Get Expert Advice for controlling your Severe Allergies

Amoxicillin / clavulanate Pregnancy and Breastfeeding Warnings

Amoxicillin / clavulanate is also known as: Amoclan, Augmentin, Augmentin ES-600, Augmentin XR

Amoxicillin / clavulanate Pregnancy Warnings

Amoxicillin-clavulanate has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal any evidence of teratogenicity. There are no controlled data in human pregnancies. The results of a study suggest an increased risk of necrotizing enterocolitis in neonates if amoxicillin-clavulanate is given prophylactically to women with premature rupture of membranes. Amoxicillin-clavulanate should only be given during pregnancy when need has been clearly established.

In the Collaborative Perinatal Project involving 50,282 mother-child pairs, there were 3,546 mother-child pairs exposed to penicillin derivatives in the first trimester. As a group, there was no significant increase in the risk of malformations. In the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there were 8,538 first trimester exposures to amoxicillin. Overall, 317 cases of birth defects were observed (363 expected). There was no evidence of an association between first trimester use of amoxicillin and major groups of malformations. In the Michigan Medicaid Birth Defects Study, there were 556 first trimester exposures to clavulanate. Overall, 24 cases of birth defects were observed (24 expected). Two cases of spina bifida occurred compared with only 0.3 cases expected, representing a statistically significant increase in the incidence of this anomaly.

Amoxicillin / clavulanate Breastfeeding Warnings

In one study, six women were administered a single 1000 mg dose of amoxicillin on the third postpartum day. Amoxicillin milk concentrations ranged from 0.10 to 0.81 mcg/mL, with a peak concentration measured at 5 hours post-dose. The milk to maternal serum concentration ratio ranged from 0.013 to 0.043.

Amoxicillin is excreted into human milk in small amounts and is considered compatible with breast-feeding by the American Academy of Pediatrics. Clavulanate has not been detected in human milk. Adverse effects in the nursing infant are unlikely. The manufacturer recommends caution when amoxicillin-clavulanate is administered to a nursing woman.

See Also...

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.

Hide
(web2)