INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo 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 (about 30 micrograms/kg body mass), providing no severe decrease in blood pressure is observed.
Patients of body mass 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 IV solution), or less if necessary.
Therapeutic administration should commence as soon as cerebral ischaemia occurs, and should continue for at least 5 days up to a maximum of 14 days.
If cerebral ischaemia occurs during administration, tablet treatment may be continued to complete the 21-day treatment period or substituted by NIMOTOP IV solution (dosage as above).
NIMOTOP IV solution may be used with or without pre-treatment with NIMOTOP 30 mg tablets. NIMOTOP IV solution and NIMOTOP 30 mg tablets should not be used concomitantly.
NIMOTOP IV solution should be administered only via a three-way stopcock into a running drip (40 mL/h) of either isotonic saline, dextrose 5% solution or Ringer's solution using an infusion pump via a central catheter. When NIMOTOP IV solution is withdrawn from the glass vial into the syringe, ensure that the cannula of the syringe is inserted vertically through the centre of the rubber stopper of the glass vial. NIMOTOP IV solution must not be added to an infusion bag or bottle.
NIMOTOP IV solution may be used during anaesthesia or surgical procedures.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Decrease in blood pressure, slight increase or decrease in heart rate, sweating, dizziness, flushing, headache, gastrointestinal disorders, nausea and feeling of warmth.
Infrequently, symptoms of overactivation of the CNS (central nervous system) , such as sleeplessness, increased motor agitation, excitation and aggression, may occur. Hyperkinesia and depressed mood may also occur. A transient rise in liver enzymes may occur during intravenous administration; this usually reverts to normal on completion of treatment. The infusion contains 25% v/v ethanol and 15% v/v polyethylene glycol-400; this should be taken into account during treatment. Thrombocytopenia and ileus have been reported.
Special Precautions:
NIMOTOP
IV solution reacts with polyvinylchloride (PVC). Polyethylene or polypropylene are the recommended plastic materials to be used during nimodipine infusion.
NIMOTOP IV solution is compatible with glass infusion bottles and infusion packs made of polyethylene. NIMOTOP IV solution is incompatible with infusion bags and any administration sets made of PVC.
Polyethylene tubes are supplied with NIMOTOP IV solution, and these must not be substituted.
Drug Interactions:
Nimodipine is metabolized via the cytochrome P450 3A4 system, located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or induce this enzyme system may therefore alter the first pass (after oral administration) or the clearance of nimodipine.
-        Nimodipine may potentiate the hypotensive effect of antihypertensives. Concomitant administration of other calcium antagonists, alpha-methyldopa or beta-blockers should be avoided. Where such co-administration is unavoidable, careful dose titration of nimodipine should be undertaken with possible reduction or discontinuation of the antihypertensive agent. Caution is required in patients with systolic blood pressure <90 mm Hg.
-        Blood levels of nimodipine may be increased with concomitant administration of cimetidine or the anticonvulsant sodium valproate.
-        In patients treated with enzyme inducing anticonvulsants such as phenytoin, phenobarbital and carbamazepine, the plasma concentrations of nimodipine may be markedly reduced.
  Concomitant administration of nimodipine with antidepressants such as fluoxetine and nortryptyline should be avoided as elevated nimodipine levels may occur.
-        From experience with other calcium antagonists it has to be expected that rifampicin accelerates the metabolism of NIMOTOP 30 mgtablets due to enzyme induction. Thus, efficacy of NIMOTOP 30 mgtablets could be reduced when concomitantly administered with rifampicin.
  Grapefruit juice inhibits the oxidative metabolism of dihydropyridines. Thus, concomitant intake of grapefruit juice and nimodipine can result in increased plasma concentrations and is not recommended.
Simultaneous administration of zidovudine i.v. and nimodipine i.v. should be avoided as animal studies have indicated a higher AUC for zidovudine and a reduced volume of distribution and clearance.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Since no specific antidote is known treatment must be symptomatic and supportive.
Symptoms of acute overdosage to be anticipated are marked lowering of the blood pressure, tachycardia or bradycardia and (after oral administration) gastrointestinal complaints and nausea.
In the event of acute overdosage treatment with NIMOTOP 30 mg tablets or NIMOTOP IV solution must be discontinued immediately.

IDENTIFICATION:
NIMOTOP 30 mg Tablets: Round, butter-yellow, coated tablets with SK on the upper side and the Bayer cross on the lower side.
NIMOTOP IV Solution: Clear, slightly yellowish solution.

PRESENTATION:
NIMOTOP 30 mg Tablets: Blister strips of 10 tablets. 100 tablets contained per box.
NIMOTOP IV Solution: 50 mL infusion solution contained in an amber coloured glass vial.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
NIMOTOP30 mgtablets:         T/7.1/229
NIMOTOP IV solution:         T/7.1/230

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Bayer (Pty) Ltd
Registration No. 68/11192/07
Wrench Road        ISANDO        1600

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
4 August 2000

® = Registered trade mark of Bayer AG, Germany

SPC3 14/10/99        C9151/0500

Updated on this site: February 2003
Source: Pharmaceutical Industry

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