PRIFTIN Film-coated tablet (2021)
Βιβλιογραφική αναφορά
Συγγραφείς
A-S Medication Solutions
Λέξεις κλειδιά
50090-5063
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1. Indications and Usage
1.1 Active Pulmonary Tuberculosis PRIFTIN (rifapentine) is indicated in adults and children 12 years and older for the treatment of active pulmonary tuberculosis (TB) caused by <em>Mycobacterium tuberculosis ...
2. Dosage and Administration
2.1 Dosage in Active Pulmonary Tuberculosis PRIFTIN is only recommended for the treatment of active pulmonary tuberculosis caused by drug-susceptible organisms as part of regimens consisting of a 2-month ...
3. Dosage Forms and Strengths
PRIFTIN is supplied as 150 mg round normal convex dark-pink film-coated tablets debossed F on one side of tablet.
4. Contraindications
4.1 Hypersensitivity PRIFTIN is contraindicated in patients with a history of hypersensitivity to rifamycins.
5. Warnings and Precautions
5.1 Hepatotoxicity Elevations of liver transaminases may occur in patients receiving PRIFTIN <em>[see Adverse Reactions (6.1)]</em>. Patients on PRIFTIN should be monitored for symptoms of liver injury. ...
6. Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Hepatotoxicity <em>[see Warnings and Precautions (5.1)]</em> Hypersensitivity ...
6.1. Clinical 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 ...
6.2. Postmarketing 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 ...
7. Drug Interactions
7.1 Protease Inhibitors and Reverse Transcriptase Inhibitors Rifapentine is an inducer of CYP450 enzymes. Concomitant use of PRIFTIN with other drugs metabolized by these enzymes, such as protease inhibitors ...
8.1. Pregnancy
Risk Summary Based on animal data, PRIFTIN may cause fetal harm when administered to a pregnant woman. Available data from clinical trials, case reports, epidemiology studies and postmarketing experience ...
8.2. Lactation
Risk Summary There are no data on the presence of rifapentine or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Since PRIFTIN may produce ...
8.3. Females and Males of Reproductive Potential
Contraception Use of PRIFTIN may reduce the efficacy of hormonal contraceptives. Advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method ...
8.4. Pediatric Use
The safety and effectiveness of PRIFTIN in the treatment of active pulmonary tuberculosis have not been established in pediatric patients under the age of 12. The safety and effectiveness of PRIFTIN in ...
8.5. Geriatric Use
Clinical studies with PRIFTIN did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In a pharmacokinetic study with ...
10. Overdosage
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), ...
11. Description
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, ...
12.1. Mechanism of Action
Rifapentine, a cyclopentyl rifamycin, is an antimycobacterial agent <em>[see Clinical Pharmacology, Microbiology (12.4)]</em>.
12.3. Pharmacokinetics
When oral doses of PRIFTIN were administered once daily or once every 72 hours to healthy volunteers for 10 days, single dose AUC<sub>(0–∞)</sub> of rifapentine was similar to its steady-state AUC<sub> ...
12.4. Microbiology
Mechanism of Action Rifapentine, a cyclopentyl rifamycin, inhibits DNA-dependent RNA polymerase in susceptible strains of <em>Mycobacterium tuberculosis</em> but does not affect mammalian cells at concentrations ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Hepatocellular carcinomas were increased in male NMRI mice (Harlan Winklemann) which were treated orally with rifapentine for two years at or above doses of 5 mg/kg/day (0.04 times the recommended human ...
14. Clinical Studies
14.1 Active Pulmonary Tuberculosis PRIFTIN was studied in two randomized, open-label controlled clinical trials in the treatment of active pulmonary tuberculosis. The first trial was an open-label, prospective, ...
16.1. How Supplied
Product: 50090-5063 NDC: 50090-5063-0 8 TABLET, FILM COATED in a BLISTER PACK / 3 in a CARTON sanofi-aventis U.S. LLC, Bridgewater, NJ 08807
17. Patient Counseling Information
Advise patient to read FDA-approved patient labeling (Medication Guide). Treatment Adherence Emphasize the importance of compliance with the full course of therapy, and the importance of not missing any ...