Claritin (loratadine) is indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients 6 years of age or older.
Loratadine, the active ingredient in Claritin, is a long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic activity.
Human histamine skin wheal studies following single and repeated 10 mg oral doses of Claritin (loratadine) have shown that the drug exhibits an antihistaminic effect beginning within 1 to 3 hours, reaching a maximum at 8 to 12 hours, and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with Claritin.
Whole body autoradiographic studies in rats and monkeys, radiolabeled tissue distribution studies in mice and rats, and in vivo radioligand studies in mice have shown that neither Claritin (loratadine) nor its metabolites readily cross the blood-brain barrier. Radioligand binding studies with guinea pig pulmonary and brain H1-receptors indicate that there was preferential binding to peripheral versus central nervous system H1-receptors.
Repeated application of Claritin (loratadine) rapidly-disintegrating tablets to the hamster cheek pouch did not cause local irritation.
The recommended dose of Claritin (loratadine) is 10 mg once daily.
The recommended dose of Claritin (loratadine) is 10 mg (2 teaspoonsful) once daily.
One tablet or two teaspoonsful every other day should be the starting dose.
Place Claritin (loratadine) rapidly-disintegrating tablets on the tongue. Tablet disintegration occurs rapidly. Administer with or without water.
In adults, somnolence, tachycardia, and headache have been reported with Claritin overdoses greater than 10 mg with the tablet formulation (40 to 180 mg). Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg of loratadine syrup. In the event of Claritin overdose, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary.
Treatment of Claritin overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents. Loratadine, the active ingredient in Claritin, is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.
No deaths occurred at oral doses up to 5000 mg/kg in rats and mice (greater than 2400 and 1200 times, respectively, the maximum recommended human daily oral dose on a mg/m2 basis). Single oral doses of Claritin (loratadine) showed no effects in rats, mice, and monkeys at doses as high as 10 times the maximum recommended human daily oral dose on a mg/m2 basis.
Patients with liver impairment or renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (10 mg every other day).
Loratadine, the active ingredient in Claritin, and its metabolite, descarboethoxyloratadine, pass easily into breast milk and achieve concentrations that are equivalent to plasma levels with an AUCmilk/AUCplasma ratio of 1.17 and 0.85 for loratadine and descarboethoxyloratadine, respectively. Following a single oral dose of 40 mg, a small amount of loratadine and descarboethoxyloratadine was excreted into the breast milk (approximately 0.03% of 40 mg over 48 hours). A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when loratadine is administered to a nursing woman.
Store between 2-30°C (36-86°F).
Store between 2-25°C (36-77°F).
Store between 2-25°C (36-77°F). Use within 6 months of opening laminated foil pouch, and immediately upon opening individual tablet blister.
Keep Claritin Reditabs in a dry place.