational phase of this drug suggest that syncopal episodes can be minimized by limiting the initial dose of the drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient's regimen with caution (see DOSAGE AND ADMINISTRATION). Hypotension may develop in patients given Minipress who are also receiving a beta-blocker such as propranolol.

If syncope occurs, the patient should be placed in the recumbent position and treated supportively as necessary. This adverse effect is self-limiting and in most cases does not recur after the initial period of therapy or during subsequent dose titration.

Patients should always be started on the 1 mg capsules of Minipress. The 2 and 5 mg capsules are not indicated for initial therapy.

More common than loss of consciousness are the symptoms often associated with lowering of the blood pressure, namely, dizziness and lightheadedness. The patient should be cautioned about these possible adverse effects and advised what measures to take should they develop. The patient should also be cautioned to avoid situations where injury could result should syncope occur during the initiation of Minipress therapy.

Precautions

General

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications to the surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery.

Information for Patients

Dizziness or drowsiness may occur after the first dose of this medicine. Avoid driving or performing hazardous tasks for the first 24 hours after taking this medicine or when the dose is increased. Dizziness, lightheadedness, or fainting may occur, especially when rising from a lying or sitting position. Getting up slowly may help lessen the problem. These effects may also occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While taking Minipress, be careful in the amount of alcohol you drink. Also, use extra care during exercise or hot weather, or if standing for long periods. Check with your physician if you have any questions.

Drug Interactions

Minipress has been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides–digitalis and digoxin; (2) hypoglycemics–insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives–chlordiazepoxide, diazepam, and phenobarbital; (4) antigout–allopurinol, colchicine, and probenecid; (5) antiarrhythmics–procainamide, propranolol (see WARNINGS however), and quinidine; and (6) analgesics, antipyretics and anti-inflammatories–propoxyphene, aspirin, indomethacin, and phenylbutazone.

Addition of a diuretic or other antihypertensive agent to Minipress has been shown to cause an additive hypotensive effect. This effect can be minimized by reducing the Minipress dose to 1 to 2 mg three times a day, by introducing additional antihypertensive drugs cautiously, and then by retitrating Minipress based on clinical response.

Concomitant administration of Minipress with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension (see DOSAGE AND ADMINISTRATION).

Drug/Laboratory Test Interactions

In a study on five patients given from 12 to 24 mg of prazosin per day for 10 to 14 days, there was an average increase of 42% in the urinary metabolite of norepinephrine and an average increase in urinary VMA of 17%. Therefore, false positive results may occur in screening tests for pheochromocytoma in patients who are being treated with prazosin. If an elevated VMA is found, prazosin should be discontinued and the patient retested after a month.

Laboratory Tests

In clinical studies in which lipid profiles were followed, there were generally no adverse changes noted between pre- and post-treatment lipid levels.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenic potential was demonstrated in an 18 month study in rats with Minipress at dose levels more than 225 times the usual maximum recommended human dose of 20 mg per day. Minipress was not mutagenic in in vivo genetic toxicology studies. In a fertility and general reproductive performance study in rats, both males and females, treated with 75 mg/kg (225 times the usual maximum recommended human dose), demonstrated decreased fertility, while those treated with 25 mg/kg (75 times the usual maximum recommended human dose) did not.

In chronic studies (one year or more) of Minipress in rats and dogs, testicular changes consisting of atrophy and necrosis occurred at 25 mg/kg/day (75 times the usual maximum recommended human dose). No testicular changes were seen in rats or dogs at 10 mg/kg/day (30 times the usual maximum recommended human dose). In view of the testicular changes observed in animals, 105 patients on long term Minipress therapy were monitored for 17-ketosteroid excretion and no changes indicating a drug effect were observed. In addition, 27 males on Minipress for up to 51 months did not have changes in sperm morphology suggestive of drug effect.

Usage in Pregnancy

Pregnancy Category C. Minipress has been shown to be associated with decreased litter size at birth, 1, 4, and 21 days of age in rats when given doses more than 225 times the usual maximum recommended human dose. No evidence of drug-related external, visceral, or skeletal fetal abnormalities were observed. No drug-related external, visceral, or skeletal abnormalities were observed in fetuses of pregnant rabbits and pregnant monkeys at doses more than 225 times and 12 times the usual maximum recommended human dose, respectively.

The use of prazosin and a beta-blocker for the control of severe hypertension in 44 pregnant women revealed no drug-related fetal abnormalities or adverse effects. Therapy with prazosin was continued for as long as 14 weeks.1

Prazosin has also been used alone or in combination with other hypotensive agents in severe hypertension of pregnancy by other investigators. No fetal or neonatal abnormalities have been reported with the use of prazosin.2

There are no adequate and well controlled studies which establish the safety of Minipress in pregnant women. Minipress should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Nursing Mothers

Minipress has been shown to be excreted in small amounts in human milk. Caution should be exercised when Minipress is administered to a nursing woman.

Usage in Children

Safety and effectiveness in children have not been established.

Adverse Reactions

Clinical trials were conducted on more than 900 patients. During these trials and subsequent marketing experience, the most frequent reactions associated with Minipress therapy are: dizziness 10.3%, headache 7.8%, drowsiness 7.6%, lack of energy 6.9%, weakness 6.5%, palpitations 5.3%, and nausea 4.9%. In most instances, side effects have disappeared with continued therapy or have been tolerated with no decrease in dose of drug.

Less frequent adverse reactions which are reported to occur in 1–4% of patients are:

Gastrointestinal: vomiting, diarrhea, constipation.

Cardiovascular: edema, orthostatic hypotension, dyspnea, syncope.

Central Nervous System: vertigo, depression, nervousness.

Dermatologic: rash.

Genitourinary: urinary frequency.

EENT: blurred vision, reddened sclera, epistaxis, dry mouth, nasal congestion.

In addition, fewer than 1% of patients have reported the following (in some instances, exact causal relationships have not been established):

Gastrointestinal: abdominal discomfort and/or pain, liver function abnormalities, pancreatitis.

Cardiovascular: tachycardia.

Central Nervous System: paresthesia, hallucinations.

Dermatologic: pruritus, alopecia, lichen planus.

Genitourinary: incontinence, impotence, priapism.

EENT: tinnitus.

Other: diaphoresis, fever, positive ANA titer, arthralgia.

Single reports of pigmentary mottling and serous retinopathy, and a few reports of cataract development or disappearance have been reported. In these instances, the exact causal relationship has not been established because the baseline observations were frequently inadequate.

In more specific slit-lamp and funduscopic studies, which included adequate baseline examinations, no drug-related abnormal ophthalmological findings have been reported.

Literature reports exist associating Minipress therapy with a worsening of pre-existing narcolepsy. A causal relationship is uncertain in these cases.

In post-marketing experience, the following adverse events have been reported:

Autonomic Nervous System: flushing.

Body As A Whole: allergic reaction, asthenia, malaise, pain.

Cardiovascular, General: angina pectoris, hypotension.

Endocrine: gynecomastia.

Heart Rate/Rhythm: bradycardia.

Psychiatric: insomnia.

Skin/Appendages: urticaria.

Vascular (Extracardiac): vasculitis.

Vision: eye pain.

Special Senses: During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha-1 blocker therapy (see PRECAUTIONS).

Overdosage

Accidental ingestion of at least 50 mg of Minipress in a two year old child resulted in profound drowsiness and depressed reflexes. No decrease in blood pressure was noted. Recovery was uneventful.

Should overdosage lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressors should then be used. Renal function should be monitored and supported as needed. Laboratory data indicate Minipress is not dialysable because it is protein bound.

Minipress Dosage and Administration

The dose of Minipress should be adjusted according to the patient's individual blood pressure response. The following is a guide to its administration:

Initial Dose

1 mg two or three times a day (see WARNINGS.)

Maintenance Dose

Dosage may be slowly increased to a total daily dose of 20 mg given in divided doses. The therapeutic dosages most commonly employed have ranged from 6 mg to 15 mg daily given in divided doses. Doses higher than 20 mg usually do not increase efficacy, however a few patients may benefit from further increases up to a daily dose of 40 mg given in divided doses. After initial titration some patients can be maintained adequately on a twice daily dosage regimen.

Use With Other Drugs

When adding a diuretic or other antihypertensive agent, the dose of Minipress should be reduced to 1 mg or 2 mg three times a day and retitration then carried out.

Concomitant administration of Minipress with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension; therefore, PDE-5 inhibitor therapy should be initiated at the lowest dose in patients taking Minipress.

How is Minipress Supplied

Strength	Capsule Color	Capsule Code	NDC	Package Size
Minipress® 1 mg	White	431	0069-4310-71	250's
Minipress® 2 mg	Pink and White	437	0069-4370-71	250's
Minipress® 5 mg	Blue and White	438	0069-4380-71	250's

References

1. Lubbe, WF, and Hodge, JV: New Zealand Med J, 94 (691) 169–172, 1981.


2. Davey, DA, and Dommisse, J: S.A. Med J, Oct. 4, 1980 (551–556).

Rx only

LAB-0212-4.0

July 2009

PRINCIPAL DISPLAY PANEL - 1 mg Bottle

NDC 0069-4310-71

250 Capsules

Minipress®

(prazosin hydrochloride)

1 mg*

Pfizer

Distributed by

Pfizer Labs

Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 2 mg Bottle

NDC 0069-4370-71

250 Capsules

Minipress®

(prazosin hydrochloride)

2 mg*

Pfizer

Distributed by

Pfizer Labs

Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL - 5 mg Bottle

NDC 0069-4380-71

250 Capsules

Minipress®

(prazosin hydrochloride)

5 mg*

Pfizer

Distributed by

Pfizer Labs

Division of Pfizer Inc, NY, NY 10017

Minipress  prazosin hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-4310 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength prazosin hydrochloride (prazosin) prazosin 1 mg

Inactive Ingredients Ingredient Name Strength FD&C Blue No. 1   FD&C Red No. 3   D&C Red No. 28   FD&C Red No. 40   magnesium stearate   sodium lauryl sulfate   sucrose

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Pfizer;431;Minipress Contains

Packaging # NDC Package Description Multilevel Packaging 1 0069-4310-71 250 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017442	05/10/1994

Minipress  prazosin hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-4370 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength prazosin hydrochloride (prazosin) prazosin 2 mg

Inactive Ingredients Ingredient Name Strength FD&C Blue No. 1   FD&C Red No. 3   D&C Red No. 28   FD&C Red No. 40   magnesium stearate   sodium lauryl sulfate   sucrose

Product Characteristics Color WHITE, PINK Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Pfizer;437;Minipress Contains

Packaging # NDC Package Description Multilevel Packaging 1 0069-4370-71 250 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017442	05/10/1994

Minipress  prazosin hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0069-4380 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength prazosin hydrochloride (prazosin) prazosin 5 mg

Inactive Ingredients Ingredient Name Strength FD&C Blue No. 1   FD&C Red No. 3   D&C Red No. 28   FD&C Red No. 40   magnesium stearate   sodium lauryl sulfate   sucrose

Product Characteristics Color WHITE, BLUE Score no score Shape CAPSULE Size 22mm Flavor Imprint Code Pfizer;438;Minipress Contains

Packaging # NDC Package Description Multilevel Packaging 1 0069-4380-71 250 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017442	05/10/1994

Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Ireland Pharmaceuticals		896090987	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Pfizer Pharmaceuticals LLC		829084545	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Pfizer Pharmaceuticals LLC		829084552	MANUFACTURE

Revised: 08/2009Pfizer Laboratories Div Pfizer Inc

More Minipress resources

• Minipress Side Effects (in more detail)
• Minipress Dosage
• Minipress Use in Pregnancy & Breastfeeding
• Minipress Drug Interactions
• Minipress Support Group
• 9 Reviews for Minipress - Add your own review/rating

• Minipress Concise Consumer Information (Cerner Multum)


• Minipress MedFacts Consumer Leaflet (Wolters Kluwer)


• Minipress Monograph (AHFS DI)


• Minipress Advanced Consumer (Micromedex) - Includes Dosage Information


• Prazosin Professional Patient Advice (Wolters Kluwer)

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Salonpas Gel-Patch

Generic Name: capsaicin topical (kap SAY sin TOP i kal)

Brand Names: Axsain, Capsicum Oleoresin, Capsin, Capzasin Back and Body, Capzasin Quick Relief, Capzasin-HP, Capzasin-P, Castiva Warming, Dolorac, Icy Hot PM, Icy Hot with Capsaicin, Menthac Arthritis Cream with Capsaicin, Qutenza, Salonpas Gel-Patch, Salonpas Pain Patch with Capsaicin, Sloan's Liniment, Trixaicin, Trixaicin HP, Zostrix, Zostrix Diabetic Foot Pain, Zostrix Foot Pain, Zostrix Neuropathy, Zostrix Sports, Zostrix-HP

What is Salonpas Gel-Patch (capsaicin topical)?

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Capsaicin used on the body causes a sensation of heat that activates certain nerve cells. With regular use of capsaicin, this heating effect reduces the amount of substance P, a chemical that acts as a pain messenger in the body.

Capsaicin topical is used for temporary relief of muscle or joint pain caused by strains, sprains, arthritis, bruising, or backaches. Capsaicin topical is also used to treat nerve pain (neuralgia) in people who have had herpes zoster, or "shingles."

Capsaicin topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Salonpas Gel-Patch (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies or serious medical conditions. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Capsaicin can cause a burning sensation, which is usually mild and should lessen over time with continued use. If the burning sensation causes significant discomfort, wash the treated skin area with soap and cool water. Stop using the medication and call your doctor if you have severe burning or redness where the medicine was applied.

Avoid getting capsaicin topical in your mouth or eyes or near your nose.

Do not apply to open wounds or irritated skin, and avoid getting the medicine on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. Accidental swallowing of capsaicin can cause problems with swallowing or breathing.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

What should I discuss with my healthcare provider before using Salonpas Gel-Patch (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether capsaicin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply capsaicin topical to your breast area if you are breast-feeding a baby. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

How should I use Salonpas Gel-Patch (capsaicin topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

Do not apply capsaicin topical to open wounds, or to skin that is sunburned, windburned, dry, chapped, or otherwise irritated. Do not get this medication in your mouth or eyes, or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

To keep the medication from getting on your fingers when you apply it, you may use a rubber glove, finger cot, cotton ball, or clean tissue to apply the medicine.

Make sure your skin is clean and dry before you apply capsaicin topical.

When using capsaicin topical cream or lotion, apply a thin layer to the affected area and rub in gently until completely absorbed.

To use capsaicin topical liquid or stick, uncap the applicator and press it firmly on your skin to apply the medication. Massage gently onto the affected are until completely absorbed.

Capsaicin topical may be used up to 4 times daily or as directed on the medicine label.

To apply a capsaicin topical patch, remove the liner and apply the patch to your skin over the area of pain. Press the edges firmly into place. Remove the patch and apply a new patch 1 or 2 times daily if needed.

Wash your hands with soap and water immediately after applying capsaicin topical or handling the topical patch. If you have applied the medicine to your hands or fingers to treat pain in those areas, wait at least 30 minutes before washing your hands. Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin topical to your skin. Also avoid swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

If the burning sensation caused by capsaicin is painful or causes significant discomfort, wash the treated skin area with soap and cool water.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days. Store capsaicin topical at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Capsaicin topical liquid is flammable. Do not use or store near fire or open flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply capsaicin more than 4 times in one day, or use extra medicine to make up a missed dose .

A missed dose of capsaicin topical will not cause harm but may make the medication less effective reducing substance P and relieving your pain.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed it.

Accidental swallowing of capsaicin can cause severe burning in or around the mouth, watery eyes, runny nose, and trouble swallowing or breathing.

Applying too much capsaicin topical to the skin can cause severe burning or redness.

What should I avoid while using Salonpas Gel-Patch (capsaicin topical)?

Avoid inhaling the odor or dried residue of capsaicin topical. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off your hands. Also avoid handling food while the medication is still on your hands.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. Capsaicin can cause a burning sensation that may be made worse by heat.

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where you have applied capsaicin, unless your doctor has told you to.

Salonpas Gel-Patch (capsaicin topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using capsaicin topical and call your doctor at once if you have a serious side effect such as:

• 
  

  severe burning or irritation where the medicine was applied;

  
  


• 
  

  skin redness where the medicine was applied; or

  
  


• 
  

  trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

  
  

Less serious side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of capsaicin topical.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Salonpas Gel-Patch (capsaicin topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied capsaicin. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Salonpas Gel-Patch resources

• Salonpas Gel-Patch Side Effects (in more detail)
• Salonpas Gel-Patch Use in Pregnancy & Breastfeeding
• Salonpas Gel-Patch Drug Interactions
• Salonpas Gel-Patch Support Group
• 0 Reviews for Salonpas-Patch - Add your own review/rating

• Axsain Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Axsain Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Capzasin-P Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Qutenza Prescribing Information (FDA)


• Qutenza Consumer Overview


• Qutenza Patch MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Salonpas Gel-Patch with other medications

• Diabetic Nerve Damage
• Osteoarthritis
• Pain
• Persisting Pain, Shingles

Where can I get more information?

• Your pharmacist can provide more information about capsaicin topical.

See also: Salonpas-Patch side effects (in more detail)

Glucosamine/Chondroitin/Primorine

Pronunciation: Not applicable
Generic Name: Glucosamine/Chondroitin/Primorine
Brand Name: Relamine

Glucosamine/Chondroitin/Primorine is used for:

A dietary supplement in certain patients with osteoarthritis. It may also be used for other conditions as determined by your doctor.

Glucosamine/Chondroitin/Primorine is a combination product that contains naturally occurring "building blocks" used by the body to make cartilage. Exactly how it works is not known.

Do NOT use Glucosamine/Chondroitin/Primorine if:

• you are allergic to any ingredient in Glucosamine/Chondroitin/Primorine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Glucosamine/Chondroitin/Primorine:

Some medical conditions may interact with Glucosamine/Chondroitin/Primorine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods (especially seafood), or other substances


• if you have diabetes or high blood sugar, or you are overweight


• if you have a bleeding problem (eg, hemophilia)


• if you are on a low-salt (sodium) diet


• if you are taking other medicine for arthritis

Some MEDICINES MAY INTERACT with Glucosamine/Chondroitin/Primorine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Glucosamine/Chondroitin/Primorine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Glucosamine/Chondroitin/Primorine:

Use Glucosamine/Chondroitin/Primorine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Glucosamine/Chondroitin/Primorine by mouth with or without food.


• If you miss a dose of Glucosamine/Chondroitin/Primorine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Ask your health care provider any questions you may have about how to use Glucosamine/Chondroitin/Primorine.

Important safety information:

• Diabetes patients - Glucosamine/Chondroitin/Primorine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Glucosamine/Chondroitin/Primorine should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Glucosamine/Chondroitin/Primorine if you are pregnant. Do not breast-feed while you are using Glucosamine/Chondroitin/Primorine.

Possible side effects of Glucosamine/Chondroitin/Primorine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Glucosamine/Chondroitin/Primorine:

Store Glucosamine/Chondroitin/Primorine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Glucosamine/Chondroitin/Primorine out of the reach of children and away from pets.

General information:

• If you have any questions about Glucosamine/Chondroitin/Primorine, please talk with your doctor, pharmacist, or other health care provider.


• Glucosamine/Chondroitin/Primorine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Glucosamine/Chondroitin/Primorine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Glucosamine/Chondroitin/Primorine resources

• Glucosamine/Chondroitin/Primorine Use in Pregnancy & Breastfeeding
• Glucosamine/Chondroitin/Primorine Drug Interactions
• Glucosamine/Chondroitin/Primorine Support Group
• 1 Review for Glucosamine/Chondroitin/Primorine - Add your own review/rating

Compare Glucosamine/Chondroitin/Primorine with other medications

• Dietary Supplementation
• Osteoarthritis

Septocaine

Generic Name: Articaine Hydrochloride
Class: Local Anesthetics
Chemical Name: 4-Methyl-3-[[1-oxo-2-(propylamino)propyl]amino]-2-thiopenecarboxylic acid methyl ester monohydrochloride
Molecular Formula: C₁₃H₂₀N₂O₃S•HCl
CAS Number: 23964-57-0

Introduction

Intermediate-acting local anesthetic (amide type).^{1 2 3 4}

Uses for Septocaine

Dental Anesthesia

Local, infiltrative, or regional (i.e., nerve block) anesthesia in simple and complex dental and periodontal procedures.^{1 8}

Anesthetic activity comparable to that of lidocaine, mepivacaine, and prilocaine.^{2 4 7}

Septocaine Dosage and Administration

General

• 
  

  Determine dosage based on type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient.¹ Use smallest dose required to produce the desired effect.¹

  
  


• 
  

  For pediatric patients, determine dosage based on age, weight, physical condition of the patient, and type and extent of surgical procedure.¹

  
  

Administration

Submucosal Injection

For solution and drug compatibility information, see Compatibility under Stability.

Administer by submucosal infiltration or by nerve block.¹

Aspirate prior to administration to guard against intravascular injection.¹

For chemical disinfection of the cartridge unit, use isopropyl (rubbing) alcohol (91%) or ethyl alcohol (70%).¹ Do not use brands that are not of USP grade, since these preparations may contain denaturants that may be injurious to rubber.¹

Dosage

Available as fixed combination containing articaine hydrochloride and epinephrine bitartrate; dosage expressed in terms of articaine hydrochloride.¹

Pediatric Patients

Dental Anesthesia

Submucosal Injection

Children ≥4 years of age: Use lower dosages than those suggested for healthy adults (see Adults under Dosage and Administration).¹

Simple procedures: 0.76–5.65 mg/kg used in clinical trials.¹

Complex procedures: 0.37–7.48 mg/kg used in clinical trials.¹

Approximately 13% of pediatric patients in clinical trials required additional injections for complete anesthesia.¹

Adults

Dental Anesthesia

Submucosal Injection

Usual dosage range: 20–204 mg.¹

Recommended Dosages (as articaine hydrochloride 4% with epinephrine 1:100,000) for Dental Anesthesia in Healthy Adults1

Procedure	Volume of Injection (mL)	Total Dose of Articaine Hydrochloride (mg)
Infiltration	0.5–2.5	20–100
Nerve block	0.5–3.4	20–136
Oral surgery	1–5.1	40–204

Prescribing Limits

Pediatric Patients

Dental Anesthesia

Submucosal Injection

Maximum 7 mg/kg (0.175 mL/kg).¹

Adults

Dental Anesthesia

Submucosal Injection

Maximum 7 mg/kg (0.175 mL/kg).¹

Special Populations

Hepatic Impairment

Reduce dosage in patients with hepatic disease.¹

Geriatric Patients

Reduce dosage in patients ≥65 years of age.¹

Patients 65–74 Years of Age

Simple procedures: 0.43–4.76 mg/kg used in clinical trials.¹

Complex procedures: 1.05–4.27 mg/kg used in clinical trials.¹

Approximately 6% of patients in clinical trials required additional injections for complete anesthesia.¹

Patients ≥75 Years of Age

Simple procedures: 0.78–4.76 mg/kg used in clinical trials.¹

Complex procedures: 1.12–2.17 mg/kg used in clinical trials.¹

None of the patients in clinical trials required additional injections for complete anesthesia.¹

Other Populations

Reduce dosage in patients with cardiac disease, debilitated patients, and patients with acute illnesses.¹

Cautions for Septocaine

Contraindications

• 
  

  Known hypersensitivity to local anesthetics of the amide type or to sodium metabisulfite.^{1 4}

  
  

Warnings/Precautions

Warnings

Epinephrine Administration

Injection contains epinephrine, which may cause tissue necrosis or systemic toxicity.¹ Consider usual precautions associated with epinephrine administration.¹

Accidental Intravascular Injection

Accidental intravascular injection may result in confusion, seizures, CNS or cardiorespiratory depression, coma, and/or respiratory arrest.¹

Aspirate prior to administration to guard against intravascular injection.¹

Should be used only by clinicians who are sufficiently knowledgeable in the diagnosis and management of dose-related toxicity and other acute emergencies that might arise.¹ Resuscitative equipment and drugs must be available for immediate use.¹

Sensitivity Reactions

Sulfite Sensitivity

Articaine injection contains sodium metabisulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.¹

General Precautions

CNS Effects

Toxic plasma concentrations of local anesthetics (resulting from systemic absorption) associated with adverse CNS effects (e.g., restlessness, anxiety, tinnitus, lightheadedness, dizziness, disorientation, excitement, blurred vision, tremors, depression, drowsiness).^{1 3}

Carefully monitor level of consciousness after each local anesthetic injection.¹

Cardiovascular Effects

Toxic plasma concentrations of local anesthetics (resulting from systemic absorption) associated with adverse cardiovascular effects (e.g., reduced myocardial contractility, peripheral vasodilation, depressed cardiac conduction and excitability).¹ Possible atrioventricular block, ventricular arrhythmia, cardiac arrest, and, rarely, death.¹ Carefully monitor cardiovascular and respiratory vital signs after each local anesthetic injection.¹

Cardiac arrhythmias may occur in patients receiving potent general anesthetics; use with caution in such patients.¹

Articaine hydrochloride injection contains epinephrine; risk of exaggerated vasoconstrictor response in patients with hypertension or peripheral vascular disease.¹ Risk of ischemic injury or necrosis.¹

Use with caution in patients with heart block or other cardiovascular disease.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether articaine or its metabolites are distributed into milk.^{1 4} Caution advised if used in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <4 years of age.^{1 4}

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.¹

Hepatic Impairment

Not studied in patients with hepatic impairment.¹ Use with caution in patients with severe hepatic impairment.¹

Common Adverse Effects

Pain,^{1 2 4 7} headache,^{1 2 4 7} facial edema,^{1 2 4} gingivitis,^{1 2 4} paresthesia,^{1 2 4} infection.^{1 2 4}

Interactions for Septocaine

Approximately 5–10% of available articaine is metabolized by CYP enzymes.^{1 3}

Specific Drugs

Drug	Interaction	Comments
Anesthetics, general	Possible cardiac arrhythmias when articaine is administered during or following administration of potent general anesthetics1	Use with caution1
Antidepressants, tricyclics	Possible severe, prolonged hypertension due to epinephrine component1	Avoid concomitant use;1 if must be used concomitantly, careful monitoring is required1
Butyrophenones	Possible reduction or reversal of pressor effect of epinephrine1	Avoid concomitant use;1 if must be used concomitantly, careful monitoring is required 1
MAO inhibitors	Possible severe, prolonged hypertension due to epinephrine component1	Avoid concomitant use;1 if must be used concomitantly, careful monitoring is required1
Phenothiazines	Possible reduction or reversal of pressor effect of epinephrine1	Avoid concomitant use;1 if must be used concomitantly, careful monitoring is required1

Septocaine Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentrations achieved approximately 25 minutes following single dose and 48 minutes following 3 doses.¹

Onset

1–6 minutes following submucosal injection.¹ Average onset of anesthesia following articaine administration appears to be similar to that of prilocaine^{5 6 8} but slightly faster than that of other local anesthetics (e.g., lidocaine).^{3 5 8}

Duration

Complete anesthesia lasts approximately 1 hour.¹

Distribution

Plasma Protein Binding

Approximately 60–80% (albumin and γ-globulins).¹

Elimination

Metabolism

Systemically absorbed articaine is rapidly metabolized by plasma carboxyesterase to articainic acid (inactive);¹ approximately 5–10% of available articaine is metabolized to articainic acid by CYP enzymes.^{1 3}

Elimination Route

Excreted principally in urine as inactive metabolites and small amounts (2%) of unchanged drug;^{1 4} approximately 53–57% of administered dose excreted within 24 hours following submucosal administration.¹

Half-life

Approximately 1.8 hours.¹

Stability

Storage

Parenteral

Injection

25°C (may be exposed to 15–30°C).¹ Protect from light.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

May be incompatible with strong oxidizing agents.^a

ActionsActions

• 
  

  Local anesthetics block the generation and conduction of nerve impulses by increasing the threshold for electrical excitation, slowing the propagation of the nerve impulse, and reducing the rate of rise of the action potential.¹

  
  


• 
  

  Formulated with epinephrine to decrease articaine's rate and extent of systemic absorption and to prolong its duration of action.^{1 4}

  
  


• 
  

  Has intermediate duration of action (approximately 1 hour).^{1 2 3 4}

  
  

Advice to Patients

• 
  

  Prior to administration, advise patients of the possibility of temporary loss of sensation and muscle function following infiltration and nerve block injections.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease).¹

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Articaine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	4% with Epinephrine Bitartrate 1:100,000 (of epinephrine)	Septocaine (with sodium metabisulfite)	Septodont

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2004. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Septodont, Inc. Septocaine (articaine hydrochloride 4% with epinephrine 1:100,000) injection prescribing information. New Castle, DE; 2000 Apr.

2. Malamed SF, Gagnon S, Leblanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc. 2000; 131:635-42. [IDIS 448169] [PubMed 10832257]

3. Oertel R, Rahn R, Kirch W. Clinical pharmacokinetics of articaine. Clin Pharmacokinet. 1997; 33:417-25. [PubMed 9435991]

4. Malamed SF, Gagnon S, Leblanc D. Articaine hydrochloride: a study of the safety of a new amide local anesthetic. J Am Dent Assoc. 2001; 132:177-85. [IDIS 466889] [PubMed 11217590]

5. Simon MAM, Gielen MJM, Alberink N et al. Intravenous regional anesthesia with 0.5% articaine, 0.5% lidocaine, or 0.5% prilocaine. Reg Anesth. 1997; 22:29-34. [PubMed 9010944]

6. Pitkanen MT, Xu M, Haasio J et al. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers. Reg Anesth Pain. 1999; 24:131-5.

7. Malamed SF, Gagnon S, Leblanc D et al. A comparison between articaine HCl and lidocaine HCl in pediatric dental patients. Pediatr Dent. 2000; 22:307-11. [PubMed 10969438]

8. Septodont Inc., New Castle, DE: Personal communication.

a. Septodont, Inc. Septocaine (articaine hydrochloride) injection material safety data sheet. New Castle, DE; 2002 Jul.

More Septocaine resources

• Septocaine Side Effects (in more detail)
• Septocaine Use in Pregnancy & Breastfeeding
• Septocaine Drug Interactions
• Septocaine Support Group
• 0 Reviews for Septocaine - Add your own review/rating

• Septocaine Prescribing Information (FDA)


• Septocaine Concise Consumer Information (Cerner Multum)

Compare Septocaine with other medications

• Anesthesia
• Local Anesthesia

narcotic analgesics - for pain relief Oral, Parenteral, Rectal

Class Name: narcotic analgesics (

FOR PAIN RELIEF (Oral route, Parenteral route, Rectal route)

Commonly used brand name(s):

In the U.S.

• Avinza


• Darvon


• Darvon-N


• Dazidox


• Demerol


• Dilaudid


• Dilaudid-5


• Dolophine


• Eth-Oxydose


• Kadian


• Kadian ER


• Levo-Dromoran


• Meperitab


• Methadone HCl Intensol


• Nucynta


• Opana


• Orlaam


• Oxycontin CR


• Pp-Cap


• Ultram


• Ultram ER

In Canada

• Codeine Phosphate


• Demerol 10%


• Demerol 5%


• Demerol 7.5%


• Hycodan


• M.O.S.-10


• M.O.S.-20


• M.O.S.-20 Concentrate


• M.O.S.-30


• Metadol


• Metadol-D

Available Dosage Forms:

• Tablet


• Liquid


• Tablet, Extended Release


• Capsule, Extended Release


• Suppository


• Solution


• Lozenge/Troche


• Tablet for Suspension


• Syrup


• Capsule


• Suspension


• Capsule, Extended Release, 24 HR


• Suppository, Extended Release


• Powder for Suspension, Extended Release


• Capsule, Delayed Release


• Tincture

Uses For This Medicine

Narcotic analgesics are used to relieve pain. Some of these medicines are also used just before or during an operation to help the anesthetic work better. Codeine and hydrocodone are also used to relieve coughing. Methadone is also used to help some people control their dependence on heroin or other narcotics. Narcotic analgesics may also be used for other conditions as determined by your doctor.

Narcotic analgesics act in the central nervous system (CNS) to relieve pain. Some of their side effects are also caused by actions in the CNS.

If a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

These medicines are available only with your medical doctor's or dentist's prescription. For some of them, prescriptions cannot be refilled and you must obtain a new prescription from your medical doctor or dentist each time you need the medicine. In addition, other rules and regulations may apply when methadone is used to treat narcotic dependence.

These medicines are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, morphine by injection is used in certain patients with the following medical conditions:

• Pain, during mechanical ventilation, neonatal


• Pain, postoperative, neonatal

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Breathing problems may be especially likely to occur in children younger than 2 years of age. These children are usually more sensitive than adults to the effects of narcotic analgesics. Also, unusual excitement or restlessness may be more likely to occur in children receiving these medicines. Hydromorphone extended-release capsules should not be used in children younger than 18 years of age.

Geriatric

Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment.

Pregnancy

Although studies on birth defects with narcotic analgesics have not been done in pregnant women, these medicines have not been reported to cause birth defects. However, hydrocodone, hydromorphone, and morphine caused birth defects in animals when given in very large doses. Buprenorphine and codeine did not cause birth defects in animal studies, but they caused other unwanted effects. Butorphanol, nalbuphine, pentazocine, and propoxyphene did not cause birth defects in animals. There is no information about whether other narcotic analgesics cause birth defects in animals.

Too much use of a narcotic during pregnancy may cause the baby to become dependent on the medicine. This may lead to withdrawal side effects after birth. Also, some of these medicines may cause breathing problems in the newborn infant if taken just before delivery.

Breast Feeding

Most narcotic analgesics have not been reported to cause problems in nursing babies.

• Codeine and other narcotic analgesics—Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects. A nursing mother should talk to her doctor if she has any questions about taking codeine or about how this medicine may affect her baby .


• Butorphanol, meperidine, morphine, opium, and propoxyphene—These medicines pass into the breast milk.


• Methadone—When a mother is taking large amounts of methadone (in a methadone maintenance program), the nursing baby may become dependent on the medicine.

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Aprindine


• Astemizole


• Azimilide


• Bepridil


• Bretylium


• Brofaromine


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Cisapride


• Citalopram


• Clarithromycin


• Clorgyline


• Desipramine


• Dibenzepin


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Dronedarone


• Droperidol


• Ebastine


• Encainide


• Erythromycin


• Flecainide


• Fluconazole


• Flucytosine


• Fluoxetine


• Fluvoxamine


• Foscarnet


• Furazolidone


• Halofantrine


• Haloperidol


• Hydroquinidine


• Ibutilide


• Imipramine


• Iproniazid


• Isocarboxazid


• Isradipine


• Itraconazole


• Lazabemide


• Lidoflazine


• Linezolid


• Lorcainide


• Mefloquine


• Mesoridazine


• Methdilazine


• Mexiletine


• Mibefradil


• Moclobemide


• Naltrexone


• Nialamide


• Nicardipine


• Nortriptyline


• Octreotide


• Olanzapine


• Pargyline


• Pentamidine


• Phenelzine


• Pimozide


• Pirmenol


• Prajmaline


• Primaquine


• Probucol


• Procainamide


• Procarbazine


• Propafenone


• Protriptyline


• Quinidine


• Rasagiline


• Risperidone


• Selegiline


• Sematilide


• Sertindole


• Sertraline


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Tedisamil


• Telavancin


• Terfenadine


• Thioridazine


• Tiapride


• Toloxatone


• Tranylcypromine


• Trimeprazine


• Trimethoprim


• Trimipramine


• Vasopressin


• Zimeldine


• Ziprasidone


• Zolmitriptan


• Zotepine

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acetazolamide


• Acetophenazine


• Adinazolam


• Alfentanil


• Almotriptan


• Alphaprodine


• Alprazolam


• Alprenolol


• Amiloride


• Amiodarone


• Amitriptyline


• Amlodipine


• Amobarbital


• Amoxapine


• Amprenavir


• Anileridine


• Aprepitant


• Aprobarbital


• Aripiprazole


• Arsenic Trioxide


• Asenapine


• Atazanavir


• Atenolol


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bepridil


• Betaxolol


• Bevantolol


• Bisoprolol


• Brofaromine


• Bromazepam


• Bromperidol


• Brotizolam


• Bucindolol


• Bumetanide


• Buprenorphine


• Buspirone


• Butabarbital


• Butalbital


• Butorphanol


• Canrenoate


• Carbamazepine


• Carisoprodol


• Carteolol


• Carvedilol


• Castor Oil


• Celiprolol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorprothixene


• Chlorthalidone


• Chlorzoxazone


• Cimetidine


• Citalopram


• Clarithromycin


• Clobazam


• Clomipramine


• Clonazepam


• Clopamide


• Clorazepate


• Clorgyline


• Clovoxamine


• Clozapine


• Codeine


• Cyclobenzaprine


• Cyclothiazide


• Dantrolene


• Desflurane


• Desipramine


• Desvenlafaxine


• Dexmedetomidine


• Dezocine


• Diazepam


• Difenoxin


• Digoxin


• Dihydrocodeine


• Diltiazem


• Diphenhydramine


• Diphenoxylate


• Docusate


• Dofetilide


• Dothiepin


• Doxepin


• Doxylamine


• Droperidol


• Duloxetine


• Eletriptan


• Enflurane


• Erythromycin


• Escitalopram


• Esmolol


• Estazolam


• Eszopiclone


• Ethacrynic Acid


• Ethchlorvynol


• Ethopropazine


• Etozolin


• Felodipine


• Femoxetine


• Fenquizone


• Fentanyl


• Fluconazole


• Flumazenil


• Flunitrazepam


• Fluoxetine


• Flupenthixol


• Fluphenazine


• Flurazepam


• Fluvoxamine


• Fosamprenavir


• Fospropofol


• Frovatriptan


• Furazolidone


• Furosemide


• Gatifloxacin


• Gemifloxacin


• Halazepam


• Halofantrine


• Haloperidol


• Halothane


• Hydrochlorothiazide


• Hydrocodone


• Hydroflumethiazide


• Hydromorphone


• Hydroxyzine


• Ibutilide


• Iloperidone


• Imipramine


• Indapamide


• Iproniazid


• Isocarboxazid


• Isoflurane


• Isradipine


• Itraconazole


• Ketamine


• Ketazolam


• Ketoconazole


• Labetalol


• Lactulose


• Lapatinib


• Lazabemide


• Levobunolol


• Levofloxacin


• Levomethadyl


• Levorphanol


• Linezolid


• Lofepramine


• Lorazepam


• Lormetazepam


• Loxapine


• Magnesium


• Mannitol


• Medazepam


• Melperone


• Meperidine


• Mephenesin


• Mephobarbital


• Mepindolol


• Meprobamate


• Mesoridazine


• Metaxalone


• Methadone


• Methdilazine


• Methocarbamol


• Methohexital


• Methotrimeprazine


• Metipranolol


• Metolazone


• Metoprolol


• Midazolam


• Milnacipran


• Mirtazapine


• Moclobemide


• Molindone


• Morphine


• Morphine Sulfate Liposome


• Moxifloxacin


• Nadolol


• Nalbuphine


• Naratriptan


• Nebivolol


• Nefazodone


• Nelfinavir


• Nialamide


• Nicardipine


• Nifedipine


• Nilotinib


• Nimodipine


• Nisoldipine


• Nitrazepam


• Nitrous Oxide


• Nordazepam


• Nortriptyline


• Olanzapine


• Opium


• Oxazepam


• Oxprenolol


• Oxycodone


• Oxymorphone


• Paliperidone


• Pargyline


• Paroxetine


• Pazopanib


• Penbutolol


• Penfluridol


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Pimozide


• Pindolol


• Pipotiazine


• Piretanide


• Polythiazide


• Prazepam


• Procarbazine


• Prochlorperazine


• Promazine


• Promethazine


• Propiomazine


• Propofol


• Propoxyphene


• Propranolol


• Protriptyline


• Quazepam


• Quetiapine


• Quinethazone


• Quinidine


• Quinine


• Ramelteon


• Ranolazine


• Rasagiline


• Remifentanil


• Remoxipride


• Risperidone


• Ritonavir


• Rizatriptan


• Secobarbital


• Selegiline


• Sertraline


• Sevoflurane


• Sibutramine


• Sildenafil


• Sodium Oxybate


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Sorbitol


• Sotalol


• Spironolactone


• Sufentanil


• Sulpiride


• Sumatriptan


• Sunitinib


• Talinolol


• Tapentadol


• Telavancin


• Telithromycin


• Temazepam


• Tertatolol


• Tetrabenazine


• Thiethylperazine


• Thiopental


• Thioridazine


• Thiothixene


• Ticrynafen


• Timolol


• Toloxatone


• Torsemide


• Tramadol


• Tranylcypromine


• Triamterene


• Triazolam


• Trichlormethiazide


• Trifluoperazine


• Triflupromazine


• Trimeprazine


• Trimipramine


• Troleandomycin


• Urea


• Vardenafil


• Venlafaxine


• Verapamil


• Xipamide


• Zaleplon


• Ziprasidone


• Zolmitriptan


• Zolpidem


• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of, or


• Drug dependence, especially narcotic abuse, or history of, or


• Emotional problems—The chance of side effects may be increased; also, withdrawal symptoms may occur if a narcotic you are dependent on is replaced by buprenorphine, butorphanol, nalbuphine, or pentazocine.

• Brain disease or head injury or


• Emphysema, asthma, or other chronic lung disease or


• Enlarged prostate or problems with urination or


• Gallbladder disease or gallstones—Some of the side effects of narcotic analgesics can be dangerous if these conditions are present.

• Colitis or


• Heart disease or


• Kidney disease or


• Liver disease or


• Underactive thyroid—The chance of side effects may be increased.

• Convulsions (seizures), history of—Some of the narcotic analgesics can cause convulsions.

Proper Use of This Medicine

Some narcotic analgesics given by injection may be given at home to patients who do not need to be in the hospital. If you are using an injection form of this medicine at home, make sure you clearly understand and carefully follow your doctor's instructions.

To take long-acting hydromorphone capsules:

• These capsules must be swallowed whole. Do not chew, crush or dissolve.


• If the capsules is not swallowed whole, you could overdose on this medicine.


• Check with your doctor right away if you are not sure how to take extended-release hydromorphone capsules.

To take the syrup form of meperidine:

• Unless otherwise directed by your medical doctor or dentist, take this medicine mixed with a half glass (4 ounces) of water to lessen the numbing effect of the medicine on your mouth and throat.

To take the oral liquid forms of methadone

• This medicine may have to be mixed with water or another liquid before you take it. Read the label carefully for directions. If you have any questions about this, check with your health care professional.

To take the dispersible tablet form of methadone:

• These tablets must be stirred into water or fruit juice just before each dose is taken. Read the label carefully for directions. If you have any questions about this, check with your health care professional.

To take oral liquid forms of morphine:

• This medicine may be mixed with a glass of fruit juice just before you take it, if desired, to improve the taste.

To take long-acting morphine and oxycodone tablets:

• These tablets must be swallowed whole. Do not break, crush, or chew them before swallowing.

To take long-acting morphine capsules:

• These capsules must be swallowed whole. Do not chew, crush or dissolve.


• Or, the capsule can be opened and all of the beads inside sprinkled over applesauce and used right away. The beads must not be chewed, crushed, or dissolved.


• If capsules or beads from the capsules are not swallowed whole, you could overdose on this medicine.


• Check with your doctor right away if you are not sure how to take long-acting morphine capsules.

To use suppositories:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.


• To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

Take this medicine only as directed by your medical doctor or dentist. Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who are especially sensitive to the effects of narcotic analgesics. If too much is taken, the medicine may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose.

If you think this medicine is not working properly after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For anileridine


• For oral dosage forms:
  
  • For pain:
    
    • Adults and teenagers—25 to 50 milligrams (mg) every 6 hours as needed.
    
    
    • Children up to 13 years of age—Dose must be determined by your doctor.
    
    
  
  

• For buprenorphine


• For injection dosage form:
  
  • For pain:
    
    • Adults and teenagers—0.3 milligrams (mg), injected into a muscle or a vein every six hours as needed.
    
    
    • Children 2 to 12 years of age—0.002 to 0.006 mg per kilogram (kg) (0.0008 to 0.0024 mg per pound) of body weight, injected into a muscle or a vein every four to six hours as needed.
    
    
    • Children up to 2 years of age—Dose must be determined by your doctor.
    
    
  
  

• For butorphanol


• For injection dosage form
  
  • For pain:
    
    • Adults—1 to 4 milligrams (mg) (usually 2 mg), injected into a muscle every three or four hours as needed. Some people may receive 0.5 to 2 mg (usually 1 mg) injected into a vein every three or four hours as needed.
    
    
    • Children and teenagers—Dose must be determined by your doctor.
    
    
  
  

• For codeine


• For oral dosage forms (oral solution or tablets):
  
  • For pain:
    
    • Adults—15 to 60 milligrams (mg) (usually 30 mg) every three to six hours as needed.
    
    
    • Children—0.5 mg per kilogram (kg) (0.2 mg per pound) of body weight every four to six hours as needed. Young children will probably take the oral solution, rather than tablets. Small doses may need to be measured by a special dropper instead of a teaspoon.
    
    
  
  
  • For cough:
    
    • Adults—10 to 20 mg every four to six hours.
    
    
    • Children 6 to 12 years of age—5 to 10 mg every four to six hours, up to a maximum of 60 mg a day.
    
    
    • Children 5 years of age—4.5 mg every four to six hours, up to a maximum of 18 mg a day. Children this young will probably take the oral solution, rather than tablets. Small doses may need to be measured by a special dropper instead of a teaspoon.
    
    
    • Children 4 years of age—4 mg every four to six hours, up to a maximum of 16 mg a day. Children this young will probably take the oral solution, rather than tablets. Small doses may need to be measured by a special dropper instead of a teaspoon.
    
    
    • Children 3 years of age—3.5 mg every four to six hours, up to a maximum of 14 mg a day. Children this young will probably take the oral solution, rather than tablets. Small doses may need to be measured by a special dropper instead of a teaspoon.
    
    
    • Children 2 years of age—3 mg every four to six hours, up to a maximum of 12 mg a day. Children this young will probably take the oral solution, rather than tablets. Small doses may need to be measured by a special dropper instead of a teaspoon.
    
    
    • Children up to 2 years of age—Use is not recommended.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults—15 to 60 mg (usually 30 mg), injected into a muscle or a vein or under the skin every four to six hours as needed.
    
    
    • Children—0.5 mg per kg (0.2 mg per pound) of body weight, injected into a muscle or under the skin every four to six hours as needed.
    
    
  
  

• For hydrocodone


• For oral dosage forms (syrup or tablets):
  
  • For pain:
    
    • Adults—5 to 10 milligrams (mg) every four to six hours as needed.
    
    
    • Children—0.15 mg per kilogram (kg) (0.06 mg per pound) of body weight every six hours as needed.
    
    
  
  
  • For cough:
    
    • Adults—5 mg every four to six hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For hydromorphone


• For short-acting oral dosage forms (oral solution or tablets):
  
  • For pain:
    
    • Adults—2 or 2.5 milligrams (mg) every three to six hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For long-acting oral dosage form (extended-release capsules):
  
  • For severe, chronic pain (severe pain that lasts a long time):
    
    • Adults—Long-acting forms of hydromorphone are usually used for patients who have already been receiving narcotics to relieve pain. The starting dose will depend on the amount of narcotic you have been receiving every day. Your doctor will then adjust the dose according to your individual needs. To be helpful, these medicines need to be taken at regularly scheduled times according to your doctor's instructions. It is important that you take the dose at the time and as often as your doctor tells you.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults—1 or 2 mg, injected into a muscle or under the skin every three to six hours as needed. Some people may receive 0.5 mg, injected slowly into a vein every three hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For rectal suppository dosage form:
  
  • For pain:
    
    • Adults—3 mg every four to eight hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For levorphanol


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—2 milligrams (mg). Some people with severe pain may need 3 or 4 mg.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults—2 mg, injected under the skin or into a vein. Some people may need 3 mg.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For meperidine


• For oral dosage forms (syrup or tablets):
  
  • For pain:
    
    • Adults—50 to 150 milligrams (mg) (usually 100 mg) every three or four hours as needed.
    
    
    • Children—1.1 to 1.76 mg per kilogram (kg) (0.44 to 0.8 mg per pound) of body weight, up to a maximum of 100 mg, every three or four hours as needed. Young children will probably take the syrup, rather than tablets. Small doses may need to be measured by a special dropper instead of a teaspoon.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults—50 to 150 milligrams (mg) (usually 100 mg), injected into a muscle or under the skin every three or four hours as needed. The medicine may also be injected continuously into a vein at a rate of 15 to 35 mg an hour.
    
    
    • Children—1.1 to 1.76 mg per kg (0.44 to 0.8 mg per pound) of body weight, up to a maximum of 100 mg, injected into a muscle or under the skin every three or four hours as needed.
    
    
  
  

• For methadone


• For oral dosage form (solution):
  
  • For pain:
    
    • Adults—5 to 20 mg every four to eight hours.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • For narcotic addiction:
    
    • Adults 18 years of age or older—
      
      • For detoxification—At first, 15 to 40 mg once a day. Your doctor will gradually decrease the dose you take every day until you do not need the medicine any more.
      
      
      • For maintenance—Dose must be determined by the needs of the individual patient, up to a maximum of 120 mg a day.
      
      
    
    
    • Children up to 18 years of age—Special conditions must be met before methadone can be used for narcotic addiction in patients younger than 18 years of age. Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—2.5 to 10 mg every three or four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • For narcotic addiction:
    
    • Adults 18 years of age or older—
      
      • For detoxification—At first, 15 to 40 mg once a day. Your doctor will gradually decrease the dose you take every day until you do not need the medicine any more.
      
      
      • For maintenance—Dose must be determined by the needs of the individual patient, up to a maximum of 120 mg a day.
      
      
    
    
    • Children up to 18 years of age—Special conditions must be met before methadone can be used for narcotic addiction in patients younger than 18 years of age. Use and dose must be determined by your doctor.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults—2.5 to 10 mg, injected into a muscle or under the skin, every three or four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • For narcotic addiction:
    
    • Adults 18 years of age or older—
      
      • For detoxification only, in patients unable to take medicine by mouth—At first, 15 to 40 mg a day. Your doctor will gradually decrease the dose you receive every day until you do not need the medicine any more.
      
      
    
    
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For morphine


• For short-acting oral dosage forms (capsules, oral solution, syrup, or tablets):
  
  • For severe, chronic pain (severe pain that lasts a long time):
    
    • Adults—At first, 10 to 30 milligrams (mg) every four hours. Your doctor will then adjust the dose according to your individual needs. If you have already been taking other narcotics to relieve severe, chronic pain, your starting dose will depend on the amount of other narcotic you were taking every day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For long-acting oral dosage forms (extended-release capsules or tablets):
  
  • For severe, chronic pain (severe pain that lasts a long time):
    
    • Adults—Long-acting forms of morphine are usually used for patients who have already been receiving narcotics to relieve pain. The starting dose will depend on the amount of narcotic you have been receiving every day. Your doctor will then adjust the dose according to your individual needs. To be helpful, these medicines need to be taken at regularly scheduled times according to your doctor's instructions. It is important that you take the dose at the time and as often as your doctor tells you. Some people may need to take a short-acting form of morphine if breakthrough pain occurs between doses of the long-acting medicine.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For once daily long-acting oral dosage forms (extended-release capsules):
  
  • For severe, chronic pain (severe pain that lasts a long time):
    
    • Adults—Long-acting forms of morphine are usually used for patients who have already been receiving narcotics to relieve pain. The starting dose will depend on the amount of narcotic you have been receiving every day. Your doctor will then adjust the dose according to your individual needs. To be helpful, these medicines need to be taken once a day at regularly scheduled times according to your doctor's instructions. It is important that you take the dose at the time and as often as your doctor tells you. Some people may need to take a short-acting form of morphine if breakthrough pain occurs between doses of the long-acting medicine.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults—5 to 20 mg (usually 10 mg), injected into a muscle or under the skin every four hours as needed. Some people may receive 4 to 10 mg, injected slowly into a vein. Morphine may also be injected continuously into a vein or under the skin at a rate that depends on the needs of the patient. This medicine may also be injected into the spinal area. The dose will depend on where and how the medicine is injected into the spinal area and on the needs of the patient.
    
    
    • Children—0.1 to 0.2 mg per kg (0.04 or 0.09 mg per pound) of body weight, up to a maximum of 15 mg, injected under the skin every four hours as needed. Some patients may receive 0.05 to 0.1 mg per kg (0.02 to 0.04 mg per pound) of body weight, injected slowly into a vein.
    
    
  
  


• For rectal dosage form (suppositories):
  
  • For pain:
    
    • Adults—10 to 30 mg every four to six hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For nalbuphine


• For injection dosage form:
  
  • For pain:
    
    • Adults—10 milligrams (mg) every three to six hours as needed, injected into a muscle or a vein or under the skin.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For opium


• For injection dosage form:
  
  • For pain:
    
    • Adults—5 to 20 milligrams (mg), injected into a muscle or under the skin every four to five hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For oxycodone


• For oral dosage forms (oral solution or tablets):
  
  • For pain:
    
    • Adults—5–15 milligrams (mg) every 4–6 hours as needed.
    
    
    • Children—Dose must be determined by your doctor. Children up to 6 years of age will probably take the oral solution, rather than tablets. Small doses may need to be measured by a special dropper instead of a teaspoon.
    
    
  
  


• For long-acting oral dosage form (extended-release tablets):
  
  • For pain (continuous and lasts a long time):
    
    • Adults—Your doctor will determine the dose according to your individual needs. To be helpful, these medicines need to be taken two times a day at regularly scheduled times.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For rectal dosage form (suppositories):
  
  • For pain (continuous and lasts a long time):
    
    • Adults—10 to 40 mg three or four times a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For oxymorphone


• For injection dosage form:
  
  • For pain:
    
    • Adults—1 to 1.5 milligrams (mg), injected into a muscle or under the skin every three to six hours as needed. Some patients may receive 0.5 mg, injected into a vein.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For rectal dosage form (suppositories):
  
  • For pain:
    
    • Adults—5 mg every four to six hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For pentazocine


• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults—50 mg every three to four hours as needed. Some patients may need 100 mg every three to four hours. The usual maximum dose is 600 mg a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults—30 mg, injected into a muscle or a vein or under the skin every three to four hours as needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For propoxyphene


• For oral dosage forms (capsules, oral suspension, or tablets):
  
  • For pain:
    
    • Adults—Propoxyphene comes in two different forms, propoxyphene hydrochloride and propoxyphene napsylate. 100 mg of propoxyphene napsylate provides the same amount of pain relief as 65 mg of propoxyphene hydrochloride. The dose of propoxyphene hydrochloride is 65 milligrams (mg) every four hours as needed, up to a maximum of 390 mg a day. The dose of propoxyphene napsylate is 100 mg every four hours as needed, up to a maximum of 600 mg a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Store hydromorphone, oxycodone, or oxymorphone suppositories in the refrigerator.

Destroy any medicine that you do not need by flushing it down the toilet.

Precautions While Using This Medicine

If you will be taking this medicine for a long time (for example, for several months at a time), your doctor should check your progress at regular visits

For patients taking a codeine-containing medicine or any other narcotic analgesic:

• Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual

For nursing mothers taking a codeine-containing medicine or any other narcotic analgesic:

• Call your doctor if you become extremely tired and have difficulty caring for your baby.


• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.


• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breast-feeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

Narcotic analgesics will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicines including other narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Dizziness, light-headedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or light-headedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Narcotic analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you have been taking this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, in order to lessen the chance of withdrawal side effects.

If you think you or someone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead to unconsciousness or death. Signs of overdose include convulsions (seizures), confusion, severe nervousness or restlessness, severe dizziness, severe drowsiness, slow or troubled breathing, and severe weakness.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

• Cold, clammy skin


• confusion


• convulsions (seizures)


• dizziness (severe)


• drowsiness (severe)


• low blood pressure


• nervousness or restlessness (severe)


• pinpoint pupils of eyes


• slow heartbeat


• slow or troubled breathing


• weakness (severe)


• Difficulty breathing


• difficulty nursing


• increased sleepiness (more than usual)


• limpness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Dark urine (for propoxyphene only)


• fast, slow, or pounding heartbeat


• feelings of unreality


• hallucinations (seeing, hearing, or feeling things that are not there)


• hives, itching, or skin rash


• increased sweating (more common with hydrocodone, meperidine, and methadone)


• irregular breathing


• mental depression or other mood or mental changes


• pale stools (for propoxyphene only)


• redness or flushing of face (more common with hydrocodone, meperidine, and methadone)


• ringing or buzzing in the ears


• shortness of breath, wheezing, or troubled breathing


• swelling of face


• trembling or uncontrolled muscle movements


• unusual excitement or restlessness (especially in children)


• yellow eyes or skin (for propoxyphene only)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness, light-headedness, or feeling faint


• drowsiness


• nausea or vomiting

Less common or rare

• Blurred or double vision or other changes in vision


• constipation (more common with long-term use and with codeine)


• decrease in amount of urine


• difficult or painful urination


• dry mouth


• false sense of well-being


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• loss of appetite


• nervousness or restlessness


• nightmares or unusual dreams


• redness, swelling, pain, or burning at place of injection


• stomach cramps or pain


• trouble in sleeping


• unusual tiredness or weakness

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Body aches


• diarrhea


• fast heartbeat


• fever, runny nose, or sneezing


• gooseflesh


• increased sweating


• increased yawning


• loss of appetite


• nausea or vomiting


• nervousness, restlessness, or irritability


• shivering or trembling


• stomach cramps


• trouble in sleeping


• unusually large pupils of eyes


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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