Galantamine Symgens

Galantamine Symgens

galantamine

Manufacturer:

Pharmathen

Distributor:

Symgens

Marketer:

Symgens
Concise Prescribing Info
Contents
Galantamine HBr
Indications/Uses
Symptomatic treatment of mild to moderately severe dementia of the Alzheimer type including Alzheimer's disease w/ cerebrovascular disease.
Dosage/Direction for Use
Adult & elderly Initially 8 mg/day for 4 wk. Maintenance dose: Initially 16 mg/day for at least 4 wk. May be increased to 24 mg/day after individual assessment. Patients intolerant to 24 mg/day Consider dose reduction to 16 mg. Moderately impaired hepatic function Start w/ 8 mg once every other day in the morning for 1 wk. Thereafter, proceed w/ 8 mg once daily for 4 wk. Max: 16 mg daily.
Administration
Should be taken with food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Severe hepatic (Child-Pugh score >9) & severe renal (CrCl <9 mL/min) impairment. Significant renal & hepatic dysfunction.
Special Precautions
Monitor wt during therapy; patients at increased risk of peptic ulcers (eg, history of ulcer diseases or those predisposed to these conditions, including those receiving concurrent NSAIDs) for symptoms. Patients w/ CV diseases eg, immediate post-MI period, new-onset atrial fibrillation, 2nd degree heart block or greater, unstable angina pectoris, or CHF especially NYHA group III-IV. Not recommended in patients w/ GI obstruction or those recovering from GI surgery; urinary outflow obstruction or recovering from bladder surgery. Patients w/ cerebrovascular disease. History of severe asthma, obstructive pulmonary disease or active pulmonary infections (eg, pneumonia). Concomitant use w/ anesth. May influence ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Vomiting, nausea. Decreased appetite, anorexia; hallucination, depression; syncope, dizziness, tremor, headache, somnolence, lethargy; bradycardia; HTN; abdominal pain, upper abdominal pain, diarrhoea, dyspepsia, stomach & abdominal discomfort; hyperhidrosis; muscle spasms; fatigue, asthenia, malaise; decreased wt; fall.
Drug Interactions
Concomitant use w/ other cholinomimetics (eg, ambenonium, donepezil, neostigmine, pyridostigmine, rivastigmine or systemically administered pilocarpine). May antagonise effect of anticholinergics. Exacerbated effect upon abrupt discontinuation of anticholinergics eg, atropine. Drugs that significantly reduce heart rate eg, digoxin, β-blockers, certain Ca-channel blockers & amiodarone; & drugs that have potential to cause Torsades de Pointes. May exaggerate succinylcholine-type muscle relaxation during anesth. Increased incidence of cholinergic adverse reactions w/ potent CYP2D6 inhibitors (eg, quinidine, paroxetine, fluoxetine) or CYP3A4 inhibitors (eg, ketoconazole, ritonavir).
MIMS Class
Neurodegenerative Disease Drugs
ATC Classification
N06DA04 - galantamine ; Belongs to the class of anticholinesterases. Used in the management of dementia.
Presentation/Packing
Form
Galantamine Symgens PR cap 16 mg
Packing/Price
28's
Form
Galantamine Symgens PR cap 8 mg
Packing/Price
28's
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