CoPlavix Use In Pregnancy & Lactation




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Use In Pregnancy & Lactation
Pregnancy: No clinical data on exposure to CoPlavix during pregnancy are available. CoPlavix should not be used during the first two trimesters of pregnancy unless the clinical condition of the woman requires treatment with clopidogrel/ASA.
Due to the presence of ASA, CoPlavix is contraindicated during the third trimester of pregnancy.
Clopidogrel: As no clinical data on exposure to clopidogrel during pregnancy are available, it is preferable not to use clopidogrel during pregnancy as a precautionary measure.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
ASA: Low doses (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Doses of 100-500 mg/day: There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the following recommendations for doses of 500 mg/day and above apply also for this dose range.
Doses of 500 mg/day and above: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Until the 24th amenorrhea week (5th month of pregnancy), acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or until the 24th amenorrhea week (5th month of pregnancy), the dose should be kept as low and duration of treatment as short as possible.
From the beginning of the sixth month of pregnancy, all prostaglandin synthesis inhibitors may expose: The foetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis.
The mother and the neonate, at the end of pregnancy, to: possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labour.
Breastfeeding: It is unknown whether clopidogrel is excreted in human breast milk. Animal studies have shown excretion of clopidogrel in breast milk. ASA is known to be excreted in limited amounts in human milk. Breastfeeding should be discontinued during treatment with CoPlavix.
Fertility: There are no fertility data with CoPlavix. Clopidogrel was not shown to alter fertility in animal studies. It is unknown whether ASA alters fertility.
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