NIMOTOP

What it is

Nimodipine Juno is a concentrated intravenous infusion solution containing 0.2 mg/mL nimodipine . It is presented as a clear slightly yellowish solution containing 10 mg nimodipine per 50 mL in a glass vial . Nimodipine belongs to the class of calcium channel blockers and is a 1,4-dihydropyridine .

Approved indications

— Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus (Hunt and Hess Grades I–III)

Dosing overview

The initial dosage is 5 mL nimodipine (1 mg nimodipine) per hour infused continuously for the first 2 hours (approximately 15 μg/kg body weight per hour) . If tolerated, the dosage should then be increased to 10 mL nimodipine (2 mg nimodipine per hour) (approximately 30 μg/kg body weight per hour) . Patients whose body weights are distinctly below 70 kg or who have labile blood pressure can start with a dose of 2.5 mL per hour (0.5 mg nimodipine per hour), and if at all possible, the dosage should not be raised above 5 mL per hour . Patients with hepatic insufficiency may have substantially reduced clearance; dosage should be reduced to 2.5 mL per hour . Treatment should commence as soon as possible or within 4 days of the diagnosis of subarachnoid haemorrhage and continue for at least 7 days up to a maximum of 14 days .

Key safety warnings

Blood pressure should be carefully monitored during treatment with nimodipine as a decrease in blood pressure has been reported in about 5% to 7% of subarachnoid haemorrhage patients receiving oral nimodipine . Caution is required in patients with hypotension (systolic pressure lower than 100 mm Hg) . Simultaneous intravenous administration of beta-blockers can lead to the mutual potentiation of negative inotropic effects and even to decompensated heart failure . Although treatment with nimodipine has not been shown to be associated with increases in intracranial pressure, cautious use and close monitoring is recommended in cases when the water content of the brain tissue is elevated (generalised cerebral oedema) . Nimodipine Juno contains 23.7% ethanol (alcohol), up to 50 g per daily dose (250 mL). This may be harmful for those suffering from alcoholism or impaired alcohol metabolism and should be taken into account in pregnant or breast feeding women, children, and high-risk groups such as patients with liver disease or epilepsy . Intestinal pseudo-obstruction (paralytic ileus) has been reported rarely, and a causal relationship to nimodipine cannot be ruled out .

Contraindications

Nimodipine Juno must not be used in cases of hypersensitivity to nimodipine or any of the excipients . The use of nimodipine tablets in combination with rifampicin is contraindicated as efficacy of nimodipine may be significantly reduced when concomitantly administered with rifampicin . The concomitant use of oral nimodipine and the antiepileptic drugs phenobarbital, phenytoin or carbamazepine is contraindicated as efficacy of nimodipine may be significantly reduced .

Regulatory history

Nimodipine 10 mg per 50 mL injection was first listed on the Australian Register of Therapeutic Goods on 9 June 1993 . Nimodipine Juno was first approved on 8 November 2021 .