"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Campral (acamprosate calcium) is supplied in an
enteric-coated tablet for oral administration. Acamprosate calcium is a
synthetic compound with a chemical structure similar to that of the endogenous
amino acid homotaurine, which is a structural analogue of the amino acid
neurotransmitter γ-aminobutyric acid and the amino acid neuromodulator
taurine. Its chemical name is calcium acetylaminopropane sulfonate. Its
chemical formula is C10H20N2O8S2Ca
and molecular weight is 400.48. Its structural formula is:
Acamprosate calcium is a white, odorless or nearly odorless powder. It is freely soluble in water, and practically insoluble in absolute ethanol and dichloromethane.
Each Campral tablet contains acamprosate calcium 333 mg, equivalent to 300 mg of acamprosate. Inactive ingredients in Campral tablets include: crospovidone, microcrystalline cellulose, magnesium silicate, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, talc, propylene glycol and Eudragit® L 30 D or equivalent. Sulfites were used in the synthesis of the drug substance and traces of residual sulfites may be present in the drug product.
What are the possible side effects of acamprosate (Campral)?
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.
Call your doctor at once if you have a serious side effects such as:
- mood or behavior changes;
- thoughts about hurting yourself;
- severe anxiety or depression;
- feeling like you might pass out;
- fast or pounding heartbeats;
- swelling, weight gain, feeling short of breath;
- confusion, increased thirst; or
- urinating less than usual or not at all.
What are the precautions when taking acamprosate calcium (Campral)?
Before taking acamprosate, tell your doctor or pharmacist if you are allergic to it 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 kidney disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other kidney disease.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Campral Information
Campral - User Reviews
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Report Problems to the Food and Drug Administration
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