Rifampin (Page 5 of 5)

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 Simple Syrup (Syrup NF):

  1. Empty the contents of four Rifampin 300 mg capsules or eight Rifampin 150 mg capsules 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 syrup, 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 (2-8°C) for four weeks. This extemporaneously prepared suspension must be shaken well prior to administration.

HOW SUPPLIED

Rifampin Capsules, USP, 150 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 150” and on the other half in radial print “VP/015”

  • Bottles of 30 (NDC 61748-015-30)
  • Unit Dose Boxes of 100 (NDC 61748-015-11)

Rifampin Capsules, USP, 300 mg opaque orange capsules printed in white on one half of the capsule in radial print “Rifampin 300” and on the other half in radial print “VP/018”

  • Bottles of 30 (NDC 61748-018-30)
  • Bottles of 60 (NDC 61748-018-60)
  • Bottles of 100 (NDC 61748-018-01)
  • Unit Dose Boxes of 100 (NDC 61748-018-11)

Storage: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Store in a dry place. Avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

REFERENCES

  1. Clinical Laboratory Standards Institute. Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard CLSI Document M24-A, Vol. 23, No. 18, CLSI, Villanova, PA, 2003.
  2. Clinical Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Eighth Edition. Approved Standard CLSI Document M7-A8, Vol. 29, No. 2, CLSI, Villanova, PA, January 2009.
  3. Clinical Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests — Tenth Edition. Approved Standard CLSI Document M2-A10, Vol. 29, No. 41, CLSI, Villanova, PA, January 2009.
  4. Clinical Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational Supplement, CLSI Document M100-S20, Vol. 30, No. 1, CLSI, Villanova, PA, January 2010.
  5. RIFATER ® (rifampin, isoniazid, and pyrazinamide) is a registered trademark of Sanofi-Aventis U.S. LLC.
  6. RIFAMATE ® (rifampin and isoniazid) is a registered trademark of Sanofi-Aventis U.S. LLC.

Manufactured for:
VersaPharm Incorporated
Marietta, GA 30062-2260

Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237

Revised September 2014
70029978

Package Labeling (55695-036-00)

rifampin
(click image for full-size original)

Package Labeling (55695-034-00)

rifampin1
(click image for full-size original)

RIFAMPIN
rifampin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55695-036(NDC:61748-015)
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
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
TALC
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
AMMONIA
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
SHELLAC
PROPYLENE GLYCOL
DIMETHICONE
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
Product Characteristics
Color orange (ORANGE) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code Rifampin;150;VP;015
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55695-036-00 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065028 07/01/2001
RIFAMPIN
rifampin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55695-034
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
LACTOSE MONOHYDRATE
SODIUM LAURYL SULFATE
TALC
SILICON DIOXIDE
MAGNESIUM STEARATE
AMMONIA
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
SHELLAC
PROPYLENE GLYCOL
DIMETHICONE
TITANIUM DIOXIDE
STARCH, CORN
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
Product Characteristics
Color orange (ORANGE) Score no score
Shape CAPSULE (CAPSULE) Size 20mm
Flavor Imprint Code Rifampin;300;VP;018
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55695-034-00 60 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065028 07/01/2001
Labeler — Department of State Health Services, Pharmacy Branch (781992540)

Revised: 02/2016 Department of State Health Services, Pharmacy Branch

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