Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4171
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Priftin (Tablet, Film Coated)
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PRIFTIN should not be used alone, in initial treatment or in retreatment of pulmonary tuberculosis. In the intensive phase of short-course therapy which is to continue for 2 months, 600 mg (four 150 mg tablets) of PRIFTIN should be given twice weekly with an interval of not less than 3 days (72 hours) between doses. For those patients with propensity to nausea, vomiting or gastrointestinal upset, administration of PRIFTIN with food may be useful. In the Intensive Phase, PRIFTIN must be administered in combination as part of an appropriate regimen which includes daily companion drugs. Compliance with all drugs in the Intensive Phase (ie, PRIFTIN, isoniazid, pyrazinamide, ethambutol, or streptomycin), especially on days when rifapentine is not administered, is imperative to assure early sputum conversion and protection against relapse. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society and the Centers for Disease Control and Prevention also recommend that either streptomycinor ethambutol be added to the regimen unless the likelihood of isoniazid resistance is very low. The need for streptomycin or ethambutol should be reassessed when the results of susceptibility testing are known. An initial treatment regimen with less than four drugs may be considered if there is little possibility of drug resistance (that is, less than 4% primary resistance to isoniazid in the community, and the patient has had no previous treatment with antituberculosis medications, is not from a countrywith a high prevalence of drug resistance, and has no known exposure to a drug-resistant case) (see Reference 2). Following the intensive phase, treatment should be continued with PRIFTIN once weekly for 4 months in combination with isoniazid or an appropriate agent for susceptible organisms. If the patient is still sputum smear or culture positive, if resistant organisms are present, or if the patient is HIV positive, follow the ATS/CDC treatment guidelines (see Reference 2). Concomitant administration of pyridoxine (Vitamin B) is recommended in the malnourished, in those predisposed to neuropathy (eg, alcoholics and diabetics), and in adolescents. The above recommendations apply to patients with drug-susceptible organisms. Patients with drug-resistant organisms may require longer duration treatment with other drug regimens.
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| dailymed-instance:descripti... |
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 antibiotic and has a similar profile of microbiological activity to rifampin (rifampicin). The molecular weight is 877.04. The molecular formula is CHNO. 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:
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This product is contraindicated in patients with a history of hypersensitivity to any of the rifamycins (eg, rifampin and rifabutin).
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PRIFTIN (rifapentine) 150 mg round normal convex dark-pink film-coated tablets debossed "Priftin" on top and "150" on the bottom, are packaged in aluminum formable foil blister strips placed in cartons of 32 tablets (4 strips of 8). Each strip of 8 tablets is inserted into an aluminum foil laminated pouch. (NDC 0088-2100-03). Store at 25��C (77��F); excursions permitted 15���30��C (59���86��F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.
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| dailymed-instance:inactiveI... |
dailymed-ingredient:FD&C_Blue_No._2_aluminum_lake,
dailymed-ingredient:calcium_stearate,
dailymed-ingredient:disodium_EDTA,
dailymed-ingredient:hydroxypropyl_cellulose,
dailymed-ingredient:hypromellose_USP,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:pregelatinized_starch,
dailymed-ingredient:propylene_glycol,
dailymed-ingredient:sodium_ascorbate,
dailymed-ingredient:sodium_lauryl_sulfate,
dailymed-ingredient:sodium_starch_glycolate,
dailymed-ingredient:synthetic_red_iron_oxide,
dailymed-ingredient:titanium_dioxide
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There is no experience with the treatment of acute overdose with rifapentine at doses exceeding 1200 mg per dose. In a pharmacokinetic study involving healthy volunteers (n=9), single oral doses up to 1200 mg have been administered without serious adverse events. The only adverse events reported with the 1200 mg dose were heartburn (3/8), headache (2/8) and increased urinary frequency (1/8). In clinical trials, tuberculosis patients ranging in age from 20 to 74 years accidentally received continuous daily doses of rifapentine 600 mg. Some patients received continuous daily dosing for up to 20 days without evidence of serious adverse effects. One patient experienced a transient elevation in SGPT and glucose (the latter attributed to pre-existing diabetes); a second patient experienced slight pruritus. While there is no experience with the treatment of acute overdose with rifapentine, 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.
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rifapentine
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Priftin (Tablet, Film Coated)
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| dailymed-instance:adverseRe... |
The investigators in the tuberculosis treatment clinical trial (Study 008) assessed the causality of adverse events as definitely, probably, possibly, unlikely or not related to one of the two drug regimens tested. The following table (Table 2-3) presents treatment-related adverse events deemed by the investigators to be at least possibly related to any of the four drugs in the regimens (rifapentine/rifampin, isoniazid, pyrazinamide, or ethambutol) which occurred in���1% of patients. Hyperuricemia was the most frequently reported event that was assessed as treatment related and was most likely related to the pyrazinamide since no cases were reported in the Continuation Phase when this drug was no longer included in the treatment regimen. Treatment-related adverse events of moderate or severe intensity in<1% of the rifapentine combination therapy patients in Study 008 are presented below by body system. Hepatic&Biliary: bilirubinemia, hepatitis Dermatologic: urticaria, skin discoloration Hematologic: thrombocytopenia, neutrophilia, leukocytosis, purpura, hematoma Metabolic&Nutritional: hyperkalemia, hypovolemia, alkaline phosphatase increased, LDH increased Body as a Whole - General: peripheral edema, fatigue Gastrointestinal: constipation, esophagitis, gastritis, pancreatitis Musculoskeletal: gout, arthrosis Psychiatric: aggressive reaction Three patients (two rifampin combination therapy patients and one rifapentine combination therapy patient) were discontinued in the Intensive Phase as a result of hepatitis with increased liver function tests (ALT, AST, LDH, and bilirubin). Concomitant medications for all three patients included isoniazid, pyrazinamide, ethambutol, and pyridoxine. The two rifampin patients and one rifapentine patient recovered without sequelae. Twenty-two deaths occurred in Study 008 (eleven in the rifampin combination therapy group and eleven in the rifapentine combination therapy group). None of the deaths were attributed to study medication. In the study, 18/361 (5.0%) rifampin combination therapy patients discontinued the study due to an adverse event compared to 11/361 (3.0%) rifapentine combination therapy patients. The overall occurrence rate of treatment-related adverse events was higher in males with the rifapentine combination regimen (50%) versus the rifampin combination regimen (43%), while in females the overall rate was greater in the rifampin combination group (68%) compared to the rifapentine combination group (59%). However, there were higher frequencies of treatment-related hematuria andALT increases for female patients in both treatment groups compared to those for male patients. Adverse events associated with rifampin may occur with rifapentine: effects of enzyme induction to increase metabolism resulting in decreased concentration of endogenous substrates, including adrenal hormones, thyroid hormones, and vitamin D.
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| dailymed-instance:indicatio... |
PRIFTIN is indicated for the treatment of pulmonary tuberculosis. PRIFTIN must always be used in conjunction with at least one other antituberculosis drug to which the isolate is susceptible. In the intensive phase of the short-course treatment of pulmonary tuberculosis, PRIFTIN should be administered twice weekly for two months, with an interval of no less than 3 days (72 hours) between doses, as part of an appropriate regimen which includes daily companion drugs (Table 2-1). It may also be necessary to add either streptomycin or ethambutol until the results of susceptibility testing are known. Compliance with all drugs in the Intensive Phase (ie, PRIFTIN, isoniazid, pyrazinamide, ethambutol or streptomycin) is imperative to assure early sputum conversion and protection against relapse. Following the intensive phase, Continuation Phase treatment should be continued with PRIFTIN for 4 months. During this phase, PRIFTIN should be administered on a once-weekly basis in combination with an appropriate antituberculous agent for susceptible organisms (Table 2-1) . In the treatment of tuberculosis, the small number of resistant cells present within large populations of susceptible cells can rapidly become the predominant type. Consequently, clinical samples for mycobacterial culture and susceptibility testing should be obtained prior to the initiation of therapy, as well as during treatment to monitor therapeutic response. The susceptibility of M. tuberculosis organisms to isoniazid, rifampin, pyrazinamide, ethambutol, rifapentine and other appropriate agents should be measured. If test results show resistance to any of these drugs and the patient is not responding to therapy, the drug regimen should be modified.
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Priftin
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