CNS Medication , NMDA Receptor Antagonist

Dementia, Alzheimer's type, moderate to severe

FDA Pregnancy Category B

Pediatrics

Appropriate studies on the relationship of age to the effects of memantine have not been performed in the pediatric population, Safety and efficacy have not been established.

Geriatrics

Appropriate studies on the relationship of age to the effects of memantine have not been performed in the geriatric population, however no geriatrics specific problems have been reported to date.

Contraindications

Except under special circumstances, this medication should not be used when the following medical problem exists:

Hypersensitivity to memantine or any excipients used in the formulation

Risk-benefit should be considered when the following medical problems exist:

Renal tubular acidosis, Urinary tract infections severe, Neurological conditions, genitourinary conditions, renal impairment mild to moderate, renal impairment severe.

Drug interactions

Hydrochlorothiazide, NMDA antagonist such as Amantadine, Dextromethrophan, Ketamine, Triamterene, Cimetidine, Nicotine, Ranitidine, Quinidine, Carbonic anhydrase inhibitors.

Alzheimer's dementia

Oral, starting dose is 5 mg daily, Target dose is 20 mg per day. May be taken with or without food .

Dose should be increased in 5 mg increments to 10 mg per day (5mg twice a day), 15 mg per day (5 mg and 10 mg as separate doses), and 20 mg per day (10 mg twice a day).The minimum recommended interval between dose increases is one week.

Note: In patients with mild to moderate renal impairment, no dosage adjustment is needed.

A target dose of 5 mg twice per day is recommended is patients with severe renal impairment (creatinine clearance of 5 to 29 mL per minute based on the Cockroft-Gault equation):

For males: CLcr= [140-age (years) x Weight (kg)/[72 x serum creatinine (mg per dL)]

For females: CLcr=0.85 x [140-age (years) x Weight (kg)/[172 x serum creatinine (mg per dL)]

Appropriate studies on the relationship of age to the effects of memantine have not been performed in the pediatric population, Safety and efficacy have not been established.

Those indicating need for medical attention:

Incidence less frequent

Hypertension, peripheral edema

Incidence not determined-

Observed during clinical practice, Stimated of frequency can not be determine, acute pancreatitis, acute renal failure, aspiration pneumonia, atrioventicular block, bone fracture, cerebral infraction, claudication, dyskinesia, grand mal convulsions, hepatic failure, ileus, intracranial hemorrhage, neuroleptic malignant syndrome, prolonged QT interval, Stevens-Johnson syndrome, sudden death, supraventricular tachycardia, tachycardia, tardive dyskinesia, thrombocytopenia

Those indicating need for medical attention only if they continue or are bothersome

Incidence less frequent

Confusion, dizziness, headache

Incidence less frequent

Abnormal gait, agitation, anorexia, anxiety, arthralgia, back pain, bronchitis, constipation, coughing, depression, diarrhea, dyspnea, fatigue, hallucination, influenza like syndrome, insomnia, nausea, pain, somnolence, upper respiratory tract infection, urinary incontinence, urinary tract infection, vomiting

Incidence not determined-Observed during clinical practice, estimates of frequency cannot be determined

Carpal tunnel syndrome, chest pain, dysphagia, gastritis, gastroesophageal reflux, hyperlipidemia, hypoglycemia, impotence, malaise, restlessness.

Store below 30°C (86°F). Protect from light and moisture & keep the medicine in the box.

Boxes of 30 Scored F.C. Tablet Memantine 5,10 & 20 mg.