Galantamine oral standard release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral standard release formulations of galantamine (as hydrobromide).
Drugs List
Therapeutic Indications
Uses
Mild - moderate dementia in Alzheimer's disease
Dosage
Adults
Initial dose: 4mg twice a day for four weeks.
Maintenance dose: 8mg twice a day for at least four weeks.
The dose may be further increased to 12mg twice a day after clinical assessment and evaluation of tolerability.
If an increased response is not seen or the patient cannot tolerate 12mg twice a day the dose should be reduced to 8mg twice a day.
Patients with Hepatic Impairment
Moderate hepatic impairment: Initial dose 4mg once daily, preferably in the morning, for at least one week. Followed by 4mg twice a day for at least four weeks. The dose should not exceed 8mg twice a day.
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
Chronic obstructive pulmonary disease
Congestive cardiac failure
Electrolyte imbalance
Hereditary fructose intolerance
History of asthma
History of gastrointestinal ulceration
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
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Ensure patient has adequate fluid intake
Consider monitoring ECG in patients at risk of QT prolongation
If rash develops, consider possibility of Stevens-Johnson Syndrome
Monitor patient's weight
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 skin rash or other allergic reaction 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 during pregnancy.
The manufacturers advise caution if galantamine is used during pregnancy. At the time of writing there is limited clinical data regarding human pregnancies exposed to galantamine. Animal studies have shown a significant delay in development and reproductive toxicity.
Lactation
Galantamine is contraindicated during breastfeeding.
Manufacturers advise that women taking galantamine should not breastfeed. It is not known whether galantamine is excreted into human breast milk and there have been no studies in lactating women. The molecular weight, low plasma protein binding and moderately long plasma elimination half life suggest excretion is likely, but the effects of exposure on the nursing infant are unknown (Briggs 2015).
Side Effects
Abdominal discomfort
Abdominal pain
Acute generalised exanthematous pustulosis
Anorexia
Arrhythmias
Asthenia
Atrial extrasystoles
Blurred vision
Bradycardia
Cerebrovascular disorders
Complete AV block
Decreased appetite
Dehydration
Depression
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Erythema multiforme
Falls
Fatigue
First degree AV block
Flushing
Hallucinations
Headache
Hepatitis
Hyperhidrosis
Hypersensitivity reactions
Hypersomnia
Hypertension
Hypotension
Increases in hepatic enzymes
Lethargy
Malaise
Muscle spasm
Muscle weakness
Nausea
Palpitations
Paraesthesia
Retching
Seizures
Severe skin reactions
Somnolence
Stevens-Johnson syndrome
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: March 2019
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: Galantamine 4mg/ml Oral Solution. Sandoz Limited. Revised April 2017.
Summary of Product Characteristics: Galzemic 4mg/ml Oral Solution. Zentiva. Revised March 2021.
Summary of Product Characteristics: Reminyl Oral Solution. Takeda Uk Ltd. Revised June 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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