Alzer

Alzer

donepezil

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Concise Prescribing Info
Contents
Donepezil HCl
Indications/Uses
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.
Dosage/Direction for Use
Adult/elderly Initially, 5 mg daily in the evening just before bedtime for at least 1 mth. Dose may be increased to 10 mg daily following 4-6 wk clinical assessment.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to donepezil HCl, piperidine derivatives. Pregnancy.
Special Precautions
Discontinue therapy if signs & symptoms of neuroleptic malignant syndrome (NMS) or w/ unexplained high fever in the absence of additional clinical manifestation of NMS; if markedly elevated CPK levels are measured &/or indicative rhabdomyolysis signs & symptoms develops. GI disorders eg, diarrhea, nausea & vomiting. Predisposing/risk factors eg, prior history of muscular disorders, uncontrolled hypothyroidism, hepatic or renal impairment & receiving concomitant medications causing rhabdomyolysis (eg, statins, antipsychotics, SSRI/serotonin norepinephrine re-uptake inhibitor). Sick sinus syndrome or other supraventricular cardiac conduction conditions eg, SA or AV block; syncope & seizures. History of ulcer disease or receiving concurrent NSAIDs. Bladder outflow obstruction; generalised convulsions; exacerbate or induce extrapyramidal symptoms. History of asthma or obstructive pulmonary disease. Avoid concomitant use w/ other acetylcholinesterase inhibitors, cholinergic agonists or antagonists. Likely to exaggerate succinylcholine-type muscle relaxation during anaesth. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Hepatic impairment. Not to be used during pregnancy & lactation. Not recommended in childn.
Adverse Reactions
Diarrhoea, nausea; headache. Common cold; anorexia; hallucinations, agitation, aggressive behaviour, abnormal dreams & nightmares; syncope, dizziness, insomnia; vomiting, abdominal disturbance; rash, pruritus; muscle cramps; urinary incontinence; fatigue, pain; accident.
Drug Interactions
Inhibited metabolism by ketoconazole, quinidine, CYP3A4 (eg, itraconazole & erythromycin) & CYP2D6 (eg, fluoxetine) inhibitors. Reduced levels by enzyme inducers eg, rifampicin, phenytoin, carbamazepine & alcohol. Interfered w/ drugs having anticholinergic activity. Synergistic activity w/ succinylcholine, other neuromuscular blockers or cholinergic agonists or β-blockers.
MIMS Class
Neurodegenerative Disease Drugs
ATC Classification
N06DA02 - donepezil ; Belongs to the class of anticholinesterases. Used in the management of dementia.
Presentation/Packing
Form
Alzer FC tab 10 mg
Packing/Price
30's
Form
Alzer FC tab 5 mg
Packing/Price
30's
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