Source: European Medicines Agency (EU) Revision Year: 2016 Publisher: Supplier: Micro Labs Limited, #27, Race Course Road, Bangalore 560 001, Karnataka, India, Tel: +91-80-2237 0451 to 2237 0457, Fax: +91-80-2237 0463, Email: jainethesh@microlabs.in
Protionamide 250mg Tablets is indicated in combination with other antituberculosis agents for the treatment of all forms of tuberculosis caused by Mycobacterium tuberculosis in adults and children.
Protionamide 250mg Tablets is only indicated as a second-line antimycobacterial drug when resistance to or toxicity from first-line drugs has developed.
Consideration should be given to official treatment guidelines for tuberculosis, e.g those of WHO available at: http://whqlibdoc.who.int/publications/2011/9789241501583_eng.pdf and also, to related
Companion Handbook, 2014, available at: http://www.who.int/tb/publications/pmdt_companionhandbook/en/)
Where necessary, information is supplemented with that from ethionamide, because it is chemically and pharmacologically similar to protionamide.
Protionamide 250mg Tablets should be prescribed by a physician experienced in the management of multidrug resistant tuberculosis.
Oral use.
Protionamide 250mg Tablets must always be given in combination with other antituberculosis agents.
The optimum daily dose is 15-20 mg/kg. The usual dose is 500 mg to 750 mg daily (up to 1 g daily), depending on body weight and tolerance. This daily dose can be taken either at a single occasion or split up in two doses over the day to improve tolerability.
In children the recommended doses of 15–20 mg/kg/day is usually divided into 2–3 doses (up to 1 gram per day). A single daily dose can sometimes be given at bedtime or with the main meal.
Protionamide weight-based dosing scheme in combination therapy of tuberculosis:
| Body weight | Number of tablets per day (dose) |
|---|---|
| Children | |
| 5-10 kg | 0.5 tablets (125 mg/day) |
| 11-18 kg | 1 tablet (250 mg/day) |
| 19-24 kg | 1.5 tablets (375 mg/day) |
| 25-29 kg | 2 tablets (500 mg/day) |
| Adults | |
| 30-45 kg | 2 tablets (500 mg/day) |
| 46-70 kg | 3 tablets (750 mg/day) |
| >70 kg | 4 tablets (1000mg/day) |
Protionamide 250mg Tablets may be taken with or without food. Intake with food or at bedtime may improve gastrointestinal tolerability (see also section 5.2).
In order to assess and improve tolerability, therapy may be initiated at a dose of 125-250 mg daily with gradual titration to optimal doses as tolerated by the patient. Doses should be increased by 125-250 mg increments over a few days until the full dose is reached.
It is recommended that all patients should receive pyridoxine (vitamin B6) while taking protionamide. Suggested dose for adults is 100 mg and children should receive a dose proportionate to their weight (1–2 mg/kg/day, with a usual range of 10–50 mg/day).
Protionamide is almost completely metabolised in the liver by the CYP450 system, though it is not known which of the CYP enzymes are responsible. Its use should be avoided in patients with severe hepatic impairment. No data are available for patients with mild to moderate hepatic impairment. Very little protionamide is excreted renally, and dose adjustments are not expected to be necessary in patients with renal impairment.
The duration of antituberculous therapy depends on the regimen chosen, the patient’s clinical and radiographical responses, smear and culture results, and susceptibility studies of Mycobacterium tuberculosis isolates from the patient or the suspected source case.
If therapy is interrupted, the treatment schedule should be extended to a later completion date depending, e.g. on the length of the interruption, the time during therapy (early or late) and the patient’s status.
When a dose is missed and this is noticed within 6 hours, the missed dose should be taken as soon as possible. The next regular dose should be taken as scheduled. If noticed later, then the normal dose should be taken when it is due. No double dose should be taken to make up for forgotten individual doses.
Cases of severe overdosage have not been described in the literature. In case of overdose, treatment should be symptomatic. Protionamide is not dialyzable.
Shelf life: 36 months.
Do not store above 30°C. Protect from light.
Blister pack: White opaque PVC/PVDC-Alu blisters. 10 or 14 tablets per blister card, 10 cards per box.
Bottle pack: White round HDPE bottle with CRC cap.100 tablets per bottle.
No special requirements.
Any unused product or waste material should be disposed off in accordance with local requirements.
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