Rifabutin (Page 4 of 4)

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 AND ADMINISTRATION

It is recommended that rifabutin capsules USP 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 size ’0′ capsules having opaque red-brown cap imprinted with ‘LU’ in white ink and opaque red-brown body imprinted with ‘R01′ in white ink, containing red-violet granular powder equivalent to 150 mg of rifabutin USP.

Rifabutin Capsules USP are available as follows:

Bottles of 60 capsules — NDC 68180-285-07

Bottles of 100 capsules — NDC 68180-285-01

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Keep tightly closed and dispense in a tight container as defined in the USP. Protect from light and from excessive heat.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Aurangabad 431 210

INDIA

Revised: December 2018 ID#: 257561

Rifabutin Capsules USP, 150 mg

NDC 68180-285-01

A Bottle Label containing 100 capsules

NDC 38180-285-01
(click image for full-size original)
RIFABUTIN rifabutin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-285
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
CROSPOVIDONE, UNSPECIFIED
FERRIC OXIDE RED
GELATIN
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (Opaque red-brown cap) , BROWN (Opaque red-brown body) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code LU;R01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-285-01 100 CAPSULE in 1 BOTTLE None
2 NDC:68180-285-07 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090033 03/26/2014
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 862272739 MANUFACTURE (68180-285)

Revised: 11/2019 Lupin Pharmaceuticals, Inc.

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