Naproxen / sumatriptan Pregnancy and Breastfeeding Warnings
Naproxen / sumatriptan is also known as: Treximet
Naproxen / sumatriptan Pregnancy Warnings
Use should be avoided during last trimester of pregnancy Prior to last trimester of pregnancy, use only if potential benefit justifies the potential risk to the fetus US FDA pregnancy category: X during the third trimester US FDA pregnancy category: C for first 2 trimesters
Use of sumatriptan and naproxen, alone or in combination, in animal studies during pregnancy resulted in increased incidences of fetal malformations, embryofetal and pup mortality, and decreased embryofetal growth at clinically relevant doses. There are no adequate and well-controlled studies in pregnant women. Naproxen-containing products should not be used during the third trimester of pregnancy because, like all NSAIDs, it may cause premature closure of the ductus arteriosus. Naproxen-containing products are not recommended in labor and delivery as prostaglandin inhibition may adversely affect fetal circulation and inhibit uterine contractions increasing the risk of uterine hemorrhage. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Naproxen / sumatriptan Breastfeeding Warnings
Although limited data suggests naproxen levels in breastmilk are low and adverse effects in breastfed infants uncommon, the long half-life of this drug and potentially serious adverse reactions that may occur make other agents preferable.
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes
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.