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AMANTADINE HYDROCHLORIDE is a brand name for Amantadine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Parkinson's disease. Herpes zoster: It is recommended that Amantadine be given to elderly or debilitated patients in whom the physician suspects that a severe and painful rash could occur. Amantadine can significantly reduce the proportion of patients experiencing pain of long duration.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Parkinson's disease. Initially 100 mg daily for the first week, increasing to 100 mg twice daily. The dose can be titrated against signs and symptoms. Doses exceeding 200 mg daily may provide some additional relief, but may also be associated with increasing toxicity.
A dose of 400 mg/day should not be exceeded. The dose should be increased gradually, at intervals of not less than 1 week. Since patients over 65 years of age tend to show lower renal clearance and consequently higher plasma concentrations, the lowest effective dose should be used.
Amantadine acts within a few days but may appear to lose efficacy within a few months of continuous treatment. Its effectiveness may be prolonged by withdrawal for three to four weeks, which seems to restore activity. During this time, existing concomitant antiparkinsonian therapy should be continued, or low dose L-dopa treatment initiated if clinically necessary.
g. half the dose at weekly intervals. 4).
Combined treatment:
Any antiparkinson drug already in use should be continued during initial Amantadine treatment. It may then be possible to reduce the other drug gradually. If increased side effects occur, the dosage should be reduced more quickly. In patients receiving large doses of anticholinergic agents or L-dopa, the initial phase of Amantadine treatment should be extended to 15 days.
Herpes zoster 100 mg twice daily for 14 days. Treatment should be started as soon as possible after diagnosis. If post-herpetic pain persists treatment can be continued for a further 14 days.
Renal impairment:
In patients with renal impairment: the dose of Amantadine should be reduced. This can be achieved by either reducing the total daily dose, or by increasing the dosage interval in accordance with the creatinine clearance. For example, Creatinine clearance ml/(min) Dose 15 Amantadine contraindicated 15-35 100 mg every 2 to 3 days 35 100 mg every day The above recommendations are for guidance only and physicians should continue to monitor their patients for signs of unwanted effects.
Paediatric population There is no relevant use of Amantadine in the paediatric population Method of administration For oral use.
Amantadine's undesirable effects are often mild and transient, usually appearing within the first 2 to 4 days of treatment and promptly disappearing 24 to 48 hours after discontinuation. A direct relationship between dose and incidence of side effects has not been demonstrated, although there seems to be a tendency towards more frequent undesirable effects (particularly affecting the CNS) with increasing doses.
List of adverse reactions The frequencies of adverse events are ranked according to the following : very common (≥ 1/10); common ( ≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to < 1/1,000) very rare (< 1/10,000), not known (cannot be estimated from the available data).
Blood and lymphatic system disorders:
Very rare: Leucopenia, reversible elevation of liver enzymes Psychiatric disorders: Not known: Impulse control disorders1 Nervous system disorders: Common: Anxiety, elevation of mood, light headedness, headache, lethargy, hallucinations, ataxia, slurred speech, loss of concentration, nervousness, depression, insomnia, myalgia.
confusion and nightmares2.
Rare:
Confusion, disorientation, psychosis, tremor, dyskinesia, convulsions, neuroleptic malignant-like syndrome Not known: Delirium, hypomanic state and mania3. g. punctate sub epithelial opacities which might be associated with superficial punctate keratitis, corneal epithelial oedema, and markedly reduced visual acuity Cardiac disorders Very common: Oedema of ankles, livedo reticularis4.
Common:
Palpitations, orthostatic hypotension Very rare: Heart insufficiency/failure Gastrointestinal disorders: Common: Dry mouth, anorexia, nausea, vomiting, constipation Rare: Diarrhoea Skin and subcutaneous tissue disorders: Common: Diaphoresis Rare: Exanthema Very rare: Photosensitisation Renal and urinary disorders: Rare: urinary retention, urinary incontinence 1 Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with products with a dopaminergic effect, including amantadine (see section “Special warnings and precautions for use”).
Amantadine should be used with caution in patients with confusional or hallucinatory states or underlying psychiatric disorders, in patients with liver or kidney disorders, and those suffering from, or who have a history of, cardiovascular disorders.
5). g. catatonia, confusion, disorientation, worsening of mental status, delirium). Amantadine should not be stopped abruptly in patients who are treated concurrently with neuroleptics. There have been isolated reports of precipitation or aggravation of neuroleptic malignant syndrome or neuroleptic-induced catatonia following the withdrawal of amantadine in patients taking neuroleptic agents.
A similar syndrome has also been reported rarely following withdrawal of amantadine and other anti-parkinson agents in patients who were not taking concurrent psychoactive medication. As some individuals have attempted suicide with amantadine, prescriptions should be written for the smallest quantity consistent with good patient management.
Peripheral oedema (thought to be due to an alteration in the responsiveness of peripheral vessels) may occur in some patients during chronic treatment (not usually before four weeks) with Amantadine. This should be taken into account in patients with congestive heart failure.
Anticholinergic effects Amantadine has anticholinergic effects, it should not be given to patients with untreated angle closure glaucoma. If blurred vision or other visual problems occur an ophthalmologist should be contacted to exclude corneal oedema.
In case that corneal oedema is diagnosed treatment with amantadine should be discontinued. Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders, including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with products with a dopaminergic effect, including amantadine.
1. Individuals subject to convulsions. A history of gastric ulceration. Severe renal disease. Pregnancy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 more common when amantadine is administered concurrently with anticholinergic agents or when the patient has an underlying psychiatric disorder. 3 reported but their incidence cannot be readily deduced from the literature. 4 usually after very high doses or use over many months.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Dose reduction or tapered discontinuation should be considered if such symptoms develop. Amantadine contains lactose, patient with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.