RIFADIN IV Dosage & Rx Info | Uses, Side Effects

Rifadin Iv Generic Name & Formulations

Legal Class

General Description

Rifampin 600mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution.

Pharmacological Class

Rifamycin.

How Supplied

Caps—contact supplier; Vials—1

Storage

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Avoid excessive heat (temperatures above 40°C or 104°F). Protect from light.

Manufacturer

Sanofi U.S.

Mechanism of Action

Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible Mycobacterium tuberculosis organisms. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.

Rifadin Iv Indications

Indications

Initial treatment and retreatment of susceptible tuberculosis, when oral therapy is not feasible.

Rifadin Iv Dosage and Administration

Adult

10mg/kg once daily; max 600mg/day. Caps: give 1hr before or 2hrs after meals with water. IV: infuse over 30mins (100mL) or within 3hrs (500mL). Initial phase: treat for up to 2 months with isoniazid and pyrazinamide (streptomycin or ethambutol may be added as fourth drug if resistance to isoniazid exists). After initial phase, continue rifampin with isoniazid for at least 4 months; longer if sputum or culture remains (+), with resistant organisms, or HIV (+).

Children

10–20mg/kg once daily; max 600mg/day. Caps: give 1hr before or 2hrs after meals with water. IV: infuse over 30mins (100mL) or within 3hrs (500mL). Initial phase: treat for up to 2 months with isoniazid and pyrazinamide (streptomycin or ethambutol may be added as fourth drug if resistance to isoniazid exists). After initial phase, continue rifampin with isoniazid for at least 4 months; longer if sputum or culture remains (+), with resistant organisms, or HIV (+). Preparation of suspension: see full labeling.

Rifadin Iv Contraindications

Contraindications

Concomitant ritonavir-boosted saquinavir (increased risk of severe hepatotoxicity). Concomitant atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir. Concomitant praziquantel. Concomitant lurasidone. Rifamycin hypersensitivity.

Rifadin Iv Boxed Warnings

Not Applicable

Rifadin Iv Warnings/Precautions

Warnings/Precautions

Meningococcal: reserve rifampin for cases where high risk of meningococcal disease exists; confirm diagnosis. Not recommended for intermittent therapy (risk of rare renal hypersensitivity reactions). Monitor for hypersensitivity or severe cutaneous reactions (eg, SJS, TEN, DRESS); discontinue if occur. Monitor for signs of liver injury (esp. in prolonged treatment). If hepatic impaired: obtain LFTs at baseline, then every 2–4 weeks during therapy. Discontinue if signs of hepatic damage occur or worsen. Vitamin K-dependent coagulation disorders, bleeding; monitor. Pulmonary toxicity. Thrombotic microangiopathy (including thrombotic thrombocytopenic purpura, hemolytic uremia syndrome). Diabetes. May stain teeth, body secretions, contact lenses. IV: avoid extravasation. Elderly. Pregnancy. Nursing mothers: not recommended.

Rifadin Iv Pharmacokinetics

Absorption

Mean peak plasma concentration: 9.0±3.0 mcg/mL (after an IV 300 mg dose); 17.5±5.0 mcg/mL (after an IV 600 mg dose).

Distribution

Widely distributed throughout the body. Plasma protein bound: ~80%. Volume of distribution: 0.66±0.14 L/kg (for 300 mg IV dose); 0.64±0.11 L/kg (for 600 mg IV dose).

Metabolism

Rifampin undergoes progressive deacetylation.

Elimination

Renal (up to 30%). Total body clearances: 0.19±0.06 L/hr/kg (for 300 mg IV dose); 0.14±0.03 L/hr/kg (for 600 mg IV dose).

Rifadin Iv Interactions

Interactions

See Contraindications. Discontinue rifampin 4 weeks before giving praziquantel; may be restarted one day after completing praziquantel treatment. Avoid concomitant zidovudine, indinavir, efavirenz, mifepristone, daclatasvir, simeprevir, sofosbuvir, telaprevir, halothane, quinine, ticagrelor, and alcohol. Concomitant hepatotoxic agents: may cause fatal liver dysfunction. Antagonizes oral or other hormonal contraceptives (consider nonhormonal methods), phenytoin, antiarrhythmics, tamoxifen, toremifene, haloperidol, azole antifungals (avoid 2 weeks before and during itraconazole), β-blockers, diazepam, zopiclone, zolpidem, CCBs, prednisolone, moxifloxacin, sulfonylureas, cyclosporine, oxycodone, morphine, ondansetron, simvastatin, rosiglitazone, nortriptyline, enalapril, chloramphenicol, clarithromycin, dapsone, doxycycline, irinotecan, levothyroxine, losartan, methadone, telithromycin, theophylline. Risk of bleeding with clopidogrel; do not use. Monitor warfarin, digoxin, tacrolimus; adjust dose as needed. May be potentiated by probenecid, cotrimoxazole. Concomitant atovaquone: not recommended. Separate dosing of antacids by at least 1hr. May cause false (+) urine tests for opiates. May inhibit assays for serum folate and Vit. B₁₂ (consider alternative methods). Perform LFTs and use contrast media prior to morning dose.

Rifadin Iv Adverse Reactions

Adverse Reactions

GI disturbances, jaundice, headache, fever, drowsiness, fatigue, ataxia, dizziness, inability to concentrate, mental confusion, muscular weakness, pain in extremities, generalized numbness, visual disturbances, elevated BUN and serum uric acid, menstrual disturbances, urticaria, rash, edema; hepatotoxicity, hepatitis, abnormal LFTs, cholestasis, paradoxical drug reaction, interstitial lung disease; rare: blood dyscrasias, anaphylaxis.

Rifadin Iv Clinical Trials

See Literature

Rifadin Iv Note