Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Mode of Action
Loratadine is a non-sedating antihistamine. It works by selectively binding to peripheral histamine H1-receptors on effector cells.
Interaction
May increase plasma concentrations w/ inhibitors of CYP3A4 and/or CYP2D6 (e.g. cimetidine, erythromycin, ketoconazole, clarithromycin, quinidine, fluconazole, fluoxetine).
Pregnancy Category Note
Pregnancy category: B
Lactation: Excreted in breast milk; avoid (AAP Committee states compatible with nursing)
Adult Dose
Oral
Allergic Rhinitis, Urticaria
Tablet
10 mg once daily or 5 mg 12 hrly.
not to exceed 10 mg qDAy
Oral Suspension
2 teaspoonful (10 ml) suspension once daily or
1 teaspoonful (5 ml) suspension 12 hrly.
Hepatic impairment: 10 mg PO every other day
Child Dose
Oral
Tablet
Allergic Rhinitis
<2 years: Safety and efficacy not established
2-6 years: 5 mg PO qDay
>6 years: 10 mg PO qDay; not to exceed 10 mg qDay
Urticaria
<6 years: Safety and efficacy not established
> 6 years: 10 mg PO qDay
Oral Suspension
Allergic Rhinitis
<2 years: Safety and efficacy not established
2-6 years: 1 teaspoonful (5 ml) suspension once daily.
>6 years: 2 teaspoonful (10 ml) suspension once daily; not to exceed 10 mg qDay
Urticaria
<6 years: Safety and efficacy not established
> 6 years: 2 teaspoonful (10 ml) suspension once daily
Renal Dose
Renal impairment
Adult
(GFR <30 mL/min): 10 mg PO every other day
2-6 years: 5 mg PO every other day
>6 years: 10 mg PO every other day
Administration
May be taken with or without food.
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