RIFADIN 300MG 8CAP

Indications

Approved Uses

Tuberculosis (pulmonary and extrapulmonary) only in combination with other antitubercular drugs; eradication of Neisseria meningitidis from the nasopharynx of asymptomatic carriers (chemoprophylaxis).

Off-Label Uses

Adjunct therapy for serious staphylococcal infections involving prosthetic material (e.g., prosthetic joint infection, prosthetic valve endocarditis) in combination; treatment of latent TB infection in specific regimens (e.g., 4 months rifampicin) depending on local approvals; cholestatic pruritus (e.g., primary biliary cholangitis) in selected patients; some nontuberculous mycobacterial infections as part of combination therapy.

Dosage & Administration

Dosing by Condition

Tuberculosis (adults): 10 mg/kg (usual 600 mg) once daily (max 600 mg/day) as part of combination therapy; some programs use weight-banded dosing (e.g., 450 mg if <50 kg, 600 mg if ≥50 kg). Meningococcal carrier eradication (adults): 600 mg orally every 12 hours for 2 days. Leprosy (adult MDT): 600 mg once monthly supervised in combination regimens. Brucellosis (adult, in combination e.g., doxycycline): 600-900 mg/day for ~6 weeks (regimen-dependent).

Maintenance Dose

600 mg once daily or as part of intermittent regimen (3 times weekly) throughout treatment course

Maximum Dose

600 mg/day for most indications.

Dose Adjustment Notes

No routine renal dose adjustment; use caution in hepatic impairment-avoid or reduce/individualize dose and monitor closely (risk of hepatotoxicity). Administer on an empty stomach for best absorption; if significant GI intolerance, may take with food acknowledging reduced absorption.

How to Take

Take orally on an empty stomach with a full glass of water (30-60 minutes before food or 2 hours after); swallow capsules whole (do not crush/chew). Harmless red‑orange discoloration of urine/sweat/saliva/tears may occur and soft contact lenses may stain.

Side Effects

Common Side Effects

Red‑orange discoloration of body fluids; gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea, anorexia); rash/pruritus; headache/dizziness; fever/flu‑like symptoms (more with intermittent dosing); elevated liver enzymes/hepatitis (less common but clinically important).

Side Effect Frequency

Common/very common: orange-red discoloration of body fluids; gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea, anorexia); rash/pruritus; and asymptomatic elevations in liver enzymes. Serious but uncommon/rare: clinically significant hepatitis/hepatotoxicity, thrombocytopenia/hemolytic anemia, acute renal failure/interstitial nephritis, severe cutaneous reactions (SJS/TEN, DRESS), and flu-like syndrome (more with intermittent dosing).

Safety & Warnings

Contraindications

Contraindicated in hypersensitivity to rifampicin/rifamycins and with concomitant saquinavir/ritonavir; avoid/contraindicated with certain HIV protease inhibitors (e.g., atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir) due to major interaction/virologic failure risk; severe hepatic disease/jaundice is a strong precaution and may be a contraindication per local labeling.

Warnings & Precautions

Baseline and periodic liver function monitoring (especially with liver disease/alcohol use or concomitant hepatotoxins); extensive interaction review due to strong enzyme induction (including reduced hormonal contraceptive efficacy); counsel on harmless orange discoloration of body fluids and staining of soft contact lenses; avoid interrupted/intermittent dosing when possible as it increases immune reactions (flu-like syndrome, thrombocytopenia, renal failure) and risk on re-challenge.

Age Restriction

No absolute minimum age; may be used in neonates/infants and children when clinically indicated under specialist supervision with weight-based dosing.

Drug Interactions

Drug Interactions

Potent inducer of CYP3A4/2C9/2C19/2C8/2B6 and P-gp: markedly lowers exposure/effect of many drugs (notably HIV protease inhibitors/NNRTIs, hormonal contraceptives, warfarin, calcineurin inhibitors, methadone, many antifungals, some statins, benzodiazepines, some CCBs/beta-blockers, oral hypoglycemics); contraindicated with saquinavir/ritonavir; antacids can reduce absorption; combined hepatotoxins (e.g., isoniazid, alcohol) increase liver injury risk.

Interaction Severity

MAJOR: Strong inducer of CYP3A4/2C9/2C19 and P-gp-markedly reduces exposure to many drugs including protease inhibitors/NNRTIs (loss of HIV control; contraindicated with many), warfarin (↓INR), combined hormonal contraceptives (failure), calcineurin inhibitors (rejection risk), methadone (withdrawal), many DOACs (reduced anticoagulation). MAJOR/CONTRAINDICATED: saquinavir/ritonavir (severe hepatotoxicity). MODERATE: additive hepatotoxicity with isoniazid and other hepatotoxins; reduced levels/effects of azole antifungals, some statins, calcium-channel blockers, some antiepileptics, oral hypoglycemics, benzodiazepines, doxycycline. MINOR: antacids may reduce absorption if coadministered (separate dosing).

Food Interaction

Take on empty stomach (30-60 minutes before meals or 2 hours after) for optimal absorption; food reduces peak plasma concentration by approximately 30%; may be taken with food if GI intolerance occurs

Special Populations

Kidney Impairment

No routine dose adjustment required in renal impairment at standard doses (including up to 600 mg/day); monitor if severe renal failure or if using high/intermittent regimens.

Storage & Patient Advice

Storage Conditions

Store below 30°C, protect from light and moisture

Missed Dose

Take the missed dose as soon as remembered the same day; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Complete the prescribed course and do not stop without medical advice; stop and seek urgent care if severe hypersensitivity/SCARs, significant hepatotoxicity (e.g., jaundice, marked LFT rise with symptoms), thrombocytopenic bleeding, or acute renal failure symptoms occur.

Overdose

Symptoms: GI upset, pruritus, headache, lethargy, and prominent orange-red discoloration of body fluids/skin; severe cases may include hypotension, facial/periorbital edema, seizures/altered consciousness, and hepatotoxicity/jaundice. Management: urgent medical care, supportive treatment, consider activated charcoal if early, and monitor liver/renal function; no specific antidote.

Patient Counseling

Take rifampicin (RIFADIN) exactly as prescribed and complete the full course. Preferably take on an empty stomach (1 hour before or 2 hours after food) to maximize absorption; if severe GI upset occurs, it may be taken with food but absorption may be reduced. Expect harmless orange-red discoloration of urine, sweat, saliva, and tears; it can permanently stain soft contact lenses. Rifampicin is a strong enzyme inducer and can reduce effectiveness of many medicines (notably hormonal contraceptives, warfarin, some antiretrovirals, azoles, anticonvulsants); use a non-hormonal/backup contraceptive and inform all healthcare providers/pharmacists. Avoid alcohol and seek urgent care for hepatotoxicity symptoms (yellow skin/eyes, dark urine, severe/persistent nausea/vomiting, right upper abdominal pain, unusual fatigue) or bleeding/bruising/rash.

Monitoring Requirements

Baseline and periodic liver function tests (AST/ALT, bilirubin) especially if risk factors; clinical monitoring for hepatitis symptoms; CBC (rare cytopenias) and renal function as clinically indicated; monitor/adjust co-medications affected by enzyme induction (e.g., INR with warfarin, contraceptive efficacy, antiretroviral levels/selection).

Pharmacology

Mechanism of Action

Binds the beta subunit of bacterial DNA-dependent RNA polymerase, inhibiting RNA synthesis (transcription) and thereby suppressing protein synthesis; bactericidal against susceptible organisms.

Onset of Action

Oral peak concentrations typically occur about 2-4 hours after dosing; clinical antibacterial activity begins after achieving therapeutic concentrations (within hours).

Half-Life

About 2-5 hours after a single dose; decreases with repeated dosing due to autoinduction (commonly ~2-3 hours).

Metabolism

Hepatic metabolism mainly via deacetylation to active 25-desacetylrifampicin; potent inducer of CYP enzymes and P-gp with autoinduction of its own metabolism.

Product Information

Available Dosage Forms

For this SFDA product: hard oral capsule. (Rifampicin as a drug is also available in some markets as oral capsules/tablets/suspension and as IV lyophilized powder for solution.)

Composition per Dose

Each capsule: 300 mg rifampicin

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad-spectrum

Antibiotic Class

Rifamycin

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