Tuesday, October 25, 2016

Myambutol


Generic Name: Ethambutol Hydrochloride
Class: Antituberculosis Agents
VA Class: AM500
CAS Number: 1070-11-7

Introduction

Antituberculosis agent.103 106 a


Uses for Myambutol


Tuberculosis


Treatment of active (clinical) tuberculosis (TB) in conjunction with other antituberculosis agents.103 c d e


First-line agent for treatment of pulmonary TB; used in the initial intensive treatment phase.106


First-line agent for management of drug-resistant pulmonary TB.106


For initial treatment of active TB caused by drug-susceptible M. tuberculosis, recommended multiple-drug regimens consist of an initial intensive phase (2 months) and a continuation phase (4 or 7 months).106 109 Although the usual duration of treatment for drug-susceptible pulmonary and extrapulmonary TB (except disseminated infections and TB meningitis) is 6–9 months,106 109 ATS, CDC, and IDSA state that completion of treatment is determined more accurately by the total number of doses and should not be based solely on the duration of therapy.106 A longer duration of treatment (e.g., 12–24 months) usually is necessary for infections caused by drug-resistant M. tuberculosis.106 109


Patients with treatment failure or drug-resistant M. tuberculosis, including multidrug-resistant (MDR) TB (resistant to both isoniazid and rifampin) or extensively drug-resistant (XDR) TB (resistant to both isoniazid and rifampin and also resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial such as capreomycin, kanamycin, or amikacin), should be referred to or managed in consultation with experts in the treatment of TB as identified by local or state health departments or CDC.106


Mycobacterium avium Complex (MAC) Infections


Treatment of M. avium complex (MAC) infections† in conjunction with other antimycobacterials, including infections in HIV-infected adults, adolescents, or children†.107 c d


For initial treatment of nodular/bronchiectatic pulmonary disease caused by macrolide-susceptible MAC, ATS and IDSA recommend a 3-times weekly regimen of clarithromycin (or azithromycin), ethambutol, and rifampin in most patients.107 For initial treatment of fibrocavitary or severe nodular/bronchiectatic pulmonary disease caused by macrolide-susceptible MAC, ATS and IDSA recommend a daily regimen of clarithromycin (or azithromycin), ethambutol, and rifampin (or rifabutin) and state that consideration can be given to adding amikacin or streptomycin during the first 2–3 months of treatment for extensive (especially fibrocavitary) disease or when previous therapy has failed.107 Although a 2-drug regimen of clarithromycin (or azithromycin) and ethambutol may be adequate for treatment of nodular/bronchiectatic MAC disease in some patients, such regimens should not be used for fibrocavitary disease because of the risk of emergence of macrolide resistance.107


For treatment of disseminated MAC disease, including in HIV-infected individuals, ATS, CDC, NIH, and IDSA recommend a regimen of clarithromycin (or azithromycin) and ethambutol with or without rifabutin.107 c d


Treatment of MAC infections is complicated and should be directed by clinicians familiar with mycobacterial diseases; consultation with a specialist is particularly important when the patient cannot tolerate first-line drugs or when the infection has not responded to prior therapy or is caused by macrolide-resistant MAC.107


Prevention of recurrence (secondary prophylaxis) of disseminated MAC infections† in HIV-infected adults, adolescents, and children†.108 c d USPHS/IDSA, CDC, NIH, IDSA, and others recommend clarithromycin (or azithromycin) given with ethambutol (with or without rifabutin) for secondary prophylaxis after the initial infection has been treated.108 c


Not used for primary prevention (primary prophylaxis) of disseminated MAC infection in HIV-infected individuals.108 Drug of choice for primary prophylaxis is azithromycin or clarithromycin;107 108 rifabutin (with or without azithromycin) is an alternative.107 108


Mycobacterium kansasii and Other Mycobacterial Infections


Treatment of M. kansasii† infections in conjunction with other antimycobacterials.107 g ATS and IDSA recommend a regimen of isoniazid, rifampin, and ethambutol for treatment of pulmonary or disseminated infections caused by rifampin-susceptible M. kansasii.107 If rifampin-resistant M. kansasii are involved, ATS and IDSA recommend a 3-drug regimen based on results of in vitro susceptibility, including clarithromycin (or azithromycin), moxifloxacin, ethambutol, sulfamethoxazole, or streptomycin.107


Treatment of M. marinum† infections in conjunction with other antimycobacterials (e.g., clarithromycin and/or rifampin).107 i j l Optimum regimens not identified.107 i j l Monotherapy (minocycline, clarithromycin, doxycycline, co-trimoxazole) may be effective for superficial cutaneous infections,j but a multiple-drug regimen usually used for severe cutaneous infections or infections in immunocompromised individuals.i j


Treatment of M. xenopi† infections in conjunction with other antimycobacterials.107 Optimum regimens not established; in vivo response may not correlate with in vitro susceptibility.107 ATS and IDSA state that a regimen of clarithromycin, rifampin, and ethambutol generally has been used, although rate of relapse is high.107 A regimen of isoniazid, rifampin (or rifabutin), ethambutol, and clarithromycin (with or without streptomycin during initial treatment) also has been suggested.107


Myambutol Dosage and Administration


Administration


Oral Administration


Administer orally without regard to meals.103 e


Dosage


Available as ethambutol hydrochloride; dosage expressed in terms of the salt.103 e


Must be used in conjunction with other antimycobacterial agents for treatment of active (clinical) TB,103 108 e treatment or prevention of MAC infections†,107 108 c or treatment of other mycobacterial infections†.107


Can be used in daily or intermittent (e.g., 2 or 3 times weekly) multiple-drug TB regimens.106 109 c d


Pediatric Patients


Tuberculosis

Treatment of Active (Clinical) Tuberculosis in Children†

Oral

Children <15 years of age or weighing ≤40 kg†: 15–25 mg/kg once daily recommended by ATS, CDC, IDSA, AAP, and others.106 109 d h If an intermittent regimen is used, 50 mg/kg twice weekly.106 109 d h ATS, CDC, and IDSA recommend that children receive a maximum of 1 g per dose;106 d AAP and others recommend a maximum of 2.5 g per dose.109 h


Treatment of Active (Clinical) Tuberculosis in Adolescents

Oral

Adolescents ≥15 years of age weighing 40–55 kg: 800 mg daily, 2 g twice weekly, or 1.2 g 3 times weekly recommended by ATS, CDC, and IDSA.106


Adolescents ≥15 years of age weighing 56–75 kg: 1.2 g daily, 2.8 g twice weekly, or 2 g 3 times weekly recommended by ATS, CDC, and IDSA.106


Adolescents ≥15 years of age weighing 76-90 kg: 1.6 g daily, 4 g twice weekly, or 2.4 g 3 times weekly recommended by ATS, CDC, and IDSA.106


Adolescents: AAP and others recommend 15–25 mg/kg (up to 2.5 g) once daily or 50 mg/kg twice weekly (up to 2.5 g per dose).109 h


Mycobacterium avium Complex (MAC) Infections†

Treatment of Disseminated MAC in HIV-infected Children†

Oral

15–25 mg/kg (up to 1 g) once daily.d h Used in conjunction with clarithromycin (7.5–15 mg/kg [up to 500 mg] twice daily) or azithromycin (10–12 mg/kg [up to 500 mg] once daily) with or without rifabutin (10–20 mg/kg [up to 300 mg] once daily).d


Treatment of Disseminated MAC in HIV-infected Adolescents†

Oral

15 mg/kg once daily in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily).107 c


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

Oral

15 mg/kg (up to 900 mg) once daily.108 h Used in conjunction with clarithromycin (7.5 mg/kg [up to 500 mg] twice daily) or azithromycin (5 mg/kg [up to 250 mg] once daily) with or without rifabutin (5 mg/kg [up to 300 mg] once daily).108


Secondary prophylaxis to prevent MAC recurrence in HIV-infected children usually continued for life.108 The safety of discontinuing secondary MAC prophylaxis in children whose CD4+ T-cell count increases in response to antiretroviral therapy has not been studied.108


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

Oral

15 mg/kg (up to 900 mg) once daily.108 c h Used in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily).108 c


Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adolescents.108 c


Consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4+ T-cell count to >100/mm3 that has been sustained for ≥6 months.108 c Reinitiate prophylaxis if CD4+ T-cell count decreases to <100/mm3.108 c


Adults


Tuberculosis

Treatment of Active (Clinical) Tuberculosis

Oral

Manufacturers recommend 15 mg/kg once daily in previously untreated adults.103 e In previously treated adults, manufacturers recommend 25 mg/kg once daily for 60 days, followed by 15 mg/kg once daily.103 e


Adults weighing 40–55 kg: 800 mg once daily, 2 g twice weekly, or 1.2 g 3 times weekly recommended by ATS, CDC, and IDSA.106 c


Adults weighing 56–75 kg: 1.2 g once daily, 2.8 g twice weekly, or 2 g 3 times weekly recommended by ATS, CDC, and IDSA.106 c


Adults weighing 76-90 kg: 1.6 g once daily, 4 g twice weekly, or 2.4 g 3 times weekly recommended by ATS, CDC, and IDSA.106 c


Mycobacterium avium Complex (MAC) Infections†

Initial Treatment of Pulmonary MAC Infections (Nodular/bronchiectatic Disease) Caused by Macrolide-susceptible Strains†

Oral

25 mg/kg 3 times weekly in conjunction with rifampin (600 mg 3 times weekly) and either clarithromycin (1 g 3 times weekly) or azithromycin (500 mg 3 times weekly) recommended by ATS and IDSA.107 Continue until patient has been culture negative on treatment for 1 year.107


Intermittent (3-times weekly) regimen is not recommended for those with cavitary or moderate or severe disease or those who have been previously treated.107


Initial Treatment of Pulmonary MAC Infections (Fibrocavitary or Severe Nodular/bronchiectatic Disease) Caused by Macrolide-susceptible Strains†

Oral

15 mg/kg once daily in conjunction with either rifampin (10 mg/kg [up to 600 mg] once daily) or rifabutin (150–300 mg once daily) and either clarithromycin (0.5–1 g daily) or azithromycin (250 mg once daily) recommended by ATS and IDSA.107 Continue until patient has been culture negative on treatment for 1 year.107 Consideration can be given to including amikacin or streptomycin 3-times weekly during the first 2–3 months of treatment for extensive, especially fibrocavitary, disease or when previous therapy has failed.107


Treatment of Disseminated MAC in HIV-infected and Other Adults†

Oral

15 mg/kg once daily in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily) recommended by ATS, CDC, and IDSA.107 c


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

Oral

15 mg/kg once daily.108 c Used in conjunction with either clarithromycin (500 mg twice daily) or azithromycin (500 mg once daily) with or without rifabutin (300 mg once daily).108 c


Secondary prophylaxis to prevent MAC recurrence usually continued for life in HIV-infected adults.108


Consideration can be given to discontinuing such prophylaxis after ≥12 months in those who remain asymptomatic with respect to MAC and have an increase in CD4+ T-cell count to >100/mm3 that has been sustained for ≥6 months.108 c Reinitiate prophylaxis if CD4+ T-cell count decreases to <100/mm3.108 c


Mycobacterium kansasii and Other Mycobacterial Infections†

Treatment of Pulmonary or Disseminated Infections Caused by Rifampin-susceptible M. kansasii†

Oral

15 mg/kg once daily in conjunction with rifampin (10 mg/kg [up to 600 mg] daily), isoniazid (5 mg/kg [up to 300 mg] daily), and pyridoxine (50 mg daily) recommended by ATS and IDSA.107


Continue until patient has been culture negative on treatment for 1 year.107 A longer duration may be needed in HIV-infected individuals with disseminated infections.107


Treatment of M. marinum Infections†

Oral

15–25 mg/kg daily in conjunction with rifampin (600 mg daily) and/or clarithromycin.107 i j l


Optimal duration of treatment not known; continue for 3–6 months or until at least 1–2 months after resolution of symptoms.107 i j l


Prescribing Limits


Pediatric Patients


Tuberculosis

Treatment of Active (Clinical) Tuberculosis in Children†

Oral

Maximum 1 g per dose recommended by ATS, CDC, and IDSA for once-daily or twice-weekly regimens;106 d maximum 2.5 g per dose recommended by AAP and others for once-daily or twice-weekly regimens.109 h


Mycobacterium avium Complex (MAC) Infections in Children†

Oral

Maximum 1 g once daily for treatment of disseminated MAC infections.d Maximum 900 mg once daily for prevention of MAC recurrence (secondary prophylaxis).108


Special Populations


Renal Impairment


Reduce dosage based on degree of renal impairment and serum concentrations of the drug.103 106 c e h


Some experts recommend 15 mg/kg once every 24–36 hours in adults with Clcr 10–50 mL/minute, 15 mg/kg once every 48 hours in those with Clcr <10 mL/minute, and 15 mg/kg 3 times weekly (after hemodialysis) in those undergoing hemodialysis.c Others recommend 15–20 mg/kg 3 times weekly (after dialysis) in adults with end-state renal disease (Clcr <30 mL/minute, on hemodialysis).106


In children with renal impairment, some experts recommend that the usual dose be given once every 24 hours in those with Clcr >50 mL/minute or once every 24–36 hours in those with Clcr 10–50 mL/minute.h In children with Clcr <10 mL/minute, these experts recommend that a decreased dose be given once every 48 hours.h Supplemental doses are recommended after hemodialysis.h


Cautions for Myambutol


Contraindications



  • Known hypersensitivity to ethambutol or any ingredient in the formulation.103 e




  • Optic neuritis, unless clinical judgment deems it necessary to use the drug.103 e




  • Patients unable to appreciate and report visual adverse effects or changes in vision (e.g., young children, unconscious patients).103 (See Pediatric Use under Cautions.)



Warnings/Precautions


Warnings


Ocular Effects

Decreased visual acuity, constriction of visual fields, central and peripheral scotomas, and loss of red-green color discrimination reported.103 106 a e May be due to optic neuritis, but has occurred in the absence of a diagnosis of optic or retrobulbar neuritis.103 e May be related to dose and duration of treatment.103 106 e


Perform ophthalmic evaluation (ophthalmoscopy, finger perimetry, test for color discrimination) at baseline and periodically during treatment.103 106 e Test each eye separately and together since change in visual acuity may be unilateral or bilateral.103 e Evaluate monthly in patients receiving >15 mg/kg daily, in those receiving the drug for >2 months, and in those with renal impairment.103 106 e


Use with caution in patients with ocular defects (e.g., cataracts, recurrent ocular inflammatory conditions, optic neuritis, diabetic retinopathy) that make visual changes difficult to detect or evaluate; weigh benefits versus possible visual deterioration in these patients.103 e


Discontinue if substantial changes in visual acuity occur.103 e Changes in visual acuity usually reversible (over several weeks or months), but irreversible blindness has been reported.103 e


Hepatic Effects

Liver toxicities, including fatalities, have been reported.103


Perform baseline and periodic assessment of hepatic function.103 e


Sensitivity Reactions


Anaphylactoid reactions, dermatitis, pruritus reported.103


General Precautions


Precautions Related to Treatment of Tuberculosis

Should not be used alone for the treatment of active TB; must be given in conjunction with other antituberculosis agents.106


Clinical specimens for microscopic examination and mycobacterial cultures and in vitro susceptibility testing should be obtained prior to initiation of antituberculosis therapy and periodically during treatment to monitor therapeutic response.106 The antituberculosis regimen should be modified as needed.106 Patients with positive cultures after 4 months of treatment should be considered to have failed treatment (usually as the result of noncompliance or drug-resistant TB).106


Compliance with the full course of antituberculosis therapy and all drugs included in the multiple-drug regimen is critical.106 Missed doses increase the risk of treatment failure and increase the risk that M. tuberculosis will develop resistance to the antituberculosis regimen.106


To ensure compliance, ATS, CDC, IDSA, and AAP recommend that directly observed (supervised) therapy (DOT) be used for treatment of active (clinical) TB whenever possible, especially when intermittent regimens are used, when the patient is immunocompromised or infected with HIV, or when drug-resistant M. tuberculosis is involved.106 109 c d


Laboratory Monitoring

Assess organ system function (e.g., renal, hepatic, hematopoietic) at baseline and periodically during treatment.103 e


Specific Populations


Pregnancy

Category C.103


Ophthalmic abnormalities have been reported in infants born to women who received antituberculosis regimens that included ethambutol during pregnancy.103


The ATS, CDC, IDSA, AAP and others consider ethambutol safe for use in pregnant women;106 108 109 AAP states potential benefits outweigh the risks to the infant.109


Lactation

Distributed into milk; use only if possible benefits outweigh potential risks.103


AAP considers ethambutol compatible with breast-feeding.b


Pediatric Use

Safety not established in children <13 years of age; manufacturers do not recommend use in this age group.103 e Has been used in pediatric patients without unusual adverse effects.d


ATS, CDC, IDSA, and AAP state that ethambutol can be used safety in older children, but should be used with caution in children in whom it may be difficult to monitor visual acuity (e.g., <5 years of age).106 109 If used in pediatric patients, perform ophthalmic evaluations once monthly during treatment.d


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity in this age group cannot be ruled out.103


Hepatic Impairment

ATS, CDC, and IDSA state that ethambutol can be used safely in patients with hepatic disease.106


Renal Impairment

Use with caution; dosage reduction based on serum concentrations is advised.103 e Closely monitor visual acuity and color discrimination (i.e., monthly).103 106 (See Renal Impairment under Dosage and Administration.)


Common Adverse Effects


Ophthalmic effects (decreased visual acuity, scotoma, color blindness, visual defect), joint pain, GI effects (anorexia, nausea, vomiting, GI upset, abdominal pain), fever, malaise, headache, dizziness, mental confusion.103 e


Interactions for Myambutol


Specific Drugs












Drug



Interaction



Comments



Antacids



Aluminum-containing antacids: Decreased ethambutol serum concentrations and urinary excretion; possible decreased oral absorption of the antimycobacterial103



Administer aluminum-containing antacids ≥4 hours after ethambutol103



Rifabutin



Pharmacokinetic interaction unlikelyf


Myambutol Pharmacokinetics


Absorption


Bioavailability


75–80% of an oral dose is absorbed from the GI tract;a peak plasma concentrations achieved within 2–4 hours.103 e


Food


Food does not appear to affect absorption.103 e


Special Populations


Serum concentrations are higher in patients with renal impairment.a


Distribution


Extent


Widely distributed into most body tissues and fluids.a Highest concentrations are found in erythrocytes, kidneys, lungs, and saliva; lower drug concentrations are found in ascitic fluid, pleural fluid, brain, and CSF.a


Crosses the placenta and is distributed into cord blood and amniotic fluid.100


Distributed into milk.103


Plasma Protein Binding


8–22%.a


Elimination


Metabolism


Undergoes oxidation in the liver to an aldehyde intermediate which is converted to a dicarboxylic acid derivative.103 e


Elimination Route


Excreted in urine as unchanged drug (50%) and metabolites (8–15%) and in feces as unchanged drug (20–22%).103 e


Removed by peritoneal dialysis and to a lesser extent by hemodialysis.a


Half-life


3.3 hours.a


Special Populations


Half-life prolonged in patients with impaired renal or hepatic function.a Half-life may be ≥7 hours in patients with renal failure.a


Stability


Storage


Oral


Tablets

15–30°Ce or 20–25°C103 , depending on the manufacturer. Protect from light and moisture.e


Actions and SpectrumActions



  • Bacteriostatic in action.a




  • Appears to inhibit the synthesis of one or more metabolites in susceptible bacteria resulting in impairment of cellular metabolism, arrest of multiplication, and cell death.103 e




  • A highly specific agent; active only against Mycobacterium.103 a Active against M. tuberculosis,a M. avium complex (MAC),a M. bovis,a M. kansasii,107 a g and some strains of M. fortuitum.a Although M. marinum may be susceptible,107 a resistance has been reported.k Active in vitro against M. gordonae,107 M. malmoense,107 and M. smegmatis.107 Has limited activity against M. genavense.107 M. haemophilum107 and some strains of M. xenopi are resistant.107




  • Natural and acquired resistance to ethambutol demonstrated in vitro and in vivo in strains of M. tuberculosis.103 a




  • No evidence of cross-resistance with other currently available antimycobacterials.103 e



Advice to Patients



  • Advise patients that poor compliance with antituberculosis regimens can result in treatment failure and development of drug-resistant TB, which can be life-threatening and lead to other serious health risks.106




  • Importance of completing full course of therapy; importance of not missing any doses.103




  • Importance of promptly informing clinicians of any change in visual acuity.103 e




  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs, as well as any concomitant illnesses.103




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.103




  • Importance of informing patients of other important precautionary information.103 (See Cautions.)



Preparations


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




























Ethambutol Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



100 mg



Ethambutol Tablets



VersaPharm



Myambutol



X-Gen



400 mg



Ethambutol Tablets



Barr, VersaPharm



Myambutol (scored)



X-Gen


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.


Ethambutol HCl 400MG Tablets (VERSAPHARM): 30/$55.99 or 90/$153.98



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



100. Holdiness MR. Transplacental pharmacokinetics of the antituberculosis drugs. Clin Pharmacokinet. 1987; 13:125-9. [IDIS 233465] [PubMed 3304771]



102. Brock PG, Roach M. Antituberculosis drugs during pregnancy. Lancet. 1981; 1:102.



103. X-Gen. Myambutol (ethambutol hydrochloride) tablets USP prescribing information. Northport, NY; 2004 Jun.



104. Gulliford M, Mackay AD, Prowse K. Cholestatic jaundice caused by ethambutol. BMJ. 1986; 292:866. [IDIS 213885] [PubMed 3083914]



105. US Centers for Disease Control and Prevention. Initial therapy for tuberculosis in the era of multidrug resistance. Recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR Recomm Rep. 1993; 42(RR-7):1-8.



106. Centers for Disease Control and Prevention. Treatment of tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR Recomm Rep. 2003; 52(No. RR-11):1-77.



107. Griffith DE, Aksamit T, Brown-Elliott BA et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007; 175:367-416. [PubMed 17277290]



108. 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 ()



109. 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.



a. AHFS drug information 2007. McEvoy GK. Ethambutol. Bethesda, MD. American Society of Health-System Pharmacists;2007:550-2.



b. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia; PA: Lippincott Wiliams & Wilkins; 2002:509-10.



c. 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.



d. 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.



e. VersaPharm. Ethambutol hydrochloride tablets USP prescribing information. Marietta, GA; 2001 Feb.



f. Pfizer. Mycobutin (rifabutin) capsules USP prescribing information. New York, NY; 2006 Feb.



g. Shitrit D, Baum GL, Priess R et al. Pulmonary Mycobacterium kansasii infection in Israel, 1999-2004: clinical features, drug susceptibility, and outcome. Chest. 2006; 129:771-6. [PubMed 16537880]



h. Robertson J, Shilkofski N, eds. The Harriet Lane handbook: a manual for pediatric house officers. 17th ed. Philadelphia, PA: Elsevier Mosby: 2005:808-9,1058.



i. Lewis FM, Marsh BJ, von Reyn CF. Fish tank exposure and cutaneous infections due to Mycobacterium marinum: tuberculin skin testing, treatment, and prevention. Clin Infect Dis. 2003; 37:390-7. [PubMed 12884164]



j. Rallis E, Koumantaki-Mathioudaki E. Treatment of Mycobacterium marinum cutaneous infections. Exp Opin Pharmacother. 2007; 8:2965-78.



k. Aubry A, Jarlier V, Escolano S et al. Antibiotic susceptibility pattern of Mycobacterium marinum. Antimicrob Agents Chemother. 2000; 44:3133-6. [PubMed 11036036]



l. Edelstein H. Mycobacterium marinum skin infections. Report of 31 cases and review of the literature. Arch Intern Med. 1994; 154:1359-64. [PubMed 8002687]



More Myambutol resources


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Mycelex-G



Generic Name: clotrimazole vaginal (kloe TRIM a zole)

Brand Names: Femcare, Gyne-Lotrimin, Mycelex-G


What is Mycelex-G (clotrimazole vaginal)?

Clotrimazole is an antifungal medication. It prevents fungus from growing.


Clotrimazole vaginal is used to treat vaginal candida (yeast) infections.


Clotrimazole vaginal may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Mycelex-G (clotrimazole vaginal)?


Use this medication for the full amount of time prescribed by your doctor or recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.


Avoid getting this medication in your eyes, nose, or mouth.

Who should not use Mycelex-G (clotrimazole vaginal)?


Do not use clotrimazole vaginal if you have ever had an allergic reaction to it.


If this is the first time that you have ever had symptoms of a vaginal yeast infection, consult your doctor before using this medication.


Do not use clotrimazole vaginal if you have a fever, abdominal pain, foul-smelling discharge, diabetes, HIV, or AIDS. Consult your doctor.


Do not use this medication without first talking to your doctor if you are pregnant. Do not use clotrimazole vaginal without first talking to your doctor if you are breast-feeding a baby. Do not use this medication if you are younger than 12 years of age.

How should I use Mycelex-G (clotrimazole vaginal)?


Use clotrimazole vaginal exactly as directed by your doctor, or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.


Insert the tablet, suppository, or cream into the vagina using the applicator as directed.


Use this medication continuously for the prescribed amount of time, even during your menstrual period.


You can use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.


If the infection does not clear up after you have finished one course of therapy, or if it appears to get worse, see your doctor. You may have another type of infection.


Avoid getting this medication in your eyes, nose, or mouth. Store clotrimazole vaginal at room temperature away from moisture and heat.

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 dose, skip the dose you missed and apply only your next regularly scheduled dose. Do not use a double dose of this medication.


What happens if I overdose?


An overdose of clotrimazole vaginal is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that clotrimazole vaginal has been ingested, contact an emergency room or a poison control center.


What should I avoid while using Mycelex-G (clotrimazole vaginal)?


Avoid wearing tight-fitting, synthetic clothing (e.g., panty hose) that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.


Avoid sexual intercourse or use a condom to prevent the infection from spreading to your partner.


Mycelex-G (clotrimazole vaginal) side effects


Stop using clotrimazole vaginal and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

Other, less serious side effects may be more likely to occur. These include burning, itching, irritation of the skin, and an increased need to urinate.


Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Mycelex-G (clotrimazole vaginal)?


Avoid using other vaginal creams or douches at the same time as clotrimazole unless your doctor approves.


Drugs other than those listed here may also interact with clotrimazole vaginal. Talk to your doctor and pharmacist before taking any prescription or over the counter medicines.



More Mycelex-G resources


  • Mycelex-G Use in Pregnancy & Breastfeeding
  • Mycelex-G Support Group
  • 2 Reviews for Mycelex-G - Add your own review/rating


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

  • Gyne-Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mycelex Prescribing Information (FDA)



Compare Mycelex-G with other medications


  • Cutaneous Candidiasis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor
  • Vaginal Yeast Infection


Where can I get more information?


  • Your pharmacist has additional information about clotrimazole vaginal written for health professionals that you may read.


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Mycifradin


Generic Name: neomycin (nee oh MY sin)

Brand Names: Mycifradin, Neo-Fradin, Neo-Tab


What is Mycifradin (neomycin)?

Neomycin is an antibiotic.


Neomycin is used to reduce the risk of infection during surgery of the bowel. Neomycin is also used to reduce the symptoms of hepatic coma.


Neomycin may also be used for purposes other than those listed here.


What is the most important information I should know about Mycifradin (neomycin)?


Neomycin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience decreased urination, hearing loss, ringing in the ears, feeling of fullness in the ears, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of kidney or nerve damage.


What should I discuss with my healthcare provider before taking Mycifradin (neomycin)?


Do not take neomycin without first talking to your doctor if you have
  • kidney disease;


  • a blockage in the intestines;




  • bowel disease such as Crohn's disease or ulcerative colitis;




  • a neuromuscular disorder such as Parkinson's disease or myasthenia gravis;




  • hearing loss or loss of balance due to ear problems; or




  • other medical problems or if you take other medications.



You may not be able to take neomycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Neomycin is in the FDA pregnancy category D. This means that it is known to be harmful to an unborn baby. Do not take neomycin without first talking to you doctor if you are pregnant or could become pregnant during treatment. It is not known whether neomycin passes into breast milk. Do not take neomycin without first talking to your doctor if you are breast-feeding a baby.

How should I take Mycifradin (neomycin)?


Take neomycin exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.


Take each oral dose with a full glass of water. Shake the liquid form of neomycin well before measuring a dose. To ensure that you get a correct dose, measure the suspension with a dose-measuring spoon, dropper, or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

It is important to take neomycin on a regular schedule to get the most benefit.


Take all of the neomycin that has been prescribed for you even if you feel well. It is important to take this medication for the full amount of time prescribed.

Neomycin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience decreased urination, hearing loss, ringing in the ears, feeling of fullness in the ears, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of kidney or nerve damage.


Store neomycin at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of an neomycin overdose may include decreased hearing, numbness or tingling, muscle twitching, seizures, and decreased urination.


What should I avoid while taking Mycifradin (neomycin)?


There are no restrictions on food, beverages, or activity while taking neomycin unless otherwise directed by your doctor.


Mycifradin (neomycin) side effects


If you experience any of the following serious side effects, stop taking neomycin and seek emergency medical attention:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);




  • little or no urine;




  • decreased hearing, ringing in the ears, or a feeling of fullness in the ears;




  • dizziness, clumsiness, or unsteadiness;




  • numbness, skin tingling, muscle twitching, or seizures; or




  • severe watery diarrhea and abdominal cramps.



Other, less serious side effects may be more likely to occur. Continue to take neomycin and talk to your doctor if you experience



  • nausea or vomiting; or




  • diarrhea.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Mycifradin (neomycin)?


Other drugs, especially those that affect the kidneys, can interact with neomycin resulting in dangerous side effects and/or decreased effectiveness. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, without first talking to your doctor during treatment with neomycin.



More Mycifradin resources


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


  • Neomycin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Neo-Fradin Prescribing Information (FDA)

  • Neo-Fradin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Neo-Fradin Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Neomycin Sulfate Monograph (AHFS DI)



Compare Mycifradin with other medications


  • Bowel Preparation
  • Diarrhea
  • Hepatic Coma
  • Hepatic Encephalopathy


Where can I get more information?


  • Your pharmacist has additional information about neomycin written for health professionals that you may read.

See also: Mycifradin side effects (in more detail)


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Mycelex Troche


Generic Name: clotrimazole (kloe TRIM a zole)

Brand Names: Mycelex Troche


What is Mycelex Troche (clotrimazole)?

Clotrimazole is an antifungal medication. It is like an antibiotic but is used to treat yeast (fungal) infections.


Oral clotrimazole is used to treat and prevent yeast infections of the mouth and throat.


Clotrimazole may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Mycelex Troche (clotrimazole)?


Take all of the clotrimazole that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

What should I discuss with my healthcare provider before taking Mycelex Troche (clotrimazole)?


Before taking this medication, tell your doctor if you have liver disease. You may not be able to take clotrimazole, or you may need a lower dose or special monitoring during treatment.


Clotrimazole is not absorbed through your stomach. It will not treat fungal infections in any part of your body other than your mouth and throat. Talk to your doctor if you have another type of fungal infection such as athlete's foot, jock itch, ringworm, or a vaginal yeast infection.


Oral clotrimazole is in the FDA pregnancy category C. This means that it is not known whether clotrimazole will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether clotrimazole will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. The safety and effectiveness of clotrimazole have not been established for children younger than 3 years of age.

How should I take Mycelex Troche (clotrimazole)?


Take clotrimazole exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.


The troches should be allowed to dissolve slowly in your mouth. Suck on one troche at a time until it is completely dissolved, usually 30 minutes.


Do not chew or swallow the troches whole.

The troches are usually used five times a day. Follow your doctor's instructions.


Store clotrimazole at room temperature away from moisture and heat.


What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a clotrimazole overdose are unknown.


What should I avoid while taking Mycelex Troche (clotrimazole)?


There are no restrictions on foods, beverages, or activities during treatment with clotrimazole unless your doctor directs otherwise.


Mycelex Troche (clotrimazole) side effects


Stop taking clotrimazole and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Side effects are not likely to occur with clotrimazole. Continue to take clotrimazole and talk to your doctor if you experience



  • nausea or stomach upset,




  • vomiting,




  • itching, or




  • an unpleasant sensation in the mouth.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Mycelex Troche (clotrimazole)?


Since clotrimazole is not absorbed by your body, drug interactions are not expected. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines.



More Mycelex Troche resources


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


  • Mycelex Troche Advanced Consumer (Micromedex) - Includes Dosage Information

  • Clotrimazole Prescribing Information (FDA)

  • Clotrimazole Professional Patient Advice (Wolters Kluwer)

  • Clotrimazole Monograph (AHFS DI)

  • Clotrimazole Cream MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Mycelex Troche with other medications


  • Oral Thrush


Where can I get more information?


  • Your pharmacist has additional information about clotrimazole written for health professionals that you may read.

See also: Mycelex Troche side effects (in more detail)


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Myambutol


Generic Name: ethambutol (eth AM bue tol)

Brand Names: Myambutol


What is Myambutol (ethambutol)?

Ethambutol is an antibiotic. It prevents growth of the tuberculous bacteria in the body.


Ethambutol is used to treat tuberculosis (TB).


Ethambutol may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Myambutol (ethambutol)?


Take all of the ethambutol that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Call your doctor immediately if you experience changes in vision (e.g., blurring, red-green color blindness) or a rash.


What should I discuss with my healthcare provider before taking Myambutol (ethambutol)?


Before taking this medication, tell your doctor if you have



  • ever had an allergic reaction to ethambutol;




  • cataracts, diabetic retinopathy, or optic neuritis; or




  • kidney disease.



You may not be able to take ethambutol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


It is not known whether ethambutol will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is also not known whether ethambutol will be harmful to a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Myambutol (ethambutol)?


Take ethambutol exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass (8 ounces) of water.

Ethambutol can be taken with or without food. Taking ethambutol with food may decrease stomach upset.


Take all of the ethambutol that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethambutol is usually combined with one or more other tuberculosis medicines.


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

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of an ethambutol overdose are unknown.


What should I avoid while taking Myambutol (ethambutol)?


There are no restrictions on foods, beverages, or activities during treatment with ethambutol unless otherwise directed by your doctor.


Myambutol (ethambutol) side effects


If you experience any of the following serious side effects, stop taking ethambutol and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);




  • vision changes (e.g., blurring, red-green color blindness);




  • a rash;




  • numbness or tingling in your fingers, toes, hands, or feet;




  • confusion, disorientation, or hallucinations; or




  • fever.



Other, less serious side effects may be more likely to occur. Continue to take ethambutol and talk to your doctor if you experience



  • stomach upset, nausea, vomiting, abdominal pain, or decreased appetite;




  • headache;




  • mild dizziness;




  • worsening gout; or




  • joint pain.



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 Myambutol (ethambutol)?


Do not take antacids that contain aluminum within several hours of taking a dose of ethambutol. Aluminum will decrease the amount of ethambutol that is absorbed by the body. If you need an antacid, ask your doctor or pharmacist to recommend one that is aluminum free.


Drugs other than those listed here may also interact with ethambutol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More Myambutol resources


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


  • Myambutol Monograph (AHFS DI)

  • Myambutol Advanced Consumer (Micromedex) - Includes Dosage Information

  • Myambutol MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ethambutol Prescribing Information (FDA)



Compare Myambutol with other medications


  • Mycobacterium avium-intracellulare, Prophylaxis
  • Mycobacterium avium-intracellulare, Treatment
  • Tuberculosis, Active


Where can I get more information?


  • Your pharmacist can provide more information about ethambutol.

See also: Myambutol side effects (in more detail)


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Mycostatin Topical


Generic Name: nystatin (Topical route)

nye-STAT-in

Commonly used brand name(s)

In the U.S.


  • Mycostatin

  • Nystop

  • Pedi-Dri

In Canada


  • Mycostatin Cream

  • Mycostatin Ointment

  • Mycostatin Powder

  • Nadostine

  • Nilstat Topical Cream

  • Nilstat Topical Ointment

  • Nyaderm Cream

  • Nyaderm Ointment

Available Dosage Forms:


  • Powder

  • Cream

  • Ointment

Therapeutic Class: Antifungal


Chemical Class: Polyene


Uses For Mycostatin


Nystatin belongs to the group of medicines called antifungals. Topical nystatin is used to treat some types of fungus infections of the skin.


Nystatin is available in the U.S. only with your doctor's prescription.


Before Using Mycostatin


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:


Allergies


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.


Pediatric


Although there is no specific information comparing use of topical nystatin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical nystatin in the elderly with use in other age groups.


Interactions with Medicines


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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Proper Use of nystatin

This section provides information on the proper use of a number of products that contain nystatin. It may not be specific to Mycostatin. Please read with care.


Topical nystatin should not be used in the eyes.


Apply enough nystatin to cover the affected area.


For patients using the powder form of this medicine on the feet:


  • Sprinkle the powder between the toes, on the feet, and in socks and shoes.

The use of any kind of occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine may increase the chance of irritation. Therefore, do not bandage, wrap, or apply any occlusive dressing over this medicine unless directed to do so by your doctor. When using this medicine on the diaper area of children, avoid tight-fitting diapers and plastic pants.


To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.


Dosing


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


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


  • For topical dosage forms (cream or ointment):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two times a day.



  • For topical dosage form (powder):
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two or three times a day.



Missed Dose


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


Storage


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.


Mycostatin Side Effects


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 as soon as possible if any of the following side effects occur:


  • Skin irritation not present before use of this medicine

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: Mycostatin Topical side effects (in more detail)



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


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Mycostatin Topical resources


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


  • Mycostatin Topical Concise Consumer Information (Cerner Multum)

  • Nyamyc Prescribing Information (FDA)

  • Nystop Prescribing Information (FDA)

  • Nystop Powder MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pediaderm AF Cream MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Mycostatin Topical with other medications


  • Cutaneous Candidiasis
  • Vaginal Yeast Infection

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Mycophenolate Mofetil Capsules


Pronunciation: MYE-koe-FEN-oh-late MOE-fe-til
Generic Name: Mycophenolate Mofetil
Brand Name: CellCept

Mycophenolate Mofetil Capsules weakens your immune system, which may decrease your ability to fight illness or infection. It may also increase the risk of certain types of cancer (eg, lymphoma). Use Mycophenolate Mofetil Capsules only under close medical supervision.


Mycophenolate Mofetil Capsules may cause birth defects or fetal death if taken during pregnancy. Women who may become pregnant must use an effective form of birth control while they are taking Mycophenolate Mofetil Capsules.





Mycophenolate Mofetil Capsules is used for:

Preventing organ rejection following kidney, liver, or heart transplants. Mycophenolate Mofetil Capsules is used in combination with other medicines. It may also be used for other conditions as determined by your doctor.


Mycophenolate Mofetil Capsules is an immunosuppressant. It works by decreasing the activity of certain cells that make up part of the immune system to help reduce the risk of organ transplant rejection.


Do NOT use Mycophenolate Mofetil Capsules if:


  • you are allergic to any ingredient in Mycophenolate Mofetil Capsules or to mycophenolic acid

  • you are taking azathioprine, cholestyramine, colestipol, or another medicine that contains mycophenolate or mycophenolic acid

  • you are taking norfloxacin and metronidazole together

  • you have a rare hereditary deficiency of hypoxanthine guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome

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



Before using Mycophenolate Mofetil Capsules:


Some medical conditions may interact with Mycophenolate Mofetil Capsules. 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 immune system problems or have been taking another medicine that may suppress your immune system

  • if you have stomach or intestinal problems (eg, ulcers), or kidney problems

  • if you have a personal or family history of skin cancer, blood cancer (eg, lymphoma), or other blood problems

  • if you are scheduled for a vaccination

  • if you will be in close contact with a person who has shingles, another type of herpes infection, or cytomegalovirus (CMV) infection

Some MEDICINES MAY INTERACT with Mycophenolate Mofetil Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Acyclovir, azathioprine, ganciclovir, mycophenolate acid, or probenecid because they may increase the risk of Mycophenolate Mofetil Capsules's side effects

  • Cholestyramine, colestipol, cyclosporine, norfloxacin along with metronidazole, or rifampin because they may decrease Mycophenolate Mofetil Capsules's effectiveness

  • Live vaccines or oral contraceptives because their effectiveness may be decreased by Mycophenolate Mofetil Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mycophenolate Mofetil Capsules 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 Mycophenolate Mofetil Capsules:


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


  • Mycophenolate Mofetil Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Mycophenolate Mofetil Capsules refilled.

  • Take Mycophenolate Mofetil Capsules by mouth on an empty stomach at least 1 hour before or 2 hours after eating unless your doctor tells you otherwise.

  • Swallow Mycophenolate Mofetil Capsules whole. Do not break, crush, chew, or open the capsule before swallowing. If capsules are opened accidentally, do not inhale or touch the powder contained inside the capsules. If contact occurs, wash the contact area immediately with soap and water; rinse eyes with plain water.

  • Do not take an antacid that has aluminum or magnesium in it within 3 hours of Mycophenolate Mofetil Capsules.

  • If you take a calcium-free phosphate binder (eg, sevelamer), take it 2 hours after taking Mycophenolate Mofetil Capsules.

  • If you miss a dose of Mycophenolate Mofetil Capsules, 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 Mycophenolate Mofetil Capsules.



Important safety information:


  • Mycophenolate Mofetil Capsules may cause blurred vision, drowsiness, or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Mycophenolate Mofetil Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Women who may become pregnant must have a negative pregnancy test within 1 week before starting Mycophenolate Mofetil Capsules.

  • Women who may become pregnant must use 2 effective forms of birth control for 4 weeks before they start Mycophenolate Mofetil Capsules, during treatment, and for 6 weeks after they stop Mycophenolate Mofetil Capsules. Check with your doctor if you have any questions about effective birth control.

  • Hormonal birth control (eg, birth control pills) may not work as well while you are taking Mycophenolate Mofetil Capsules. Discuss any questions or concerns with your doctor.

  • Mycophenolate Mofetil Capsules may increase your risk of developing certain types of cancer (eg, lymphoma, skin cancer). Avoid the sun, sunlamps, or tanning booths while you take Mycophenolate Mofetil Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Tell your doctor right away if you notice a change in the size or color of a mole, or if you develop any new or unusual skin growths.

  • Mycophenolate Mofetil Capsules may lower the ability of your body to fight infection and may increase the risk of severe or fatal infections. Avoid contact with people who have colds, shingles, other herpes infections, cytomegalovirus (CMV), or other infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.

  • Some patients treated with Mycophenolate Mofetil Capsules have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. Discuss any questions or concerns with your doctor.

  • Tell your doctor right away if you notice symptoms of PML (eg, confusion or disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination).

  • Tell your doctor right away if you notice symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Discuss any questions or concerns with your doctor.

  • Some patients treated with Mycophenolate Mofetil Capsules have developed a type of anemia called pure red cell aplasia (PRCA). Contact your doctor right away if you experience severe or persistent tiredness or weakness, sluggishness, or unusually pale skin.

  • Mycophenolate Mofetil Capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

  • Diarrhea may occur with Mycophenolate Mofetil Capsules. If you develop diarrhea, check with your doctor or pharmacist about ways to lessen this effect. Do not stop Mycophenolate Mofetil Capsules without talking with your doctor.

  • Do not change brands or doseforms (eg, tablets, suspension, injection) of Mycophenolate Mofetil Capsules without talking with your doctor.

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Mycophenolate Mofetil Capsules. Talk with your doctor before you receive any vaccine.

  • Lab tests, including complete blood cell counts and kidney function, may be performed while you use Mycophenolate Mofetil Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Mycophenolate Mofetil Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially infection, stomach or intestinal bleeding, and trouble breathing.

  • Caution is advised when using Mycophenolate Mofetil Capsules in CHILDREN; they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: Mycophenolate Mofetil Capsules may cause birth defects or fetal death if you take it while you are pregnant. Do not become pregnant while you are taking Mycophenolate Mofetil Capsules. If you think you may be pregnant, contact your doctor right away. It is not known if Mycophenolate Mofetil Capsules is found in breast milk. Do not breast-feed while taking Mycophenolate Mofetil Capsules.


Possible side effects of Mycophenolate Mofetil Capsules:


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:



Anxiety; back pain; constipation; cough; diarrhea; dizziness; headache; loss of appetite; mild stomach pain; mild tiredness or weakness; nausea; tremor; trouble sleeping; upset stomach; vomiting.



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); blood in the urine; bloody or black stools; change in the amount of urine produced; chest pain or pounding in the chest; fainting; irregular heartbeat; mental or mood changes (eg, abnormal thinking); night sweats; numbness, tingling, or swelling of the arms, legs, hands, ankles, or feet; severe headache, dizziness, or blurred vision; severe vomiting or stomach pain; shortness of breath; sluggishness; swollen glands; symptoms of infection (eg, fever, chills, cough, sore throat); symptoms of urinary tract infection (eg, blood in the urine; difficult, frequent, or painful urination; lower stomach or back pain); unusual bruising or bleeding; unusual or persistent tiredness or weakness; unusual skin lumps or growths; unusual weight loss; unusually pale skin; vomiting blood that looks like coffee grounds; white patches in the mouth or throat; 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: Mycophenolate Mofetil 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. Symptoms may include diarrhea; nausea; vomiting.


Proper storage of Mycophenolate Mofetil Capsules:

Store Mycophenolate Mofetil Capsules at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mycophenolate Mofetil Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Mycophenolate Mofetil Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Mycophenolate Mofetil Capsules 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 Mycophenolate Mofetil Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mycophenolate Mofetil resources


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


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