Drug: Claritin D

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.

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Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets Experience from controlled and uncontrolled clinical studies involving approximately 10,000 patients who received the combination of loratadine; pseudoephedrine sulfate for a period of up to 1 month provides information on adverse reactions. The usual dose was one tablet every 12 hours for up to 28 days. In controlled clinical trials using the recommended dose of one tablet every 12 hours, the incidence of reported adverse events was similar to those reported with placebo, with the exception of insomnia (16%) and dry mouth (14%). TABLE 2 Reported Adverse Events with an Incidence of ³2% in Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets in Placebo-Controlled Clinical Trials Percent of Patients Reporting   Loratadine; Pseudoephedrine Sulfate 12 Hour Loratadine Pseudoephedrine Placebo   n=1023 n=543 n=548 n=922  Headache 19 18 17 19  Insomnia 16 4 19 3  Dry Mouth 14 4 9 3  Somnolence 7 8 5 4  Nervousness 5 3 7 2  Dizziness 4 1 5 2  Fatigue 4 6 3 3  Dyspepsia 3 2 3 1  Nausea 3 2 3 2  Pharyngitis 3 3 2 3  Anorexia 2 1 2 1  Thirst 2 1 2 1
Adverse event rates did not appear to differ significantly based on age, sex, or race, although the number of non-white subjects was relatively small. In addition to those adverse events reported above (³2%), the following less frequent adverse events have been reported in at least one patient treated with loratadine; pseudoephedrine sulfate 12 hour extended release tablets. Autonomic Nervous System: Abnormal lacrimation, dehydration, flushing, hypoesthesia, increased sweating, mydriasis. Body as a Whole: Asthenia, back pain, blurred vision, chest pain, conjunctivitis, earache, ear infection, eye pain, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, photophobia, rigors, tinnitus, viral infection, weight gain. Cardiovascular System: Hypertension, hypotension, palpitations, peripheral edema, syncope, tachycardia, ventricular extrasystoles. Central and Peripheral Nervous System: Dysphonia, hyperkinesia, hypertonia, migraine, paresthesia, tremors, vertigo. Gastrointestinal System: Abdominal distension, abdominal distress, abdominal pain, altered taste, constipation, diarrhea, eructation, flatulence, gastritis, gingival bleeding, hemorrhoids, increased appetite, stomatitis, taste loss, tongue discoloration, toothache, vomiting. Liver and Biliary System: Hepatic function abnormal. Musculoskeletal System: Arthralgia, myalgia, torticollis. Psychiatric: Aggressive reaction, agitation, anxiety, apathy, confusion, decreased libido, depression, emotional lability, euphoria, impaired concentration, irritability, paroniria. Reproductive System: Dysmenorrhea, impotence, intermenstrual bleeding, vaginitis. Respiratory System: Bronchitis, bronchospasm, chest congestion, coughing, dry throat, dyspnea, epistaxis, halitosis, nasal congestion, nasal irritation, sinusitis, sneezing, sputum increased, upper respiratory infection, wheezing. Skin and Appendages: Acne, bacterial skin infection, dry skin, eczema, edema, epidermal necrolysis, erythema, hematoma, pruritus, rash, urticaria. Urinary System: Dysuria, micturition frequency, nocturia, polyuria, urinary retention. 24 Hour Extended Release Tablets Information on adverse reactions is provided from placebo-controlled studies involving over 2000 patients, 605 of whom received loratadine; pseudoephedrine sulfate 24 hour extended release tablets once daily for up to 2 weeks. In these studies, the incidence of adverse events reported with loratadine; pseudoephedrine sulfate 24 hour extended release tablets was similar to those reported with twice-daily (q12h) 120 mg sustained-release pseudoephedrine alone. TABLE 3 Reported Adverse Events With an Incidence of ³2% in Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets Treatment Group in Double-Blind, Randomized, Placebo-Controlled Clinical Trials Percent of Patients Reporting   Loratadine; phedrine Sulfate 24 Hour Loratadine 10 mg Pseudoephedrine 120 mg q12h Placebo   (n = 605) (n = 449) (n = 220) (n = 605)  Dry Mouth 8 2 7 2  Somnolence 6 4 5 4  Insomnia 5 1 9 1  Pharyngitis 5 5 5 5  Dizziness 4 2 3 2  Coughing 3 2 3 1  Fatigue 3 4 1 2  Nausea 3 2 4 2  Nervousness 3 1 4 1  Anorexia 2

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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

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No specific interaction studies have been conducted with loratadine; pseudoephedrine extended release tablets. However, loratadine (10 mg once daily) has been safely coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies. Although increased plasma concentrations (AUC 0-24 hrs) of loratadine and/or descarboethoxyloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers (n=24 in each study), there were no clinically relevant changes in the safety profile of loratadine, as assessed by electrocardiographic parameters, clinical laboratory tests, vital signs, and adverse events. There was no significant effects on QTc intervals, and no reports of sedation of syncope. No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone. The clinical relevance of this difference is unknown. These above findings are summarized in TABLE 1. TABLE 1 Effects on Plasma Concentrations (AUC 0-24 hrs) of Loratadine and Descarboethoxyloratadine After 10 Days of Coadministration (Loratadine 10 mg) in Normal Volunteers   Loratadine Descarboethoxyloratadine  Erythromycin (500 mg q8h) +40% +46%  Cimetidine (300 mg q.i.d.) +103% +6%  Ketoconazole (200 mg q12h) +307% +73%
There does not appear to be an increase in adverse events in subjects who received oral contraceptives and loratadine. Loratadine; pseudoephedrine sulfate extended release tablets (pseudoephedrine component) are contraindicated in patients taking monoamine oxidase inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, mecamylamine, reserpine, and veratrum alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. Read the Claritin D Drug Interactions Center for a complete guide to possible interactions Learn More »

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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).

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Loratadine; pseudoephedrine sulfate extended release tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. This product, due to its pseudoephedrine component, is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see DRUG INTERACTIONS). It is also contraindicated in patients with severe hypertension, severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. Treatment of 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 is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis. Somnolence, tachycardia, and headache have been reported with doses of 40 to 180 mg of loratadine; pseudoephedrine. In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure. The oral median lethal dose for the mixture of the two drugs was greater than 525 and 1839 mg/kg in mice and rats, respectively (approximately 10 and 58 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hour dose on a mg/m2 basis). The oral median lethal dose for loratadine was greater than 5000 mg/kg in rats and mice (greater than 2000 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hourdose on a mg/m2 basis). Single oral doses of 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.

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Claritin-D 12 Hour Extended Release Tablets Claritin-D 12 hour extended release tablets contain 5 mg loratadine and 120 mg pseudoephedrine sulfate. Claritin-D 12 hour extended release tablets are white tablets branded in green with "CLARITIN-D". Storage: Keep Unit-of-Use packaging and Unit Dose-Hospital Pack in a dry place. Store between 2-25°C (36-77°F). Claritin-D 24 Hour Extended Release Tablets Claritin-D 24 hour extended release tablets contain 10 mg loratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate in an extended-release core. Claritin-D 24 hour extended release tablets are white to off-white oval, biconvex, coated tablets branded in black with "CLARITIN-D 24 HOUR". Storage: Protect Unit Dose-Hospital Pack from light and store in a dry place. Store between 15-25°C (59-77°F). Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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General Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets: Because there have been reports of esophageal obstruction and perforation in patients who have taken a previously marketed formulation of CLARITIN-D 24 HOUR Extended Release Tablets, it is recommended that patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis not use this product. Furthermore, since it is not known whether this formulation of CLARITIN-D 24 HOUR Extended Release Tablets has the potential for this adverse event, it is reasonable to recommend that all patients take this product with a full glass of water (see Information for the Patient, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION). Loratadine; Pseudoephedrine Sulfate 12 and 24 Hour Extended Release Tablets: 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

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