Disclaimer:

Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.

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?

Sorry No Records found


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.