Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: RPH Pharmaceuticals AB, Lagervägen 7, 136 50 Haninge, Sweden
Isoniazid is indicated in the treatment of all forms of pulmonary and extra-pulmonary tuberculosis.
Official guidance should always be consulted when selecting the dose regimens to be used for adults and children (according to age and body weight), the duration of therapy and the total content of the combination treatment regimen.
The dose of isoniazid for the treatment of tuberculosis is commonly 4 to 5mg per kilogram body-weight daily given by mouth in single or divided doses up to a maximum of 300mg daily. Up to 10mg per kilogram body-weight daily may be given particularly during the first 1 to 2 weeks of treatment of tuberculous meningitis. A dose of 15mg per kilogram has been given two or three times weekly in intermittent treatment regimens.
No dosage reduction is necessary in the elderly, but caution should be exercised due to the possible decrease in renal and hepatic function.
The usual daily dose for children aged three months and above is from 10 up to 15mg per kilogram body-weight daily in single or divided doses.
Isoniazid should not be used in children aged 0 to 3 months because of the lack of specific data.
Isoniazid tablets should be taken preferably on an empty stomach, i.e. at least 30 minutes before a meal or 2 hours after a meal.
The most commonly reported adverse events associated with isoniazid overdose are nausea, vomiting and central nervous system toxicity such as vertigo, seizures and coma.
Treatment of overdosage consists of gastric lavage following intubation and the control of convulsions by anti-convulsants given intravenously as well as the intravenous injection of large doses of pyridoxine. Any acidosis is corrected with sodium bicarbonate. Forced diuresis may be tried and haemodialysis or peritoneal dialysis has been used.
Shelf life: 36 months.
Store below 25°C.
Pigmented polypropylene container fitted with a tamper-evident closure containing 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120 or 250 tablets. Not all pack sizes may be marketed.
No special precautions are required.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
