muscle mass [15:59 years of age: Maximum 750 mg per dose in once-daily or 2- or 3-times weekly regimens. 100 Special Populations Renal Impairment Reduce dosage based on the degree of renal impairment. 100 102 Use with caution and monitor serum capreomycin concentrations. 100 102 (See Ototoxicity and Nephrotoxicity under Cautions.) Manufacturer recommends that dosage in adults with renal impairment be based on Cl cr and adjusted to maintain mean steady-state serum capreomycin concentrations of 10 mcg/mL. 102 Consult manufacturer's literature for specific dosage recommendations for these patients. 102 Some experts suggest a reduced dosage of 12 15 mg/kg given 2 or 3 times weekly. 100 Doses in patients undergoing hemodialysis should be given after dialysis since the drug is removed by this procedure. 100 Geriatric Patients Manufacturer states no dosage adjustments except those related to renal impairment. 102 Select dosage with caution (usually starting at low end of dosage range). 102 (See Geriatric Use under Cautions.) Adults >59 years of age: ATS, CDC, and IDSA recommend 10 mg/kg (up to 750 mg) per dose. 100 (See Geriatric Use under Cautions.) Cautions for Capastat Contraindications Hypersensitivity to capreomycin. 102 Warnings/Precautions Warnings Ototoxicity and Nephrotoxicity Nephrotoxicity and ototoxicity, the most serious adverse effects of capreomycin, a are most likely to occur in patients with renal impairment, in geriatric patients, and in patients receiving other nephrotoxic and/or ototoxic drugs. 102 a (See Interactions.) Renal toxicity may be manifested by tubular necrosis, increased BUN, increased S cr , decreased Cl cr , abnormal urinary sediment, proteinuria, and presence of casts, erythrocytes, and leukocytes in the urine. 102 a Usually reversible when the drug is discontinued, but fatal toxic nephritis has occurred rarely. a Nephrotoxicity is most closely related to AUC of the drug. 102 Electrolyte disturbances resembling Bartter s syndrome reported rarely. 102 May cause damage to both the auditory and vestibular portions of the eighth-cranial nerve. a Some audiometric changes have been reversible, but hearing loss that was permanent (but not progressive) has been reported. 102 Injury to the vestibular branch of the eighth-cranial nerve has resulted in headache, tinnitus, and vertigo. a Damage to auditory and vestibular divisions of the eighth-cranial nerve generally associated with capreomycin therapy in patients with impaired renal function or dehydration or those receiving other drugs with additive auditory toxicities; these patients often experience dizziness, tinnitus, vertigo, and a loss of high-tone acuity. 102 Assess renal, auditory, and vestibular function prior to and at regular intervals during capreomycin therapy. 102 Manufacturer recommends that renal function be monitored once weekly. 102 (See Geriatric Use under Cautions.) BUN concentrations >30 mg/dL or any other evidence of decreasing renal function (with or without an increase in BUN) requires careful evaluation; dosage should be decreased or the drug discontinued. 102 Clinical importance of abnormal urine sediment and slightly increased BUN (or S cr ) during long-term capreomycin therapy not established. 102 Use with extreme caution in patients with renal insufficiency or auditory impairment; weigh the risk of additional renal impairment or eighth cranial nerve damage against the possible benefits of capreomycin therapy. 102 Neuromuscular Blockade Partial neuromuscular blockade, which was enhanced by ether anesthesia and antagonized by neostigmine, has been reported with large IV doses of capreomycin. 102 Neuromuscular blockade or respiratory paralysis may occur following rapid IV infusion. 102 Sensitivity Reactions Hypersensitivity Reactions Hypersensitivity reactions (e.g., urticaria, photosensitivity, maculopapular rash), which may be associated with fever, have occurred. 102 a Use with caution in patients with a history of allergic reaction, especially to drugs. 102 General Precautions Precautions Related to Treatment of Tuberculosis Should not be used alone for treatment of active (clinical) TB; must be given in conjunction with other antituberculosis agents. 100 101 102 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. 100 102 The antituberculosis regimen should be modified as needed. 100 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). 100 If added as a new drug to a regimen in patients experiencing treatment failure who have proven or suspected drug-resistant TB, at least 2 (preferably 3) new drugs known or expected to be active against the resistant strain should be added at the same time. 100 Compliance with the full course of antituberculosis therapy and all drugs included in the multiple-drug regimen is critical. 100 Missed doses increase the risk of treatment failure and increase the risk that M. tuberculosis will develop resistance to the antituberculosis regimen. 100 To ensure compliance, ATS, CDC, IDSA, and AAP recommend that directly observed (supervised) therapy (DOT) be used for treatment of active 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. 100 101 Laboratory Monitoring Monitor renal function prior to and once weekly during capreomycin treatment. 102 Monitor hepatic function periodically. 102 Monitor serum potassium concentrations since hypokalemia may occur. 102 Some experts recommend that serum potassium and magnesium be assessed at baseline and at least once monthly. 100 Specific Populations Pregnancy Category C. 102 ATS, CDC, and IDSA state that use of capreomycin should be avoided during pregnancy because of risk of fetal nephrotoxicity and ototoxicity. 100 Lactation Not known whether capreomycin is distributed into milk. 102 Use caution in nursing women. 102 Pediatric Use Safety and efficacy not established. 102 Geriatric Use No evidence that patients 65 years of age respond differently than younger adults. 102 Select dosage with caution (usually starting at low end of dosage range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy. 102 Substantially eliminated by kidneys; risk of toxicity may be greater in patients with impaired renal function. 102 Monitor renal function since geriatric patients are more likely to have renal impairment. 102 (See Renal Impairment under Dosage and Administration.) Because geriatric patients are more likely to have impaired hearing at baseline, perform audiometric measurements and assess vestibular function prior to and at regular intervals during capreomycin therapy. 102 Renal Impairment Use with caution because of risk of nephrotoxicity and/or neurotoxicity. 100 102 Dosage adjustments required in those with known or suspected renal impairment. 100 102 If BUN concentrations increase to >30 mg/dL or there is any other evidence of decreasing renal function (with or without an increase in BUN), the patient should be carefully evaluated and capreomycin dosage reduced or the drug discontinued. 102 Common Adverse Effects Nephrotoxicity, ototoxicity, injection site reactions. 102 Interactions for Capastat Ototoxic or Nephrotoxic Drugs Concomitant or sequential use with other drugs that have ototoxic or nephrotoxic effects may result in additive toxicity and should be avoided, if possible. 102 Use concomitantly only with great caution. 102 Specific Drugs Drug Interaction Comments Aminoglycosides Possible increased risk of ototoxicity or nephrotoxicity 102 Concomitant use with streptomycin not recommended; 102 use concomitantly with other aminoglycosides (amikacin, gentamicin, kanamycin, neomycin, tobramycin) only with great caution 102 Colistimethate/Colistin Possible increased risk of nephrotoxicity and/or neurotoxicity 102 Use concomitantly only with great caution 102 Neuromuscular blocking agents Possible potentiation of neuromuscular blockade 102 Polymyxin B Possible increased risk of nephrotoxicity and/or neurotoxicity 102 Use concomitantly only with great caution 102 Vancomycin Possible increased risk of nephrotoxicity and/or neurotoxicity 102 Use concomitantly only with great caution 102 Capastat Pharmacokinetics Absorption Bioavailability Not appreciably absorbed from the GI tract; must be given parenterally. 102 Following IM administration, peak serum concentrations attained within 1 2 hours. 102 Plasma Concentrations Peak serum concentrations after IV infusion are 30% higher than those following IM injection; 102 AUC is similar for both routes. 102 No evidence of accumulation in plasma in patients with normal renal function. 102 Distribution Extent Information not available on distribution of capreomycin into body tissues or fluids. a Does not distribute into CSF. 100 Not known if capreomycin crosses the placenta or is distributed into milk. 102 a Elimination Elimination Route Eliminated mainly unchanged in urine by glomerular filtration. a Animal studies suggest small amounts may also be excreted in bile. a Approximately 52% of an IM dose is excreted in urine within 12 hours. 102 Removed by hemodialysis. 102 Half-life 4 6 hours in patients with normal renal function. a Special Populations Half-life prolonged in patients with impaired renal function. a Stability Storage Parenteral Powder for Injection 15 30 C. 102 Following reconstitution with 0.9% sodium chloride injection or sterile water for injection, solutions may be stored for up to 24 hours in a refrigerator. 102 Capreomycin solutions may develop a pale straw color and darken with time; this is not associated with loss of potency or development of toxicity. 102 Actions and Spectrum Usually bacteriostatic in action. a Mechanism of antibacterial action not known. a Spectrum of activity includes many mycobacterium and some gram-positive and -negative bacteria. a Mycobacteria: Active against M. tuberculosis , M. bovis , and M. avium complex (MAC). a M. kansasii generally is resistant. 107 108 Natural and acquired resistance to capreomycin demonstrated in vitro and in vivo in strains of M. tuberculosis . 103 104 a Cross-resistance frequently occurs between capreomycin and viomycin (not commercially available in the US); 102 104 cross-resistance also can occur between capreomycin and kanamycin or neomycin. 102 104 No evidence of cross-resistance between capreomycin and other antituberculosis agents available in the US. 102 There have been recent reports of extensively drug-resistant (XDR) TB. 105 106 XDR TB is caused by M. tuberculosis resistant to rifampin and isoniazid (multiple-drug resistant strains) that also are resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial (capreomycin, kanamycin, amikacin). 105 106 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. 100 Importance of discontinuing therapy and informing clinicians if an allergic reaction occurs. 102 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 102 Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed. 102 Importance of advising patients of other important precautionary information. 102 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Capreomycin Sulfate Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection 1 g (of capreomycin) Capastat Sulfate Lilly AHFS DI Essentials. Copyright 2017, Selected Revisions January 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 100. Centers for Disease Control and Prevention. Treatment of tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR Recomm Rep . 2003; 52(RR-11):1-77. 101. 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. 102. Eli Lilly and Company. Capastat sulfate (capreomycin for injection) prescribing information. Indianapolis, IN; 2003 Dec 8. 103. Mause CE, Plikaytis BB, Shinnick TM. Mutation of tlyA confers capreomycin resistance in Mycobacterium tuberculosis . Antimicrob Agents Chemother . 2005; 49:571-7. [PubMed 15673735] 104. Mause CE, Plikaytis BB, Shinnick TM. Molecular analysis of cross-resistance to capreomycin, kanamycin, amikacin, and viomycin in Mycbacterium tuberculosis . Antimicrob Agents Chemother . 2005; 49:3192-7. [PubMed 16048924] 105. World Health Organization. Extensively drug-resistant tuberculosis (XDR-TB): recommendations for prevention and control. Wkly Epidemiol Rec . 2006; 45:430-2. 106. Gandhi NR, Moll A, Sturm AW et al. Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. Lancet . 2006; 368:1575-80. [PubMed 17084757] 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. 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] a. AHFS Drug Information 2007. McEvoy GK, ed. Capreomycin. American Society of Health-System Pharmacists; 2007:546-8. Next Interactions Print this page Add to My Med List More about Capastat (capreomycin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: streptomyces derivatives Consumer resources Professional resources Capastat (FDA) Capreomycin Sulfate (AHFS Monograph) Related treatment guides Tuberculosis, Active]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Streptomyces derivatives Related Drugs Tuberculosis, Active ciprofloxacin , Levaquin , levofloxacin , rifampin , moxifloxacin , Avelox , isoniazid , ethambutol , amikacin , gatifloxacin , streptomycin , pyrazinamide , Floxin , Rifadin , Amikin , Myambutol , cycloserine , Tequin , isoniazid / pyrazinamide / rifampin , rifapentine , kanamycin , ethionamide , Rifamate , More... Capastat Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } needful
keep off Capastat understand that
EmoticonEmoticon