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Trimbow

Trimbow Use In Pregnancy & Lactation

Manufacturer:

Chiesi

Distributor:

Zuellig Pharma

Marketer:

Orient Europharma
Full Prescribing Info
Use In Pregnancy & Lactation
There is no experience with or evidence of safety issues on the use of the propellant norflurane (HFA134a) during human pregnancy or lactation. However, studies on the effect of HFA134a on the reproductive function and embryofetal development in animals revealed no clinically relevant adverse effects.
Pregnancy: There are no or limited amount of data from the use of Trimbow in pregnant women.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Glucocorticoid agents are known to cause effects in the early gestation phase, while beta2-sympathomimetic agents like formoterol have tocolytic effects. Therefore, as a precautionary measure, it is preferable to avoid the use of Trimbow during pregnancy and during labour.
Trimbow should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus. Infants and neonates born to mothers receiving substantial doses of Trimbow should be observed for adrenal suppression.
Breast-feeding: There are no relevant clinical data on the use of Trimbow during breast-feeding in humans.
Glucocorticoids are excreted in human milk. It is reasonable to assume that beclometasone dipropionate and its metabolites are also excreted into breast-milk.
It is unknown whether formoterol or glycopyrronium (including their metabolites) pass into human breast-milk but they have been detected in the milk of lactating animals. Anticholinergic agents like glycopyrronium could suppress lactation.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Trimbow therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mothers.
Fertility: No specific studies have been performed with Trimbow with regard to the safety in human fertility. Animal studies have shown impairment of fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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