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Rivastigmine
Overview
What is Rivastigmine?
Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of CHNO as the baseand a molecular weight of 250.34 (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate.
The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27.
Rivastigmine transdermal system is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use.
Figure 1: Cross Section of the Rivastigmine Transdermal System
Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.
What does Rivastigmine look like?
What are the available doses of Rivastigmine?
Rivastigmine transdermal system:
3
What should I talk to my health care provider before I take Rivastigmine?
How should I use Rivastigmine?
Rivastigmine transdermal system is indicated for the treatment of dementia of the Alzheimer’s type (AD). Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer’s disease.
Initial Dose
Initiate treatment with one 4.6 mg/24 hours rivastigmine transdermal system applied to the skin once daily .
Dose Titration
Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. For mild to moderate AD and PDD patients, continue the effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. For patients with severe AD, 13.3 mg/24 hours is the effective dose. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [)].
Mild to Moderate Alzheimer’s Disease and Mild to Moderate Parkinson’s Disease Dementia
The effective dosage of rivastigmine transdermal system is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.
Severe
Alzheimer’s Disease
The effective dosage of rivastigmine transdermal system in patients with severe Alzheimer’s disease is 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.
Interruption of Treatment
If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength rivastigmine transdermal system. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours rivastigmine transdermal system and titrate as described above.
What interacts with Rivastigmine?
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What are the warnings of Rivastigmine?
Sorry No Records found
What are the precautions of Rivastigmine?
Sorry No Records found
What are the side effects of Rivastigmine?
Sorry No records found
What should I look out for while using Rivastigmine?
Rivastigmine transdermal system is contraindicated in patients with:
Isolated cases of generalized skin reactions have been described in postmarketing experience .
What might happen if I take too much Rivastigmine?
Overdose with rivastigmine transdermal system has been reported in the postmarketing setting . Overdoses have occurred from application of more than one patch at one time and not removing the previous day’s patch before applying a new patch. The symptoms reported in these overdose cases are similar to those seen in cases of overdose associated with rivastigmine oral formulations.
Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. As rivastigmine has a plasma half-life of about 3.4 hours after patch administration and a duration of acetylcholinesterase inhibition of about 9 hours, it is recommended that in cases of asymptomatic overdose the patch should be immediately removed and no further patch should be applied for the next 24 hours.
As in any case of overdose, general supportive measures should be utilized.
Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Atypical responses in blood pressure and heart rate have been reported with other drugs that increase cholinergic activity when coadministered with quaternary anticholinergics such as glycopyrrolate. Additional symptoms associated with rivastigmine overdose are diarrhea, abdominal pain, dizziness, tremor, headache, somnolence, confusional state, hyperhidrosis, hypertension, hallucinations and malaise. Due to the short plasma elimination half-life of rivastigmine after patch administration, dialysis (hemodialysis, peritoneal dialysis, or hemofiltration) would not be clinically indicated in the event of an overdose.
In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. A fatal outcome has rarely been reported with rivastigmine overdose.
How should I store and handle Rivastigmine?
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. Rivastigmine Transdermal System: 4.6 mg/24 hoursEach patch of 5 cm contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours. Carton of 30………………………NDC 0781-7304-31Rivastigmine Transdermal System: 9.5 mg/24 hoursEach patch of 10 cm contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Carton of 30………………………..NDC 0781-7309-31Rivastigmine Transdermal System: 13.3 mg/24 hoursEach patch of 15 cm contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours. Carton of 30………………………..NDC 0781-7313-31Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep rivastigmine transdermal system in the individual sealed pouch until use. Each pouch contains 1 patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although the precise mechanism of action of rivastigmine is unknown, it is thought to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. The effect of rivastigmine may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that rivastigmine alters the course of the underlying dementing process.
Non-Clinical Toxicology
Rivastigmine transdermal system is contraindicated in patients with:Isolated cases of generalized skin reactions have been described in postmarketing experience .
Medication errors with rivastigmine transdermal system have resulted in serious adverse reactions; some cases have required hospitalization, and rarely, led to death. The majority of medication errors have involved not removing the old patch when putting on a new one and the use of multiple patches at one time.
Instruct patients and their caregivers on important administration instructions for rivastigmine transdermal system .
The following adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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