Loratadine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: Alavert D-12 Hour Allergy and Sinus, AllerClear D-24 Hour, Allergy & Congestion Relief, Allergy Relief D 24 Hour, Allergy Relief D12, Claritin-D, Claritin-D 12 Hour, Claritin-D 24 Hour, Clear-Atadine-D, Leader Allergy Relief D-24, Loratadine-D 12 Hour, Loratadine-D 24 Hour

Medically reviewed by Drugs.com. Last updated on Dec 7, 2023.

Loratadine / pseudoephedrine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Animal studies are not available for the combination product. There are no controlled data in human pregnancy.

Loratadine: Animal studies at up to 150 times the maximum recommended human dose found no teratogenicity. It is unknown if it crosses the placenta, but it is probable with its low molecular weight (about 383). Human pregnancy exposure has not shown it to be a major teratogen.

Pseudoephedrine: A monitoring study of 50, 282 mother/child pairs (3082 first trimester sympathomimetic drug exposures, 9719 any time pregnancy exposures) suggested a link to categories of minor malformations (non-life-threatening, no major cosmetic defects) including inguinal hernia and clubfoot. Pseudoephedrine may be associated with gastroschisis, but this may also be caused by maternal health factors. First trimester oral decongestant exposure or maternal smoking may increase the risk of gastroschisis, small intestinal atresia (SIA), and hemifacial microsomia.


AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.


US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Loratadine / pseudoephedrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes (loratadine, pseudoephedrine)

Comments:
-Milk levels of loratadine are expected to be low (about 3 mcg per 10 mg dose) and it is generally non-sedating.
-A survey study of 51 loratadine breastfeeding exposures reported 2 incidences of minor sedation in the infants but no changes to weight gain or psychomotor development; an extension study found no difference in sedation between the loratadine group and a control group.
-Loratadine may negatively affect lactation, particularly when combined with a sympathomimetic such as pseudoephedrine.
-The small amounts of pseudoephedrine (about 4.3 to 5.5% of maternal dose) may cause occasional irritability.
-A single pseudoephedrine dose acutely decreases milk production (average 24%); repeated use interferes with lactation.
-Do not use pseudoephedrine in patients with insufficient milk production or in those just establishing lactation.

Loratadine: One 40 mg dose led to loratadine average peak milk levels (at 2 hours after dosing) of 29.2 mcg/L (range 20.4 to 39 mcg/L), and desloratadine average peak milk levels (at 5.3 hours after dosing) of 16 mcg/L (range 9 to 29.6 mcg/L); over 48 hours, 11.7 mcg of loratadine and metabolites were excreted in milk (estimated to be about 3 mcg with a 10 mg dose).

See references

Further information

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