Loading…
AMANTADINE HYDROCHLORIDE DAWA is a brand name for Amantadine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Prophylaxis and treatment of signs and symptoms of infection caused by influenza A virus It is suggested that amantadine be given to patients suffering from clinical influenza in which complications might be expected to occur. In addition, amantadine is recommended prophylactically in cases particularly at risk.…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Influenza A:
Treatment It is advisable to start treating influenza as early as possible and to continue for 4 to 5 days. When amantadine is started within 48 hours of symptoms appearing, the duration of fever and other effects is reduced by one or two days and the inflammatory reaction of the bronchial tree that usually accompanies influenza resolves more quickly.
Prophylaxis Treat daily for as long as protection from infection is required. In most instances this is expected to be for 6 weeks. When used with inactivated influenza A vaccine, amantadine is continued for 2 to 3 weeks following inoculation.
Children over 10 years of age, adolescents and adults: 10 ml (100 mg) daily for the recommended period.
Children under 10 years of age:
Dosage not established.
Elderly:
Plasma amantadine concentrations are influenced by renal function. In elderly patients, the elimination half-life is longer and renal clearance of the compound is diminished in comparison to young people. Therefore, a daily dose of less than 10 ml (100 mg), or 10 ml (100 mg) given at intervals of greater than one day, may be appropriate.
Parkinson's disease Initially 10 ml (100 mg) daily for the first week, increasing to 10 ml (100 mg) twice daily. The dose can be titrated against signs and symptoms. Doses exceeding 20 ml (200 mg) daily may provide some additional relief but may also be associated with increasing toxicity.
A dose of 40 ml (400 mg) per 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.
Summary of the safety profile 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.
The side effects reported after the pivotal clinical studies in influenza in over 1200 patients receiving amantadine at 100mg daily were mostly mild, transient, and equivalent to placebo. Only 7% of subjects reported adverse events, many being similar to the effects of influenza itself.
The most commonly reported effects were gastro-intestinal disturbances (anorexia, nausea), CNS effects (loss of concentration, dizziness, agitation, nervousness, depression, insomnia, fatigue, weakness), or myalgia. Tabulated list of adverse reactions The following list of adverse reactions is based on clinical trial experience and/or post-marketing use via spontaneous case reports and literature cases.
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified as "not known". Undesirable effects are listed by MedDRA System Organ Classes.
Within each system organ class, ADRs are presented in order of decreasing seriousness.
Assessment of undesirable effects is based on the following frequency groupings:
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. 4) Investigations Very rare Hepatic enzyme increased * see section ‘Description of selected adverse reactions’ Description of selected adverse reactions Nightmares are more common when amantadine is administered concurrently with anticholinergic agents or when the patient has an underlying psychiatric disorder.
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. Resistance to amantadine occurs during serial passage of influenza virus strains in vitro or in vivo in the presence of the drug.
Apparent transmission of drug-resistant viruses may have been the cause of failure of prophylaxis and treatment in household contacts and in nursing-home patients. However, there is no evidence to date that the resistant virus produces a disease that is in any way different from that produced by sensitive viruses.
Attempted suicide Cases of suicidal ideation and behaviour have been reported during treatment with amantadine. Patients should be monitored for signs of suicidal ideation and behaviour and treatment initiated as needed. Patients (and caregivers of patients) should be advised to seek medical advice if any signs of suicidal ideation or behaviour emerge.
The smallest quantity consistent with good patient management should be prescribed, as there have been cases of attempted suicide with amantadine. Peripheral oedema/Glaucoma 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 4 weeks) with 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.
Other brands of Amantadine in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 10 ml (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 10 ml (100 mg) every 2 to 3 days > 35 10 ml (100 mg) every day The above recommendations are for guidance only and physicians should continue to monitor their patients for signs of unwanted effects.
Method of administration For oral administration.
Impulse control disorders: 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”).
Corneal lesions such as punctate subepithelial opacities which might be associated with superficial punctate keratitis. Livedo reticularis can develop usually after very high doses or use over many months. 4 Special warnings and precautions for use).
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.
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. Hypothermia Hypothermia has been observed in children, especially in those younger than 5 years of age. 2). 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.
Dose reduction or tapered discontinuation should be considered if such symptoms develop. Excipients Sorbitol This medicinal product contains 1000mg sorbitol in each 5 ml dose. The additive effect of concomitantly administered products containing sorbitol and dietary intake of sorbitol should be taken into account.
Patients with hereditary fructose intolerance (HFI) should not take/be given this medicine unless strictly necessary. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect. 9mg propylene glycol in each 5 ml dose. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 5 ml dose, that is to say essentially ‘sodium-free’.