Dimenta 5 mg Tablet

    Dimenta 5 mg

    Generic: Donepezil Hydrochloride

    Category: Tablet

    Manufacturer: Healthcare Pharmaceuticals Ltd.

    Indications

    Uses of Dimenta: - Alzheimer's disease Mild to moderately, severe dementia in Alzheimer's disease. Donepezil is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.

    Therapeutic Class

    Drugs for Dementia

    Pharmacology

    Donepezil Hydrochloride is a centrally acting anticholinesterase agent. It binds reversibly with acetylcholinesterase and inactivates it, thus inhibiting hydrolysis of acetylcholine. As a result the concentration of acetylcholine increases at cholinergic synapses in the brain.

    Dosage and Administration

    How to use Donepezil Hydrochloride: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Donepezil Hydrochloride may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Mild to moderately severe dementia in Alzheimer's disease Adult: Initially, 5 mg daily at bedtime, increase if necessary up to 10 mg once daily at bedtime after 4-6 wk. Elderly: Initially, 5 mg daily at bedtime, increase if necessary up to 10 mg once daily at bedtime after 4-6 wk. Hepatic impairment: A similar dose schedule can be followed for patients with mild to moderate hepatic impairment as clearance of donepezil hydrochloride is not affected by these conditions. Renal Dose: Renal impairment: A similar dose schedule can be followed for patients with renal impairment as clearance of donepezil hydrochloride is not affected by these conditions.

    Interaction

    May increase the neurotoxic effect of antipsychotics. Concurrent use with systemic corticosteroids may increase the adverse effects of donepezil. May increase the neuromuscular-blocking effect of succinylcholine. May increase the adverse effects of cholinergic agonists. May increase the bradycardic effect of beta-blockers.

    Contraindications

    Donepezil is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.

    Side Effects

    Common - Nausea - Vomiting - Diarrhea Nausea, vomiting, anorexia, wt loss, diarrhoea, insomnia, fatigue, muscle cramps; headache and dizziness; syncope, bradycardia; convulsions; increased liver transaminases; sinoatrial and atrioventricular block; hallucinations, agitation and aggressive behavior; minor increases in plasma creatine kinase; potentially bladder outflow obstruction.

    Pregnancy And Lactation

    There are no adequate and well controlled studies in pregnant woman. Donepezil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Donepezil Hydrochloride is secreted in human breast milk or not. Donepezil is not indicated in nursing mother.

    Precautions And Warnings

    Precaution: Caution when used in patients with sick sinus syndrome or cardiac conduction abnormalities. May increase secretion of gastric acid; caution when used in patients at risk of ulcer disease. Patients with COPD, asthma, history of epilepsy, bladder obstruction, prostatic hypertrophy. May cause dose-related diarrhoea, nausea and/or vomiting which usually resolves after 1-3 wk. Safety and efficacy have not been established in children. Pregnancy, lactation.

    Overdose Effects

    Symptoms of overdose includes nausea, vomiting, salivation. Over dosage with very high dose of donepezil may result in cholinergic crisis characterized by severe nausea, vomiting, salivation, bradycardia, hypotension, increasing muscle weakness, respiratory depression, collapse and convulsion. As in any case of over dose, general supportive measures should be utilized. In case of cholinergic crisis hospitalization of the patient is required.

    Storage Conditions

    Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

    Drug Classes

    Drugs for Dementia

    Mode of Action

    Donepezil reversibly and noncompetitively inhibits centrally-active acetylcholinesterase. It is used for the symptomatic treatment of Alzheimer's disease.

    Pregnancy Category

    Pregnancy There are no adequate data on developmental risks associated with use in pregnant women Lactation There are no data on presence of donepezil or metabolites in human milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
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