Ketotifen ophthalmic Pregnancy and Breastfeeding Warnings
Ketotifen ophthalmic Pregnancy Warnings
Ketotifen ophthalmic has been assigned to pregnancy category C by the FDA. Animal data have revealed evidence of an increased incidence of retarded ossification of the sternebrae and increased postnatal mortality and slightly decreased body weight among offspring associated with doses at least 30,000 times the maximum recommended human daily dose (MRHDD, on a per kg basis). Other animal data have failed to reveal evidence of embryofetal toxicity after maternal doses of 10,000 times the MRHDD. There are no controlled data in human pregnancy. It is not significantly absorbed after ocular administration (less than 20 pg/mL). Ketotifen ophthalmic should only be given during pregnancy when benefit outweighs risk.
Ketotifen ophthalmic Breastfeeding Warnings
There are no data on the excretion of ketotifen ophthalmic into human milk. It is excreted into rat milk after oral administration. Ketotifen is not significantly absorbed after ocular administration (< 20 pg/mL). The manufacturer recommends caution when administering ketotifen ophthalmic to nursing women.
- Ketotifen use while Breastfeeding (in more detail)
- ketotifen drops 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 of 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.