Indications

Rivastigmine Tartrate capsule is indicated for the symptomatic treatment of mild to moderately severe Alzheimer's dementia. Symptomatic treatment of mild to moderately severe dementia in patients with Idiopathic Parkinson's disease.

Composition

Pharmacology

Rivastigmine is a carbamate derivative that is structurally related to physostigmine, but not to donepezil and tacrine. The precise mechanism of rivastigmine has not been fully determined, but it is suggested that rivastigmine binds reversibly with and inactivates chlolinesterase (eg. acetylcholinesterase, butyrylcholinesterase), preventing the hydrolysis of acetycholine, and thus leading to an increased concentration of acetylcholine at cholinergic synapses. The anticholinesterase activity of rivastigmine is relatively specific for brain acetylcholinesterase and butyrylcholinesterase compared with those in peripheral tissues.

Dosage & Administration

Rivastigmine capsule: Rivastigmine capsule should be administered twice a day, with morning and evening meals. Initial dose : Rivastigmine 1.5 mg twice a day. Dose titration: The starting dose is Rivastigmine 1.5 mg twice a day. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to Rivastigmine 3 mg twice a day. Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level. Maintenance dose : The effective dose is 3 mg to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose. The recommended maximum daily dose is 6 mg twice a day. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Re-initiation of therapy : If treatment is interrupted for more than several days, it should be re-initiated at 1.5 mg twice daily. Dose titration should then be carried out as described above. Rivastigmine transdermal patch: Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours. Initial Dose : Initiate treatment with 4.6 mg/24 hours Rivastigmine transdermal patch. Dose Titration : After a minimum of 4 weeks, if tolerated, increase dose to 9.5 mg/24 hours, which is the minimum effective dose. Following a minimum additional 4 weeks, may increase dosage to maximum dosage of 13.3 mg/24 hours. Mild to Moderate Alzheimer's Disease and Parkinson’s Disease Dementia : Rivastigmine transdermal patch 9.5 mg/24 hours or 13.3 mg/24 hours once daily. Severe Alzheimer’s Disease : Rivastigmine transdermal patch 13.3 mg/24 hours once daily. For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg per 24 hours.

Contraindications

The use of this medicinal product is contraindicated in patients with hypersensitivity to the active substance or other carbamate derivatives.

Side Effects

The most commonly reported adverse reactions are gastrointestinal, including nausea (38%) and vomiting (23%), especially during titration. Female patients in clinical studies were found to be more susceptible than male patients to gastrointestinal adverse reactions and weight loss.

Pregnancy & Lactation

For Rivastigmine no clinical data are available. Rivastigmine should not be used during pregnancy unless clearly necessary. In animals, rivastigmine is excreted into milk. It is not known if rivastigmine is excreted into human milk. Therefore, women on rivastigmine should not breast-feed.

Precautions & Warnings

Patients with sick sinus syndrome or conduction defects, resp diseases. Cholinergic stimulation may increase gastric acid secretion. May exacerbate urinary obstruction and seizures. Pregnancy. Renal impairment, mild to moderate hepatic impairment. Monitor body wt. Asthma or obstructive pulmonary disease. May worsen extrapyramidal symptoms. Lactation.

Therapeutic Class

Drugs for Dementia

Storage Conditions

Store in a cool and dry place, protected from light.