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Rivacap

Rivastigmine USP

NAME STRENGTH PACK SIZE DOSAGE FORM
RivaCap 1.5 1.5 mg 3X10 Capsule

Description

Rivastigmine has an ameliorative effect on cholinergic mediated cognitive deficits associated with Alzheimer’s disease. It interacts with its target enzymes by forming a covalently bound complex that temporarily inactivates the enzymes. Activity of the enzyme returns to baseline levels about 9 hours after the maximum inhibitory effect has been achieved.

Each capsule contains Rivastigmine Tartrate USP equivalent to Rivastigmine 1.5 mg.

Rivacap is indicated for the treatment of mild to moderate dementia in Alzheimer’s disease.

Rivastigmine should be administered twice a day, morning and evening with food. The capsules should be swallowed whole.The starting dose of Rivastigmine is 1.5 mg twice daily. If this dose is well tolerated after a minimum of two weeks of treatment, the dose may be increased to 3 mg twice daily. Subsequent increase to 4.5 mg and 6 mg twice daily should be attempted after a minimum treatment of two weeks at the previous dose. If adverse effects such as nausea, vomiting, abdominal pain, loss of appetite or weight decrease are observed during treatment, these may respond to omitting one or more doses. If adverse effects persist, the daily dose should be temporarily reduced to previous well tolerated dose. If the treatment is interrupted for longer than several days, it should be reinitiated 1.5 mg twice daily and titrated as described above. The effective maintenance dose is 3 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. The clinical benefit of Rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day. Discontinuation should be considered when evidence of a therapeutic benefit is no longer present. Individual responses to Rivastigmine cannot be predicted. Renal and Hepatic Impairment : Due to increased exposure in renal and mild to moderate hepatic impairment, dosing recommendations to titrate according to individual tolerability should be closely followed. Pediatric Use: Rivastigmine is not recommended for use in children

The most commonly reported adverse effects with Rivastigmine are nausea, vomiting, diarrhea, loss of appetite, abdominal pain and dyspepsia, increased sweating, dizziness, headache, somnolence, tremor, syncope, seizures, agitation, confusion, weight loss, fatigue/asthenia and malaise.

Gastrointestinal disorders such as nausea and vomiting may occur particularly when initiating treatment and/or increasing the dose. These adverse effects occur more commonly in women. If treatment is interrupted for more than several days, it should be reinitiated at 1.5 mg twice daily to reduce the possibility of adverse reactions. During therapy patient’s weight should be monitored. As with other cholinomimetics, caution is advised when using Rivastigmine in patients with sick sinus syndrome or conduction defects (sinoatrial block, atrioventriculer block) active gastric or duodenal ulcer or those that are predisposed to this condition and in patients with a history of asthma or obstructive pulmonary disease. Like other cholinomimetics Rivastigmine may exacerbate or induce parkinsonian extrapyramidal symptoms, including worsening in patients with Parkinson’s disease. Cholinomimetics may induce or exacerbate urinary obstruction and seizures so cautions is advised in patients predistosed to such diseases. The use of Rivastigmine in patients with severe Alzheimer’s dementia, other types of dementia or other types of memory impairment such as age related cognitive decline, has not been investigated.

No clinical data on exposed pregnancies are available. Rivastigmine should not be used during pregnancy unless clearly necessary. In animals Rivastigmine is excreted into milk. It is not known whether it is excreted in human milk, therefore, women on Rivastigmine should not breast feed.

As a cholinesterase inhibitor, Rivastigmine may exaggerate the effects of succinylcholine type muscle relaxants during anesthesia. Rivastigmine should not be given with cholinomimetic drugs and might interfere with the activity of anticholinergic medications. Metabolic interactions appear unlikely although Rivastigmine may inhibit the butyrylcholinesterase mediated metabolism of other drugs. No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine.

Store in a cool and dry place, protected from light. Keep out of the reach of children.

Known hypersensitivity to Rivastigmine, other carbamate derivatives or any other excipients used in the formulation. Severe liver impairment.

Each box contains 3 X 10 capsules in Alu-Alu blister pack.