Rivastigmine

What is Rivastigmine?

• Rivastigmine (EXELON PATCH) is an acetylcholinesterase inhibitor used for therapy of Alzheimer disease, Parkinson’s disease.

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Rivastigmine

Rivastigmine ball-and-stick

Rivastigmine Structural Formulae

What are the uses of this medicine?

EXELON PATCH is a prescription medicine used to treat:

• Mild, moderate, and severe memory problems (dementia) associated with Alzheimer’s disease.
• Mild-to-moderate memory problems (dementia) associated with Parkinson’s disease (PD).

How does this medicine work?

• Rivastigmine (riv" a stig' meen) is a selective acetylcholinesterase inhibitor which acts by inhibition of the metabolism of acetylcholine in the postsynaptic clefts, thus enhancing cholinergic neurotransmission.
• Rivastigmine has selective activity for acetylcholinesterase in the central nervous system with little effect on the enzyme in peripheral tissue.
• The increase in concentration of acetylcholine is associated with improvement in cognitive function in patients with Alzheimer disease who typically have relative cholinergic deficiency in the cerebral cortex.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to rivastigmine, carbamate derivatives, or any of the ingredients in EXELON PATCH.

have had a skin reaction that:

• spread beyond the EXELON PATCH size
• had blisters, increased skin redness, or swelling
• did not get better within 48 hours after you removed the EXELON PATCH

What drug interactions can this medicine cause?

• The concomitant use of metoclopramide and EXELON PATCH is not recommended.
• Concomitant use of EXELON PATCH with anticholinergic medications (e.g., oxybutynin, tolterodine) medications not recommended unless deemed clinically necessary.
• Concomitant use of EXELON PATCH with beta-blockers, especially cardioselective beta-blockers (including atenolol) is not recommended when signs of bradycardia, including syncope are present.

Is this medicine FDA approved?

• Rivastigmine was approved for use in the United States in 2007 for treatment of mild-to-moderate dementia in Alzheimer and Parkinson disease.

How should this medicine be used?

Recommended dosage: Initial Dose:

• Initiate treatment with 4.6 mg/24 hours EXELON PATCH.

Dose Titration:

• 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:

• EXELON PATCH 9.5 mg/24 hours or 13.3 mg/24 hours once daily.

Severe Alzheimer’s Disease:

• EXELON PATCH 13.3 mg/24 hours once daily.
• For treatment interruption longer than 3 days, retitrate dosage starting at 4.6 mg per 24 hours.

Dosing Modifications in Patients with Hepatic Impairment:

• Consider using the 4.6 mg/24 hours EXELON PATCH as both the initial and maintenance dose in patients with mild to moderate hepatic impairment.

Dosing Modifications in Patients with Low Body Weight:

• Consider reducing the maintenance dose to the 4.6 mg/24 hours EXELON PATCH.

Administration:

• EXELON PATCH comes in 3 different dosage strengths.
• Your healthcare provider may change your dose as needed.
• Wear only 1 EXELON PATCH at a time.
• EXELON Patch is for skin use only.
• Only apply EXELON PATCH to healthy skin that is clean, dry, hairless, and free of redness, irritation, burns or cuts.
• Avoid applying EXELON PATCH to areas on your body that will be rubbed against tight clothing.
• Do not apply EXELON PATCH to skin that has cream, lotion, or powder on it.
• Change your EXELON PATCH every 24 hours at the same time of day. You may write the date and time you put on the EXELON PATCH with a ballpoint pen before applying the patch to help you remember when to remove it.
• Change your application site every day to avoid skin irritation. You can use the same area, but do not use the exact same spot for at least 14 days after your last application.
• Check to see if the EXELON PATCH has become loose when you are bathing, swimming, or showering.
• EXELON PATCH is designed to deliver medication during the time it is worn. If your EXELON PATCH falls off before its usual replacement time, put on a new EXELON PATCH right away. Replace the new patch the next day at the same time as usual. Do not use overlays, bandages, or tape to secure an EXELON PATCH that has become loose or try to reapply an EXELON PATCH that has fallen off.
• If you miss a dose or forget to change your EXELON PATCH, apply your next EXELON PATCH as soon as you remember. Do not apply 2 EXELON PATCHes to make up for the missed dose.
• If you miss more than 3 doses of applying EXELON PATCH, call your healthcare provider before putting on a new EXELON PATCH. You may need to restart EXELON PATCH at a lower dose.
• Always remove the old EXELON PATCH from the previous day before you apply a new one.
• Having more than 1 EXELON PATCH on your body at the same time can cause you to get too much medicine. If you accidentally use more than 1 EXELON PATCH at a time, call your healthcare provider right away. If you are unable to reach your healthcare provider, call your local Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• What should I avoid while using EXELON PATCH?
• Do not touch your eyes after you touch the EXELON PATCH. In case of accidental contact with your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
• EXELON PATCH can cause drowsiness, dizziness, weakness, or fainting. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EXELON PATCH affects you.
• Avoid exposure to heat sources, such as excessive sunlight, saunas, or sunrooms for long periods of time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Patch: 4.6 mg/24 hours or 9.5 mg/24 hours or 13.3 mg/24 hours

This medicine is available in fallowing brand namesː

• EXELON

What side effects can this medication cause?

The most common side effects of this medicine include:

• depression
• headache
• anxiety
• dizziness
• stomach pain
• urinary tract infections
• muscle weakness
• tiredness
• trouble sleeping

EXELON PATCH may cause serious side effects, including:

• Medication overdose
• Stomach or bowel (intestinal) problems
• Skin reactions

What special precautions should I follow?

• Hospitalization and, rarely, death have been reported due to application of multiple patches at same time. Ensure patients or caregivers receive instruction on proper dosing and administration.
• EXELON PATCH can cause gastrointestinal adverse reactions, including significant nausea, vomiting, diarrhea, anorexia/decreased appetite, and weight loss. Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes.
• Skin application-site reactions may occur with EXELON PATCH. Discontinue treatment if application-site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g., increasing erythema, edema, papules, vesicles), and if symptoms do not significantly improve within 48 hours after patch removal.
• Do not touch your eyes after you touch the EXELON PATCH. In case of accidental contact with your eyes or if your eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.
• EXELON PATCH can cause drowsiness, dizziness, weakness, or fainting. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EXELON PATCH affects you.
• Avoid exposure to heat sources, such as excessive sunlight, saunas, or sunrooms for long periods of time.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• vomiting
• salivation
• sweating
• bradycardia
• hypotension
• respiratory depression
• convulsions
• diarrhea
• abdominal pain
• dizziness
• tremor
• headache
• somnolence
• confusional state
• hyperhidrosis
• hypertension
• hallucinations
• malaise

Management of overdosage:

• As in any case of overdose, general supportive measures should be utilized.
• 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.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risks associated with the use of EXELON in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established. The use of EXELON PATCH in pediatric patients (below 18 years of age) is not recommended.

What are the active and inactive ingredients in this medicine?

• Active ingredient: rivastigmine
• Excipients include: acrylic copolymer, poly (butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E.

Who manufactures and distributes this medicine?

• Distributed by:

Novartis Pharmaceuticals Corporation East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store EXELON PATCH between 68°F to 77°F (20°C to 25°C).
• Keep EXELON PATCH in the sealed pouch until ready to use.

• Dailymed label info on Rivastigmine
• FDA Rivastigmine

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