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Capastat Sulfate

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Capastat Sulfate

Indications
Dosage
How Supplied

INDICATIONS

Capastat Sulfate (capreomycin for injection) , which is to be used concomitantly with other appropriate antituberculosis agents, is indicated in pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli.

Susceptibility studies should be performed to determine the presence of a capreomycin­susceptible strain of M. tuberculosis.

DOSAGE AND ADMINISTRATION

Capastat Sulfate (capreomycin for injection) may be administered intramuscularly or intravenously following reconstitution. Reconstitution is achieved by dissolving the vial contents (1 g) in 2 mL of 0.9% Sodium Chloride Injection or Sterile Water for Injection. Two to 3 minutes should be allowed for complete dissolution.

Intravenously - For intravenous infusion, reconstituted Capastat Sulfate should be diluted in 100 mL of 0.9% Sodium Chloride Injection and administered over 60 minutes.

Intramuscularly - Reconstituted Capastat Sulfate (capreomycin for injection) should be given by deep intramuscular injection into a large muscle mass, since superficial injection may be associated with increased pain and the development of sterile abscesses.

For administration of a 1-g dose, the entire contents of the vial should be given. For doses lower than 1 g, the following dilution table may be used.

DILUTION TABLE

Diluent Added to 1-g, 10-mL Vial Volume of Capastat Sulfate Solution Concentration (Approx)
2.15 mL 2.85 mL 370 mg*/mL
2.63 mL 3.33 mL 315 mg*/mL
3.3 mL 4 mL 260 mg*/mL
4.3 mL 5 mL 210 mg*/mL
* Equivalent to capreomycin activity. Approximated concentration takes into account the retention volume.

The solution may acquire a pale straw color and darken with time, but this is not associated with loss of potency or the development of toxicity. After reconstitution, all solutions of Capastat Sulfate (capreomycin for injection) may be stored for up to 24 hours under refrigeration.

Capreomycin is always administered in combination with at least 1 other antituberculosis agent to which the patient's strain of tubercle bacilli is susceptible. The usual dose is 1 g daily (not to exceed 20 mg/kg/day) given intramuscularly or intravenously for 60 to 120 days, followed by 1 g by either route 2 or 3 times weekly. (Note - Therapy for tuberculosis should be maintained for 12 to 24 months. If facilities for administering injectable medication are not available, a change to appropriate oral therapy is indicated on the patient's release from the hospital.)

Patients with reduced renal function should have dosage reduction based on creatinine clearance using the guidelines included in Table 1. These dosages are designed to achieve a mean steady-state capreomycin level of 10 µg/mL.

Table 1. Estimated Dosages to Attain Mean Steady-State Serum Capreomycin Concentration of 10 µg/mL (Based on Creatinine Clearance)

CrCl (mL/min) Capreomycin Clearance (L/kg/h x 10-2) Half-life (hours) Dosea (mg/kg) for the Following Dosing Intervals
24 h 48 h 72 h
0 0.54 55.5 1.29 2.58 3.87
10 1.01 29.4 2.43 4.87 7.30
20 1.49 20.0 3.58 7.16 10.7
30 1.97 15.1 4.72 9.45 14.2
40 2.45 12.2 5.87 11.7  
50 2.92 10.2 7.01 14.0
60 3.40 8.8 8.16  
80 4.35 6.8 10.4b
100 5.31 5.6 12.7b
110 5.78 5.2 13.9b
a For patients with renal impairment, initial maintenance dose estimates are given for optional dosing intervals; longer dosing intervals are expected to provide greater peak and lower trough serum capreomycin levels than shorter dosing intervals.
b The usual dosage for patients with normal renal function is 1000 mg daily, not to exceed 20 mg/kg/day, for 60 to120 days, then 1000 mg 2 to 3 times weekly.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Capastat® Sulfate, Capreomycin for Injection, USP, is available in:

Vials: 1 g*, 10 mL size (No. 718) (1s) NDC 0002-1485-01

Store at controlled room temperature 15° to 30°C (59° to 86°F) prior to reconstitution.

*Equivalent to capreomycin activity.

Literature revised January 14, 2008. Eli Lilly and Company, Indianapolis, IN 46285, USA. FDA Rev date: 7/24/2008

Last reviewed on RxList: 9/4/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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