Josty Antiparasite Classic may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dimpylate is reported as an ingredient of Josty Antiparasite Classic in the following countries:
International Drug Name Search
Generic Name: brompheniramine, dextromethorphan, and phenylephrine (brome fen IR a meen, dex troe metho OR fan, fen il EFF rin)
Brand Names: Alacol DM, Alahist DM, BP Allergy DM, BPM PE DM, Bromatan-DM, Bromtuss DM, BroveX PEB DM, Children's Cold & Cough DM, Cold & Cough Childrens, Dimaphen DM, Dimetapp Cold & Cough, Dimetapp DM Cold & Cough, DuraTan DM, Duravent DPB, Lohist-DM, Lortuss DM (obsolete), Tusdec-DM
Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Brompheniramine, dextromethorphan, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.
Brompheniramine, dextromethorphan, and phenylephrine may also be used for other purposes not listed in this medication guide.
Before taking this medication, tell your doctor if you are allergic to brompheniramine, dextromethorphan, or phenylephrine, or if you have:
diabetes;
glaucoma;
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
a stomach ulcer or a stomach obstruction,
emphysema or chronic bronchitis; or
an enlarged prostate or urination problems.
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
Artificially-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid using other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine, dextromethorphan, and phenylephrine.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
confusion, hallucinations, unusual thoughts or behavior;
slow, shallow breathing;
urinating less than usual or not at all;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
blurred vision;
dry mouth;
nausea, stomach pain, constipation;
mild loss of appetite, stomach upset;
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
restless or excitability (especially in children);
skin rash or itching;
dizziness, drowsiness;
problems with memory or concentration; or
ringing in your ears.
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.
Before taking this medication, tell your doctor if you are using any of the following drugs:
an antidepressant;
a diuretic (water pill);
medication to treat irritable bowel syndrome;
celecoxib (Celebrex);
cinacalcet (Sensipar);
darifenacin (Enablex);
imatinib (Gleevec);
quinidine (Quinaglute, Quinidex);
ranolazine (Ranexa)
ritonavir (Norvir);
sibutramine (Meridia);
terbinafine (Lamisil);
medicines to treat high blood pressure;
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol); or
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.
This list is not complete and there may be other drugs that can interact with brompheniramine, dextromethorphan, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Lohist-DM side effects (in more detail)
Treating bacterial infections of the ear and throat. It may also be used to treat impetigo (skin infection).
Ceftin Suspension is a cephalosporin antibiotic. It works by interfering with the formation of the bacteria's cell wall so that the wall ruptures, resulting in the death of the bacteria.
Contact your doctor or health care provider right away if any of these apply to you.
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Ceftin Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ceftin Suspension 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.
Use Ceftin Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Ceftin Suspension.
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; headache; loose stools; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; change in the amount of urine; dark urine; easy bruising or bleeding; fatigue; fever; seizures; severe diarrhea; stomach cramps/pain; vaginal irritation or discharge; yellowing of the skin or eyes.
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.
See also: Ceftin side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include seizures.
Store medicine in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), for up to 10 days. Keep the container tightly closed. Throw away any unused portion after 10 days. Keep Ceftin Suspension out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Ceftin Suspension. 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.
NIPENT 10 mg powder for solution for injection, powder for solution for infusion.
One vial contains 10 mg Pentostatin.
When reconstituted (see Section 6.6), the resulting solution contains pentostatin 2 mg/ml.
For a full list of excipients, see section 6.1.
Powder for solution for injection, powder for solution for infusion.
The vials contain a solid white to off-white cake or powder.
The pH of reconstituted solution is 7.0 – 8.2.
Pentostatin is indicated as single agent therapy in the treatment of adult patients with hairy cell leukaemia.
Pentostatin is indicated for adult patients.
Administration to Patient
It is recommended that patients receive hydration with 500 to 1,000 ml of 5% glucose only or 5% glucose in 0.18% or 0.9% saline or glucose 3.3% in 0.3% saline or 2.5% glucose in 0.45% saline or equivalent before pentostatin administration. An additional 500 ml of 5% glucose only or 5% glucose in 0.18% or 0.9% saline or 2.5% glucose in 0.45% saline or equivalent should be administered after pentostatin is given.
The recommended dosage of pentostatin for the treatment of hairy cell leukaemia is 4 mg/m2 in a single administration every other week. Pentostatin may be given intravenously by bolus injection or diluted in a larger volume and given over 20 to 30 minutes. (See Special precautions for disposal and other handling under Section 6.6.)
Higher doses are not recommended.
No extravasation injuries were reported in clinical studies.
The optimal duration of treatment has not been determined. In the absence of major toxicity and with observed continuing improvement, the patient should be treated until a complete response has been achieved. Although not established as required, the administration of two additional doses has been recommended following the achievement of a complete response.
All patients receiving pentostatin at 6 months should be assessed for response to treatment. If the patient has not achieved a complete or partial response, treatment with pentostatin should be discontinued.
If the patient has achieved a partial response, pentostatin treatment should be continued in an effort to achieve a complete response. At any time after a complete response is achieved, two additional doses of pentostatin are recommended. Pentostatin treatment should then be stopped. If the best response to treatment at the end of 12 months is a partial response, it is recommended that treatment with pentostatin be stopped.
Withholding or discontinuation of individual doses may be needed when severe adverse reactions occur. Drug treatment should be withheld in patients with severe rash, and withheld or discontinued in patients showing evidence of nervous system toxicity.
Pentostatin treatment should be withheld in patients with active infection occurring during the treatment but may be resumed when the infection is controlled.
Dosage in Patients with Cytopenias
No dosage reduction is recommended at the start of therapy with pentostatin in patients with anaemia, neutropenia, or thrombocytopenia. In addition, dosage reductions are not recommended during treatment in patients with anaemia and thrombocytopenia. Pentostatin should be temporarily withheld if the absolute neutrophil count during treatment falls below 200 cells/mm3 in a patient who had an initial neutrophil count greater than 500 cells/mm3 and may be resumed when the count returns to predose levels.
Renal Insufficiency
There is limited experience in patients with impaired renal function (creatinine clearance (Clcr) <60 ml/min) (see section 5.2).
Creatinine clearance should be determined prior to each administration of NIPENT.
Liver Impairment
Because of limited experience treating patients with abnormal liver function, treatment of such patients should be done with caution.
Administration to Elderly Patients
The recommended dosage of pentostatin for the treatment of hairy cell leukaemia in the elderly is 4 mg/m2 in a single administration every other week. Clinical trials have included patients over 65 years old and no adverse reactions specific to this age group have been reported.
Paediatric Use
Hairy cell leukaemia is a disease affecting adults, most commonly in the sixth decade of life. Safety and effectiveness of Nipent in children have not been established.
Pentostatin is contraindicated in patients who have demonstrated hypersensitivity to the active ingredient or to any of the excipients.
Pentostatin is contraindicated in patients with impaired renal function (Creatinine clearance < 60 ml/min).
Pentostatin is contraindicated in patients with active infection.
Pentostatin is contraindicated in pregnancy.
Warnings
Pentostatin should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of doses higher than those specified (see Section 4.2) is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used pentostatin at a higher dose (20-50 mg/m2/course) than recommended.
In a clinical investigation in patients with refractory chronic lymphocytic leukaemia using pentostatin at the recommended dose in combination with fludarabine phosphate, four of six patients entered on the study had severe or fatal pulmonary toxicity. The use of pentostatin in combination with fludarabine phosphate is not recommended.
Biochemical studies have demonstrated that pentostatin enhances the effects of vidarabine, a purine nucleoside with antiviral activity. The combined use of vidarabine and pentostatin may result in an increase in adverse reactions associated with each drug. The therapeutic benefit of the drug combination has not been established.
Patients with hairy cell leukaemia may experience myelosuppression primarily during the first few courses of treatment. Patients with infections prior to pentostatin treatment have in some cases developed worsening of their condition leading to death; whereas others have achieved complete response. Patients with infection should be treated only when the potential benefit of treatment justifies the potential risk to the patient. Efforts should be made to control the infection before treatment is initiated or resumed.
In patients with progressive hairy cell leukaemia, the initial courses of pentostatin treatment were associated with worsening of neutropaenia. Therefore, frequent monitoring of complete blood counts during this time is necessary. If severe neutropenia continues beyond the initial cycles, patient should be evaluated for disease status, including a bone marrow examination.
Pentostatin might have harmful effects on the genotype. Therefore, it is recommended that men undergoing treatment with pentostatin should not father a child during treatment up to 6 months thereafter. Contraception is to be guaranteed for women of childbearing age. Should a pregnancy occur during treatment, the possibility of a genetic consultation is to be considered.
Bone Marrow Transplant Regimen with high dose cyclophosphamide
Acute pulmonary oedema and hypotension leading to death, have been reported in the literature in patients treated with pentostatin in combination with carmustine, etoposide and high dose cyclophosphamide as part of an ablative regimen for bone marrow transplant. The combination of pentostatin and high dose cyclophosphamide is not recommended.
Elevations in liver function tests occurred during treatment with pentostatin and were generally reversible.
Renal toxicity was observed at higher doses in early studies; however, in patients treated at the recommended dose, elevations in serum creatinine were usually minor and reversible. There were some patients who began treatment with normal renal function who had evidence of mild to moderate toxicity at a final assessment. (See Administration to Patient [4.2].)
Rashes, occasionally severe, were commonly reported and may worsen with continued treatment. Withholding of treatment may be required. (See Administration to Patient [4.2].)
Extra care should be taken in treating patients beginning therapy with poor performance.
Precautions
Therapy with pentostatin requires regular patient observation and monitoring of haematologic parameters and blood chemistry values. If severe adverse reactions occur, the drug should be withheld (see Administration to Patient [4.2]) and appropriate corrective measures should be taken according to the clinical judgement of the physician.
Pentostatin treatment should be withheld or discontinued in patients showing evidence of nervous system toxicity.
Prior to initiating therapy with pentostatin, renal function should be assessed with a serum creatinine and/or a creatinine clearance assay. (See Pharmacokinetic Properties [5.2], Administration to Patient [4.2].) Complete blood counts, serum creatinine, and BUN should be performed before each dose of pentostatin and at appropriate periods during therapy. Severe neutropenia has been observed following the early courses of treatment with pentostatin and therefore frequent monitoring of complete blood counts is recommended during this time. If haematologic parameters do not improve with subsequent courses, patients should be evaluated for disease status, including a bone marrow examination. Periodic monitoring of the peripheral blood for hairy cells should be performed to assess the response to treatment.
In addition, bone marrow aspirates and biopsies may be required at 2 to 3 month intervals to assess the response to treatment.
Allopurinol
Allopurinol and pentostatin are both associated with skin rashes. Based on clinical studies in 25 refractory patients who received both pentostatin and allopurinol, the combined use of pentostatin and allopurinol did not appear to produce a higher incidence of skin rashes than observed with pentostatin alone. There has been a report of one patient who received both drugs and experienced a hypersensitivity vasculitis that resulted in death. It was unclear whether this adverse event and subsequent death resulted from the drug combination.
Vidarabine
Biochemical studies have demonstrated that pentostatin enhances the effects of vidarabine, a purine nucleoside with antiviral activity. The combined use of vidarabine and pentostatin may result in an increase in adverse reactions associated with each drug. The therapeutic benefit of the drug combination has not been established.
Fludarabine
The combined use of pentostatin and fludarabine phosphate is not recommended because it has been associated with an increased risk of fatal pulmonary toxicity. (See Section 4.4, Warnings.)
Bone Marrow Transplant Regimen with high dose cyclophosphamide
Acute pulmonary oedema and hypotension leading to death, have been reported in the literature in patients treated with pentostatin in combination with carmustine, etoposide and high dose cyclophosphamide as part of an ablative regimen for bone marrow transplant. The combination of pentostatin and high dose cyclophosphamide is not recommended.
Pentostatin must not be used during pregnancy (see Section 4.3). Women of childbearing potential receiving pentostatin should be advised not to become pregnant.
No fertility studies have been conducted in animals. Incompletely reversible seminiferous tubular atrophy and degeneration in rats and in dogs may be indicative of potential effects on male fertility. The possible adverse effects on human fertility have not been determined.
Pentostatin is teratogenic in mice and rats. There are no adequate and well-controlled studies in pregnant women. If the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazards to the foetus.
It is not known whether pentostatin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from pentostatin in nursing infants, nursing is not recommended.
Pentostatin has a minor or moderate influence on the ability to drive and use machines. Patients should be advised to use caution in driving or using machinery following drug administration.
Pentostatin is lymphotoxic. Aside from myelosuppression, pentostatin is immunosuppressive in particular by suppression of the CD4+ lymphocyte subset. CD4+ counts smaller than 200 per µl are usually seen during treatment with pentostatin and CD4+ count suppression can outlast the end of treatment by more than 6 months. With the exception of frequent herpes zoster infections the clinical consequences of the suppression of CD4+ counts in hairy cell leukaemia are not well understood yet. Long term consequences are not predictable, but currently there is no evidence for higher frequency of secondary malignancies.
The following adverse events were reported during clinical studies in patients with hairy cell leukaemia who were refractory to alpha-interferon or were treated as front-line therapy. Most patients experienced an adverse event. The most commonly reported reactions were nausea and/or vomiting or leucopenia, each occurring in about 60% of patients. Fever, rash and fatigue were reported in about 40% of patients. Most adverse events were either mild or moderate diminished in frequency with continued therapy. Twelve percent of patients withdrew from treatment due to an adverse event. Many hairy cell leukaemia patients experience adverse events while under therapy with pentostatin. Given the natural history of the disease and the pharmacological properties of the drug it may be difficult in certain cases to discriminate between drug-related and disease-related adverse events. No extravasation injuries were reported in clinical studies.
The following adverse reactions have been reported during clinical studies in patients with HCL or during post-authorization use of pentostatin, either as single agent or in combinations with various agents for unapproved indications. They have been listed as Very common (>10%), Common (1-10%), Uncommon (0.1-1%) or Rare (0.01-0.1%)
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1Includes all events which occurred in less than 3% of NIPENT-treated patients during the initial phase of the SWOG study:
2Based on 1549 patients included in post-marketing studies through Oct 10, 2005.
3Reported only in GVHD studies.
No specific antidote for pentostatin overdose is known. Pentostatin administered at higher doses (20-50 mg/m2/course) than recommended was associated with deaths due to severe renal, hepatic, pulmonary, and CNS toxicity. In case of overdose, management would include general supportive measures through any period of toxicity that occurs.
LO1X X08
Pharmacotherapeutic Group
Pentostatin is an adenosine deaminase (ADA) inhibitor.
Mechanism of Action
Pentostatin is a potent transition state inhibitor of the enzyme adenosine deaminase. The greatest activity of ADA is found in cells of the lymphoid system with T-cells having higher activity than B- cells and T-cell malignancies higher ADA activity than B-cell malignancies. Pentostatin inhibition of ADA, as well as direct inhibition of RNA synthesis and increased DNA damage, may contribute to the overall cytotoxic effect of pentostatin. The precise mechanism of pentostatin's antitumour effect, however, in hairy cell leukaemia is not known.
Pentostatin has been shown to have activity against a variety of lymphoid malignancies, but is most active against indolent cancers with lower ADA concentration, such as hairy cell leukaemia.
In man, pentostatin pharmacokinetics are linear with plasma concentrations increasing proportionately with dose. Following a single dose of 4 mg/m2 of pentostatin infused over 5 minutes, the distribution half-life was 11 minutes and the mean terminal half-life was 5.7 hours, with a range of 2.6 to 10 hours; the mean plasma clearance was 68 ml/min/m2, and approximately 90% of the dose was excreted in the urine as unchanged pentostatin and/or metabolites as measured by adenosine deaminase inhibitory activity. The plasma protein binding of pentostatin is low, approximately 4%.
A positive correlation was observed between pentostatin clearance and creatinine clearance (CrCl) in patients with creatinine clearance values ranging from 60 ml/min to 130 ml/min. Pentostatin half-life in patients with renal impairment (CrCl <50 ml/min, n = 2) was 18 hours, which was much longer than that observed in patients with normal renal function (CrCl>60 ml/min, n = 14), about 6 hours.
Results from a published study in 13 patients with impaired renal function suggested dosage adjustment of NIPENT based on creatinine clearance (Clcr) values. Dosage was adjusted to 75% at a Clcr of 40-59 ml/min (3 mg/m2) and to 50% at a Clcr of 35-39 ml/min (2 mg/m2). There are insufficient data to recommend a starting or a subsequent dose for patients with creatinine clearance < 35 ml/min.
A tissue distribution and whole-body autoradiography study in the rat revealed that radioactivity concentrations were highest in the kidneys with very little central nervous system penetration.
Pentostatin penetrates the blood-brain barrier leading to measurable concentrations in the cerebrospinal fluid (CSF).
Adver
Preventing nausea and vomiting caused by cancer chemotherapy and radiation. It may also be used for other conditions as determined by your doctor.
Kytril is a 5-HT3 receptor antagonist. It works by blocking a chemical called serotonin that can cause vomiting.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Kytril. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Kytril. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Kytril 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.
Use Kytril as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Kytril.
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:
Agitation; anxiety; constipation; diarrhea; dizziness; drowsiness; headache; indigestion; nausea; stomach pain; taste changes; trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; fever, chills, or sore throat; unusual muscle movement.
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.
See also: Kytril side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include headache.
Store Kytril 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 Kytril out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Kytril. 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.
Generic Name: tapentadol (Oral route)
ta-PEN-ta-dol
Tapentadol extended-release contains tapentadol, a mu-opioid agonist and Schedule II controlled substance, with risk of misuse, abuse, and diversion similar to other opioid analgesics. Tapentadol extended-release is not intended for use as an as-needed analgesic or for the management of acute or postoperative pain. Tapentadol extended-release tablets should be swallowed whole. Taking split, broken, chewed, dissolved, or crushed tapentadol extended-release tablets could lead to rapid release and absorption of a potentially fatal dose of tapentadol. Patients must not consume alcoholic beverages, prescription or non-prescription medications containing alcohol. Co-ingestion of alcohol with tapentadol extended-release may result in a potentially fatal overdose of tapentadol .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Chemical Class: Opioid
Tapentadol is a narcotic analgesic that acts in the central nervous system to relieve moderate or severe pain. If tapentadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine. Since this medicine is only used for short-term relief of pain, physical dependence will probably not occur.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Appropriate studies have not been performed on the relationship of age to the effects of tapentadol in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tapentadol in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving tapentadol.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine 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.
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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain tapentadol. It may not be specific to Nucynta ER. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects and the chances of abuse.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.
You should not use this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system and may cause drowsiness. Some examples of CNS depressants are antihistamines or medicines for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines including other narcotics; barbiturates; medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using tapentadol.
This medicine may cause some people to become dizzy, lightheaded, faint, drowsy, or less alert than they are normally. 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 not alert. Getting up slowly from a lying or sitting position may also help.
Make sure your doctor knows about all the other medicines you are using. This medicine may cause a serious condition called serotonin syndrome. This is more likely to occur when it is taken with certain medicines for depression (e.g., amitriptyline, doxepin, fluoxetine, nortriptyline, paroxetine, Celexa®, Effexor®, Elavil®, Lexapro™, Pamelor®, Paxil®, Sinequan®, or Zoloft®), pain (e.g., tramadol [e.g., Ultram®]), or migraine headaches (sumatriptan [e.g., Imitrex®], zolmitriptan [e.g., Zomig®], or rizatriptan [e.g., Maxalt®]). Check with your doctor first before taking any other medicines.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.
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.
Check with your doctor immediately if any of the following side effects occur:
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:
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.
See also: Nucynta ER side effects (in more detail)
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