Rivastigmine — uses, dosing, side effects & the brands that sell it · pharmaranks
Rivastigmine: uses, dosing, side effects & brands
Rivastigmine is a cholinesterase inhibitor sold in the U.S. under 3 brand and generic names, for alzheimer disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Cholinesterase Inhibitor
Treats
Alzheimer Disease
Available as
Patch · Patch, extended release · Capsule
Sold as
3 products — Rivastigmine, Exelon and Rivastigmine Tartrate
Prescription?
Prescription only
Generic available?
Yes
Typical price
about $6 for a 30-count supply
How rivastigmine is dosed
From the FDA label for Rivastigmine (application ANDA204403). Other rivastigmine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours. ( 2.1 , 2.4 ) • Initial Dose : Initiate treatment with 4.6 mg/24 hours rivastigmine transdermal system. ( 2.1 ) • Dose Titration ( 2.1 ): After a minimum of 4 weeks, if tolerated, increase dose to 9.5 mg/24 hours, which is the minimum effective dose. Following a minimum additional 4 weeks, may increase dosage to maximum dosage of 13.3 mg/24 hours. • Mild-to-Moderate Alzheimer’s Disease and Parkinson’s Disease Dementia : rivastigmine transdermal system 9.5 mg/24 hours or 13.3 mg/24 hours once daily. ( 2.1 ) • Severe Alzheimer’s Disease : rivastigmine transdermal system 13.3 mg/24 hours once daily. ( 2.1 ) • For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg per 24 hours. ( 2.1 ) • Consider dose adjustments in patients with ( 2.2 ): ∘ Mild-to-moderate hepatic impairment ( 8.6 ) ∘ Low (less than 50 kg) body weight ( 8.7 ) 2.1 Recommended Dosing Initial Dose Initiate treatment with one 4.6 mg/24 hours rivastigmine transdermal system applied to the skin once daily [see Dosage and Administration ( 2.4 )] . 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…
Rivastigmine side effects
The following clinically significant adverse reactions are described below and elsewhere in the labeling: • Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.2 )] . • Skin Reactions [see Warnings and Precautions ( 5.3 )] . • Other Adverse Reactions from Increased Cholinergic Activity [see Warnings and Precautions ( 5.4 )] . Most common adverse reactions (less than 5% and higher than with placebo): Nausea, vomiting, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Rivastigmine transdermal system has been administered to 4516 patients with Alzheimer’s disease during clinical trials worldwide. Of these, 3005 patients have been treated for at least 26 weeks, 1771 patients have been treated for at least 52 weeks, 974 patients have been treated for at least 78 weeks, and 24 patients have been treated for at least 104 weeks. Mild-to-Moderate Alzheimer’s Disease 24-Week International Placebo-Controlled Trial (Study 1) Most Common Adverse Reactions The most common adverse…
Every rivastigmine product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Rivastigmine pill imprints
Imprint
Strength
Colour
Shape
Maker
H;67
1.5 mg
yellow
capsule
—
H;67
1.5 mg
yellow
capsule
—
H;68
3 mg
orange
capsule
—
H;70
6 mg
red, orange
capsule
—
CE;1pt5RIV
1.5 mg
yellow
capsule
—
CE;3pt0RIV
3 mg
Frequently asked questions
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 C 14 H 22 N 2 O 2 as the base and a molecular weight of 250.34 g/mol (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 Layer 1: Backing Film Layer 2: Drug Product (Acrylic) Matrix Layer 3: Adhesive (Silicone) Matrix Layer 4: Release Liner (removed at time of use) Excipients within the formulation include acrylic copolymer, poly(butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E. rivastigmine chemical structure Fig 1
What kind of drug is rivastigmine?
The FDA classifies rivastigmine as a cholinesterase inhibitor. Cholinesterase inhibitors block the enzyme that breaks down acetylcholine, a chemical messenger nerves use to communicate. By letting acetylcholine build up and act longer, they can help preserve memory and thinking in Alzheimer's disease, where this messenger runs low. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take rivastigmine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run rivastigmine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is rivastigmine sold under?
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take rivastigmine
Rivastigmine transdermal system is contraindicated in patients with: • known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see Description ( 11 )] . • previous history of application-site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see Warnings and Precautions ( 5.3 )] . Isolated cases of generalized skin reactions have been described in postmarketing experience [see Adverse Reactions ( 6.2 )] . • Known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation. ( 4 ) • History of application-site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis. ( 4 , 6.2 )
Rivastigmine drug interactions
Concomitant use with metoclopramide, beta-blockers, or cholinomimetics and anticholinergic medications is not recommended. ( 7.1 , 7.2 , 7.3 ) 7.1 Metoclopramide Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and rivastigmine transdermal system is not recommended. 7.2 Cholinomimetic and Anticholinergic Medications Rivastigmine transdermal system may increase the cholinergic effects of other cholinomimetic medications and may also interfere with the activity of anticholinergic medications (e.g., oxybutynin, tolterodine). Concomitant use of rivastigmine transdermal system with medications having these pharmacologic effects is not recommended unless deemed clinically necessary [see Warnings and Precautions ( 5.5 )]. 7.3 Beta-Blockers Additive bradycardic effects resulting in syncope may occur when rivastigmine is used concomitantly with beta-blockers, especially cardioselective beta-blockers (including atenolol). Concomitant use is not recommended when signs of bradycardia, including syncope are present.
We track 3 rivastigmine-containing products in the U.S.: Rivastigmine, Exelon and Rivastigmine Tartrate. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does rivastigmine come in?
Across the brands we track, rivastigmine is currently marketed as patch, patch, extended release and capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic rivastigmine?
Yes. Our catalog lists 2 generic rivastigmine products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.