Galantamine oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral modified release formulations of galantamine.
Drugs List
Therapeutic Indications
Uses
Mild - moderate dementia in Alzheimer's disease
Dosage
Adults
Initial: 8mg once daily for 4 weeks.
Maintenance: 16mg once daily. If tolerated and clinically indicated, the dose may be further increased to 24mg once daily after 4 weeks. If an increased response is not seen or the patient cannot tolerate 24mg per day the dose should be reduced to 16mg once daily.
Patients with Renal Impairment
The Renal Drug Handbook advises using lower initial doses in patients with a glomerular filtration rate below 10 ml/minute.
Patients with Hepatic Impairment
Moderate hepatic impairment:
Initial: 8mg every other day, preferably in the morning, for at least one week.
Maintenance: 8mg once daily for at least 4 weeks. Maximum dose 16mg per day.
Additional Dosage Information
Switching to prolonged release capsules from tablets or oral solution
The same total daily dose of galantamine should be administered.
When switching to the once-daily regimen, take the last dose of tablets/oral solution in the evening and start the modified release capsules the following morning.
Contraindications
Children under 18 years
Breastfeeding
Gastrointestinal obstruction
Long QT syndrome
Recent gastrointestinal surgery
Recent surgery of the urinary tract
Renal impairment - creatinine clearance less than 9ml/minute
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Torsade de pointes
Urinary obstruction
Precautions and Warnings
Anaesthesia
Family history of long QT syndrome
Predisposition to gastrointestinal ulceration
Acute pulmonary infection
Atrial fibrillation
Bradycardia
Cardiovascular disorder
Cerebrovascular disorder
Congestive cardiac failure
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of gastrointestinal ulceration
History of obstructive pulmonary disease
History of seizures
History of torsade de pointes
Moderate hepatic impairment
Non-paced sinus node dysfunction
Parkinsonism
Pregnancy
Recent myocardial infarction
Second degree atrioventricular block
Supraventricular cardiac conduction disorder
Third degree atrioventricular block
Unstable angina
Correct electrolyte disorders before treatment
Reduce dose in patients with moderate hepatic impairment
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
Some brands contain sucrose. Consult specific brand literature
Ensure patient has adequate fluid intake
Assess patient's tolerance to treatment
Consider monitoring ECG in patients at risk of QT prolongation
If rash develops, consider possibility of Stevens-Johnson Syndrome
Monitor patient's weight
Monitor patients with history of peptic ulceration
Monitor serum electrolytes
Review treatment after 3 months then periodically thereafter
Advise patient to report skin reaction, pain, erythema, pruritus
Discontinue if therapeutic effect is no longer present
Discontinue treatment if rash occurs
Advise patient not to take NSAIDs unless advised by clinician
Galantamine as a cholinomimetic, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia, especially in cases of pseudocholinesterase deficiency.
Pregnancy and Lactation
Pregnancy
Use galantamine with caution in pregnancy.
At the time of writing there is limited published information regarding the use of galantamine during pregnancy. Animal data has shown reproductive toxicity. Transfer across the placenta is unknown but likely, based on the molecular weight, low plasma protein binding and moderately long plasma elimination half life of galantamine.
The manufacturer advises caution.
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 ).
Lactation
Galantamine is contraindicated in breastfeeding.
It is unknown whether galantamine is excreted in breast milk however, based on the molecular weight, low plasma protein binding and moderately long plasma elimination half life of galantamine, excretion is likely. Effects on breastfed infants are unknown.
The manufacturer states that patients should not breastfeed during treatment.
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
Side Effects
Abdominal discomfort
Abdominal pain
Acute generalised exanthematous pustulosis
Anorexia
Arrhythmias
Asthenia
Atrial extrasystoles
Blurred vision
Bradycardia
Cerebrovascular disorders
Complete AV block
Confusion
Decreased appetite
Dehydration
Depression
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Dysphagia
Erythema multiforme
Falls
Fatigue
First degree AV block
Flushing
Gastric discomfort
Gastrointestinal bleeding
Hallucinations
Headache
Hepatitis
Hyperhidrosis
Hypersensitivity reactions
Hypersomnia
Hypertension
Hypotension
Increases in hepatic enzymes
Lethargy
Malaise
Muscle spasm
Muscle weakness
Myocardial infarction
Nausea
Palpitations
Paraesthesia
Retching
Seizures
Severe skin reactions
Sinus bradycardia
Sleep disturbances
Somnolence
Stevens-Johnson syndrome
Stomach pain
Syncope
Tinnitus
Tremor
Vomiting
Weight loss
Worsening of Parkinson's disease
Overdosage
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 ).
Further Information
Last Full Review Date: September 2018
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Acumor XL 8mg capsules. Generics UK Ltd. Revised June 2017.
Summary of Product Characteristics: Acumor XL 16mg capsules. Generics UK Ltd. Revised June 2017.
Summary of Product Characteristics: Acumor XL 24mg capsules. Generics UK Ltd. Revised June 2017.
Summary of Product Characteristics: Consion XL 8mg capsules, hard. Dr Reddys Laboratories. Revised January 2018.
Summary of Product Characteristics: Consion XL 16mg capsules, hard. Dr Reddys Laboratories. Revised January 2018.
Summary of Product Characteristics: Consion XL 24mg capsules, hard. Dr Reddys Laboratories. Revised January 2018.
Summary of Product Characteristics: Elmino XL 8mg capsules. Zentiva. Revised July 2013.
Summary of Product Characteristics: Elmino XL 16mg capsules. Zentiva. Revised July 2013.
Summary of Product Characteristics: Elmino XL 24mg capsules. Zentiva. Revised July 2013.
Summary of Product Characteristics: Gaalin XL 8mg prolonged release capsules, hard. Milpharm Limited. Revised April 2018.
Summary of Product Characteristics: Gaalin XL 16mg prolonged release capsules, hard. Milpharm Limited. Revised April 2018.
Summary of Product Characteristics: Gaalin XL 24mg prolonged release capsules, hard. Milpharm Limited. Revised April 2018.
Summary of Product Characteristics: Galsya XL 8 mg prolonged-release capsules, hard. Consilient Health Ltd. Revised November 2013.
Summary of Product Characteristics: Galsya XL 16 mg prolonged-release capsules, hard. Consilient Health Ltd. Revised November 2013.
Summary of Product Characteristics: Galsya XL 24 mg prolonged-release capsules, hard. Consilient Health Ltd. Revised November 2013.
Summary of Product Characteristics: Galzemic XL 8 mg prolonged release capsules, hard. Creo Pharma Ltd. Revised September 2016.
Summary of Product Characteristics: Galzemic XL 16 mg prolonged release capsules, hard. Creo Pharma Ltd. Revised September 2016.
Summary of Product Characteristics: Galzemic XL 24 mg prolonged release capsules, hard. Creo Pharma Ltd. Revised September 2016.
Summary of Product Characteristics: Gatalin XL 8mg prolonged release capsules, hard. Aspire Pharma Ltd. Revised December 2018.
Summary of Product Characteristics: Gatalin XL 16mg prolonged release capsules, hard. Aspire Pharma Ltd. Revised December 2018.
Summary of Product Characteristics: Gatalin XL 24mg prolonged release capsules, hard. Aspire Pharma Ltd. Revised December 2018.
Summary of Product Characteristics: Gazylan XL 8 mg prolonged release capsules, hard. Teva UK Ltd. Revised March 2014.
Summary of Product Characteristics: Gazylan XL 16 mg prolonged release capsules, hard. Teva UK Ltd. Revised March 2014.
Summary of Product Characteristics: Gazylan XL 24 mg prolonged release capsules, hard. Teva UK Ltd. Revised March 2014.
Summary of Product Characteristics: Lotprosin XL 8mg prolonged release hard capsules. Actavis UK Ltd. Revised September 2013.
Summary of Product Characteristics: Lotprosin XL 16mg prolonged release hard capsules. Actavis UK Ltd. Revised September 2013.
Summary of Product Characteristics: Lotprosin XL 24mg prolonged release hard capsules. Actavis UK Ltd. Revised September 2013.
Summary of Product Characteristics: Luventa XL 8mg prolonged release hard capsules. Fontus Health Ltd. Revised July 2016.
Summary of Product Characteristics: Luventa XL 16mg prolonged release hard capsules. Fontus Health Ltd. Revised July 2016.
Summary of Product Characteristics: Luventa XL 24mg prolonged release hard capsules. Fontus Health Ltd. Revised July 2016.
Summary of Product Characteristics: Reminyl XL 8mg prolonged release capsules. Shire. Revised May 2017.
Summary of Product Characteristics: Reminyl XL 16mg prolonged release capsules. Shire. Revised May 2017.
Summary of Product Characteristics: Reminyl XL 24mg prolonged release capsules. Shire. Revised May 2017.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
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