Rivastigmine Tartrate Recall
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FDA Labeling Changes
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Rivastigmine tartrate capsules, USP are indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
Rivastigmine tartrate capsules, USP are indicated for the treatment of mild to moderate dementia associated with Parkinson’s disease.
There is currently no drug history available for this drug.
Rivastigmine tartrate is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 • C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.42 (hta salt). Rivastigmine tartrate is a white powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/ phosphate buffer solution pH 7 is 3.0.
Rivastigmine tartrate capsules, USP contain rivastigmine tartrate, equivalent to 1.5, 3, 4.5 and 6 mg of rivastigmine base for oral administration. Inactive ingredients are microcrystalline cellulose, starch and stearic acid. Each hard-gelatin capsule contains gelatin, iron oxides black, red and yellow and titanium dioxide.
Rivastigmine Tartrate Manufacturers
Golden State Medical Supply, Inc.
Alembic Pharmaceuticals Limited
Sun Pharmaceutical Industries Limited
Watson Laboratories, Inc.
Dr.reddy’s Laboratories Limited
American Health Packaging
Mckesson Packaging Services A Business Unit Of Mckesson Corporation
Breckenridge Pharmaceutical, Inc
Carilion Materials Management
Macleods Pharmaceuticals Limited
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