Abixa 10mg

Tablet
Memantine Hydrochloride
ACI Pharmaceuticals

Other Strength:

Alternative:



Abixa
Description
Abixa® is a preparation of memantine which is a antidementia drugwithlow to moderateaffinityto voltage-dependent NMDA (N-methyl-D-aspartate) receptorantagonist.Memantine selectively blocksthe excitotoxic effects associated with abnormal transmission of glutamate, while allowing for the physiological transmission associated with normal cell functioning.

Indication and usage
Abixa®is indicated forthe treatment of moderate to severe dementia in Alzheimer’s disease.

Dosage and administration
Initial doseThe recommended initialdose is5mgonce daily, which is stepwise increased over the first 4 weeks and the recommended maximum daily dose is20mg.Maintenance doseThe recommended maintenance dose is 20mgdaily.In case renal impairmentIn patients with moderate renal impairment (creatinine clearance 30-49ml/min) daily doseshould be 10mg(1ml solution, equivalent to two downward strokes). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10mg(1ml solution, equivalent to two downward strokes) per day.In case of hepatic impairment In patients with mild or moderate hepatic impaired function, no dosage adjustment is needed. Administration of memantine is not recommended in patients with severe hepatic impairment.

Children under18years
Memantineis not recommendedfor use in children below 18 years due to lack of data on safety and efficacy.

Use in pregnancy and lactation
No clinical data on exposed pregnancies are available. Animal studies indicate a potential for reducing intrauterine growth at exposure levels that are identical or slightly higher than at human exposure. The potential risk of humans is unknown. Memantine should not be used during pregnancy unless clearly necessary.It is not known whether memantine is excreted in human breast milk but, taking into consideration the lipophilicity of the substance, this probably occurs. Women taking memantine should not breast-feed.

Side effects
The most commonside effects areheadache, dizziness, drowsiness, constipation, dyspnea, hypertension; Less commonside effects arevomiting, confusion, fatigue, hallucination, abnormal gait, thrombosis, heart failure; Very rare side effects areseizures, pancreatitis, psychosis, depression and suicidal ideation.

Precautions
Mamantineshould be used withcaution in patients with epilepsy, former history of convulsionsorpatients with predisposing factors for epilepsy. Some factors that may raise urine pH may necessitate careful monitoring of the patient.These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalizing gastric buffets.Urine pH may also be elevated bystates of renaltubular acidosis (RTA) or severe infection ofthe urinary tracts with Proteusbacteria.

Contraindications
Memantineis contraindicated in patients with aknownhypersensitivity to memantineor any of the exipients.

Drug interactions
Due to the pharmacological effects and mechanism of action ofmemantine suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of mematine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary.Memantineshould not be used withamantadine, ketamine, dextromethorphan, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinidine, quinine & nicotine.

Pharmaceutical precautions
Keep away from the reach of children. Store in a cool and dry place protected from light. To be taken and sold only on the prescription of a registered physician.

Presentation
Abixa®10 tablet: Each tablet contains memantine10mgasHydrochloride INN.

Packaging
Abixa®10 tablet: Carton of 20tablets in blister pack.

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