- Approval Id
- c841794bbb5f0ed9
- Drug Name
- JUBDOZIL FILM COATED TABLET 5MG
- Product Name
- JUBDOZIL FILM COATED TABLET 5MG
- Approval Number
- SIN15565P
- Approval Date
- 2018-10-22
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **RECOMMENDED DOSE:**
**Adults/Elderly:**
The dosages of Donepezil shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once daily. Although there is no statistically significant evidence that a greater treatment effect is obtained from the use of the 10 mg dose, there is a suggestion, based on analysis of group data, that some additional benefits may accrue to some patients from the use of the higher dose.
Treatment is initiated at 5 mg/day (once-a-day dosing). Donepezil should be taken orally, in the evening, just prior to retiring.
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 tablets 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.
Upon discontinuation of treatment, a gradual abatement of the beneficial effects of Donepezil is seen.
**Renal & Hepatic Impairment:**
A similar dose scheduled can be followed for patients with renal impairment as clearance of donepezil hydrochloride is not affected by this condition.
Due to possible increase of exposure in mild to moderate hepatic impairment, dose escalation should be performed according to individual tolerability. There are no data for patient with severe hepatic impairment.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATION:**
Donepezil hydrochloride tablets are indicated for the symptomatic treatment of mild, moderate and severe dementia in Alzheimer’s disease.
- Contraindications
- **CONTRA-INDICATION:**
Donepezil is contraindicated in patients with a known hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.
The safety of Donepezil in pregnancy and lactation has not been established.
Donepezil is not recommended for use in children.
- Atc Code
- N06DA02
- Atc Item Name
- donepezil
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
- Company Detail Path
- /organization/goldplus-universal-pte-ltd
