Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bayer
NIMOTOP®30 mg Tablets NIMOTOP®IV Solution SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form) NIMOTOP ® 30 mg Tablets NIMOTOP ® IV Solution COMPOSITION: Tablets: Nimodipine 30 mg Solution: Nimodipine 10 mg/50 mL - Contains 25% v/v Ethanol PHARMACOLOGICAL CLASSIFICATION: A 7.1 Vasodilators, hypotensive medicines PHARMACOLOGICAL ACTION: Nimodipine is a calcium antagonist of the dihydropyridine group. INDICATIONS: Nimotop is indicated for the reduction of cerebral infarction and improvement of outcome after subarachnoid haemorrhage. CONTRA-INDICATIONS: Safety during pregnancy and lactation has not been established. In patients with severely impaired liver function, dosage reduction may be required and discontinuation of treatment should be considered, if hypotension occurs. WARNINGS: NIMOTOP 30 mg tablets should not be administered concomitantly with NIMOTOP IV solution. NIMOTOP 30 mg tablets and NIMOTOP IV solution must be used with care when cerebral oedema or severely raised intracranial pressure are present. Patients with known renal disease and/or receiving nephrotoxic drugs, should have renal function monitored closely during intravenous treatment with NIMOTOP IV solution. DOSAGE AND DIRECTIONS FOR USE: NIMOTOP 30 mg Tablets: The recommended dose is two tablets at 4-hourly intervals, (total daily dose 360 mg), to be taken with water. Administration should commence as soon as possible, but not later than 96 hours after the event and should be continued for 21 days. NIMOTOP IV Solution (may be used in lieu of tablets): For the first two hours of treatment 1 mg of nimodipine i.e. 5 mL NIMOTOP IV solution, (about 15 micrograms/kg body mass), should be infused each hour. The dose should be increased after 2 hours to 2 mg nimodipine i.e. 10 mL NIMOTOP IV solution per hour (ab Read the complete document