Read PLR Articles Directory Louisiana: August 2012

Thursday, 30 August 2012

Sulfadiazine

Class: Sulfonamides
VA Class: AM650
Chemical Name: N1-2-pyrimidinylsulfanilamide
Molecular Formula: C₁₀H₁₀N₄O₂S
CAS Number: 68-35-9

Introduction

Antibacterial; intermediate-acting sulfonamide.^a ^b ^c

Uses for Sulfadiazine

Prevention of Rheumatic Fever Recurrence

Alternative for prevention of recurrence (secondary prophylaxis) of rheumatic fever.¹¹⁸ ¹²⁶ ^c

AHA and AAP recommend long-term (continuous) secondary prophylaxis in patients who have been treated for documented rheumatic fever (even if manifested solely by Sydenham chorea) and in those with evidence of rheumatic heart disease.¹¹⁸ ¹²⁶

IM penicillin G benzathine is the drug of choice for secondary prophylaxis of rheumatic fever; oral penicillin V and oral sulfadiazine are alternatives.¹¹⁸ ¹²⁶

Do not use sulfadiazine for treatment of Streptococcus pyogenes (group A β-hemolytic streptococci) infections, including pharyngitis and tonsillitis.¹¹⁸ ¹²⁶ ^c Sulfadiazine will not eradicate S. pyogenes.¹²⁶ ^c

Toxoplasmosis

Treatment of toxoplasmosis caused by Toxoplasma gondii, including encephalitis, retinochoroiditis, and congenital toxoplasmosis.¹⁰⁸ ¹¹⁴ ¹¹⁵ ¹¹⁶ ¹¹⁷ ¹¹⁸ ^c ^e ^f Designated an orphan drug by FDA for treatment of toxoplasmosis.

Sulfadiazine used in conjunction with pyrimethamine and leucovorin is the regimen of choice for treatment of toxoplasmosis in adults, adolescents, or children, including HIV-infected individuals.¹⁰⁸ ¹¹⁸ ^e ^f

Sulfadiazine used in conjunction with atovaquone is one of several alternative regimens for treatment of toxoplasmosis in HIV-infected adults or adolescents when the regimen of choice cannot be used;^e this regimen not studied for treatment of toxoplasmosis in children.^f

Sulfadiazine used in conjunction with pyrimethamine and leucovorin is the regimen of choice for treatment of symptomatic or asymptomatic congenital toxoplasmosis.¹¹⁸ ^f Empiric treatment of the infant should be strongly considered if the mother had symptomatic Toxoplasma infection during pregnancy, even if the mother was treated.^f

Sulfadiazine used in conjunction with pyrimethamine and leucovorin is the regimen of choice for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of T. gondii encephalitis† in HIV-infected adults, adolescents, or children who have completed treatment for the disease.¹²⁴ ^e ^f

Acute Otitis Media (AOM)

Has been used in conjunction with penicillin or erythromycin for treatment of AOM caused by susceptible Haemophilus influenzae.^b ^c

Chancroid

Has been used for treatment of chancroid caused by H. ducreyi.^b ^c Not included in CDC recommendations for treatment of chancroid.ⁱ

Chlamydial Infections

Has been used for treatment of inclusion conjunctivitis caused by Chlamydia trachomatis.^c Oral or IV erythromycin usually is drug of choice; oral sulfonamides are alternatives (except in neonates).¹¹⁸ ^g

Has been used for treatment of trachoma caused by C. trachomatis.^c Oral azithromycin may be the drug of choice for treatment of ocular trachoma; prolonged treatment with combined oral and topical anti-infectives (e.g., erythromycin, tetracyclines, sulfonamides) also has been used.¹¹⁸ ^g

Haemophilus influenzae Infections

Has been used for treatment of meningitis caused by H. influenzae; used in conjunction with another suitable anti-infective (e.g., streptomycin).^c

Malaria

Has been used as an adjunct in the treatment of malaria caused by chloroquine- resistant Plasmodium falciparum.^c Not a preferred or alternative agent for treatment of malaria.¹⁰⁸

Neisseria meningitidis Infections

Has been used to eliminate meningococci from the nasopharynx of asymptomatic Neisseria meningitidis carriers and for chemoprophylaxis in close contacts of individuals with invasive meningococcal disease when the organism is known to be susceptible to sulfonamides.^a ^b ^c Not a drug of choice; CDC and AAP recommend use of rifampin, ciprofloxacin, or ceftriaxone for chemoprophylaxis of meningococcal disease.¹¹⁸ ^h

Nocardia Infections

Has been used for treatment of nocardiosis.^a ^b ^c

Sulfonamides (usually co-trimoxazole) are treatment of choice for most Nocardia infections.¹¹⁸ ^g Some experts suggest that sulfonamides that are less urine soluble (e.g., sulfadiazine) should be avoided.¹¹⁸

Plague

Has been used for treatment of plague† caused by Yersinia pestis.^j

Not considered a preferred or alternative agent for treatment of plague;^g ^j sulfonamides appear to be less effective than other anti-infectives used in the treatment of plague (e.g., streptomycin, tetracycline, doxycycline).^j

Urinary Tract Infections (UTIs)

Has been used for treatment of UTIs (e.g., pyelonephritis, pyelitis, cystitis) in the absence of obstructive uropathy or foreign bodies.^b ^c

Use only when UTIs are caused by susceptible Escherichia coli, Klebsiella, Enterobacter, Staphylococcus aureus, Proteus mirabilis, or P. vulgaris and only when other more soluble sulfonamides have been ineffective.^b ^c

Sulfadiazine Dosage and Administration

Administration

Oral Administration

Administer orally with a full glass (250 mL) of water.^a ^c

Maintain adequate fluid intake during therapy to minimize risk of crystalluria and stone formation.^a ^b ^c

Dosage

Individualize dosage according to the severity of the infection, the pharmacokinetics of sulfadiazine, and the response and tolerance of the patient.^b

Pediatric Patients

General Pediatric Dosage

Oral

Infants and children ≥2 months of age: Manufacturer recommends 75 mg/kg or 2 g/m² initially, followed by 150 mg/kg or 4 g/m² daily given in 4–6 equally divided doses.^c

AAP recommends 100–150 mg/kg daily given in 4 divided doses for the treatment of mild to moderate infections or 120–150 mg/kg daily given in 4–6 divided doses for the treatment of severe infections.¹¹⁸

Prevention of Rheumatic Fever Recurrence

Oral

Infants and children ≥2 months of age: Manufacturer recommends 500 mg once daily in those weighing <30 kg or 1 g once daily in those weighing >30 kg.^c

AHA and AAP recommend 500 mg once daily in those weighing ≤27 kg or 1 g once daily in those weighing >27 kg.¹¹⁸ ¹²⁶

Long-term, continuous prophylaxis required.¹¹⁸ ¹²⁶ (See Table in Adult Dosage: Prevention of Rheumatic Fever Recurrence under Dosage and Administration.)

Toxoplasmosis

Treatment of Congenital Toxoplasmosis

Oral

50 mg/kg twice daily used in conjunction with oral pyrimethamine (2 mg/kg once daily for 2 days, then 1 mg/kg once daily for 2–6 months, then 1 mg/kg 3 times weekly) and oral or IM leucovorin (10 mg with each pyrimethamine dose).^f

Optimal duration of treatment is unclear and should be determined in consultation with an expert; treatment often is continued for 12 months.¹¹⁸ ^f

Treatment in HIV-infected Infants and Children

Oral

25–50 mg/kg (up to 1–1.5 g) 4 times daily used in conjunction with oral pyrimethamine (2 mg/kg once daily for 3 days, then 1 mg/kg once daily) and oral leucovorin (10–25 mg once daily).^f

Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.^f

Treatment in HIV-infected Adolescents

Oral

1 g every 6 hours in those weighing <60 kg or 1.5 g every 6 hours in those weighing ≥60 kg used in conjunction with oral pyrimethamine (200 mg once, then 50 mg once daily in those weighing <60 kg or 75 mg once daily in those weighing ≥60 kg) and oral leucovorin (at least 10–20 mg once daily).^e

Alternatively, 1–1.5 g every 6 hours used in conjunction with oral atovaquone (1.5 mg twice daily).^e

Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.^e

Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Infants and Children†

Oral

85–120 mg/kg daily in 2–4 divided doses used in conjunction with oral pyrimethamine (1 mg/kg or 15 mg/m² daily [up to 25 mg]) and oral leucovorin (5 mg once every 3 days).¹²⁴

Secondary prophylaxis against toxoplasmosis generally is continued for life.¹²⁴ ^e ^f The safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected infants and children receiving potent antiretroviral therapy has not been extensively studied.¹²⁴ ^e ^f

Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Adolescents†

Oral

Dosage for secondary prophylaxis against toxoplasmosis in adolescents and criteria for initiation or discontinuance of such prophylaxis in this age group are the same as those recommended for adults.¹²⁴ ^e (See Adult Dosage under Dosage and Administration.)

Neisseria meningitidis Infections

Treatment of Asymptomatic Meningococcal Carriers or Prophylaxis in Contacts

Oral

Children 2–12 months of age: 500 mg once daily for 2 days.^a

Children 1–12 years of age: 500 mg twice daily for 2 days.^a

Adults

General Adult Dosage

Oral

2–4 g initially, followed by 2–4 g daily in 3–6 equally divided doses.^c

Prevention of Rheumatic Fever Recurrence

Oral

Adults weighing >30 kg: Manufacturer recommends 1 g once daily.^c

Adults weighing >27 kg: AHA and AAP recommend 1 g once daily.¹¹⁸ ¹²⁶

Long-term, continuous prophylaxis required.¹¹⁸ ¹²⁶ (See Table.)

Recommended Duration of Prophylaxis for Prevention of Rheumatic Fever Recurrence
Patient Category	Duration
Rheumatic fever without carditis	5 years or until 21 years of age, whichever is longer¹¹⁸ ¹²⁶
Rheumatic fever with carditis but no residual heart disease (no valvular disease)	10 years or well into adulthood, whichever is longer¹¹⁸ ¹²⁶
Rheumatic fever with carditis and residual heart disease (persistent valvular disease)	At least 10 years since last episode and at least until 40 years of age; sometimes for life¹¹⁸ ¹²⁶

Toxoplasmosis

Treatment in HIV-infected Adults

Oral

Alternatively, 1–1.5 g every 6 hours used in conjunction with oral atovaquone (1.5 mg twice daily).^e

Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.^e

Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Adults†

Oral

0.5–1 g every 6 hours used in conjunction with oral pyrimethamine (25–50 mg daily) and oral leucovorin (10–25 mg once daily).¹²⁴ ^e

Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients who have completed initial treatment of toxoplasmosis encephalitis (TE).¹²⁴ ^e

Consideration can be given to discontinuing secondary prophylaxis in adults or adolescents who successfully completed initial treatment for TE, are asymptomatic with respect to TE, and have a sustained (≥6 months) increase in CD4⁺ T-cell counts to >200/mm³.¹²⁴ ^e

Reinitiate secondary prophylaxis if CD4⁺ T-cell count decreases to <200/mm³.¹²⁴ ^e

Neisseria meningitis Infections

Treatment of Asymptomatic Meningococcal Carriers or Prophylaxis in Contacts

Oral

1 g twice daily for 2 days.^a

Nocardiosis

Oral

4–8 g daily for a minimum of 6 weeks.^a Continue for several months after apparent cure to prevent relapse.^a

Prescribing Limits

Pediatric Patients

General Pediatric Dosage

Oral

Maximum 6 g daily.^c

Toxoplasmosis

Treatment in HIV-infected Infants and Children

Oral

Maximum 1–1.5 g per dose.^f

Special Populations

No special population dosage recommendations at this time.^c

Cautions for Sulfadiazine

Contraindications

Hypersensitivity to sulfonamides^c or other chemically related drugs (e.g., sulfonylureas, thiazides).^b

Infants <2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis).^c (See Toxoplasmosis under Uses.)

Pregnancy at term.^c ^d

Nursing women.^c

Porphyria.^b

Warnings/Precautions

Warnings

Severe Reactions

Severe (sometimes fatal) reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias, have been reported with sulfonamides.^b ^c

Sore throat, fever, pallor, purpura, or jaundice may be early indications of serious reactions.^c

Discontinue sulfadiazine at the first appearance of rash or any sign of adverse reactions.^b

Sensitivity Reactions

Hypersensitivity Reactions

Deaths associated with sulfonamide hypersensitivity reactions have been reported.^c

Serum sickness syndrome or serum sickness-like reactions (e.g., fever, chills, rigors, flushing, joint pain, urticarial eruptions, conjunctivitis, bronchospasm, leukopenia) reported with sulfonamides.^b

Various dermatologic reactions, including rash, pruritus, urticaria, erythema nodosum, erythema multiforme (Stevens-Johnson syndrome), Lyell’s syndrome (may be associated with corneal damage), Behcet’s syndrome, toxic epidermal necrolysis, and exfoliative dermatitis, reported in patients receiving sulfonamides.^b

Photosensitivity has been reported.^b

Incidence of hypersensitivity reactions appears to increase with increased sulfonamide dosage.^b

Use with caution in patients with severe allergy or bronchial asthma.^c

If a hypersensitivity reaction occurs during sulfonamide therapy, immediately discontinue the drug.^b

Desensitization

Desensitization to sulfadiazine has been performed when use of the drug for the treatment of toxoplasmosis was considered necessary in HIV-infected patients who had a history of sulfadiazine hypersensitivity.

Consult specialized references for specific information on desensitization procedures and dosage.

Cross-sensitivity

Although cross-sensitization has been reported to occur between the various anti-infective sulfonamides, some diuretics such as acetazolamide and the thiazides, some goitrogens, and sulfonylurea antidiabetic agents,^c the association between hypersensitivity to sulfonamide anti-infectives and subsequent sensitivity reactions to non-anti-infective sulfonamides (e.g., thiazides, sulfonylurea antidiabetic agents, furosemide, dapsone, probenecid) appears to result from a predisposition to allergic reactions in general rather than to cross-sensitivity to the sulfa moiety per se.

General Precautions

Renal Effects

Sulfonamides have been associated with renal toxicity manifested by renal colic, nephritis, urolithiasis, toxic nephrosis with anuria and oliguria, hematuria, proteinuria, crystalluria, kidney stone formation, and elevation of BUN and serum creatinine concentrations.^b Nephritis and hemolytic-uremic syndrome also have been reported.^b

Adverse renal effects usually are the result of crystalluria.^b Risk of crystalluria may be decreased by maintaining an adequate urinary output and by increasing urinary pH.^b Unless the urine is highly acidic and/or the drug is relatively insoluble, alkalinization of the urine usually is not necessary if urinary output is maintained at a minimum of 1.5 L daily.^b

Perform urinalysis and assess kidney function frequently during sulfonamide therapy.^b Maintain adequate fluid intake to minimize risk of crystalluria and stone formation.^b ^c

If persistent, heavy crystalluria, hematuria, or oliguria occurs, sulfonamide therapy should be discontinued and alkali therapy maintained.^b

Patients with G6PD Deficiency

Hemolysis may occur in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency; this effect may be dose-related.^b ^c

Laboratory Monitoring

Perform CBCs frequently during sulfadiazine therapy.^c

Perform urinalysis (with careful microscopic examination) frequently during sulfadiazine therapy, especially in patients with impaired renal function.^c

Considerable interindividual variations in sulfadiazine plasma concentrations occur with a given dosage.^c Measure sulfadiazine blood concentrations in patients being treated for serious infections.^c Free sulfonamide concentrations of 5–15 mg/100 mL may be considered therapeutically effective for most infections; concentrations of 12–15 mg/100 mL may be considered optimal for serious infections.^c Do not exceed total blood concentrations of 20 mg/100 mL since adverse reactions occur more frequently above this level.^c

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of sulfadiazine and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.^b

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.^b ^c Consider that in vitro susceptibility tests are not always reliable for sulfonamides.^c If the patient is already taking sulfonamides, ensure that follow-up cultures have aminobenzoic acid added to the culture media.^c

Specific Populations

Pregnancy

Category C.^c

Contraindicated in pregnant women at term.^c ^d May increase risk of neonatal hyperbilirubinemia and kernicterus.^e

Lactation

Contraindicated in nursing women;^c discontinue drug or nursing.^c Distributed into milk; may cause kernicterus in the infant.^c

Pediatric Use

Avoid use in infants <2 months of age (except when considered necessary for adjunctive use with pyrimethamine for the treatment of congenital toxoplasmosis).^b ^c (See Toxoplasmosis under Uses.)

Kernicterus, caused by displacement of bilirubin from protein binding sites, has occurred in neonates treated with sulfonamides.^b ^c

Hepatic Impairment

Use with caution in patients with impaired hepatic function.^c

Renal Impairment

Use with caution in patients with impaired renal function.^c (See Renal Effects under Cautions.)

Common Adverse Effects

GI effects (anorexia, nausea, vomiting, abdominal pain), headache, peripheral neuritis, fever, rash, pancreatitis, stomatitis, depression.^c

Interactions for Sulfadiazine

Specific Drugs

Drug	Interaction	Comments
Anticoagulants, oral (warfarin)	Possibility that sulfonamides may potentiate the effects of coumarin anticoagulants by displacing them from their protein-binding sites or by impairing anticoagulant metabolism^b ^c	Closely monitor PT or INR^b
Antidiabetic agents, sulfonylureas (chlorpropamide, tolbutamide)	Sulfonamides may potentiate the hypoglycemic effects by displacing the antidiabetic agents from their protein-binding sites^b ^c	Use with caution^b
Digoxin	Possible decreased GI absorption of digoxin^b	If used concomitantly, monitor to ensure adequate digoxin concentrations ^b
Methotrexate	Possibility that sulfonamides may potentiate the effects of methotrexate by displacing it from protein-binding sites^b ^c	Use with caution^b
Probenecid	May displace sulfonamides from plasma albumin and increase concentrations of free drug in plasma^c
NSAIAs (indomethacin)	May displace sulfonamides from plasma albumin and increase concentrations of free drug in plasma^b ^c	Observe patient for possible adverse effects^b
Salicylates	May displace sulfonamides from plasma albumin and increase concentrations of free drug in plasma^b ^c
Thiazide diuretics	Sulfonamides may potentiate the diuretic effects by displacing thiazide diuretics from their protein-binding sites^c
Uricosuric agents	Sulfonamides may potentiate the effects of uricosuric agents by displacing the agents from their protein-binding sites^c

Sulfadiazine Pharmacokinetics

Absorption

Bioavailability

Readily absorbed from the GI tract.^a ^c

Peak plasma concentrations are attained within 3–7 hours.^b ^c Considerable interindividual variations in plasma sulfadiazine concentrations occur with a given dosage.^c

Exists in blood as free, conjugated, and protein-bound drug; only the free form is microbiologically active.^c

Distribution

Extent

Distributed into most body tissues; appears to freely cross cell membranes.^a

Distributed into CSF.^c Free and total CSF concentrations may reach 32–65 and 40–60% of concurrent blood concentrations, respectively.^c Higher sulfonamide CSF concentrations may be reached if meninges are inflamed.^a

Crosses the placenta.^c

Distributed into milk.^c

Plasma Protein Binding

38–48%.^c

Elimination

Metabolism

Liver; undergoes N⁴-acetylation (up to 40%).^b

Elimination Route

Excreted principally in urine in the N⁴-acetylated form (about 15–40%) and unchanged (about 43–60%).^a ^c Approximately 50% of a single dose is excreted in the urine within 24 hours; 60–85% can be recovered within 72 hours.^a ^c

Half-life

About 7–17 hours.^b

Stability

Storage

Oral

Tablets

20–25°C in tight, light resistant container.^c

Actions and SpectrumActions

Competitively inhibits bacterial synthesis of folic acid (pteroylglutamic acid) from aminobenzoic acid.^c

Bacteriostatic in action.^c

Inhibits only microorganisms that synthesize their own folic acid.^b Animal cells and bacteria capable of utilizing folic acid precursors or preformed folic acid are resistant to sulfonamides.^b

Advice to Patients

Advise patients to drink a full glass of water (250 mL) with each dose and at frequent intervals throughout the day to prevent crystalluria and stone formation.^c

Importance of reporting the occurrence of sore throat, fever, pallor, purpura, or jaundice to a clinician since this may indicate a serious blood disorder.^c

Advise patients that photosensitivity has been reported with sulfonamides and they should avoid exposure to UV light or prolonged exposure to sunlight.^b

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^c

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

Importance of advising patients of other important precautionary information.^c (See Cautions.)

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	500 mg*	Tablets (with povidone)	Sandoz

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

SulfADIAZINE 500MG Tablets (SANDOZ): 30/$79.99 or 90/$205.96

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 February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

108. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter website ().

114. Dannemann B, McCutchan A, Israelski D et al. Treatment of toxoplasmic encephalitis in patients with AIDS: a randomized trial comparing pyrimethamine plus clindamycin to pyrimethamine plus sulfadiazine. Ann Intern Med. 1992; 116:33-43. [IDIS 289401] [PubMed 1727093]

115. Porter SB, Sande MA. Toxoplasmosis of the central nervous system in the acquired immunodeficiency syndrome. N Engl J Med. 1992; 327:1643-8. [IDIS 305877] [PubMed 1359410]

116. Protocol for use of sulfadiazine in persons with toxoplasmosis. Atlanta, GA: US Centers for Disease Control and Prevention; 1993 Feb 1.

117. Centers for Disease Control and Prevention, Atlanta, GA: Personal communication.

118. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

121. Centers for Disease Control and Prevention. Update: availability of sulfadiazine—United States. MMWR Morb Mortal Wkly Rep. 1994; 43:671. [IDIS 335152] [PubMed 8072481]

124. US Public Health Service (USPHS) and Infectious Diseases Society of America (IDSA) Prevention of Opportunistic Infections Working Group. 2001 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons with human immunodeficiency virus. From the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website ().

126. Dajani A, Taubert K, Ferrieri P et al and the American Heart Association Committee on Rheumatic Fever et al. Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals. Pediatrics. 1995; 96:758-64. [IDIS 355409] [PubMed 7567345]

127. Kaplan J, Centers for Disease Control and Prevention: Personal communication.

a. AHFS Drug Information 2007. McEvoy GK, ed. Sulfadiazine. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 418-9.

b. AHFS Drug Information 2007. McEvoy GK, ed. Sulfonamides General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:406-10.

c. Sandoz Inc. Sulfadiazine tablets prescribing information. Princeton, NJ. 2006 Jun.

d. Sandoz Inc. Princeton, NJ: Personal communication.

e. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.

f. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-14):1-92.

g. Anon. Choice of antibacterial drugs Med Lett Treat Guidel. 2004; 13-26.

h. Centers for Disease Control and Prevention. Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005; 54(RR-7):1-21.

i. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006; 55(RR-11):1-96.

j. Inglesby TV, Dennis DT, Henderson DA for the Working Group on Civilian Biodefense. Plague as a biological weapon: medical and public health management. JAMA. 2000; 283:2281–90.

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P-Hist DM Drops

Generic Name: brompheniramine, dextromethorphan, and pseudoephedrine (brom fen EER a meen, dex troe me THOR fan, soo doe e FED rin)

Brand Names: Allanhist PDX Drops, Anaplex DM, Anaplex DMX, Andehist DM NR Syrup, Brom Tann, Brometane DX, Bromfed DM, Bromhist PDX, Bromhist-DM Drops, Bromophed-DX, Bromph DM, Bromplex DM, BroveX PSB DM, BroveX PSE DM, Carbofed DM Syrup, Dallergy DM, EndaCof-DM, Histacol BD Drops, Myphetane DX Cough, PBM Allergy, Pediahist DM Drops, ProHist DM, Q-Tapp DM, Resperal-DM Drops, Robitussin Allergy & Cough, Sildec DM

What is P-Hist DM Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

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.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine, dextromethorphan, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, cough, 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 pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about P-Hist DM Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Brompheniramine, dextromethorphan, and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be? awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking P-Hist DM Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine, dextromethorphan, and pseudoephedrine if you have:

kidney disease;

diabetes;

glaucoma;

heart disease or high blood pressure;

diabetes;

a thyroid disorder;

emphysema or chronic bronchitis;

an enlarged prostate; or

problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine, dextromethorphan, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine 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.

How should I take P-Hist DM Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

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 for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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.

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.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough and 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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking P-Hist DM Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

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.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

P-Hist DM Drops (brompheniramine, dextromethorphan, and pseudoephedrine) 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 this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;

slow, shallow breathing;

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);

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

urinating less than usual or not at all.

Less serious side effects may include:

dry mouth;

nausea, stomach pain, constipation, mild loss of appetite, upset stomach;

blurred vision;

warmth, tingling, or redness under your skin;

sleep problems (insomnia);

restless or excitability (especially in children);

skin rash or itching;

dizziness, drowsiness, or headache;

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.

What other drugs will affect P-Hist DM Drops (brompheniramine, dextromethorphan, and pseudoephedrine)?

Tell your doctor if you regularly use 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.

Tell your doctor about all other medications you use, especially:

a diuretic (water pill), or blood pressure medicine;

medication to treat irritable bowel syndrome;

bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), darifenacin (Enablex), or tolterodine (Detrol);

aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with brompheniramine, dextromethorphan, and pseudoephedrine. 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.

More P-Hist DM Drops resources

P-Hist DM Drops Use in Pregnancy & Breastfeeding
P-Hist DM Drops Drug Interactions
P-Hist DM Drops Support Group
0 Reviews for P-Hist DM - Add your own review/rating

Anaplex DMX Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Bromdex D Prescribing Information (FDA)

Bromfed DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

Bromfed DM Prescribing Information (FDA)

Myphetane DX Prescribing Information (FDA)

Neo DM Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Resperal-DM Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare P-Hist DM Drops with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about brompheniramine, dextromethorphan, and pseudoephedrine.

Sunday, 26 August 2012

Uramaxin Foam

urea

Dosage Form: foam
Uramaxin™ (20% Urea) Foam

Rx Only

In a vehicle containing Ammonium Lactate

For external use only. Not for ophthalmic use.

Uramaxin Foam Description

Uramaxin™ (20% Urea) Foam is a keratolytic emollient moisturizer. Each gram contains 20% urea, purified water, ammonium lactate, white petrolatum, octyl palmitate, caprylic/capric triglyceride, hydrogenated polyisobutene, propylene glycol, rice starch, polysorbate 60, cyclomethicone, glyceryl stearate & PEG-100 stearate, cetearyl alcohol & cetearyl glucoside, polysorbate-20, phenoxyethanol, cetyl alcohol, dimethicone, potassium sorbate, allantoin, tocopheryl acetate, xanthan gum. In propellants isobutane & propane & butane.

Urea is a diamide of carbonic acid with the following chemical structure:

Uramaxin Foam - Clinical Pharmacology

Urea gently lyses/dissolves the intercellular matrix of surface skin cells loosening and allowing a shedding of rough, thickened and scaly hyperkeratotic skin. Urea also moisturizes and softens skin.

PHARMACOKINETICS

The mechanism of action of topically applied Urea is not yet known.

INDICATIONS AND USES

For softening, smoothing and removing rough scaling hyperkeratotic skin in conditions such as xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

Contraindications

Known hypersensitivity to any of the listed ingredients. Discontinue if hypersensitivity is observed. Sun exposure to areas of skin treated with Uramaxin™ (20% Urea) Foam should be minimized or avoided.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

PREGNANCY

Pregnancy Category C

Animal reproduction studies have not been conducted with Uramaxin™ (20% Urea) Foam. It is also not known whether Uramaxin™ (20% Urea) Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Uramaxin™ (20% Urea) Foam should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Uramaxin™ (20% Urea) Foam is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Adverse Reactions

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

Uramaxin Foam Dosage and Administration

Apply Uramaxin™ (20% Urea) Foam to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

How is Uramaxin Foam Supplied

Uramaxin™ (20% Urea) Foam is supplied in a 100 g (3.5 oz.) canister, NDC 43538-220-10

Store at room temperature 15°-25° C (59°-77° F).

Protect from freezing.

Manufactured for:

MEDIMETRIKS PHARMACEUTICALS, INC.

363 Route 46 West

Fairfield, NJ 07004-2402 USA

www.medimetriks.com

Made in Israel

Manufactured by Perrigo

Yeruham 80500, Israel

IP005-R2

Rev. 8/10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - CARTON

Rx Only

Uramaxin™

(20% Urea) Foam

In a vehicle containing ammonium lactate

See package insert for full prescribing information

For Topical Use Only

Medimetriks Pharmaceuticals, Inc.

Uramaxin(tm) Carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - CANISTER

Rx Only

Uramaxin™

(20% Urea) Foam

In a vehicle containing ammonium lactate

See package insert for full prescribing information

For Topical Use Only

Medimetriks Pharmaceuticals, Inc.

Uramaxin(tm) Canister

URAMAXIN
urea aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	43538-220
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	20 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	43538-220-99	10 g In 1 CANISTER	None
2	43538-220-10	1 CANISTER In 1 CARTON	contains a CANISTER
2		100 g In 1 CANISTER	This package is contained within the CARTON (43538-220-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/13/2009

Labeler - Medimetriks Pharmaceuticals Inc (019903816)

Registrant - L Perrigo Company (006013346)

Establishment
Name	Address	ID/FEI	Operations
Perrigo Israel Pharmaceuticals LTD		600093611	MANUFACTURE

Revised: 08/2010Medimetriks Pharmaceuticals Inc

More Uramaxin Foam resources

Uramaxin Foam Side Effects (in more detail)
Uramaxin Foam Use in Pregnancy & Breastfeeding
Uramaxin Foam Support Group
0 Reviews for Uramaxin - Add your own review/rating

Compare Uramaxin Foam with other medications

Dermatological Disorders
Dry Skin
Pityriasis rubra pilaris

Friday, 24 August 2012

Sucraid

Generic Name: Sacrosidase
Class: Enzymes
ATC Class: A16AB06
VA Class: GA500
Chemical Name: Saccharomyces cerevisiae clone F14 protein moiety reduced
CAS Number: 85897-35-4

REMS:

FDA approved a REMS for sacrosidase to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Synthetic form of sucrase; derived from Saccharomyces cerevisiae.¹ ² ³

Uses for Sucraid

Congenital Sucrase-Isomaltase Deficiency

Oral replacement therapy for the genetic sucrase deficiency that is part of congenital sucrase-isomaltase deficiency (CSID)¹ ² ³ (designated an orphan drug by FDA for this use).^b

May be used as a short (e.g., 1-week) therapeutic trial to assess response in patients suspected of having CSID when the diagnosis is in doubt.¹ ²

Sucraid Dosage and Administration

Administration

Oral Administration

Administer orally with each meal or snack.¹ ² ³ ⁴

Use measuring scoop or dropper dispensing tip provided by manufacturer for measurement of the dose.¹ ² ³ ⁴

Dose must be diluted with 60–120 mL of water, milk, or infant formula prior to administration.¹ ² ⁴ Do not dilute or consume with fruit juice.¹ ² ⁴ (See Compatibility under Stability.)

Do not warm or heat diluents before or after addition of sacrosidase; decreased potency likely with heat.¹ ² ⁴ Administer cold or at room temperature.¹ ² ⁴

Administration with food and/or milk appears to diminish the degradation of the enzyme by intragastric pepsin.² (See Elimination under Pharmacokinetics.)

Administer half of each dose at the beginning of each meal or snack, and the other half at the end of meal or snack.¹ ² ³ ⁴

Dosage

Dosage expressed in international units (IU, units).¹ ² Each mL of sacrosidase contains 8500 units of the enzyme.¹ ²

Pediatric Patients

Congenital Sucrase-Isomaltase Deficiency

Oral

For patients weighing ≤15 kg: 8500 units (1 mL using the measuring scoop provided or 22 drops from the Sucraid container tip) with each meal or snack.¹ ² ³ ⁴

For patients weighing >15 kg: 17,000 units (2 mL using the measuring scoop provided or 44 drops from the Sucraid container tip) with each meal or snack.¹ ² ³ ⁴

Adults

Congenital Sucrase-Isomaltase Deficiency

Oral

17,000 units (2 mL using the measuring scoop provided or 44 drops from the Sucraid container tip) with each meal or snack.¹ ² ³ ⁴

Special Populations

No special population dosage recommendations at this time.^c

Cautions for Sucraid

Contraindications

Known hypersensitivity to yeast, yeast products, or glycerin (glycerol).¹ ²

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Serious hypersensitivity reactions (i.e., severe wheezing) reported 90 minutes after administration of a second dose.¹ ² ³

Administer initial doses near a facility where adequate treatment for acute hypersensitivity reactions can be obtained.¹ ² ⁴ Alternatively, perform skin testing to assess presence of hypersensitivity to sacrosidase.¹ ³

If hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen).¹ ³

General Precautions

Dietary Restriction of Starch

Sacrosidase does not provide replacement for isomaltase deficiency; restriction of dietary starch may be necessary to achieve greatest reduction in symptoms.¹ ² ⁴ Evaluate each patient treated to determine need for restriction of dietary starch.¹ ²

Acquired Disaccharidase Deficiencies

Not evaluated in patients with secondary (acquired) disaccharidase deficiencies.¹ ²

Diabetes Mellitus

Sacrosidase allows absorption of glucose and fructose (products of sucrose hydrolysis); careful consideration recommended in dietary planning in patients with diabetes mellitus.¹ ²

Specific Populations

Pregnancy

Category C.¹ ²

Lactation

Not distributed into milk; sacrosidase not absorbed intact into systemic circulation.²

Pediatric Use

Safety and efficacy established in pediatric patients; sacrosidase has been used in patients ≥5 months of age.³

Common Adverse Effects

Abdominal pain, vomiting, constipation, diarrhea, nausea, dehydration, headache, insomnia, nervousness.¹ ² ³ ⁴

Sucraid Pharmacokinetics

Absorption

Bioavailability

Not absorbed intact into systemic circulation.²

Elimination

Metabolism

Undergoes degradation to simple amino acids by pepsin produced by the GI mucosa; resultant amino acids and peptides are absorbed into systemic circulation as nutrients.¹ ²

Stability

Storage

Oral

Solution Concentrate

2–8°C; protect from heat and light.⁴ ^a Discard 4 weeks after opening.¹ ²

Compatibility

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

Oral

Solution Compatibility

May be diluted with water, milk, or infant formula.¹ ⁴ ^a

Do not dilute or consume with fruit juice; acidity may reduce enzyme activity.¹ ² ⁴

Actions

Replaces the deficient endogenous enzyme (sucrase) in patients with CSID.¹ ² ³

Hydrolyzes sucrose into glucose and fructose.¹

Advice to Patients

Importance of notifying clinician immediately if swelling of the face, difficulty breathing, wheezing, or other manifestations of an allergic reaction are experienced.¹ ² ⁴

Importance of storing sacrosidase oral solution in a refrigerator, protecting the bottle from heat and light,⁴ and discarding 4 weeks after first opening the bottle.¹ ²

Importance of taking sacrosidase as prescribed with each meal or snack.¹ ² ³ ⁴

Importance of rinsing the measuring cup with water after each use because of potential for bacterial growth.¹ ²

Importance of not diluting or consuming sacrosidase oral solution with fruit juice because of possible reduction in enzyme activity caused by juice acidity.¹ ² ⁴

Importance of not diluting sacrosidase oral solution in warm or hot beverages or heated infant formula because of possible heat-related reduction in enzyme activity.¹ ² ⁴

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

Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses, especially diabetes mellitus.^a

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

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

Sacrosidase
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For solution, concentrate	8500 units/mL	Sucraid	QOL

Disclaimer

References

1. Orphan Medical, Inc. Sucraid (sacrosidase) oral solution prescribing information. Minnetonka, MN; 1998 Apr.

2. Orphan Medical, Inc. Product monograph on Sucraid (sacrosidase) oral solution. Minnetonka, MN; 1998.

3. Treem WR, McAdams L, Stanford L et al. Sacrosidase therapy for congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr. 1999; 28:137`42. (IDIS 422478) [IDIS 422478] [PubMed 9932843]

4. Orphan Medical, Inc. Sucraid (sacrosidase) oral solution patient information. Minnetonka, MN; 1998 Apr.

a. QOL Medical, LLC. Sucraid (sarcrosidase) oral solution product information. In: Package Insert. From the DailyMed website (). Last revised 2006 Jun. Accessed 2007 Sept 28.

b. Food and Drug Administration. Cumulative list of orphan drugs designated and/or approved. Rockville, MD; 2007, Oct 3. From FDA web site (http: / / www.fda.gov / ForIndustry / DevelopingProductsforRareDiseasesConditions / HowtoapplyforOrphanProductDesignation / default.htm).

c. AHFS drug information 2007. McEvoy GK, ed. Sacrosidase. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2741-2.

More Sucraid resources

Sucraid Side Effects (in more detail)
Sucraid Use in Pregnancy & Breastfeeding
Sucraid Support Group
0 Reviews · Be the first to review/rate this drug

Sucraid Prescribing Information (FDA)

Sucraid Concise Consumer Information (Cerner Multum)

Sucraid Advanced Consumer (Micromedex) - Includes Dosage Information

Sucraid MedFacts Consumer Leaflet (Wolters Kluwer)

neomycin, polymyxin B, and prednisolone ophthalmic

Generic Name: neomycin, polymyxin B, and prednisolone ophthalmic (NEE oh MYE sin, POL ee MIX in B, and pred NIS oh lone off THAL mik)

Brand Names: Poly Pred

What is neomycin, polymyxin B, and prednisolone ophthalmic?

Neomycin and polymyxin B are antibiotics. They are used to treat bacterial infections.

Prednisolone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Neomycin /polymyxin B/prednisolone ophthalmic is used to treat bacterial infections of the eyes.

Neomycin, polymyxin B, and prednisolone ophthalmic may be used for purposes other than those listed in this medication guide.

What is the most important information I should know about neomycin, polymyxin B, and prednisolone ophthalmic?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Who should not use neomycin, polymyxin B, and prednisolone ophthalmic?

Do not use neomycin, polymyxin B, and prednisolone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether neomycin, polymyxin B, and prednisolone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether neomycin, polymyxin B, and prednisolone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use neomycin, polymyxin B, and prednisolone ophthalmic?

Use neomycin, polymyxin B, and prednisolone ophthalmic eye drops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using your eye drops.

To apply the eye drops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head slightly back and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye near your nose for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

Do not touch the dropper to any surface, including your hands or eyes. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eye drop that is discolored or has particles in it.

Store neomycin, polymyxin B, and prednisolone ophthalmic at room temperature away from heat and moisture. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using neomycin, polymyxin B, and prednisolone ophthalmic?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Neomycin, polymyxin B, and prednisolone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Neomycin, polymyxin B, and prednisolone ophthalmic side effects

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

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.

Neomycin, polymyxin B, and prednisolone ophthalmic Dosing Information

Usual Adult Dose for Uveitis:

Steroid-responsive inflammatory ocular conditions with superficial bacterial infection or risk of infection:
To treat eyes: Instill 1 or 2 drops in the conjunctival sac of the affected eye(s) every 3 to 4 hours, or more frequently depending on the severity of the condition.

To treat eyelids: Instill 1 or 2 drops in the affected eye every 3 to 4 hours, close the eye, and rub excess drops on the eyelid and lid margin.

Usual Adult Dose for Bacterial Conjunctivitis:

Usual Adult Dose for Keratitis:

Usual Adult Dose for Keratoconjunctivitis:

Usual Adult Dose for Blepharitis:

What other drugs will affect neomycin, polymyxin B, and prednisolone ophthalmic?

Avoid other eye medications unless they are approved by your doctor.

Although drug interactions between neomycin, polymyxin B, and prednisolone ophthalmic and drugs taken by mouth are not expected, they can occur. Be sure that your pharmacist and doctor know about any other medications that you are taking.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with neomycin, polymyxin B, and prednisolone ophthalmic.

More neomycin, polymyxin B, and prednisolone ophthalmic resources

Neomycin, polymyxin B, and prednisolone ophthalmic Side Effects (in more detail)
Neomycin, polymyxin B, and prednisolone ophthalmic Dosage
Neomycin, polymyxin B, and prednisolone ophthalmic Use in Pregnancy & Breastfeeding
Neomycin, polymyxin B, and prednisolone ophthalmic Drug Interactions
Neomycin, polymyxin B, and prednisolone ophthalmic Support Group
0 Reviews for Neomycin, polymyxin B, and prednisolone - Add your own review/rating

Compare neomycin, polymyxin B, and prednisolone ophthalmic with other medications

Blepharitis
Conjunctivitis, Bacterial
Keratitis
Keratoconjunctivitis
Uveitis

Where can I get more information?

Your pharmacist has additional information about neomycin, polymyxin B, and prednisolone ophthalmic written for health professionals that you may read.

See also: neomycin, polymyxin B, and prednisolone side effects (in more detail)

Thursday, 23 August 2012

Electrolyte

Pronunciation: e-LECK-troe-lite
Generic Name: Electrolyte
Brand Name: Examples include Medi-Lyte and Temp Tabs

Electrolyte is used for:

Decreasing fatigue, muscle cramps, or heat exhaustion due to excessive sweating. The use of Electrolyte for these conditions has not been evaluated or approved by the Food and Drug Administration. It may also be used for other conditions as determined by your doctor.

Electrolyte is an electrolyte combination. It works by replacing electrolytes in the body.

Do NOT use Electrolyte if:

you are allergic to any ingredient in Electrolyte

you have high blood potassium levels

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

Before using Electrolyte:

Some medical conditions may interact with Electrolyte. 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, or other substances

if you have heart disease, high blood pressure, fluid retention (eg, swelling of the hands, ankles, or feet), intestinal holes or punctures, difficulty urinating, kidney problems, or unexplained rectal bleeding

if you have severe or persistent vomiting or severe diarrhea, or you are dehydrated

if you have high levels of sodium in the blood

if you are unable to properly absorb glucose from food

Some MEDICINES MAY INTERACT with Electrolyte. However, no specific interactions with Electrolyte are known at this time.

Ask your health care provider if Electrolyte 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 Electrolyte:

Use Electrolyte as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Electrolyte with a full glass of water (8 oz/240 mL).

If you miss a dose of Electrolyte, 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 Electrolyte.

Important safety information:

If vomiting, fever, or stomach pain or bloating occurs, or if you have diarrhea that continues for longer than 24 hours, check with your doctor.

Electrolyte should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Electrolyte while you are pregnant. It is not known if Electrolyte is found in breast milk. If you are or will be breast-feeding while you use Electrolyte, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Electrolyte:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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.

See also: Electrolyte side effects (in more detail)

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 Electrolyte:

Store Electrolyte at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Electrolyte out of the reach of children and away from pets.

General information:

If you have any questions about Electrolyte, please talk with your doctor, pharmacist, or other health care provider.

Electrolyte 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 Electrolyte. 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

More Electrolyte resources

Electrolyte Side Effects (in more detail)
Electrolyte Support Group
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