Rifampin (Page 5 of 5)

Miscellaneous

Edema of the face and extremities has been reported. Other reactions which have occurred with intermittent dosage regimens include “flu syndrome” (such as episodes of fever, chills, headache, dizziness, and bone pain), shortness of breath, wheezing, decrease in blood pressure and shock. The “flu syndrome” may also appear if rifampin is taken irregularly by the patient or if daily administration is resumed after a drug-free interval.

OVERDOSAGE

Signs and Symptoms

Nausea, vomiting, abdominal pain, pruritus, headache, and increasing lethargy will probably occur within a short time after ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange discoloration of the skin, urine, sweat, saliva, tears, and feces will occur, and its intensity is proportional to the amount ingested.

Liver enlargement, possibly with tenderness, can develop within a few hours after severe overdosage; bilirubin levels may increase and jaundice may develop rapidly. Hepatic involvement may be more marked in patients with prior impairment of hepatic function. Other physical findings remain essentially normal. A direct effect upon the hematopoietic system, electrolyte levels, or acid-base balance is unlikely.

Facial or periorbital edema has also been reported in pediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures, and cardiac arrest were reported in some fatal cases.

Acute Toxicity

The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 gm rifampin. Fatal acute overdoses in adults have been reported with doses ranging from 14 to 60 gm. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports. Nonfatal overdoses in pediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses has been reported.

Treatment

Intensive support measures should be instituted and individual symptoms treated as they arise. The airway should be secured and adequate respiratory exchange established. Since nausea and vomiting are likely to be present, gastric lavage within the first 2 to 3 hours after ingestion is probably preferable to induction of emesis. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting.

Active diuresis (with measured intake and output) will help promote excretion of the drug.

For severe cases, extracorporeal hemodialysis may be required. If this is not available, peritoneal dialysis can be used along with forced diuresis.

DOSAGE AND ADMINISTRATION

Rifampin can be administered by the oral route (see INDICATIONS AND USAGE ). See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.

Tuberculosis

Adults

10 mg/kg, in a single daily administration, not to exceed 600 mg/day, oral

Pediatric Patients

10 to 20 mg/kg, not to exceed 600 mg/day, oral

It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water.

Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., RIFATER®*) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin, and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

Following the initial phase, treatment should be continued with rifampin and isoniazid (e.g., RIFAMATE®**) for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.

Meningococcal Carriers

Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days.

Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days.

Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days.

Preparation of Extemporaneous Oral Suspension

For pediatric and adult patients in whom capsule swallowing is difficult or where lower doses are needed, a liquid suspension may be prepared as follows:

Rifampin 1% w/v suspension (10 mg/mL) can be compounded using one of four syrups–Simple Syrup (Syrup NF), Simple Syrup (Humco Laboratories), SyrPalta®+ Syrup (Emerson Laboratories), or Raspberry Syrup (Humco Laboratories).

  1. Empty the contents of four rifampin capsules 300 mg or eight rifampin capsules 150 mg onto a piece of weighing paper.
  2. If necessary, gently crush the capsule contents with a spatula to produce a fine powder.
  3. Transfer the rifampin powder blend to a 4-ounce amber glass or plastic (high density polyethylene [HDPE], polypropylene, or polycarbonate) prescription bottle.
  4. Rinse the paper and spatula with 20 mL of one of the above-mentioned syrups, and add the rinse to the bottle. Shake vigorously.
  5. Add 100 mL of syrup to the bottle and shake vigorously.

This compounding procedure results in a 1% w/v suspension containing 10 mg rifampin/mL. Stability studies indicate that the suspension is stable when stored at room temperature (25 ± 3°C) or in a refrigerator (2 to 8°C) for four weeks. This extemporaneously prepared suspension must be shaken well prior to administration.

HOW SUPPLIED

Rifampin Capsules USP, 150 mg are size ’2′ capsules having dark red cap, imprinted with “LU” in white ink and light red body, imprinted with “E01″ in white ink, containing reddish brown powder.

Bottles of 30 (NDC 68180-658-06)

Bottles of 100 (NDC 68180-658-01)

Rifampin Capsules USP, 300 mg are size ’1′ capsules having dark red cap, imprinted with “LU” in white ink and light red body, imprinted with “E02″ in white ink, containing reddish brown powder.

Bottles of 30 (NDC 68180-659-06)

Bottles of 60 (NDC 68180-659-07)

Bottles of 100 (NDC 68180-659-01)

Storage

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. Store in a dry place. Avoid excessive heat.

* RIFATER® is a registered trademark of Aventis Pharmaceuticals Inc

** RIFAMATE® is a registered trademark of Aventis Pharmaceuticals Inc

+ Syrpalta® is a registered trademark of Emerson Laboratories.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Aurangabad 431 210

INDIA.

Revised: July 2020 ID # 265493

PRINCIPAL DISPLAY PANEL

RIFAMPIN CAPSULES USP

150 mg

Rx Only

30 CAPSULES

NDC 68180-658-06

Rifampin Capsules USP
150 mg
													30s Pack
(click image for full-size original)

RIFAMPIN CAPSULES USP

300 mg

Rx Only

30 CAPSULES

NDC 68180-659-06

Rifampin Capsules USP
300 mg
													30s Pack
(click image for full-size original)
RIFAMPIN rifampin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-658
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIFAMPIN (RIFAMPIN) RIFAMPIN 150 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color RED (dark red cap and light red body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code LU;E01
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-658-06 30 CAPSULE in 1 BOTTLE None
2 NDC:68180-658-01 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090034 01/08/2014
RIFAMPIN rifampin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-659
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RIFAMPIN (RIFAMPIN) RIFAMPIN 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE, UNSPECIFIED
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color RED (dark red cap and light red body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code LU;E02
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-659-06 30 CAPSULE in 1 BOTTLE None
2 NDC:68180-659-01 100 CAPSULE in 1 BOTTLE None
3 NDC:68180-659-07 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090034 01/08/2014
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 862272739 MANUFACTURE (68180-658), MANUFACTURE (68180-659), PACK (68180-658), PACK (68180-659)

Revised: 07/2020 Lupin Pharmaceuticals, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.