Pyrazinamide

Composition:
Each tablet contains:
Pyrazinamide                              500 mg

Properties:
Pyrazinamide may be bacteriostatic or bactericidal against Mycobacterium tuberculosis depending on the concentration of the drug attained at the site of infection. It is active only at a slightly acidic PH.

Pharmacokinetics:

Pyrazinamide is well absorbed from the GIT and reaches peak plasma concentrations within 2 hours.
It is widely distributed in body tissues and fluids. The half–life of Pyrazinamide is 9–10 hours. Approximately 70% of an oral dose is excreted in urine.


Indications & usage:
Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents.

Contraindications:
Pyrazinamide is contraindicated in persons:
- With severe hepatic damage or acute gout.
- Who have shown hypersensitivity to Pyrazinamide.

Side effects:
Some of the following side effects may occur in some cases:
- Hepatotoxicity which appears to be dose related, and may appear at any time during therapy.
- Nausea, Vomiting, anorexia, mild arthralgia, myalgia,hypersensitivity reactions including rashes, urticaria and pruritus.

Drug Interactions:
- Pyrazinamide may reduce contraceptive effects of oestrogens.
- Pyrazinamide antagonizes effects of probenecid and sulfinpyrazone.

Warnings & precautions:
- Patients started on Pyrazinamide should have baseline serum uric acid and liver function determinations.
- Pyrazinamide should be discontinued and not be resumed if signs of hepatocellular damage or hyperuricemia accompanied by an acute gouty arthritis appear.
- Pyrazinamide should be used with caution in patients with a history of diabetes mellitus.

Pregnancy:
Pyrazinamide should be given to a pregnant woman only if clearly needed.

Lactation:

Pyrazinamide should be used with caution in nursing mothers taking into account the risk-benefit of this therapy.

Overdosage:

In case of overdose, abnormal liver function tests may develop. Clinical monitoring and supportive therapy should be employed.
Pyrazinamide is dialyzable.

Dosage and administration:
- Pyrazinamide should always be administered with other effective antituberculous drugs.
- Pyrazinamide is administered for the initial 2 months of a 6- months or longer treatment regimen for drug- susceptible patients.
- The usual dose: 15 to 30 mg/kg once daily.

Therapeutic category: Antibacterial.
Legal category: Prescription only medicine (POM).
Package: Box containing 20 tablets.
Storage: Store in a dry place at a temperature below 30° C, protect from light.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.