NIMOTOP 0.02% Solution for infusion Ref.[7830] Active ingredients: Nimodipine

Posology

Recommended dose – Aneurysmal Subarachnoid Haemorrhage

For the first two hours of treatment 1 mg of nimodipine, i.e. 5 ml Nimotop solution, (about 15 μg/kg bw/h), should be infused each hour via a central catheter. If it is well tolerated, the dose should be increased after two hours to 2 mg nimodipine, i.e. 10 ml Nimotop solution per hour (about 30 μg/kg bw/h), providing no severe decrease in blood pressure is observed.

Patients of body weight less than 70 kg or with unstable blood pressure should be started on a dose of 0.5 mg nimodipine per hour (2.5 ml of Nimotop solution), or less if necessary.

Duration of treatment

Aneurysmal subarachnoid haemorrhage

Intravenous treatment should begin as early as possible after neurological deficit occurs due to arterial spasm, post subarachnoid haemorrhage. This should continue for at least five days up to a maximum of 14 days.

In the event of surgical intervention during treatment, administration of nimodipine should be continued (dose as above) for at least five days.

Nimotop solution may be used with or without pre-treatment with Nimotop tablets. In the event of Nimotop tablets and Nimotop solution being administered sequentially the total duration of treatment should not exceed 21 days. Nimotop solution should not be administered for longer than 14 days. Nimotop solution and tablets should not be used concomitantly.

Traumatic subarachnoid haemorrhage

Not recommended as a positive benefit to risk ratio has not been established (see section 4.4).

Paediatric Population

The safety and efficacy of Nimotop in patients under 18 years of age have not been established.

Method of administration

Nimotop solution is administered as a continuous I.V. infusion via a central catheter using an infusion pump. It should be connected to a three-way stopcock using the infusion line provided. The three-way stopcock should be used to connect the Nimotop polyethylene tube with the co-infusion line and the central catheter. (The stopcock must allow for concomitant flow of the Nimotop solution and a co-infusion solution.) Nimotop solution must be administered with a co-infusion running at a rate of 40 ml/hr of either sodium chloride 0.9%, glucose 5%, Ringer’s lactate solution, lactated Ringer’s solution with magnesium, dextran 40, HAES (poly[O-2-hydroxyethyl]) starch 6%, human albumin 5%, blood or mannitol 10% in a ratio of about 1:4 (Nimotop:co-infusion), which is connected to the second port of the three-way stopcock prior to its connection with the central line catheter.

Nimotop solution must not be added to an infusion bag or bottle and must not be mixed with other drugs.

Nimotop solution may be used during anaesthesia, angiography or surgical procedures.

Symptoms of intoxication

Symptoms of acute overdosage to be anticipated are marked lowering of the blood pressure, tachycardia, bradycardia and (after oral administration) gastro-intestinal complaints and nausea.

Treatment of intoxication

In the event of acute overdosage, treatment with Nimotop must be discontinued immediately. Emergency measures should be governed by the symptoms. If the substance was ingested orally, gastric lavage with addition of charcoal should be considered as an emergency therapeutic measure. If there is a marked fall in blood pressure, dopamine or noradrenaline can be administered intravenously. As no specific antidote is known, subsequent treatment for other side effects should be aimed at the most prominent symptoms.

Shelf life of the product as packaged for sale:

A = Unopened
B = After reconstitution or when the container is opened for the first time, if appropriate.

Nimotop solution is light sensitive and therefore should be stored in the manufacturer’s light-protective container within the cardboard carton at a temperature not above 25°C.

Brown glass type II infusion vials containing 50 ml of solution; with grey chlorobutyl stopper laminated with fluoropolymer.

150 cm of colorless transparent polyethylene tubing with conus connector for each vial of 50 ml of Nimotop 0.02% Solution for Infusion.

The only plastic materials suitable for use are polyethylene or polypropylene. Nimotop solution is compatible with glass infusion bottles and infusion packs made of polyethylene (e.g. Polyfusor, Boots).

The solution when in the syringe must be protected from direct sunlight during administration, but it is stable in diffuse daylight and artificial light for up to 10 hours. Nimotop solution should be infused using a glass or rigid plastic (polyethylene or polypropylene) syringe and giving set (Gillette Sabre syringe; BD plastipak syringe; Monoject disposable syringe, Sherwood Medical Ltd; Combidyn tubes, Braun; Nitrocassette giving set, Imed Ltd.). Nimotop solution is incompatible with infusion bags and any giving sets made of PVC (e.g. Viaflex, Travenol; Steriflex, Boots).

To penetrate the coated injection stoppers correctly, fine acute injection needles are recommended. DO NOT use large-core infusion needles, since this may result in cracked or bruised stoppers and the stoppers may be forced into the vial.