Fixcom 2/Fixcom 3/Fixcom 4 Use In Pregnancy & Lactation

Pregnancy: Fixcom 2: A woman should be asked before starting TB treatment if she is pregnant. Most antituberculosis drugs are safe for use in pregnancy. A pregnant woman should be advised that successful treatment of TB with the recommended standardized regimen is important for successful outcome of pregnancy.
Fixcom 3: There are no adequate and well-controlled studies from the use of rifampicin, isoniazid and ethambutol on pregnancy and the fetus. Thus, these drugs should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
Rifampicin: The International Union Against Tuberculosis and the WHO Expert Committee on Leprosy recommend treatment of pregnant patients with the same rifampicin-containing multidrug regimens as would be used in nonpregnant patients.
While administration of rifampicin to pregnant patients is generally considered to be safe, the drug does cross into the fetus and malformations and bleeding tendencies have been reported. It was considered that rifampicin did not increase the overall risk of congenital malformations.
Rifampicin treatment can increase the metabolism of vitamin K resulting in clotting disorders associated with vitamin K deficiency. Thus, it is recommended to have blood coagulation monitoring and prophylactic administration of vitamin K to mothers and neonates when the mother has received rifampicin during pregnancy.
Isoniazid: Isoniazid is recognized as being suitable for use in regimens for the treatment of tuberculosis in pregnant patients. Pyridoxine supplementation is recommended. Preventive therapy with isoniazid is generally delayed until after delivery unless other risk factors are present.
Ethambutol: Ethambutol crosses the placenta and is present in fetal tissue in amounts of at least 74.5% of the maternal serum concentration. Use of ethambutol during pregnancy has not been associated with fetal abnormalities. It is generally considered that the benefits of ethambutol in the treatment of tuberculosis outweigh any potential risks in pregnancy.
Breastfeeding: Fixcom 2: A breastfeeding woman who has TB should receive a full course of TB treatment. Timely and properly applied chemotherapy is the best way to prevent transmission of tubercle bacilli to her baby. All tuberculosis are compatible with breastfeeding; a woman taking them can safely continue to breastfeed. Mother and baby should stay together and the baby continue to be breastfed in the normal way, but be given prophylactic Isoniazid for at least 3 months beyond the time the mother is considered to be non-infectious. BCG vaccination of the newborn should be postponed until the end of isoniazid prophylaxis.
Fixcom 3: The use of these drugs during breastfeeding should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.
Rifampicin is present in small amounts in breast milk. Mothers taking rifampicin may breastfeed.
Isoniazid is distributed into breast milk. Adverse effects on infants during breast feeding have not been reported, although such infants should be monitored for toxic reactions. Ethambutol diffuses into breast milk to produce concentrations similar to those in plasma.
Oral Contraception: Rifampicin interacts with oral contraceptive medications with a risk of deceased protective efficacy against pregnancy. A woman receiving oral contraception may choose between two options while receiving treatment with rifampicin: following consultation with a clinician, an oral contraceptive pill containing a higher dose of estrogen (5Oug) may be taken. or another form of contraception used.