Brand Name

Priftin

Generic Name
Rifapentine
View Brand Information
FDA approval date: February 08, 2017
Classification: Rifamycin Antimycobacterial
Form: Tablet

What is Priftin (Rifapentine)?

PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis caused by Mycobacterium tuberculosis in combination with one or more antituberculosis drugs to which the isolate is susceptible.

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Brand Information

Priftin (rifapentine)
1DOSAGE FORMS AND STRENGTHS
PRIFTIN is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed "F" on one side of tablet.
2ADVERSE REACTIONS
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
  • Hepatotoxicity
  • Hypersensitivity
  • Severe Cutaneous Adverse Reactions
  • Discoloration of Body Fluids
  • Clostridioides Difficile–Associated Diarrhea [see
  • Porphyria
2.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
2.2Postmarketing Experience
The following adverse reactions have been identified from postmarketing surveillance of rifapentine. Because these reactions are reported from a population of unknown size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.
3OVERDOSAGE
While there is no experience with the treatment of acute overdose with PRIFTIN, 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 adsorb any remaining drug from the gastrointestinal tract.
Rifapentine and 25-desacetyl rifapentine are 97.7% and 93.2% plasma protein bound, respectively. Rifapentine and related compounds excreted in urine account for only 17% of the administered dose, therefore, neither hemodialysis nor forced diuresis is expected to enhance the systemic elimination of unchanged rifapentine from the body of a patient with PRIFTIN overdose.
4DESCRIPTION
PRIFTIN (rifapentine) for oral administration contains 150 mg of the active ingredient rifapentine per tablet.
The 150 mg tablets also contain, as inactive ingredients: calcium stearate, disodium EDTA, FD&C Blue No. 2 aluminum lake, hydroxypropyl cellulose, hypromellose USP, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, propylene glycol, sodium ascorbate, sodium lauryl sulfate, sodium starch glycolate, synthetic red iron oxide, and titanium dioxide.
Rifapentine is a rifamycin derivative antimicrobial and has a similar profile of microbiological activity to rifampicin. The molecular weight is 877.04.
The molecular formula is C
The chemical name for rifapentine is rifamycin, 3-[[(4-cyclopentyl-1-piperazinyl)imino]methyl]- or 3-[N-(4-cyclopentyl - 1-piperazinyl)formimidoyl] rifamycin or 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-8-[N-(4-cyclopentyl-l-piperazinyl)-formimidoyl]-2,7-(epoxypentadeca[1,11,13]trienimino)naphtho[2,1-b]furan-1,11(2H)-dione 21-acetate. It has the following structure:
Chemical Structure
5PATIENT COUNSELING INFORMATION
Advise patient to read FDA-approved patient labeling (Medication Guide).
6PRINCIPAL DISPLAY PANEL - 150 mg Tablet Blister Pack Carton
NDC 0088-2102-24
PRIFTIN
Dispense with Medication Guide
24 Tablets
sanofi
PRINCIPAL DISPLAY PANEL - 150 mg Tablet Blister Pack Carton