Dementa 5mg Tablet

Description

Indications:
Dementa is indicated for the treatment of all forms of dementia of the Alzheimer’s type. It may also be used for other types of dementia.

Consult a registered healthcare professional before using this medication.

Pharmacology:
Persistent activation of N-methyl-D-aspartate (NMDA) receptors in the Central Nervous System by the excitatory amino acid glutamate is believed to contribute to the symptoms of Alzheimer’s disease. Memantine, the active ingredient in Dementa, is thought to exert its therapeutic effect by acting as a low to moderate affinity uncompetitive (open-channel) NMDA receptor antagonist, preferentially binding to the NMDA receptor-operated cation channels.

Memantine is well absorbed after oral administration and follows linear pharmacokinetics over the therapeutic dose range. It is predominantly excreted unchanged in the urine with a terminal elimination half-life of approximately 60-80 hours. Peak concentrations are reached 3-7 hours after oral administration, and food does not affect its absorption. The plasma protein binding of Memantine is low (45%), and it undergoes partial hepatic metabolism. About 48% of the administered drug is excreted unchanged, while the rest is converted into three polar metabolites with minimal NMDA receptor antagonistic activity.

Dosage & Administration:
The recommended maintenance dose for adults and elderly patients is 20 mg per day. To minimize side effects, the dose should be gradually increased by 5 mg per week over 3 weeks, reaching the maintenance dose by the 4th week as per the following schedule:

• Week 1: Morning – 5 mg (1 tablet), Night – No dose
• Week 2: Morning – 5 mg (1 tablet), Night – 5 mg (1 tablet)
• Week 3: Morning – 10 mg (2 tablets), Night – 5 mg (1 tablet)
• Week 4 and onwards: Morning – 10 mg (2 tablets), Night – 10 mg (2 tablets)

For missed doses: If a dose is missed, take the next dose at the usual time. Do not double the dose to compensate.

In cases of renal impairment:

• Moderate renal impairment (creatinine clearance 30-49 ml/min): Daily dose should be 10 mg (1 ml solution), which may be increased to 20 mg/day after 7 days of treatment if well tolerated.
• Severe renal impairment (creatinine clearance 5-29 ml/min): Daily dose should be 10 mg (1 ml solution).

In cases of hepatic impairment:
For mild or moderate hepatic impairment, no dosage adjustment is required. Memantine is not recommended for severe hepatic impairment.

For children under 18 years:
Memantine is not recommended due to insufficient safety and efficacy data.

Consult a registered healthcare professional before using this medication.

Interaction:
Dementa may enhance the effects of L-dopa, dopaminergic agonists, and anticholinergics when used concurrently. The effects of barbiturates and neuroleptics may be reduced. Co-administration with dantrolene or baclofen may require dosage adjustments.
Dementa should not be used with amantadine, ketamine, dextromethorphan, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, or nicotine.

Contraindications:
Dementa is contraindicated in patients with a known hypersensitivity to Memantine Hydrochloride or any of its excipients.

Side Effects:
Common side effects (frequency of 2% or less) include:

• Hallucinations
• Confusion
• Dizziness
• Headache
• Fatigue

Occasional side effects include:

• Anxiety
• Hypertonus (heightened muscle tension)
• Vomiting
• Bladder infections
• Increased sexual drive

Patients with a history of epileptic seizures may have an increased likelihood of seizure episodes.

Pregnancy & Lactation:
Pregnancy Category B. There are no adequate and well-controlled studies of Memantine in pregnant women. It should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. The excretion of Memantine in human breast milk is unknown, so caution is advised when administered to nursing mothers.

Precautions & Warnings:

• Caregivers should be instructed in the proper administration (twice daily for doses above 5 mg) and dose escalation (with a minimum of one-week intervals between dose increases).
• Kidney function should be monitored regularly in patients with renal dysfunction.
• Seizures: Dementa has not been fully evaluated in patients with seizure disorders. In clinical trials, seizures occurred in 0.2% of patients treated with Dementa and 0.5% of those treated with a placebo.
• Carcinogenesis, Mutagenesis, and Impairment of Fertility: No evidence suggests that Dementa causes carcinogenesis, mutagenesis, or fertility impairment.
• Driving and Machinery: Dementa may impair reaction times. Caution is advised when operating vehicles or machinery.

Therapeutic Class:

• Drugs for Dementia

Storage Conditions:
Store in a cool, dry place, protected from light. Keep out of reach of children.