DEMENTEXA TABLET

Description

PHARMACEUTICAL DOSAGE FORM:
Film coated tablets
PROPERTIES:
Persistent activation of central nervous system NMDA receptors by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer’s disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity uncompetitive (open channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor – operated cation channels.
PHARMACOKINETICS:
Memantine is well absorbed after oral administration with peak concentrations reached in about 3-7 hours. Food has no effect on the absorbtion of Memantine. Memantine undergoes partial hepatic metabolism. About 48% of administered drug is excreted unchanged in urine. Memantine has a terminal elimination half life of about
60 – 80 hours. Renal clearance involve active tubular secretion moderated by pH dependent tubular reabsorption.
INDICATIONS:
DEMENTEXA is indicated for the treatment of moderate to severe dementia of Alzheimer’s type.
DOSAGE:
The recommended starting dose of DEMENTEXA is 5 mg once daily. The
recommended target dose is 20 mg / day (10 mg twice daily). DEMENTEXA can be taken with or without food.
CONTRAINDICATIONS:
DEMENTEXA is contraindicated in patients with known hypersensitivity to memantine HC1 or to any excipients used in the formulation.
SIDE EFFECTS:
Body as a -whole: Syncope, fatigue, pain.
Cardiovascular system: Cardiac failure, Hypertension.
Central and peripheral nervous system: Transient ischemic attack, vertigo, ataxia, hypokinesia, dizziness, headache.
Musculoskeletal system: Back pain.
Gastrointestinal system: Constipation, vomiting.
Hemic and lymphatic disorders: Anemia.
Metabolic and Nutritional disorders: increased alkaline phosphatase, decreased weight.
Psychiatric disorders: Aggressive reactions, confusion, somnolence, hallucination.
Respiratory system: Pneumonia, coughing, dyspnea.
Skin and appendages: Rash.
Special senses: cataract, conjunctivitis.
Urinary system: Frequent micturition.
DRUG INTERACTIONS:
 Drugs that alkalinize the urine would be expected to reduce renal elimination of memantine.
 The combined use of DEMENTEXA with other NMDA antagonists has not been systematically evaluated and such use should be approached with caution.
PREGNANCY & LACTATION:
 Pregnancy (Category B): There are no adequate and well controlled studies of DEMENTEXA in pregnant women. DEMENTEXA should be used during pregnancy only if the potential benefit justifies the potential risk to the featus.
 It is not known whether DEMENTEXA is excreted in human breast milk. Caution should be exercised when DEMENTEXA is administered to a nursing mother.
PRECAUTIONS & WARNINGS:
 Patients and caregivers should be instructed in the recommended administration and dose escalation.
 DEMENTEXA has not been systemically evaluated in patients with a seizure disorder.
 Conditions that raise urine pH may decrease the urinary elimination of DEMENTEXA resulting in increased plasma levels of memantine.
 No dosage adjustment is needed in patients with mild or moderate hepatic impairment. DEMENTEXA should be administered with caution to patients with severe hepatic impairment.
 No dosage adjustment is needed in patients with mild or moderate renal impairment. A dosage reduction is recommended in patients with severe renal impairment.
PACKING;
A carton box containing 2 (PVC/Aluminium) strips each of 7 tablets with a pamphlet.
STORAGE;
Keep at a temperature not exceeding 30C, in dry place.
Keep out of reach of children.
INSTRUCTIONS TO PATIENTS:
Caregivers should be instructed in the recommended administration and dose escalation.