Nimodipine

Registered South African indications:

• Improvement of outcome after subarachnoid haemorrhage

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Myocardial infarction within the last month
• Unstable angina episode within the last month
• Coadministration with rifampicin (tab)
• Coadministration with anti-epileptic drugs, phenobarbital, phenytoin or carbamazepine (tab)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Severe hepatic impairment
• Cirrhosis
• Alcoholism
• Patients on a low-sodium diet
• Traumatic subarachanoid haemorrhage
• Children
• Epilepsy
• Cerebral oedema
• Raised intracranial pressure
• Hypotension
• Coadministration with CYP 3A4 inhibitors (tab)
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab, inj

Improvement of outcome after subarachnoid haemorrhage

• Oral (tab): 60mg, 4hrly; Treatment duration: 21 days

Initiate within 96hrs of subarachnoid haemorrhage

• IV: Initial: 1mg, hourly for 2hrs; Then 2mg, hourly; Treatment duration: 5-14 days

Initiate as soon as cerebral ischaemia occurs

Dose adjustment for weight < 70kg, or unstable blood pressure

Monitor for hypotension

See additional prescribing points for administration directions

Not established for use in children below 18 years

Pregnancy

• Caution
• There are no adequate and well-controlled studies in pregnant women. Reproductive toxicology studies in animals using oral administration showed no teratogenic effect, although studies in animals have shown reproductive toxicity
• 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

Breastfeeding

• Caution; not recommended
• 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. Breastfeeding mothers are advised not to breastfeed when taking nimodipine

Fertility

• In single cases of in-vitro fertilisation calcium antagonists have been associated with reversible biochemical changes in the spermatozoa's head section that may result in impaired sperm function. The relevance of this finding in short-term treatment is unknown

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Mild to moderate (Child-Pugh class A and B): No dose adjustment recommended
  Treatment duration: 7-10 days, whenever possible
• Severe/cirrhosis (Child-Pugh class C): Caution; dose adjustment recommended
  Oral (tab): 30mg, 6-8hrly

Elderly

• No dose adjustment recommended

Porphyria Information

• Porphyrinogenic (P)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Sleeplessness
• Increased motor agitation
• Excitation 
• Aggression
• Hyperkinesia
• Depressed mood

Cardiovascular Disorders

• Tachycardia
• Bradycardia
• Hypotension
• Vasodilatation

Gastrointestinal Disorders

• Nausea
• Ileus

Hepato-biliary disorders

• Transient increase in liver enzymes

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Allergic reaction

Skin and Subcutaneous Tissue Disorders

• Rash
• Thrombophlebitis

Others

• Sweating
• Flushing
• Feeling of warmth

• Polyvinylchloride (IV)
• CYP3A4 inhibitors
• CYP3A4 inducers
• Antihypertensives
• Antiepileptic agents
• Phenobarbital
• Phenytoin
• Carbamazepine
• Nortryptyline
• Rifampicin
• Grapefruit juice
• Zidovudine 
• Ritonavir
• Macrolide antibiotics
• Azole anti-mycotics (ketoconazole)
• H2-antagonist (cimetidine)

• Blood pressure
• Intracranial pressure

Administration directions

•  IV: Admin. only via a three-way stopcock into a running drip (40 mL/h) of either isotonic saline, dextrose 5% solution or Ringer's solution; Use an infusion pump via a central catheter; Do not add to an infusion bag or bottle
• DO NOT administer the tablets and IV solution concomitantly
• The tablets should be swallowed whole with a little liquid, with or without food
• The interval between successive tablet doses must not be less than 4 hours

Nimodipine is a dihydropyridine calcium channel blocker with cerebrovascular effects. Nimodipine increases cerebral perfusion, particularly in poorly perfused areas, by arterial dilatation.

Tablet 30mg

• Nimotop (Bayer) originator

Injection (per 50ml) 10mg

• Nimotop (Bayer) originator