NIMOTOP FOR INFUSION 0.02%

INDICATION(S)

Prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin

CONTRAINDICATIONS

Nimotop solution for infusion must not be used in cases of hypersensitivity to nimodipine or to any of the excipients.

POSOLOGY AND METHOD OF ADMINISTRATION

Unless otherwise prescribed, the following dosage is recommended:

Dosage:

Intravenous infusion:

At the beginning of treatment 1 mg/h nimodipine (= 5 mL Nimotop solution for infusion /h) for 2 h (about 15 mcg/kg body weight/h).

If this is well tolerated, and particularly if there is no marked reduction in blood pressure, the dose is increased after 2 h to 2 mg/h nimodipine (= 10 mL Nimotop solution for infusion/h) (about 30 mcg/kg body weight/h).

Patients whose body weight is appreciably below 70 kg or who have labile blood pressure should be started with a dose of 0.5 mg/h nimodipine (= 2.5 mL Nimotop solution for infusion/h).

Intracisternal instillation:

During surgery, a freshly prepared dilute solution of nimodipine (1 mL Nimotop solution for infusion and 19 mL Ringer’s solution) warmed up to blood temperature may be instilled intracisternally.

This dilute solution of Nimotop solution for infusion must be used immediately after preparation.

Administration

Nimotop solution for infusion is administered as a continuous i.v. infusion via a central catheter using an infusion pump. It should be given via a three-way stopcock together with either glucose 5 %, sodium chloride 0.9 %, lactated Ringer's solution, lactated Ringer's solution with magnesium, dextran 40 solution or HAES® (poly(O-2-hydroxyethyl) starch 6 % in a ratio of about 1:4 (NIMOTOP:co-infusion). Also mannitol, human albumin or blood are suitable for co-infusion.

Nimotop solution for infusion must not be added to an infusion bag or bottle and must not be mixed with other drugs. Administration of Nimotop solution for infusion should be continued during anaesthesia, surgery and angiography.

The three-way stopcock should be used to connect the Nimotop polyethylene tube with the co-infusion line and the central catheter.

Duration of use

Prophylactic Use:

Intravenous therapy should be started no later than 4 days after the haemorrhage and be continued during the period of maximum risk of vasospasm, i.e. up to 10 –14 days after the subarachnoid haemorrhage.

If during prophylactic administration of Nimotop solution for infusion, the source of the haemorrhage is treated surgically, intravenous treatment with Nimotop solution for infusion should be continued post-operatively for at least 5 days.

After the end of the infusion therapy, it is advisable to continue with oral administration of 6 x 60 mg nimodipine a day at 4 h intervals for about a further 7 days.

Therapeutic Use:

If ischaemic neurological disturbances caused by vasospasm after aneurysmal subarachnoid haemorrhage are already present, treatment should be started as early as possible and be continued for at least 5 days up to a maximum of 14 days.

Thereafter, oral administration of 6 x 60 mg nimodipine/day at 4 h intervals for 7 days is recommended.

If during therapeutic administration of Nimotop solution for infusion, the source of the haemorrhage is treated surgically, i.v. treatment with Nimotop solution for infusion should be continued postoperatively for at least 5 days.