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Valheart

Valheart Use In Pregnancy & Lactation

ivabradine

Manufacturer:

KRKA

Distributor:

UNILAB, Inc
Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
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Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no adequate and well-controlled studies of ivabradine in pregnant women. However, embryo-fetal toxicity and cardiac teratogenic effects were observed in fetuses of pregnant rats treated during organogenesis at exposures 1 to 3 times the human exposures (AUC0-24hr) at the maximum recommended human dose (MRHD). Therefore, ivabradine is contraindicated during pregnancy.
Lactation: It is not known if ivabradine is distributed in human milk. However, animal studies have shown that ivabradine is distributed into milk in rats. Therefore, ivabradine is contraindicated during breastfeeding.