Antial 4 tablet: Each coated tablet contains Galantamine 4 mg as Hydrobromide USP.
Antial 8 tablet: Each coated tablet contains Galantamine 12 mg as Hydrobromide USP.
Antial ® is a preparation of Galantamine practical which is a cholinomimetic agent. It is a competitive and reversible inhibitor of the enzyme acetylcholinesterase. In addition, Galantamine enhances the intrinsic action of acetylcholine on nicotinic receptors. As a result, an increased activity in the cholinergic system associated with improved cognitive function can be achieved in patients with dementia of the Alzheimer's type.
Adults: The recommended starting dose of Antial ® is 4 mg twice daily (8 mg/day). The dose should be increased to the initial maintenance dose of 8 mg twice daily (16 mg/day) after a minimum of 4 weeks. A further increase to 12 mg twice daily (24 mg/day) should be attempted after a minimum of 4 weeks at 8 mg twice daily (16 mg/day). Antial ® tablets should be administered twice daily, preferably with morning and evening meals. Children Galantamine is not recommended in children. Hepatic impaired patients In patients with moderately impaired hepatic function, the total daily dose should generally not exceed 16 mg/day. The use of Galantamine in patients with severe hepatic impairment is not recommended.
Renally impaired patients For patients with moderate renal impairment the dose should generally not exceed 16 mg/day. In patients with severe renal impairment (creatinine clearance <9 mL/min), the use of Galantamine is not recommended.
Cholinesterase inhibitors and succinylcholine show enhanced neuromuscular blockade; cholinergic agonists and beta-blockers risk severe bradycardia and syncope; anticholinergics antagonize galantamine efficacy; CYP2D6 and CYP3A4 inhibitors (ketoconazole, paroxetine, erythromycin) increase bioavailability.
Galantamine is contraindicated in patients with renal impairment; breast feeding and known hypersensitivity to the active substance or to any of the excipients.
Common: Nausea, vomiting, diarrhea, abdominal pain, dyspepsia, syncope, rhinitis, sleep disturbances, dizziness, confusion, depression, headache, fatigue, anorexia, tremor, fever, weight loss. Less Common: Arrhythmias, palpitation, myocardial infarction, cerebrovascular disease, paresthesia, tinnitus, leg cramps.
Overdose
The symptoms of overdose usually involve areas like central nervous system, parasympathetic nervous system, and neuromuscular junction. Management of the overdose may require general supportive measures. In severe cases, anticholinergics, such as atropine, can be used as a general antidote for cholinomimetics. An initial dose of 0.5 to 1.0 mg intravenously is recommended, with subsequent doses based on the clinical response.
Category B. Use during pregnancy only if potential benefit justifies potential fetal risk. Lactation: Excretion in human milk unknown; discontinue nursing or discontinue drug.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.