Company: Viropharma Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Midazolam (as hydrochloride) 2.5mg, 5mg, 7.5mg, 10mg.
Description: Oromucosal solution in pre-filled syringes.
Presentation: 2.5mg-4, €84.29; 5mg-4, €86.14; 7.5mg-4, €87.99; 10mg-4, €89.31.
Indications: Treatment of prolonged acute convulsive seizures in children aged from 3 months to <18 years.
Pharmacology: Midazolam is a derivative of the imidazobenzodiazepine group and has an anticonvulsant effect. It also exerts a sedative and sleep-inducing effect of pronounced intensity, and an anxiolytic and a muscle-relaxant effect. Its pharmacological action is characterized by short duration because of rapid metabolic transformation.
Dosage: Children: For oromucosal use; insert slowly into space between gum and cheek (avoid laryngo-tracheal insertion). 3-6 months (hospital setting only), 2.5mg. >6 months-<1 year, 2.5mg. 1-<5 years, 5mg. 5-<10 years, 7.5mg. 10-<18 years, 10mg. <3 months, safety and efficacy not established. If seizure does not stop within 10 minutes after administration seek emergency assistance. If seizures re-occur after initial response, do not administer second dose without prior medical advice.
Contraindications: Hypersensitivity to the active substance, benzodiazepines or to any of the excipients, myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic impairment.
Special precautions: Caution: Chronic respiratory insufficiency, chronic renal failure, impaired hepatic or cardiac function. Patients aged 3-6 months (only in hospital setting where monitoring possible and resuscitation equipment available). Debilitated patients (lower doses may be required). History of alcohol or drug abuse (avoid). May cause anterograde amnesia. Driving/using machines. Pregnancy (only if clearly necessary), lactation.
Drug interactions: CYP3A4 inhibitors or inducers, anaesthetics and narcotic analgesics (fentanyl), antiepileptics (e.g. phenytoin), calcium-channel blockers (diltiazem, verapamil), dopaminergic agents (levodopa), muscle relaxants (baclofen), nabilone, ulcer-healing drugs (cimetidine, ranitidine, omeprazole), xanthines, azole antifungals (ketoconazole, voriconazole, fluconazole, itraconazole, posaconazole), macrolide antibiotics (erythromycin, clarithromycin), HIV protease inhibitors, atorvastatin, rifampicin, St. John’s Wort, grapefruit juice, other sedative/hypnotic agents and CNS depressants (including alcohol).
Adverse drug reactions: Sedation, somnolence, depressed levels of consciousness, respiratory depression, GI upset.
Full prescribing information and references available from Viropharma Ltd. Telephone: +44 (2075) 721222.