Description
INDICATIONS
Nimodipine is indicated for the prevention of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage.
DOSAGE
Aneurysmal subarachnoid haemorrhage:
Prophylactic administration – Adults
The recommended dose is two tablets at 4-hourly intervals (total daily dose 360 mg) to be taken with water. Prophylactic administration should commence within four days of onset of subarachnoid haemorrhage and should be continued for 21 days.
In the event of surgical intervention, administration of Nimotop tablets should be continued (dosage as above) to complete the 21 days treatment period.
In patients who develop adverse reactions the dose should be reduced as necessary or the treatment discontinued
Traumatic subarachnoid haemorrhage:
Not recommended as a positive benefit to risk ratio has not been established.
Special populations:
Patients with hepatic impairment
Severely disturbed liver function, particularly liver cirrhosis, may result in an increased bioavailability of nimodipine due to a decreased first-pass capacity and a reduced metabolic clearance. The effects and side-effects, e.g. reduction in blood pressure, may be more pronounced in these patients.
In such cases, the dose should be reduced (depending on the blood pressure) or, if necessary, discontinuation of the treatment should be considered.
Upon co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers a dose adaption may be necessary.
Elderly
There are no special dosage requirements for use in the elderly.
Paediatric population
The safety and efficacy of Nimotop in patients under 18 years of age have not been established.
Method of administration
In general, the tablets should be swallowed whole with a little liquid, with or without food. The interval between successive doses must not be less than 4 hours.
Grapefruit juice is to be avoided.
PREGNANCY AND LACTATION
Pregnancy
There are no adequate and well controlled studies in pregnant women. If nimodipine is to be administered during pregnancy, the benefits and potential risks must be carefully weighed according to the severity of the clinical picture.
Breast-feeding
Nursing mothers are advised not to breast-feed when taking this drug. Nimodipine and its metabolites have been shown to be present in human milk at concentrations of the same order of magnitude as corresponding maternal plasma concentrations.
SIDE EFFECTS
Thrombocytopenia
Allergic reaction
Vasodilatation
Rash
Nausea
Hypotension
Headache
Tachycardia
ACTIVE INGREDIENTS
Nimodipine
