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Rivastigmine Transdermal System
Overview
What is Rivastigmine Transdermal System?
Rivastigmine Patch (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 base and 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 Patch is for transdermal administration. The patch comprises a multi-layer laminate containing the coversheet, backing film, reservoir layer, adhesive layer, and release liner as described below. The release liner is removed and discarded prior to use. See Figure 1 for a detailed illustration.
Figure 1
Schematic drawing of Rivastigmine Transdermal System
Excipients within the formulation include colloidal silicon dioxide, light mineral oil, polyisobutylene adhesive, acrylate-vinylacetate pressure sensitive adhesive, aluminum coated polyester backing.
What does Rivastigmine Transdermal System look like?
What are the available doses of Rivastigmine Transdermal System?
Patch: 4.6 mg/24 hours or 9.5 mg/24 hours or 13.3 mg/24 hours ()
What should I talk to my health care provider before I take Rivastigmine Transdermal System?
How should I use Rivastigmine Transdermal System?
What interacts with Rivastigmine Transdermal System?
Sorry No Records found
What are the warnings of Rivastigmine Transdermal System?
Sorry No Records found
What are the precautions of Rivastigmine Transdermal System?
Sorry No Records found
What are the side effects of Rivastigmine Transdermal System?
Sorry No records found
What should I look out for while using Rivastigmine Transdermal System?
Rivastigmine Patch 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 Transdermal System?
Overdose with Rivastigmine Patch 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 Transdermal System?
Store the vials in original cartons between 20° to 25°C (68° to 77°F). [See .] Retain in the original package to protect from light.Rivastigmine Patch: 4.6 mg/24 hoursin vivoRivastigmine Patch: 9.5 mg/24 hoursin vivo Rivastigmine Patch: 13.3 mg/24 hoursin vivo Store 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 Patch 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 Patch: 4.6 mg/24 hoursin vivoRivastigmine Patch: 9.5 mg/24 hoursin vivo Rivastigmine Patch: 13.3 mg/24 hoursin vivo Store 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 Patch 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 Patch: 4.6 mg/24 hoursin vivoRivastigmine Patch: 9.5 mg/24 hoursin vivo Rivastigmine Patch: 13.3 mg/24 hoursin vivo Store 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 Patch 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 Patch: 4.6 mg/24 hoursin vivoRivastigmine Patch: 9.5 mg/24 hoursin vivo Rivastigmine Patch: 13.3 mg/24 hoursin vivo Store 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 Patch 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 Patch: 4.6 mg/24 hoursin vivoRivastigmine Patch: 9.5 mg/24 hoursin vivo Rivastigmine Patch: 13.3 mg/24 hoursin vivo Store 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 Patch 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 Patch: 4.6 mg/24 hoursin vivoRivastigmine Patch: 9.5 mg/24 hoursin vivo Rivastigmine Patch: 13.3 mg/24 hoursin vivo Store 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 Patch 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 Patch: 4.6 mg/24 hoursin vivoRivastigmine Patch: 9.5 mg/24 hoursin vivo Rivastigmine Patch: 13.3 mg/24 hoursin vivo Store 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 Patch 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 Patch is contraindicated in patients with:Isolated cases of generalized skin reactions have been described in postmarketing experience.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving Tetracycline HCl Capsules, USP in conjunction with penicillin or other bactericidal antibiotics.
Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
The concurrent use of Tetracycline HCl Capsules, USP and methoxyflurane has been reported to result in fatal renal toxicity.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc, or sodium bicarbonate.
Concurrent use of Tetracycline HCl Capsules, USP may render oral contraceptives less effective.
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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