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DONEPEZIL HYDROCHLORIDE is a brand name for Donepezil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Donepezil Hydrochloride tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimers’s dementia.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults/Elderly people Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved.
Following a one- month clinical assessment of treatment at 5 mg/day, the dose of Donepezil Hydrochloride can be increased to 10 mg/day (once-a-day dosing). The maximum recommended daily dose is 10 mg. Doses greater than 10 mg/day have not been studied in clinical trials.
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. g. DSM IV, ICD 10). Therapy with donepezil should only be started if a caregiver is available who will regularly monitor drug intake for the patient.
Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of donepezil should be reassessed on a regular basis. Discontinuation should be considered when evidence of a therapeutic effect is no longer present.
Individual response to donepezilcannot be predicted. Upon discontinuation of treatment, a gradual abatement of the beneficial effects ofDonepezil Hydrochloride is seen. Paediatric population Donepezil Hydrochloride is not recommended for use in children and adolescentsbelow 18 years of age.
Patients with renal and hepatic impairment A similar dose schedule can be followed for patients with renal impairment, asclearance of donepezil hydrochloride is not affected by this condition. There are no data for patients with severe hepatic impairment.
Method of administration Donepezil Hydrochloride should be taken orally, in the evening, just prior to retiring. 8) intake of Donepezil hydrochloride in the morning may be considered. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference.
The most common adverse events are diarrhoea, muscle cramps, fatigue, nausea,vomiting and insomnia. Adverse reactions reported as more than an isolated case are listed below, by systemorgan class and by frequency. Frequencies are defined as: 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) and not known (cannot be estimated from available data).
4). ** Reports of hallucinations, abnormal dreams, nightmares, agitation andaggressive behaviour have resolved on dose-reduction or discontinuation of treatment. *** In cases of unexplained liver dysfunction, withdrawal of DonepezilHydrochloride should be considered.
**** Rhabdomyolysis has been reported to occur independently of Neuroleptic Malignant syndrome and in close temporal association with donepezil initiation ordose increase. 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 medicinalproduct. uk/yellowcard. or search for MHRAYellow Card in the Google Play or Apple App Store.
, age-related cognitive decline), has not been investigated. Anaesthesia Donepezil Hydrochloride as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia. g. bradycardia). The potential for this action may be particularly important to patients with “sick sinus syndrome” or other supraventricular cardiac conduction conditions, such as sinoatrial or atrioventricular block.
There have been reports of syncope and seizures. In investigating such patients the possibility of heart block or long sinusal pauses should be considered. g. those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), should be monitored for symptoms.
However, the clinical studies with Donepezil Hydrochloride showed no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Genitourinary Although not observed in clinical trials of Donepezil Hydrochloride, cholinomimetics may cause bladder outflow obstruction.
Neurological Conditions Seizures:
Cholinomimetics are believed to have some potential to cause generalised convulsions. However, seizure activity may also be a manifestation of Alzheimer's disease. Cholinomimetics may have the potential to exacerbate or induce extrapyramidal symptoms.
Neuroleptic Malignant Syndrome (NMS) NMS, a potentially life-threatening condition characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur very rarely in association with donepezil, particularly in patients also receiving concomitant antipsychotics.
Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, treatment should be discontinued.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Pulmonary Conditions Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. The administration of Donepezil Hydrochloride concomitantly with other inhibitors of acetylcholinesterase, agonists or antagonists of the cholinergic system should be avoided.
Severe Hepatic Impairment There are no data for patients with severe hepatic impairment. Mortality in Vascular Dementia Clinical Trials Three clinical trials of 6 months duration were conducted studying individuals meeting the NINDS-AIREN criteria for probable or possible vascular dementia (VaD).
The NINDS-AIREN criteria are designed to identify patients whose dementia appears to be due solely to vascular causes and to exclude patients with Alzheimer’s disease. 5%) on placebo. 5%) on placebo. 7%) on donepezil hydrochloride 5 mg and 0/326 (0%) on placebo.
1%), however, this difference was not statistically significant. The majority of deaths in patients taking either donepezil hydrochloride or placebo appear to result from various vascular related causes, which could be expected in this elderly population with underlying vascular disease.
An analysis of all serious non-fatal and fatal vascular events showed no difference in the rate of occurrence in the donepezil hydrochloride group relative to placebo. In pooled Alzheimer’s disease studies (n=4146), and when these Alzheimer’s disease studies were pooled with other dementia studies including the vascular dementia studies (total n=6888), the mortality rate in the placebo groups numerically exceeded that in the donepezil hydrochloride groups.