Patient
Information Sheet
Galantamine hydrobromide (marketed as Razadyne, formerly Reminyl)
This is a summary of the most important information
about Razadyne. For details, talk to your healthcare professional.
FDA ALERT [3/2005]:
FDA and other international health authorities are reviewing the
safety of Razadyne after data from two clinical studies indicated
that people taking the drug had a higher death rate than those
taking a placebo (sugar pill). Based on this information, FDA has
asked the manufacturer to revise the labeling. Please ask your
healthcare provider if Razadyne is right for you.
This information reflects FDA’s
preliminary analysis of data concerning this drug. FDA is
considering, but has not reached a final conclusion about, this
information. FDA intends to update this sheet when additional
information or analyses become available.
What Is Razadyne?
Razadyne is a medicine used to treat mild to moderate Alzheimer’s
disease.
Who Should Not Take Razadyne?
You should NOT take Razadyne if you:
What Are The Risks?
The most frequent side effects experienced in patients taking
Razadyne were:
-
Nausea
-
Vomiting
-
Diarrhea
-
Loss of appetite
-
Weight loss
What Should I Tell My Healthcare Professional Before Taking
Razadyne?
Tell your healthcare professional if you:
-
Have or have ever had asthma; an enlarged prostate; stomach
ulcers; or heart, kidney, liver, or lung disease
-
Have seizures or a history of seizures
-
Are pregnant, plan to become pregnant, or are breast-feeding. If
you become pregnant while taking Razadyne, call your healthcare
professional.
-
Are having surgery, including dental surgery that
will require anesthesia.
Are There Any Interactions With Drugs or Foods?
Tell your healthcare professional about all the medicines you take,
including prescription and over-the-counter drugs, and
supplements. Your healthcare professional may have to adjust your
dose or watch you more closely if you take any of the following
medications:
-
Amitriptyline
-
Fluoxetine
-
Fluvoxamine
-
Quinidine
-
Cimetidine
-
Ketoconazole
-
Erythromycin
-
Paroxetine
How Do I Take Razadyne?
Razadyne comes as a tablet and an oral solution to take by mouth. It
is usually taken twice a day, preferably with the morning and
evening meals. Your healthcare professional will start you on a low
dose of Razadyne and gradually increase your dose over time, with a
minimum of 4 weeks between each increase in dose. This helps to
minimize the amount of side effects.
Is There Anything Else I Need To Know?
Razadyne may make you drowsy. Do not drive a car or operate machinery
until you know how Razadyne affects you.
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Galantamine
Date created: March, 2005, updated August 9, 2006 |