Omeprazole / sodium bicarbonate Pregnancy and Breastfeeding Warnings
Omeprazole / sodium bicarbonate Pregnancy Warnings
In rabbits, omeprazole in a dose range of 6.9 to 69 mg/kg/day (about 2.8 to 28 times the human dose of 40 mg/day, based on body surface area (BSA)) produced dose-related increases in embryolethality, fetal resorptions and pregnancy disruptions. In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 2.8 to 28 times the human dose of 40 mg/day, based on BSA).
Omeprazole-sodium bicarbonate has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Some animal studies using omeprazole have revealed evidence of embryolethality and fetotoxicity. Some experts consider the use of sodium bicarbonate as an antacid during human pregnancy to be relatively contraindicated because of the availability of preferable therapeutic agents. Omeprazole-sodium bicarbonate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Omeprazole / sodium bicarbonate Breastfeeding Warnings
The peak concentration of omeprazole in breast milk following an oral dose of 20 mg was less than 7% of the mother's peak serum concentration. The concentration was calculated to be 0.004 mg of omeprazole in 200 mL of milk.
Omeprazole is excreted into human milk. There are no data on the excretion of sodium bicarbonate into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
- omeprazole/sodium bicarbonate Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.