INH CIBA

INH - CIBA^®
Tablet - Syrup

PRESCRIPTION ONLY

Composition
Each tablet INH-CIBA^® 400 mg contains:
Isoniazid 400 mg and Pyridoxine HCl 10 mg.

Each tablet INH-CIBA^® 300 mg contains:
Isoniazid 300 mg.

Each 5 ml INH^® syrup contains:
Isoniazid 100 mg and Pyridoxine HCl 5 mg

Properties
Isoniazid INH is a hidrazide derivate that acts as bacteriostatic to M. Tuberculosis, its bactericide effects is shown on the bacteria that multiplies actively, by interfering with cell wall mycolic acid biosynthesis of mycobacterium.
Isoniazid has no antibacterial activity on other microorganisms except on mycobacterium.
For the prevention of dose-dependent peripheral neuritis which quite often occurs in undernourished patients, vitamin B6 is added purposely.

Indications
Tuberculosis in combination with any other antituberculous drug.

Contraindications
Hypersensitivity to Isoniazid
Drug-Induced hepatitis patients.

Administration and dosage
Therapy
Tablet
Adult:
1 tablet daily or depending on the body weight: 5 mg/ kg of body weight daily. (maximal 300 mg/ day)

Children:
10 - 20 mg/ kg/ BW/ daily in single dose (maximal 300 mg/ day)

Syrup
Adult:
5 mg/ kg/ BW / daily single dose (maximal 300 mg/ day)

Children:
10 - 20 mg/ kg/ BW / daily single dose (maximal 300 mg/ day)

Prophylaxis
Children : 5 - 10 mg/ kg/ BW / daily (maximal 300 mg/ day)

Side effects
Peripheral neuritis, optic neuritis, hepatotoxic necrosis, insomnia, musde twitching, convulsion epigastric distress, psychotic episode, hypersensitivity reactions, agranulocytocis, hepatitis (especially for those above 35 year old), systemic lupus erythematosus like syndrome, pellagra, hyperglicaemia, gynecomastia and epilepsy.

Warning and Precautions

• It is advisable for patients to come to the physicians if prodomal hepatotoxicity occurs, like weakness, exhausted, anorexia, nausea and vomiting.
• INH should be prescribed carefully for patients with the history of psychotic alcoholism, pregnant women or lactation, porphyria.
• INH should be prescribed carefully for patients with "slow acetylator status", because it may increase adverse events risk.
• INH should be prescribed carefully for patients with hepatic and renal dysfunction.

Drug Interaction.
INH may inhibit metabolism of carbamazepin ethosuximide and phenytoin.
The absorption of isoniazid is reduced by antacids (that contains of Al and Mg)
Cycloserin and disulfiram may enhance central nervous system toxicity.

Storage
Tablets and syrup: Do not store above 25°C, protectfrom light and moisture.
Drug should be kept out o fthe reach of children.

Package
INH-CIBA^® 400 mg + Vit. B6: Box of 10 strips of 10 tablets, Reg. No. DKL 9930410010A1.
INH-CIBA^® 300 mg, pack of 10 strips of 10 tablets, Reg. No. DKL 9930409910A1.

Manufactured by
PT Novartis Indonesia
Under license of Sandoz GmbH, Kundl, Austria

INH^® syrup: Bottle of 120 ml,
Reg. No. DKI 0721200137 A1

Manufactured by
Interphil Laboratories Inc., Cabuyao
Laguna, Philippines
For Sandoz Philippines Corp.
Makati, Philippines
Imported by PT Novartis Indonesia
Citeureup, Bogor, Indonesia

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