Reminyl PRC

Reminyl PRC

galantamine

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Galantamine HBr
Indications/Uses
Mild to moderately severe dementia of the Alzheimer type.
Dosage/Direction for Use
Adult Starting dose: 8 mg daily in the morning for 4 wk. Maintenance dose: Initially 16 mg daily for at least 4 wk, increase to max 24 mg once daily after evaluation of clinical benefit & tolerability. Patient w/ moderate hepatic impairment (Child-Pugh score 7-9) 8 mg every other day for at least 1 wk, preferably in the morning. Thereafter, 8 mg once daily for at least 4 wk. Max total daily dose: 16 mg.
Administration
Should be taken with food: Ensure adequate fluid intake.
Contraindications
Hypersensitivity.
Special Precautions
Not indicated for individuals w/ mild cognitive impairment. Benefit in patients w/ other types of dementia or other types of memory impairment has not been demonstrated. Reports of serious skin reactions (Stevens-Johnson syndrome & acute generalized exanthematous pustulosis). Discontinue at the 1st appearance of skin rash. Monitor wt during therapy. Use w/ caution in patients w/ sick sinus syndrome or other supraventricular cardiac conduction disturbances, or who concomitantly use drugs that significantly reduce heart rate eg, digoxin & β-blockers. Monitor patients at increased risk of developing peptic ulcers. Not recommended in patients w/ GI obstruction or recovering from GI surgery. Reports of convulsions. Use w/ caution in patients w/ history of severe asthma or obstructive pulmonary disease. Not recommended in patients w/ urinary outflow obstruction or recovering from bladder surgery. May impair ability to drive or operate machinery. Not recommended in patients w/ CrCl <9 mL/min; severe hepatic impairment (Child-Pugh score >9). Pregnancy. Do not breastfeed. Not recommended in childn.
Adverse Reactions
Decreased appetite; depression; dizziness, headache, tremor, syncope, lethargy, somnolence; bradycardia; nausea, vomiting, diarrhea, abdominal pain, upper abdominal pain, dyspepsia, abdominal discomfort; muscle spasms; fatigue, asthenia, malaise; decreased wt; fall, laceration.
Drug Interactions
Do not concomitantly use w/ other cholinomimetics. Antagonizes the effect of anticholinergic drugs. Possible pharmacodynamic interaction w/ drugs that significantly reduce the heart rate (eg, digoxin & β-blockers). Exaggerates succinylcholine-type muscle relaxation during anesth. Increased AUC w/ potent CYP2D6 or CYP3A4 inhibitors.
MIMS Class
Neurodegenerative Disease Drugs
ATC Classification
N06DA04 - galantamine ; Belongs to the class of anticholinesterases. Used in the management of dementia.
Presentation/Packing
Form
Reminyl PRC PR cap 16 mg
Packing/Price
28's
Form
Reminyl PRC PR cap 24 mg
Packing/Price
28's
Form
Reminyl PRC PR cap 8 mg
Packing/Price
28's
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