Donepezil hydrochloride oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations containing donepezil
Mild - moderate dementia in Alzheimer's disease
Treatment is initiated at 5 mg once daily in the evening.
The 5 mg dose should be maintained for at least one month in order to allow the earliest clinical response 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, the dose may be increased to 10 mg once daily. The maximum recommended daily dose is 10 mg. Doses greater than 10 mg have not been studied in clinical trials.
Maintenance therapy may be continued for as long as a therapeutic benefit to the patient exists. Regular patient monitoring is recommended to assess the clinical benefit of therapy with donepezil hydrochloride.
Upon discontinuation of treatment, a gradual abatement of the beneficial effects of donepezil is seen.
Children under 18 years
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Predisposition to gastrointestinal ulceration
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of asthma
History of gastrointestinal ulceration
History of obstructive pulmonary disease
History of torsade de pointes
Non-paced sinus node dysfunction
Sinoatrial exit block
Supraventricular cardiac conduction disorder
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Do not start treatment unless a carer is available to monitor drug intake
Treatment to be initiated and supervised by a specialist
Contains sodium metabisulfite. Caution,may cause allergic reactions
Oral liquid contains hydroxybenzoate: caution in hypersensitivity
Oral solution contains sodium metabisulfite: May cause allergic reaction
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Monitor cardiac function before and regularly during treatment
Perform ECG before and during treatment
Monitor for syncope and bradycardia
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor serum electrolytes
Patients on prolonged therapy should be regularly reviewed
When used with neuroleptics, risk of neuroleptic malignant syndrome
May cause convulsions
May cause or exacerbate extrapyramidal symptoms
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue if patient develops neuroleptic malignant syndrome
Discontinue if significant/persistent hepatic function abnormalities occur
Pregnancy and Lactation
Donepezil hydrochloride is contraindicated during pregnancy.
There are no adequate or well-controlled studies in pregnant women. The potential risk for humans is unknown.
Teratology studies conducted in pregnant rats at doses up to approximately 13 times the maximum recommended human dose and in pregnant rabbits at doses up to approximately 16 times the maximum recommended human dose did not disclose any evidence for a teratogenic potential. However, in a study in which pregnant rats were given approximately 8 times the maximum recommended human dose from day 17 of gestation through to day 20 postpartum, there was a slight increase in stillbirths and a slight decrease in pup survival through day 4 postpartum at this dose. No effect was observed at the next lower dose tested (Briggs, 2011).
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Donepezil hydrochloride is contraindicated in breastfeeding.
It is not known whether donepezil is excreted in human breast milk and there are no studies in lactating women. However, donepezil is known to be excreted in the milk of rats.
Due to its long half-life, and its ability to affect cholinergic function in all mammals, some caution is recommended in breastfeeding women until data is available.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Bladder outflow obstruction
Creatine kinase increased
Neuroleptic malignant syndrome
Prolongation of QT interval
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: July 2014
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Aricept tablets. Eisai Ltd. Revised November 2016.
Summary of Product Characteristics: Aricept Evess tablets. Eisai Ltd. Revised January 2013.
Summary of Product Characteristics: Donepezil hydrochloride 1mg/1ml oral solution. Rosemont Pharmaceuticals Limited. Revised January 2014.
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