Capreomycin

Black Box Warnings

Use great caution in patients with renal insufficiency and pre-existing auditory impairment. Weigh the risk of additional cranial nerve VIII impairment or renal injury against the benefits of the therapy. Simulatneous administration with parenteral nonantituberculous agents with ototoxic potential (e.g., polymixin A sulfate, colisitin sulfate, amikacin, gentamicin, tobramycin, vancompycin, kanamycin, and neomycin) is not recommended.

Coadministration with antituberculous agents like streptomycin is also not recommended since they have similar and sometimes irreversible effects in cranial nerve VIII.

Safety in pregnancy has not been determined.

Effectiveness in pediatric patients has not been established.

Contraindications

Hypersensitivity

Pregnancy

Cautions

Renal impairment, auditory impairment, history of allergic rxns

Risk of hypokalemia

Risk of rare but potentially fatal toxic nephritis

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Capreomycin can harm your kidneys or damage the nerve that controls your hearing. These effects are increased when you also use certain other medicines. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with capreomycin, especially:

• other antibiotics (oral, injected, or inhaled);
• antivirals;
• chemotherapy;
• medicine for bowel disorders;
• medicine to prevent organ transplant rejection; or
• some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

This list is not complete. Other drugs may interact with capreomycin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Usual Adult Dose for Tuberculosis -- Active:

10 to 15 mg/kg (up to 1 g) IM or IV once every 24 hours or 5 days a week.

Usual Pediatric Dose for Tuberculosis -- Active:

15 to 30 mg/kg (up to 1 g) IM or IV 5 to 7 days per week, in 1 or 2 divided doses.

• It is used to treat TB (tuberculosis).
• This medicine is used with other drugs. Talk with your doctor.

• If you have an allergy to capreomycin or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take capreomycin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Store intact vials at 15°C to 30°C (59°F to 86°F). Following reconstitution, may store under refrigeration for up to 24 hours.

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.

Because 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 nonantituberculosis drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having nephrotoxic potential should be undertaken only with great caution.

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.

Because 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 nonantituberculosis drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having ototoxic potential should be undertaken only with great caution.

The safety of the use capreomycin in pregnancy has not been determined.

Safety and effectiveness in pediatric patients have not been established.

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.

• Auditory impairment: [US Boxed Warning]: Use 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 to be derived from therapy.

• Renal impairment: [US Boxed Warning]: Use in patients with renal impairment must be undertaken with great caution, and the risk of additional renal injury should be weighed against the benefits to be derived from therapy. Dosage reductions are recommended for known or suspected renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Drugs with ototoxic or nephrotoxic potential: [US Boxed Warning]: Use with nonantituberculous drugs (eg, polymyxin A sulfate, colistin sulfate, gentamicin, tobramycin, vancomycin, neomycin) having ototoxic or nephrotoxic potential should be undertaken only with great caution.

• Parenteral antituberculous agents: [US Boxed Warning]: Because other parenteral antituberculous agents (eg, streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on cranial nerve VIII and renal function, simultaneous administration of these agents with capreomycin is not recommended.

Special populations:

• Elderly: Use with caution.

• Pediatric: [US Boxed Warning]: Safety has not been established in pediatric patients.

• Pregnancy: [US Boxed Warning]: Safety has not been established in pregnant women.

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