"The US Food and Drug Administration (FDA) has approved a fixed-dose combination of memantine hydrochloride extended-release (XR) and donepezil hydrochloride (Namzaric, Actavis plc/Adamas Pharm) for moderate to severe Alzheimer's-related de"...
(galantamine hydrobromide) Extended-release Capsules
RAZADYNE® ER capsules, RAZADYNE® tablets, and RAZADYNE® oral solution contain galantamine, a reversible, competitive acetylcholinesterase inhibitor, as the hydrobromide salt. Galantamine hydrobromide is known chemically as (4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3methoxy-11-methyl-6H-benzofuro[3a,3,2-ef]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 extended-release capsules contain 8 mg, 16 mg, and 24 mg galantamine as 10.25 mg, 20.51 mg, and 30.76 mg of galantamine hydrobromide, respectively. Inactive ingredients include diethyl phthalate, ethylcellulose, gelatin, hypromellose, polyethylene glycol, sugar spheres (sucrose and starch), and titanium dioxide. The 16 mg capsule also contains red ferric oxide. The 24 mg capsule also contains red ferric oxide and yellow ferric oxide.
RAZADYNE® tablets contain 4 mg, 8 mg, and 12 mg galantamine as 5.126 mg, 10.253 mg, 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® oral solution contains 4 mg galantamine (as 5.13 mg galantamine hydrobromide) per mL. The inactive ingredients are methylparaben, propylparaben, purified water, sodium hydroxide, and saccharin sodium.
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 a serious side effect such as:
- chest pain, slow heart rate;
- feeling like you might pass out;
- blood in your urine or stool;
- coughing up blood or vomit that looks like coffee grounds;
- painful or difficult urination;
- urinating less than usual or not at all;
- weakness, confusion, decreased...
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.,...
Last reviewed on RxList: 2/20/2015
This monograph has been modified to include the generic and brand name in many instances.
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