Composition: RivaCap 1.5 Capsule: Each capsule contains Rivastigmine Tartrate USP equivalent to Rivastigmine 1.5 mg.
Clinical Pharmacology: Rivastigmine is an acetyl, and butyrylcholinesterase inhibitor of the carbamate type, thought to
facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact
cholinergic neurones.
Mechanism of Action:Â 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.
Pharmacokinetics:Â Rivastigmine is rapidly and completely absorbed. Absolute bioavailability after a 3 mg dose is about 36%
+-13%. Peak plasma concentrations are reached in approximately 1 hour, but administration with food delays the absorption
by 90 minutes and lowers Cmax and increases AUC by approximately 30%. Rivastigmine is widely distributed through out
the body with a volume of distribution in the range of 1.8-2.7 L/Kg and readily crosses the blood brain barrier. About 40 %
of the drug is bound to plasma proteins, which cover the therapeutic range. Rivastigmine is rapidly and extensively
metabolised, primarily via cholinesterase mediated hydrolysis to the decarbamylated metabolite. Based on evidences from
in vitro and animal studies the major cytochrome P450 isozymes are minimally involved in Rivastigmine metabolism.
Following administration of 14C–Rivastigmine, renal elimination was rapid and essentially complete >90% within 24 hours.
Less than 1% of the administered dose is excreted in the faeces. The elimination half life is about 1 hour, with most
elimination as metabolite in urine. The Cmax of Rivastigmine was approximately 60% higher and the AUC was more than
twice as high in subjects with mild to moderate hepatic impairment as compared to healthy subjects. There was no change
in the Cmax and AUC of Rivastigmine in subjects with severe renal impairment but they were more than twice as high in
subjects with moderate renal impairment compared with healthy subjects. While bioavailability of Rivastigmine is greater
in elderly than in young healthy volunteers, studies in Alzheimer’s diseases aged between 50 and 92 years showed no
change in bioavailability with age.
Indication: Rivacap is indicated for the treatment of mild to moderate dementia in Alzheimer’s disease.
Dosage and Administration:Â 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.
Rivacap 1.5mg 10pcs
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