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Capreomycin (United States and Canada: Not available): Drug information

Capreomycin (United States and Canada: Not available): Drug information
(For additional information see "Capreomycin (United States and Canada: Not available): Patient drug information" and see "Capreomycin (United States and Canada: Not available): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Clinical outcomes:

The use of capreomycin may be associated with worse clinical outcomes (ie, decreased effectiveness and increased mortality) compared with other parenteral therapy for pulmonary multidrug-resistant tuberculosis (MDR-TB). In patients who require parenteral treatment for pulmonary MDR-TB, reserve capreomycin for those with resistance to injectable aminoglycosides and limited treatment options.

Renal impairment:

The use of capreomycin in patients with renal insufficiency must be undertaken with great caution, and the risk of additional renal injury should be weighed against the benefits derived from therapy.

Since other parenteral antituberculosis agents (streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on renal function, simultaneous administration of these agents with capreomycin is not recommended. Use with other drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having nephrotoxic potential should be undertaken only with great caution.

Auditory impairment:

The use of capreomycin in patients with preexisting auditory impairment must be undertaken with great caution, and the risk of additional cranial nerve VIII impairment should be weighed against the benefits derived from therapy.

Since other parenteral antituberculosis agents (streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on cranial nerve VIII, simultaneous administration of these agents with capreomycin is not recommended. Use with other drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having ototoxic potential should be undertaken only with great caution.

Brand Names: US
  • Capastat Sulfate [DSC]
Pharmacologic Category
  • Antibiotic, Miscellaneous;
  • Antitubercular Agent
Dosing: Adult

Note: Capastat has been discontinued in the United States for >1 year.

Tuberculosis, pulmonary

Tuberculosis, pulmonary (alternative agent): Note: Current guidelines recommend against the use of capreomycin (ATS/CDC/ERS/IDSA [Nahid 2019]).

IM, IV: 15 mg/kg once daily or 25 mg/kg 3 times weekly, in combination with other appropriate agents; duration depends on clinical and microbiological response (ATS/CDC/IDSA [Nahid 2016]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Adults:

Manufacturer's labeling (maximum: 1 g/dose):

CrCl 110 mL/minute: 13.9 mg/kg every 24 hours

CrCl 100 mL/minute: 12.7 mg/kg every 24 hours

CrCl 80 mL/minute: 10.4 mg/kg every 24 hours

CrCl 60 mL/minute: 8.2 mg/kg every 24 hours

CrCl 50 mL/minute: 7 mg/kg every 24 hours or 14 mg/kg every 48 hours

CrCl 40 mL/minute: 5.9 mg/kg every 24 hours or 11.7 mg/kg every 48 hours

CrCl 30 mL/minute: 4.7 mg/kg every 24 hours or 9.5 mg/kg every 48 hours or 14.2 mg/kg every 72 hours

CrCl 20 mL/minute: 3.6 mg/kg every 24 hours or 7.2 mg/kg every 48 hours or 10.7 mg/kg every 72 hours

CrCl 10 mL/minute: 2.4 mg/kg every 24 hours or 4.9 mg/kg every 48 hours or 7.3 mg/kg every 72 hours

CrCl 0 mL/minute: 1.3 mg/kg every 24 hours or 2.6 mg/kg every 48 hours or 3.9 mg/kg every 72 hours

Alternate dosing:

CrCl ≥30 mL/minute: No adjustment necessary (ATS/CDC/IDSA [Nahid 2016]).

CrCl <30 mL/minute: 15 mg/kg/dose 2 to 3 times weekly (ATS/CDC/IDSA [Nahid 2016]).

End-stage renal disease on hemodialysis: 15 mg/kg/dose 2 to 3 times weekly; administer after hemodialysis if given on dialysis days (ATS/CDC/IDSA [Nahid 2016]).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Use with caution because of the increased potential for preexisting renal dysfunction or impaired hearing. For older patients, consider giving 15 mg/kg 3 times weekly to allow for drug clearance (ATS/CDC/IDSA [Nahid 2016]).

Dosing: Pediatric

(For additional information see "Capreomycin (United States and Canada: Not available): Pediatric drug information")

Tuberculosis, active, treatment; drug-resistant

Tuberculosis, active, treatment; drug-resistant (alternative agent): Limited data available:

Note: Current guidelines recommend against the use of capreomycin due to questionable efficacy as well as increased toxicity compared with other options. If used, it should be as part of an appropriate combination regimen; duration should be individualized based on extent of disease, rapidity of culture conversion, clinical response, and toxicity (ATS/CDC/IDSA [Nahid 2016]; ATS/CDC/ERS/IDSA [Nahid 2019]; Red Book [AAP 2021]; WHO 2022).

Infants, Children, and Adolescents: IM, IV: 15 to 30 mg/kg/dose once daily; some experts recommend an initial dose range of 15 to 20 mg/kg/dose once daily; maximum daily dose: 1,000 mg/day; monitor serum concentrations (ATS/CDC/IDSA [Nahid 2016]; HHS [OI pediatric] 2013; Red Book [AAP 2021]; Schaaf 2015; Seddon 2012).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Drug clearance is decreased and half-life increased with decreasing renal function; specific recommendations in pediatric patients are lacking; consider dosing adjustment and frequent therapeutic drug monitoring in patients with renal impairment (ATS/CDC/IDSA [Nahid 2016]).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Otic: Hearing loss (subclinical: 11%; clinically apparent: 3%)

Renal: Nephrotoxicity (including increased blood urea nitrogen [36%], increased serum creatinine, renal tubular necrosis urine sedimentation abnormality)

Frequency not defined:

Hematologic & oncologic: Eosinophilia, leukocytosis, leukopenia

Nervous system: Vertigo

Otic: Tinnitus

Postmarketing:

Endocrine & metabolic: Hypocalcemia, hypokalemia, hypomagnesemia

Hematologic & oncologic: Thrombocytopenia

Local: Injection-site reaction (including abscess at injection site, bleeding at injection site, induration at injection site, pain at injection site)

Contraindications

Hypersensitivity to capreomycin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Electrolyte imbalance: Hypocalcemia, hypokalemia, and hypomagnesemia have been reported with use. Monitor electrolytes periodically during treatment.

• Nephrotoxicity: May cause nephrotoxicity, including tubular necrosis, increased BUN or serum creatinine, and abnormal urinary sediment; slight elevations in BUN and serum creatinine with urinary RBCs, WBCs, and casts have been observed with prolonged treatment. Monitor renal function at baseline and periodically during treatment. A BUN >30 mg/dL or other evidence of decreasing renal function should prompt clinical evaluation and dosage adjustment or therapy discontinuation.

• Ototoxicity: May cause impairment of cranial nerve VIII, which may be irreversible; perform audiometric assessment and assessment of vestibular function prior to initiation and periodically during treatment.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Allergies: Use with caution in patients who demonstrate some form of allergy.

• Renal impairment: Dosage reductions are recommended for known or suspected renal impairment.

Special populations:

• Older adult: Use with caution.

Warnings: Additional Pediatric Considerations

In pediatric patients treated for multidrug-resistant tuberculosis, the reported incidence of hearing loss is variable (7% to 24%) with regimens that included either capreomycin or an aminoglycoside; the majority of children received amikacin compared to capreomycin; specific incidence with capreomycin not determined (Drobac 2006; Seddon 2013).

Product Availability

Capastat has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Injection, as sulfate [preservative free]:

Capastat Sulfate: 1 g (1 ea [DSC])

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Capastat Sulfate Injection)

1 g (per each): $258.54

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IM: Administer by deep IM injection into a large muscle mass.

IV: Administer over 60 minutes.

Administration: Pediatric

Parenteral:

IV: Administer over 60 minutes.

IM: Administer by deep IM injection into large muscle mass.

Use: Labeled Indications

Tuberculosis, pulmonary: Alternative agent for the treatment of pulmonary infections caused by capreomycin-susceptible strains of Mycobacterium tuberculosis, in combination with other appropriate antituberculosis agents, when other agents have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli (ATS/CDC/IDSA [Nahid 2016]).

Medication Safety Issues
Sound-alike/look-alike issues:

Capastat may be confused with Cepastat

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: Capreomycin may enhance the neuromuscular-blocking effect of Aminoglycosides. Risk C: Monitor therapy

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Colistimethate: Capreomycin may enhance the neuromuscular-blocking effect of Colistimethate. Risk C: Monitor therapy

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Mecamylamine: Capreomycin may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination

Neuromuscular-Blocking Agents: Capreomycin may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Polymyxin B: Capreomycin may enhance the neuromuscular-blocking effect of Polymyxin B. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Reproductive Considerations

Evaluate pregnancy status prior to treatment of multidrug-resistant tuberculosis in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment for multidrug-resistant tuberculosis (Esmail 2018).

Pregnancy Considerations

Adverse events were observed in animal reproductions studies; the safety of capreomycin in pregnancy has not been determined.

Tuberculosis (TB) disease (active TB) is associated with adverse fetal outcomes, including intrauterine growth restriction, low birth weight, preterm birth, and perinatal death (Esmail 2018; Miele 2020), as well as adverse maternal outcomes, including increased risks for anemia and cesarean delivery. Placental transmission may rarely occur with active maternal disease (Miele 2020).

Data are limited for use of second-line drugs during pregnancy (ie, capreomycin). The treatment of multidrug-resistant tuberculosis in pregnant patients should be individualized; evidence to support a specific regimen is not available; however, agents other than capreomycin are preferred if an injectable agent is needed (ATS/CDC/ERS/IDSA [Nahid 2019]; WHO 2020).

Breastfeeding Considerations

It is not known if capreomycin is present in breast milk.

Capreomycin is not significantly absorbed when administered orally, limiting any potential exposure via breast milk. The manufacturer recommends that caution be exercised when administering capreomycin to patients who are breastfeeding. Patients with multidrug-resistant tuberculosis and a sputum smear-positive test should avoid breastfeeding when possible (Esmail 2018).

Monitoring Parameters

Audiometric measurements and vestibular function at baseline and during therapy; renal function at baseline and weekly during therapy; baseline and frequent assessment of serum electrolytes (including calcium, magnesium, and potassium), liver function tests

Reference Range

Adults: Recommended concentration for susceptibility testing: 10 mcg/mL (ATS/CDC/IDSA 2003)

Mechanism of Action

Capreomycin is a cyclic polypeptide antimicrobial. It is administered as a mixture of capreomycin IA and capreomycin IB. The mechanism of action of capreomycin is not well understood. Mycobacterial species that have become resistant to other agents are usually still sensitive to the action of capreomycin. However, significant cross-resistance with viomycin, kanamycin, and neomycin occurs.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Oral: Not absorbed

Half-life elimination: CrCl 100 to 110 mL/minute: 5 to 6 hours; CrCl 50 to 80 mL/minute: 7 to 10 hours; CrCl 20 to 40 mL/minute: 12 to 20 hours; CrCl 10 mL/minute: 29 hours; CrCl 0 mL/minute: 55 hours

Time to peak, serum: IM: 1 to 2 hours

Excretion: Urine (52% unchanged within 12 hours)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Capastat;
  • (AU) Australia: Capastat;
  • (BE) Belgium: Capreomycine;
  • (CN) China: Capreomycin | Caprocin sulfate;
  • (CZ) Czech Republic: Capastat;
  • (EE) Estonia: Capastate | Capreomycin;
  • (ES) Spain: Capastat;
  • (FI) Finland: Capastat;
  • (GB) United Kingdom: Capastat | Capreomycin;
  • (GR) Greece: Capastat | Capreomycin;
  • (IN) India: Capreo | Capreotec | Kapocin;
  • (JP) Japan: Capastat;
  • (KE) Kenya: Kapocin;
  • (KR) Korea, Republic of: Capacin | Capastat | Caprecin;
  • (LT) Lithuania: Capastat | Capreomycin | Capreotec;
  • (LV) Latvia: Capastat;
  • (NO) Norway: Capastat | Capreomycin;
  • (PE) Peru: Capastat | Capreomicina;
  • (PL) Poland: Capastat | Capreomycin;
  • (PR) Puerto Rico: Capastat sulfate;
  • (PT) Portugal: Capastat;
  • (RU) Russian Federation: Capastat | Capremabol | Capreomycin | Capreomycin deco | Capreomycin ferein | Capreomycin s | Capreostat | Capricyn | Kapocin | Leukocin | Lykocin;
  • (SE) Sweden: Capastat;
  • (UA) Ukraine: Capreomicin | Capreomycin | Kapocin;
  • (UG) Uganda: Kapocin;
  • (ZA) South Africa: Capastat | Kapreon;
  • (ZM) Zambia: Kapocin
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