Indications for PRIFTIN:
Susceptible active pulmonary tuberculosis. Latent tuberculosis infection in patients ≥2yrs old at high risk of progression to tuberculosis disease.
Limitations of Use:
Active: not for monotherapy use in either phases. Latent: rule out active tuberculosis disease before treatment initiation.
Adults and Children:
Take with food. If unable to swallow tabs: may crush and add to semi-solid food. Active TB: <12yrs: not established. ≥12yrs: Initial phase: 600mg twice weekly for 2 months, with an interval of no less than 3 consecutive days (72hrs) between doses, in combination with other antituberculosis drugs (eg, isoniazid, ethambutol, pyrazinamide); Continuation phase: Following Initial phase, 600mg once weekly for 4 months in combination with isoniazid or an appropriate antituberculosis agent. Latent TB: <2yrs: not established. Give once weekly in combination with isoniazid (see full labeling for dosage) for 12 weeks. ≥2yrs: (10–14kg): 300mg; (14.1–25kg): 450mg; (25.1–32kg): 600mg; (32.1–50kg): 750mg; (>50kg): 900mg. Max 900mg once weekly.
HIV seropositive patients: Initial Phase treatment regimen has not been studied, also do not use once weekly Continuation Phase regimen in combination with isoniazid; higher rate of failure and/or relapse with presence of rifampin-resistant organisms. Cavitary pulmonary lesions and/or positive sputum cultures after initial phase of treatment, bilateral pulmonary disease, poor compliance, HIV positive patients: higher rates of relapse. Hepatic impairment: obtain serum transaminase levels prior to and every 2–4 weeks during therapy; discontinue if liver disease occurs or worsens. Monitor for severe rash, mucosal lesions, or any hypersensitivity reactions; discontinue if occur. Porphyria: not recommended. May discolor body tissue/fluids, contacts and dentures may become permanently stained. Advise patients to use non-hormonal contraception or additional barrier method during treatment. Pregnancy. Neonates. Labor & delivery: increased risk of postpartum hemorrhage. Nursing mothers: monitor infants.
May antagonize protease inhibitors, reverse transcriptase inhibitors (significant decrease in plasma concentrations and loss of therapeutic effect), antiarrhythmics (eg, disopyramide, mexiletine, quinidine, tocainide), antibiotics (eg, chloramphenicol, clarithromycin, dapsone, doxycycline, fluoroquinolones), oral anticoagulants (eg, warfarin), anticonvulsants (eg, phenytoin), antimalarials (eg, quinine), azole antifungals (eg, fluconazole, itraconazole, ketoconazole), antipsychotics (eg, haloperidol), barbiturates (eg, phenobarbital), benzodiazepines (eg, diazepam), β-blockers (eg, propranolol), calcium channel blockers (eg, diltiazem, nifedipine, verapamil), cardiac glycoside preparations (eg, digoxin), corticosteroids (eg, prednisone), fibrates (eg, clofibrate), oral hypoglycemics (eg, sulfonylureas), hormonal contraceptives (eg, ethinyl estradiol, levonorgestrel), immunosuppressants (eg, cyclosporine, tacrolimus), theophylline, methadone, PDE-5 inhibitors (eg, sildenafil), levothyroxine, tricyclic antidepressants (eg, amitriptyline, nortriptyline). May inhibit standard assays for serum folate and Vit. B12; use alternative method.
Lymphopenia, neutropenia, anemia, increased ALT, arthralgia, conjunctivitis, headache, vomiting, nausea, diarrhea, rash, pruritus, anorexia, lymphadenopathy, hypersensitivity reactions; hepatotoxicity, C. difficile-associated diarrhea, severe cutaneous adverse reactions (eg, SJS, DRESS).
Generic Drug Availability: