DIACOMIT Capsule / Powder for suspension Ref.[10826] Active ingredients: Stiripentol

2.1 Laboratory Tests Prior to First Dose of DIACOMIT

Hematologic testing should be obtained prior to starting treatment with DIACOMIT [see Warnings and Precautions (5.3)].

2.2 Dosing Information

The recommended oral dosage of DIACOMIT is 50 mg/kg/day, administered in 2 or 3 divided doses (i.e., 16.67 mg/kg three times daily or 25 mg/kg twice daily). If the exact dosage is not achievable given the available strengths, round to the nearest possible dosage, which is usually within 50 mg to 150 mg of the recommended 50 mg/kg/day. A combination of the two DIACOMIT strengths can be used to achieve this dosage. The maximum recommended total dosage is 3,000 mg/day.

2.3 Gradual Withdrawal

As is advisable for most antiepileptic drugs, if DIACOMIT treatment is discontinued, the drug should be withdrawn gradually to minimize the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.4)].

In situations where rapid withdrawal of DIACOMIT is medically required, appropriate monitoring is recommended.

2.4 Important Administration Instructions

DIACOMIT Capsules

DIACOMIT capsules must be swallowed whole with a glass of water during a meal. Capsules should not be broken or opened.

DIACOMIT Powder for Oral Suspension

DIACOMIT should be mixed in a glass of water (100 mL) and should be taken immediately after mixing during a meal. To be sure there is no medicine left in the glass, add a small amount of water (25 mL) to the drinking cup and drink all of the mixture [see Instructions for Use].

2.5 Missed Dose

A missed dose should be taken as soon as possible. If it is almost time for the next dose, the missed dose should not be taken. Instead, the next scheduled dose should be taken. Doses should not be doubled.

There are no data concerning overdose in humans. In mice treated with high doses of stiripentol (600 to 1800 mg/kg i.p.), decreased motor activity and decreased respiration were observed. Treatment of an overdose should be supportive (symptomatic measures in intensive care units).

For management of a suspected drug overdose, contact your regional Poison Control Center.

Store in a dry place at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in original package to protect from light.