"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
(omeprazole/sodium bicarbonate) Immediate-release Capsules
ZEGERID® (omeprazole/sodium bicarbonate) is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:
Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.
ZEGERID is supplied as immediate-release capsules and unit-dose packets as powder for oral suspension. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. Packets of powder for oral suspension contain either 40 mg or 20 mg of omeprazole and 1680 mg of sodium bicarbonate with the following excipients: xylitol, sucrose, sucralose, xanthan gum, and flavorings.
What are the possible side effects of omeprazole and sodium bicarbonate (Zegerid, Zegerid OTC)?
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:
- stiffness or loss of movement in any part of your body;
- diarrhea that is watery or bloody;
- fast or slow heartbeats;
- seizure (convulsions); or
- low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or...
What are the precautions when taking omeprazole, sodium bicarbonate (Zegerid)?
Before taking omeprazole/sodium bicarbonate, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as esomeprazole, lansoprazole, pantoprazole); 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.
Before taking this medication, tell your doctor or pharmacist your medical history, especially of: conditions affected by the sodium in this medication (such as congestive heart failure, high blood pressure, swelling/edema), kidney problems (such as Bartter's syndrome, kidney failure), liver disease (such as cirrhosis), low blood calcium or potassium levels, metabolic imbalance (such as acid-base balance problems).
Last reviewed on RxList: 1/12/2015
This monograph has been modified to include the generic and brand name in many instances.
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