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Claritin-D 12 Hour Extended Release Tablets: Claritin-D 12 hour extended release tablets contain 5 mg loratadine in the tablet coating for immediate release and 120 mg pseudoephedrine sulfate equally distributed between the tablet coating for immediate release and the barrier-coated extended release core.
The inactive ingredients are acacia, butylparaben, calcium sulfate, carnauba wax, corn starch, lactose, magnesium stearate, microcrystalline cellulose, neutral soap, oleic acid, povidone, rosin, sugar, talc, titanium dioxide, white wax, and zein.
Claritin-D 24 Hour Extended Release Tablets: Claritin-D 24 hour extended release tablets contain 10 mg loratadine in the tablet film coating for immediate release and 240 mg pseudoephedrine sulfate in the tablet core which is released slowly allowing for once-daily administration.
The inactive ingredients for oval, biconvex Claritin-D 24 hour extended release tablets are calcium phosphate, carnauba wax, ethylcellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, silicon dioxide, sugar, titanium dioxide, and white wax.
Loratadine is a long-acting antihistamine having the empirical formula C22H23ClN2O2; the chemical name ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate.
The molecular weight of loratadine is 382.89. It is a white to off-white powder, not soluble in water, but very soluble in acetone, alcohol, and chloroform.
Pseudoephedrine sulfate is the synthetic salt of one of the naturally occurring dextrorotatory diastereomers of ephedrine and is classified as an indirect sympathomimetic amine. The empirical formula for pseudoephedrine sulfate is (C10H15NO)2H2SO4; the chemical name is a-[1-(methyl-amino) ethyl]-[S-(R*,R*)]-benzenemethanol sulfate (2:1)(salt).
The molecular weight of pseudoephedrine sulfate is 428.54. It is a white powder, freely soluble in water and methanol and sparingly soluble in chloroform.
Loratadine; pseudoephedrine sulfate extended release tablets are indicated for the relief of symptoms of seasonal allergic rhinitis. Loratadine; pseudoephedrine sulfate extended release tablets should be administered when both the antihistaminic properties of loratadine and the nasal decongestant activity of pseudoephedrine are desired (see CLINICAL PHARMACOLOGY).
Adults and Children 12 Years of Age and Over: 12 Hour Tablet: One tablet twice a day (every 12 hours); 24 Hour Tablet: One tablet daily taken with a full glass of water (see PRECAUTIONS and ADVERSE REACTIONS). Because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of loratadine to a much greater extent than pseudoephedrine, loratadine; pseudoephedrine sulfate extended release tablets should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency (GFR
