Razadyne ER (Galantamine HBr ER) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Razadyne ER

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*Dementia Facts Medically Edited by: Charles P. Davis, MD, PhD

Dementia is a term that describes a collection of symptoms that include decreased intellectual functioning that interferes with normal life functions and is usually used to describe people who have two or more major life functions impaired or lost such as memory, language, perception, judgment or reasoning; they may lose emotional and behavioral control, develop personality changes and have problem solving abilities reduced or lost.
There are different classification schemes for dementias roughly based (and with overlap) on observed problems; some frequently used are cortical (memory, language, thinking, social) , subcortical (emotions, movement, memory), progressive (cognitive abilities worsen over time), primary (results from a specific disease such as Alzheimer's disease and secondary (occurs because of disease or injury).
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Razadyne® ER
(galantamine HBr) Extended-Release Capsules

Razadyne®
(galantamine HBr) Tablets and Oral Solution

DRUG DESCRIPTION

RAZADYNE® ER (galantamine hbr er) /RAZADYNE® (galantamine hydrobromide) is galantamine hydrobromide, a reversible, competitive acetylcholinesterase inhibitor. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef] [2]benzazepin-6-ol hydrobromide. It has an empirical formula of C₁₇H₂₁NO₃ •HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water.The structural formula for galantamine hydrobromide is:

Razadyne® ER
(galantamine HBr) Structural Formula Illustration

RAZADYNE® ER (galantamine hbr er) is available in opaque hard gelatin extended-release capsules of 8 mg (white), 16 mg (pink), and 24 mg (caramel) containing galantamine hydrobromide, equivalent to respectively 8, 16 and 24 mg galantamine base. Inactive ingredients include gelatin, diethyl phthalate, ethylcellulose, hypromellose, polyethylene glycol, titanium dioxide and sugar spheres (sucrose and starch).The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide.

RAZADYNE® for oral use is available in circular biconvex film-coated immediate-release tablets of 4 mg (off-white), 8 mg (pink), and 12 mg (orange-brown). Each 4, 8, and 12 mg (base equivalent) tablet contains 5.126, 10.253, and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc, and titanium dioxide. The 4 mg tablets contain yellow ferric oxide. The 8 mg tablets contain red ferric oxide. The 12 mg tablets contain red ferric oxide and FD&C yellow #6 aluminum lake. RAZADYNE® is also available as a 4 mg/mL oral solution. The inactive ingredients for this solution are methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, sodium hydroxide and purified water.

What are the possible side effects of galantamine (Razadyne, Razadyne ER)?

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

Stop using galantamine and call your doctor at once if you have any of these serious side effects:

chest pain, slow heart rate;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
weakness, confusion, decreased sweating, extreme thirst, hot dry skin; or
urinating less...

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What are the precautions when taking galantamine hbr er (Razadyne ER)?

Before taking galantamine, tell your doctor or pharmacist if you are allergic to it; or to daffodil plants; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, stomach/intestinal problems (e.g., ulcers, bleeding), heart problems (e.g., sick sinus syndrome, bradycardia, AV block, arrhythmias), breathing/lung problems (e.g.,...

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Last reviewed on RxList: 1/20/2009
This monograph has been modified to include the generic and brand name in many instances.