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|Razadyne ER

GALANTAMINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Razadyne

• Note:

  In April 2005, the manufacturer changed the name of this product from Reminyl to Razadyne .

• Razadyne ER

Category

• Dementia symptoms treatment adjunct

Description

Galantamine ((ga-LAN-ta-meen)) is used to treat the symptoms of mild to moderate Alzheimer"s disease. Galantamine will not cure Alzheimer"s disease, and it will not stop the disease from getting worse. However, galantamine can improve thinking ability in some patients with Alzheimer"s disease

In Alzheimer"s disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is less of a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Galantamine slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer"s disease gets worse, there will be less and less ACh, so galantamine may not work as well.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Extended-release capsules (U.S.)
• Oral solution (U.S.)
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For galantamine the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to galantamine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Galantamine has not been studied in pregnant women. Galantamine has been shown to cause birth defects or other problems in animal studies. Before taking this medicine, make sure your knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether galantamine passes into breast milk. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor. Use in breast-feeding mothers is not indicated.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of galantamine in children with use in other age groups. Use in children is not recommended.

Older adults—Galantamine levels are higher in older adults than in healthy young subjects.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.”

Other medical problems—The presence of other medical problems may affect the use of galantamine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma (or history of) or
• Lung disease—May make breathing problems worse

• Epilepsy or history of seizures—Galantamine may cause seizures

• Heart problems, including slow heartbeat or heart block (slow and irregular heartbeat)—May make condition worse

• Kidney problems or
• Liver problems—Your doctor may need to adjust your dose. If the problems are severe, you should not take galantamine.

• Mild cognitive impairment (memory problems)—Galantamine should not be used for this condition.

• Stomach ulcer (or history of) or
• Urinary tract blockage or difficult urination—Galantamine may make these conditions worse

Proper Use of This Medicine

Dosing—Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more or less often than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

If you are taking the tablets or oral solution: Take this medicine with your morning and evening meals

If you are taking the extended-release capsules: Take this medicine with your morning meal

Follow the instruction sheet for the proper dosing of the oral solution and ask your doctor or pharmacist if you have any questions.

Make sure that you are drinking plenty of fluids while you are taking this medicine.

The dose of galantamine 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 galantamine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets 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 taking galantamine.

• For oral dosage forms (oral solution and tablets):
  • For treatment of Alzheimer"s disease:
    • Adults—To start, take 4 mg (milligrams) two times a day. Your doctor may increase your dose gradually if you are doing well on this medicine.

• For long acting oral dosage forms (extended-release capsules):
  • For treatment of Alzheimer"s disease:
    • Adults—To start, take 8 mg (milligrams) one time a day. Your doctor may increase your dose gradually if you are doing well on this medicine.

Missed dose— If you miss a dose of this medicine, take it as soon as possible. However, if you do not remember within a few hours, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Do not take your morning and evening doses close together.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits.

Tell your doctor if your symptoms get worse, or if you notice any new symptoms.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Galantamine causes a large number of patients to have problems with their stomachs and intestines. Tell your doctor about any nausea, vomiting, diarrhea, stomach pain or loss of appetite.

If you think you or someone else may have taken an overdose of galantamine, get emergency help at once. Taking an overdose of galantamine may lead to convulsions (seizures) or shock. Some signs of shock are large pupils, irregular breathing, and fast weak pulse. Other signs of an overdose are severe nausea and vomiting, increasing muscle weakness, greatly increased sweating, and greatly increased watering of the mouth.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 05/17/2001
Revised: 05/10/2005

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