"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).
- Patient Information:
Details with Side Effects
The active ingredient in NEXIUM® I.V. (esomeprazole sodium) for Injection is (S)-5-methoxy-2[[(4-methoxy-3,5dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole sodium, a proton pump inhibitor that inhibits gastric acid secretion. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its empirical formula is C17H18N3O3SNa with molecular weight of 367.4 g/mol (sodium salt) and 345.4 g/mol (parent compound). Esomeprazole sodium is very soluble in water and freely soluble in ethanol (95%). The structural formula is:
NEXIUM I.V. for Injection is supplied as a sterile, freeze-dried, white to off-white, porous cake or powder in a 5 mL vial, intended for intravenous administration after reconstitution with 0.9% Sodium Chloride Injection, USP; Lactated Ringer's Injection, USP or 5% Dextrose Injection, USP. NEXIUM I.V. for Injection contains esomeprazole sodium 21.3 mg or 42.5 mg equivalent to esomeprazole 20 mg or 40 mg, edetate disodium 1.5 mg and sodium hydroxide q.s. for pH adjustment. The pH of reconstituted solution of NEXIUM I.V. for Injection depends on the reconstitution volume and is in the pH range of 9 to 11. The stability of esomeprazole sodium in aqueous solution is strongly pH dependent. The rate of degradation increases with decreasing pH.
What are the possible side effects of esomeprazole (Nexium)?
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 esomeprazole and call your doctor at once if you have symptoms of low magnesium such as:
- dizziness, confusion;
- fast or uneven heart rate;
- jerking muscle movements;
- jittery feeling;
- muscle cramps, muscle weakness or limp feeling;
- cough or choking feeling; or
- seizure (convulsions).
Less serious side effects may include:
Last reviewed on RxList: 2/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Nexium I.V. Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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