What should I Know Regarding Pregnancy, Nursing and Administering Naproxen-Esomeprazole Tablet, Immediate Release And Delayed Release, Biphasic (Tablet,IR & Release,Biphasic) to Children or the Elderly?
If you are PREGNANT
- FDB Only When Necessary: INSUFFICIENT HUMAN DATA AVAIL; ANIMAL DATA DO NOT SUG DEV TOX
- FDB Contraindicated or Not Recommended: FDA C BEFORE 30WKS;PREMATURE CLOSURE OF DUCTUS ARTERIOSUS;EARLY MISCARRIAGE RISK
If you are NURSING
- Precaution: INSUFFICIENT DATA AVAILABLE; LOW LEVELS FOUND IN BREASTMILK
- Precaution: INSUFFICIENT HUMAN DATA AVAIL; SIMILAR DRUG OMEPRAZOLE EXCRETED AT LOW LEVELS
If you are an adult over 60
- management or monitoring precaution: General-Prolonged use may decrease absorption of Vitamin B-12. Avoid for >8 weeks duration unless for high risk patients (eg. oral corticosteroids or chronic NSAID use), erosive esophagitis, Barrett's esophagitis, pathologic hypersecretory condition, or demonstrated need for maintenance treatment. Musculoskeletal-Increased risk of fracture with high dose or prolonged use of greater than 1 year. Gastrointestinal-Long term use may be associated with C. difficile diarrhea.
- management or monitoring precaution: Gastrointestinal-Risk for ulceration or serious GI bleed; highest with history of PUD or GI bleed. Renal-Risk for exacerbation of CKD. Cardiovascular-May exacerbate pre-existing hypertension or CHF. Risk of cardiovascular thrombotic events, including MI and stroke. This risk may occur early in treatment and increases with duration of use. Risk for reinfarction with minimal NSAID use post-MI. Contraindicated with CABG. Hepatic-Elevated hepatic transaminases may occur with chronic use.
Giving Naproxen-Esomeprazole Tablet, Immediate Release And Delayed Release, Biphasic (Tablet,IR & Release,Biphasic) to a child under 12
- Severe Precaution: Safety and efficacy not established.
- management or monitoring precaution: No safety and efficacy in age < 12 years or weight < 38 kg.
- management or monitoring precaution: Increased incidence of tachypnea, regurgitation and increased ALT in patients age < 1 year.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.