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Ceptia

Ceptia

donepezil

Manufacturer:

Sriprasit Pharma

Distributor:

SPS Medical

Marketer:

SPS Medical
Concise Prescribing Info
Contents
Donepezil HCl
Indications/Uses
Symptomatic treatment of mild, moderately severe & severe dementia of Alzheimer's type; vascular dementia (dementia associated w/ cerebrovascular disease); dementia w/ Lewy bodies (DLB).
Dosage/Direction for Use
Adult/elderly Initially 5 mg once daily for at least 1 mth. May be increased to 10 mg once daily following a 4-6 wk of clinical assessment in patients who tolerated treatment at 5 mg daily. Vascular dementia, DLB Max daily dose: 10 mg. DLB May decrease dose to 5 mg depending on patient symptoms.
Administration
May be taken with or without food: Place on tongue & allow to disintegrate before swallowing w/ or w/o water.
Contraindications
Hypersensitivity to donepezil HCl or piperidine derivatives. Pregnancy.
Special Precautions
Consider discontinuation in the absence of therapeutic effect. May exaggerate succinylcholine-type muscle relaxation during anaesth. Syncope & seizures; possibility of heart block or long sinusal pauses. May cause bladder outflow obstruction. Potential to cause generalised convulsions; exacerbate or induce extrapyramidal symptoms. Patients w/ sick sinus syndrome or other supraventricular cardiac conditions eg, SA or AV block; pre-exisiting or family history of QTc prolongation, treated w/ drugs affecting QTc interval, or w/ relevant pre-existing cardiac disease (eg, uncompensated heart failure, recent MI, bradyarrhythmias), or electrolyte disturbances (hypokalaemia, hypomagnesaemia); history of asthma or obstructive pulmonary disease. Monitor ulcer symptoms in patients at increased risk for developing ulcers eg, those w/ history of ulcer or receiving concurrent NSAIDs. Perform ECG. Avoid concomitant use w/ other cholinesterase inhibitors, agonists or antagonists of cholinergic system. May impair ability to drive & use machinery. Mild to moderate hepatic impairment. Not to be used during pregnancy. Not to breastfeed while on treatment. Not recommended for use in childn. Elderly.
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 including falls.
Drug Interactions
Inhibited metabolism w/ CYP3A4 (eg, ketoconazole, itraconazole, erythromycin) & CYP2D6 (eg, quinidine, fluoxetine) inhibitors. Increased mean conc w/ ketoconazole. Reduced levels w/ rifampicin, phenytoin, carbamazepine, alcohol. May interfere w/ medications having anticholinergic activity. Synergistic activity on cardiac conduction w/ succinylcholine, other neuromuscular & β-blocking agents, & cholinergic agonists. Concomitant use w/ other medicinal products known to prolong QTc interval eg, class IA antiarrhythmics (eg, quinidine), class III antiarrhythmics (eg, amiodarone, sotalol), certain antidepressants (eg, citalopram, escitalopram, amitriptyline), other antipsychotics (eg, phenothiazine derivatives, sertindole, pimozide, ziprasidone), certain antibiotics (eg, clarithromycin, erythromycin, levofloxacin, moxifloxacin).
MIMS Class
Neurodegenerative Disease Drugs
ATC Classification
N06DA02 - donepezil ; Belongs to the class of anticholinesterases. Used in the management of dementia.
Presentation/Packing
Form
Ceptia orodispersible tab 10 mg
Packing/Price
3 × 10's
Form
Ceptia orodispersible tab 5 mg
Packing/Price
3 × 10's
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