Precautions and warnings

**Care should be taken in patients with kidney or liver problems, diabetes, long-term alcohol use, poor nutrition, a history of gout, seizure disorders, or acute porphyria.**

**Precautions:** Blood tests and liver function tests (like SGPT and SGOT) should be done regularly, especially during long-term treatment, and ideally before starting.

If a patient already has liver disease or poor liver function, they should only be treated with close medical supervision. Liver function should be checked regularly, and early signs of hepatitis—such as tiredness, weakness, feeling unwell, loss of appetite, nausea, or vomiting—should be watched for. If these symptoms appear or there are signs of liver damage, stop the treatment immediately. Serious, and sometimes fatal, hepatitis may occur even after months of treatment.

Drug Interactions

**Rifampicin** can make some medicines less effective, including birth control pills, ACE inhibitors (like enalapril or imidapril), anti-nausea drugs (like aprepitant), cancer medicines (like imatinib), diuretics (like eplerenone), erectile dysfunction drugs (like tadalafil), some diabetes medicines (like nateglinide or repaglinide), and some painkillers (like etoricoxib). Rifampicin can also lower the levels of atovaquone and ketoconazole in your blood. Taking antacids can lower how well your body absorbs rifampicin. Using certain anesthetics and halothane together with rifampicin and isoniazid can raise the risk of liver damage.

**Isoniazid** can increase the amount of phenytoin and theophylline in your blood, and it can slow down the breakdown of carbamazepine. Taking stavudine with isoniazid can increase the risk of nerve problems (neuropathy). Antacids can also lower how well your body absorbs isoniazid. Taking isoniazid with para-aminosalicylic acid can increase isoniazid levels. Using isoniazid and cycloserine together can raise the risk of brain and nerve side effects.

**Pyrazinamide** can reduce the effectiveness of probenecid and sulfinpyrazone.

**Warning:** Taking saquinavir or ritonavir with these drugs can greatly increase the risk of serious liver damage. Rifampicin may also make certain antiviral medicines (such as atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir) less effective.

Contraindications

Do not use this medicine if you are known or suspected to be allergic to rifamycins, isoniazid, pyrazinamide, or any of the other ingredients in this drug. It should also not be used if you have a history of liver problems caused by medication, currently have any serious liver disease, or have experienced nerve problems such as peripheral neuritis.

Mode of actions

Rifampicin, isoniazid, and pyrazinamide are all powerful antibiotics used to treat tuberculosis. Rifampicin and isoniazid work especially well against fast-growing TB bacteria found outside of cells, and they are also effective against bacteria inside cells. Rifampicin works by blocking a key enzyme (DNA-dependent RNA polymerase) and is able to kill not just fast-growing, but also slower and irregularly growing TB bacteria. Pyrazinamide is most effective inside cells, particularly in the acidic environment inside immune cells called macrophages. Using these three drugs together helps target all types of TB bacteria—those growing quickly, slowly, and those hiding inside cells.

Dosage & Administration

Total Dosage Requirement: Rifampicin: 10 (8-12) mg/kg body mass/day.
Isoniazid: 5 (4-6) mg/kg body mass/day.
Pyrazinamide: 25 (20-30) mg/kg body mass/day.

Patients weighing 55 kg – 6 tablets

Pediatric Patients

The ratio of the drugs may not be appropriate in pediatric patients under the age of 15 (e.g., higher mg/kg doses of isoniazid are usually given in pediatric patients than adults).

The tablets should be given as a single dose, preferably on an empty stomach, at least 30 min before breakfast to ensure a high peak serum concentration.
Tablets are recommended in the initial intensive phase of the short course treatment of tuberculosis. During this phase which lasts for 2 months,

Pregnancy & Lactation

Although animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in pregnant women, but during pregnancy, this medicine can be used just when definitely required despite potential risks.

Mothers with a newborn baby who have used this drug during the last 3 months of pregnancy may seldom create symptoms including drowsiness, muscle stiffness or shakiness, feeding or breathing troubles, constant crying. If you notice any of these symptoms of your baby's particularly during their first month, tell the doctor immediately.

This medicine passes into breast milk. Talk to your doctor before breastfeeding.

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