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PK-Merz Infusion 0.4 mg/ml

Amantadine Sulphate
 

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Active ingredient

Active substance: Amantadine sulphate.
One infusion bottle of 500 ml solution for infusion contains 200 mg Amantadine sulphate.
 

Indications

  • Decreased vigilance in comatose states of varying aetiology within the framework of an overall treatment concept under hospital conditions.
  • Intensive care and initial treatment of akinetic crisis in acute exacerbations of parkinsonian symptoms.

Dosage and Administration

Parkinson’s syndromes: In the event of an acute exacerbation in parkinsonian symptoms in the sense of an akinetic crisis, intravenous doses of 200 mg amantadine sulphate in 500 ml of solution should be administered 1-3 times a day The rate of infusion should not exceed 55 drops/min, equivalent to an infusion time of approximately 3 hours.

Contraindication

  • Hypersensitivity to amantadine, or to any of the other constituents of the medicinal product.
  • Severe decompensated heart failure (NYHA stage IV).

Side effects

Side effects are primarily behavioral including the following:
• Insomnia, anorexia, hallucination, irritability, nervousness and hyperactivity.
These symptoms transient and often abate with a lowering of dosage.

Drug Interaction

The simultaneous use of Amantadine and drugs known to cause prolongation of the QT interval is contraindicated for example:
• Certain antiarrythmic agents of class 1A (e.g,quinidine  disopyramide and procainamide) and class 3 (e.g. amiodarone and sotalol).
• Certain antipsychotics (e.g. thioridazine, chlorpromazine haloperidol and pimozide Certain tricyclic and tetracyclic antidepressants (e.g. amitriptyline).
• Certain antihistamines (e.g. astemizole and terfenadine).
• Certain macrolide antibiotics (e.g. erythromycin and clarithromycin).
• Certain gyrase inhibitors (e.g. sparfloxacin Azole antimycotics and other drugs such as budipine  halofantrine, co-trimoxazole, peptamidine, cisapride and bepridil.

Pregnancy and Lactation

  • No data are available on placental transfer.
  • There are no adequate data from the use of amantadine in pregnant women.
  • The potential risk for humans is not known Amantadine may therefore only be used during pregnancy if considered absolutely essential.
  • If therapy is carried out during the 1st trimester, ultrasonography should be performed If amantadine is prescribed to a woman of child-bearing age, the patient should be instructed to contact her doctor immediately  if she wishes to become pregnant or suspects that she is pregnant Lactation Amantadine is excreted into the breast milk.
  • If use during lactation is considered absolutely essential, the infant should be kept under observation.

Warning and Precaution

See the insert leaflet.

Package and Storage

One infusion bottle of 500 ml solution for infusion contains 200 mg Amantadine sulphate.

Mother Company

Manufactured by MERZ