Rivastigmine Transdermal

rivastigmine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

To use the skin patch:

• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to a clean, dry, and hairless skin area on your upper or lower back, upper arm, or chest. Do not put the patch over rashes, cuts, or irritated skin. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
• Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.
• Press the patch firmly in place for 30 seconds with the palm of your hand to make sure that the edges of the patch stick well.
• The patch should stay in place, even when you are showering, bathing, or swimming. Apply a new patch if it falls off.
• After 24 hours, remove the patch. Choose a different place on your skin to apply the new patch. Do not put a new patch in the same place for at least 14 days. Do not leave the patch on for more than 24 hours. It will not work as well after that time and it may irritate your skin.
• After removing a used patch, fold the patch in half with the sticky sides together. Place the folded, used patch in its protective pouch. Make sure to dispose of it out of the reach of children and pets.
• Try to change the patch at the same time each day. If you forget to change the patch at the usual time, remove the patch you are wearing and put on a new patch. After that, apply a fresh patch at the usual time on the next day.
• Do not put cream, lotion, ointment, oil, or powder on the skin area where the patch will be placed.
• Do not touch your eyes after you touch the patch.
• Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight for long periods of time.
• Make sure you wash your hands with soap and water before and after applying the patch.

Do not stop using rivastigmine without asking your doctor. If you have not used your medicine for several days in a row, do not start using it again without talking to your doctor first. You may need to start the medicine again using a lower dose.

Dosing

The dose of rivastigmine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of rivastigmine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (patch):
  • For dementia associated with Alzheimer's disease or Parkinson's disease:
    • Adults—At first, one 4.6 milligram (mg) patch once a day. After at least 4 weeks, your doctor will increase your dose as needed. If you have mild to moderate Alzheimer's disease or Parkinson's disease dementia, usual dose is 9.5 mg patch or 13.3 mg patch per day. If you have severe Alzheimer's disease, 13.3 mg patch per day. However, the dose is usually not more than one 13.3 mg patch per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

If you go 3 days in a row or longer without wearing a patch, do not apply a new one until you have talked to your doctor. You might need to go back to a lower dose.

Storage

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

If you forget to change the skin patch, remove it and apply a new one as soon as you remember. Do not wear extra patches to make up a missed dose.

Call your doctor for instructions if you miss more than 3 doses of rivastigmine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• redness, swelling, or irritation where the skin patch is worn;

• a light-headed feeling, like you might pass out;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• pain or burning when you urinate;

• tremors (uncontrolled shaking), restless muscle movements in your eyes, tongue, jaw, or neck;

• seizures (convulsions);

• severe or ongoing vomiting or diarrhea with weight loss; or

• if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin.

Common side effects may include:

• nausea;

• vomiting; or

• upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Alzheimer's Disease:

MILD TO MODERATE ALZHEIMER'S DISEASE:
ORAL:
-Initial dose: 1.5 mg orally twice a day
-Maintenance dose: After a minimum of 2 weeks of treatment, if the initial dosage is well tolerated, it can be increased to 3 mg twice a day; subsequent increases to 4.5 mg and 6 mg twice a day should be attempted only after a minimum of 2 weeks at the previous dosage

TRANSDERMAL PATCH:
-Initial Dose: 4.6 mg/24 hour patch applied to the skin once daily
-Maintenance Dose: After a minimum of 4 weeks of treatment at the initial dose, and if well tolerated, the dose can be increased to 9.5 mg/24 hours for as long as this dose is beneficial; the dose can then be increased to 13.3 mg/24 hours
-Maximum Dose: 13.3 mg/24 hour patch applied to skin daily; higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events

SEVERE ALZHEIMER'S DISEASE:
TRANSDERMAL PATCH:
-Recommended dose: 13.3 mg/24 hours transdermal patch applied to skin once daily; replace with a new patch every 24 hours

Use: For the treatment of mild, moderate, or severe dementia of the Alzheimer's type (AD)

Usual Adult Dose for Parkinson's Disease:

MILD TO MODERATE PARKINSON'S DISEASE DEMENTIA:
ORAL:
Initial dose: 1.5 mg orally twice a day with morning and evening meals
Maintenance dose: Subsequently, the dose can be increased to 3 mg orally twice a day and further to 4.5 mg twice a day and 6 mg twice a day (based on tolerability) with a minimum of 4 weeks at each dose

TRANSDERMAL PATCH:
Initial dose: 4.6 mg/24 hours applied to the skin once a day
Maintenance dose: After a minimum of four weeks of treatment and if well tolerated, the dose of the patch can be increased to 9.5 mg/24 hours for as long as this dose is beneficial. The dose can then be increased to 13.3 mg/24 hours.
Maximum dose: 13.3 mg/24 hours. Higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events.

Use: For the treatment of mild to moderate dementia associated with Parkinson's disease

Do not take rivastigmine capsules or oral liquid at the same time you are wearing the skin patch.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• atropine;

• metoclopramide;

• cold or allergy medicine that contains an antihistamine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• a beta blocker--atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others;

• bladder or urinary medicines--darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or

• bronchodilators--aclidinium, ipratropium, or tiotropium.

This list is not complete. Other drugs may interact with rivastigmine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.