Rifabutin (Page 4 of 4)

ANIMAL PHARMACOLOGY & OR TOXICOLOGY

Liver abnormalities (increased bilirubin and liver weight) occurred in mice, rats and monkeys at doses (respectively) 0.5, 1, and 3 times the recommended human daily dose based on body surface area comparisons. Testicular atrophy occurred in baboons at doses 2 times the recommended human dose based on body surface area comparisons, and in rats at doses 6 times the recommended human daily dose based on body surface area comparisons.

OVERDOSAGE

No information is available on accidental overdosage in humans.

Treatment

While there is no experience in the treatment of overdose with Rifabutin Capsules, clinical experience with rifamycins suggests that gastric lavage to evacuate gastric contents (within a few hours of overdose), followed by instillation of an activated charcoal slurry into the stomach, may help absorb any remaining drug from the gastrointestinal tract.

Rifabutin is 85% protein bound and distributed extensively into tissues (Vss:8 to 9 L/kg). It is not primarily excreted via the urinary route (less than 10% as unchanged drug); therefore, neither hemodialysis nor forced diuresis is expected to enhance the systemic elimination of unchanged rifabutin from the body in a patient with an overdose of Rifabutin.

DOSAGE & ADMINISTRATION

It is recommended that Rifabutin Capsules be administered at a dose of 300 mg once daily. For those patients with propensity to nausea, vomiting, or other gastrointestinal upset, administration of Rifabutin at doses of 150 mg twice daily taken with food may be useful.

For patients with severe renal impairment (creatinine clearance less than 30 mL/min), consider reducing the dose of Rifabutin by 50%, if toxicity is suspected. No dosage adjustment is required for patients with mild to moderate renal impairment. Reduction of the dose of Rifabutin may also be needed for patients receiving concomitant treatment with certain other drugs (see PRECAUTIONS- Drug Interactions).

Mild hepatic impairment does not require a dose modification. The pharmacokinetics of rifabutin in patients with moderate and severe hepatic impairment is not known.

HOW SUPPLIED

Rifabutin Capsules, USP are supplied as hard gelatin capsule shell with maroon colored cap and body, imprinted with black ink as 041 on cap and Novitium 150 mg (150 mg under Novitium) on body, filled with red-violet powder, each containing 150 mg of Rifabutin, USP.

Rifabutin is available as follows:

NDC 10135-0738-01 Bottles of 100 capsules

Keep tightly closed and dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

Rev. 05/22 NP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rifabutin Capsules, USP 150 mg NDC 10135-0738-01 Bottles of 100 capsules

label
(click image for full-size original)
RIFABUTIN rifabutin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-738(NDC:70954-041)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIFABUTIN (RIFABUTIN) RIFABUTIN 150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
GELATIN
WATER
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color red (Maroon) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 041;Novitium150mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-738-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215041 05/01/2022
Labeler — Marlex Pharmaceuticals, Inc. (782540215)

Revised: 03/2023 Marlex Pharmaceuticals, Inc.

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