Propafenone Pregnancy and Breast Feeding Warnings
Propafenone is also known as: Rythmol, Rythmol SR
Overview
If you become pregnant while taking Propafenone , discuss with your doctor the benefits and risks of using Propafenone during pregnancy. Propafenone is excreted in breast milk. Do not breast-feed while taking Propafenone .
Propafenone Pregnancy Warnings
Propafenone has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity, but no teratogenicity after administration of dosages 10 to 40 times the maximum recommended human dose (on a per kg basis). There are no controlled data in human pregnancy. Limited data indicate that propafenone has been administered during the third trimester of pregnancy without adverse maternal or fetal effects. Propafenone should be given during pregnancy only when benefit outweighs risk.
Both propafenone and 5-hydroxypropafenone cross the placenta. Two cases describing the use of propafenone 900 mg daily during pregnancy are reported. The placental blood or umbilical cord to maternal plasma drug concentration ratios were 0.1 to 0.3 for propafenone and 0.4 to 0.5 for 5-hydroxypropafenone in each case. Unbound drug and metabolite freely cross the placenta, with cord and maternal plasma concentrations approximately equal. No harmful effects on the human fetus have been reported during the third trimester of pregnancy, but data are limited. Data are unavailable regarding the use of propafenone earlier in pregnancy. Increased maternal alpha-1-acid glycoprotein serum levels are expected during and after pregnancy. This may result in increased plasma protein binding of propafenone, although the clinical importance of this is not known.
Propafenone Lactation Warnings
Propafenone is excreted into human milk. The manufacturer recommends that caution be used when administering propafenone to nursing women.
In one case, 3 days following propafenone dosing the milk to maternal plasma concentration ratios were 0.15 and 0.55 for propafenone and 5-hydroxypropafenone, respectively. An intake of 150 mL/kg/day of maternal milk would result in a nursing infant exposure of 16 to 24 mcg per day.
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.
