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USP DI Vol. II - GALANTAMINE (Systemic)

GALANTAMINE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Razadyne
  • Note:

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

  • Razadyne ER

Category

  • Dementia symptoms treatmentadjunct

Description

Galantamine ((ga-LAN-ta-meen)) is used totreat the symptoms of mild to moderate Alzheimer's disease. Galantamine willnot cure Alzheimer's disease, and it will not stop the disease from gettingworse. However, galantamine can improve thinking ability in some patientswith 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 chemicalcalled acetylcholine (ACh). ACh helps the brain to work properly. Galantamineslows 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 thefollowing 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 willdo. This is a decision you and your doctor will make. For galantamine thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to galantamine. Also tell your doctor and pharmacistif 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 animalstudies. Before taking this medicine, make sure your knows if you are pregnantor if you may become pregnant.

Breast-feeding?It is not known whether galantamine passes intobreast milk. Mothers who are taking this medicine and who wish to breast-feedshould discuss this with their doctor. Use in breast-feeding mothers is notindicated.

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

Older adults?Galantamine levels are higher in older adults than in healthyyoung subjects.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.?

Other medical problems?The presence of other medicalproblems may affect the use of galantamine. Make sure you tell your doctorif 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 andirregular heartbeat)?May make condition worse
  • Kidney problems or
  • Liver problems?Your doctor may need to adjust your dose. Ifthe problems are severe, you should not take galantamine.
  • Mild cognitive impairment (memory problems)?Galantamine shouldnot be used for this condition.
  • Stomach ulcer (or history of) or
  • Urinary tract blockage or difficult urination?Galantamine maymake these conditions worse

Proper Use of This Medicine

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

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

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

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

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

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 unlessyour 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 timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking galantamine.

  • For oral dosage forms (oral solutionand tablets):
    • For treatment of Alzheimer's disease:
      • Adults?To start, take 4 mg (milligrams) two times a day. Yourdoctor may increase your dose gradually if you are doing well on this medicine.
  • For long acting oral dosage forms (extended-releasecapsules):
    • For treatment of Alzheimer's disease:
      • Adults?To start, take 8 mg (milligrams) one time a day. Yourdoctor may increase your dose gradually if you are doing well on this medicine.

Missed dose? If you miss a dose of this medicine, take itas soon as possible. However, if you do not remember within a few hours, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses. 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 otherdamp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. 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 regularvisits.

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 medicinesfor appetite control, asthma, colds, cough, hay fever, or sinus problems.

Galantamine causes a large number of patients to have problems with theirstomachs 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 anoverdose of galantamine, get emergency help at once. Taking an overdoseof galantamine may lead to convulsions (seizures) or shock. Some signs ofshock are large pupils, irregular breathing, and fast weak pulse. Other signsof 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 medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

    Check with your doctor as soon as possibleif any of the following side effects occur:

      Less common

        Chest pain or discomfort; Shortnessof breath

      Incidence not known

        Attack, assault, force; bloody or black,tarry stools; confusion; constipation; convulsions; decreased urination; dry mouth; increase in heart rate; increased thirst; irregular heartbeat; mood changes; muscle pain or cramps; numbness or tinglingin hands, feet, or lips; rapid breathing; severe stomach pain; sunken eyes; vomiting of blood or material that looks like coffee grounds; wrinkled skin

      Symptoms of overdose

        Cramping; defecation or urination, uncontrolled; dizziness; drooling; fainting; increased sweating; low blood pressure; muscle weakness; seizures; slow heart beat; severe nausea or vomiting; slow or troubled breathing; tearing of the eyes; watering of the mouth

    Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

      More common

        Bladder pain; bloody or cloudy urine; diarrhea; difficult, burning,or painful urination; discouragement; feeling sad or empty; frequent urgeto urinate; irritability; loss of appetite; loss of interest or pleasure; lower back or side pain; nausea; tiredness; trouble concentrating; vomiting; weight loss

      Less common

        Abdominal pain; pale skin; troubled breathing with activity; slowor irregular heartbeat (less than 50 beats per minute); light-headedness; dizziness or fainting; unusual tiredness or weakness; indigestion; headache; blood in urine; lower back pain; painor burning while urinating; trouble sleeping; unable to sleep; sleepiness; sleeplessness; stuffy nose; unusual bleeding or bruising; unusualdrowsiness; high or low blood pressure; tremor

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


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