Ranitidine Pregnancy and Breastfeeding Warnings
Ranitidine is also known as: Acid Control 150, Acid Control 75, Acid Reducer Non-Prescription Strength, Acid Relief, Berkley and Jensen Acid Reducer Maximum Strength, Careone Acid Reducer, Deprizine, Equaline Heartburn Relief, Sunmark Acid Reducer Maximum Strength, Taladine, Zantac, Zantac 150, Zantac 150 EFFERdose, Zantac 25 mg EFFERdose, Zantac 300, Zantac 300 GELdose, Zantac 75, Zantac EFFERdose, Zantac GELdose, Zantac Injection
Ranitidine Pregnancy Warnings
Ranitidine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Ranitidine is known to cross the placenta, although it has been used safely during labor and delivery for the prevention of Mendelson's syndrome. Ranitidine is only recommended for use during pregnancy when benefit outweighs risk.
In one study, ranitidine 50 mg was administered by slow intravenous injection to 20 women at 38 weeks gestation or more for the prevention of Mendelson's syndrome. The maternal serum concentration to umbilical cord concentration ratio averaged 0.9 by three hours post-dose. Following oral administration of 150 mg one to eight hours prior to scheduled Cesarean section in 80 women at 37 weeks gestation or more, the maternal serum concentration to umbilical cord concentration ratio averaged 0.38. No adverse fetal or neonatal effects could be attributed to ranitidine. In another study, ranitidine 150 mg was administered orally every 6 hours for the prevention of Mendelson's syndrome in 909 women in labor. There were no differences in the incidence of operative intervention, placental hemorrhage, or post-partum hemorrhage compared to a control group of 378 women treated with conventional alkali therapy. In addition, there was no difference in Apgar scores or admissions to the neonatal intensive care unit compared to the control group. There are no data on the safety of ranitidine during the first and second trimesters of pregnancy.
Ranitidine Breastfeeding Warnings
Ranitidine is excreted into human milk in concentrations exceeding those found in plasma. While the effects of small amounts of ranitidine on the nursing infant have not been studied, the American Academy of Pediatrics considers a related drug, cimetidine, to be compatible with breast-feeding. The manufacturer recommends that caution be used when administering ranitidine to nursing women.
References for breastfeeding information
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
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 material 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 combination thereof in no way should be construed to indicate that the drug or 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 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.