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Claritin D

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Claritin D

Claritin D

WARNINGS

Loratadine; pseudoephedrine sulfate extended release tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.

Use in Patients Approximately 60 Years of Age and Older: The safety and efficacy of loratadine; pseudoephedrine sulfate extended release tablets in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly are more likely to have adverse reactions to sympathomimetic amines.

PRECAUTIONS

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 <30 ml/min) should be given a lower initial dose (one 12 hour tablet per day and one 24 hour tablet every other day) because they have reduced clearance of loratadine and pseudoephedrine.

Information for the Patient

Patients Taking Loratadine; Pseudoephedrine Sulfate Extended Release Tablets Should Receive the Following Information: Loratadine; pseudoephedrine sulfate extended release tablets are prescribed for the relief of symptoms of seasonal allergic rhinitis. Patients should be instructed to take loratadine; pseudoephedrine sulfate extended release tablets only as prescribed and not to exceed the prescribed dose. Patients should also be advised against the concurrent use of loratadine; pseudoephedrine sulfate extended release tablets with over-the-counter antihistamines and decongestants.

Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use the 24 hour tablet.

This product should not be used by patients who are hypersensitive to it or to any of its ingredients. Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor. It also should not be used by patients with severe hypertension or severe coronary artery disease.

Patients who are or may become pregnant should be told that this product should be used in pregnancy or during lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant.

Patients should be instructed not to break or chew the tablet and to take the 24 hour tablet with a full glass of water (see General, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

Drug/Laboratory Test Interactions

The in vitro addition of pseudoephedrine to sera containing the cardiac isoenzyme MB of serum creatinine phosphokinase progressively inhibits the activity of the enzyme. The inhibition becomes complete over 6 hours.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

There are no animal or laboratory studies on the combination product loratadine and pseudoephedrine sulfate to evaluate carcinogenesis, mutagenesis, or impairment of fertility.

In an 18-month carcinogenicity study in mice and a 2-year study in rats loratadine was administered in the diet at doses up to 40 mg/kg (mice) and 25 mg/kg (rats). In the carcinogenicity studies pharmacokinetic assessments were carried out to determine animal exposure to the drug. AUC data demonstrated that the exposure of mice given 40 mg/kg of loratadine was 3.6 (loratadine) and 18 (active metabolite) times higher than a human given 10 mg/day of loratadine; pseudoephedrine sulfate 12 hour extended release tablets (for the 24 hour extended release tablets, in humans given the maximum recommended daily oral dose). Exposure of rats given 25 mg/kg of loratadine was 28 (loratadine) and 67 (active metabolite) times higher than in humans given the maximum recommended daily oral dose (for the 24 hour extended release tablets, 10 mg/day). Male mice given 40 mg/kg had a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) than concurrent controls. In rats, a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg and in males and females given 25 mg/kg. The clinical significance of these findings during long-term use of loratadine is not known.

Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets Only: Loratadine administration produced hepatic microsomal enzyme induction in the mouse at 40 mg/kg and rat at 25 mg/kg, but not at lower doses.

Decreased fertility in male rats, shown by lower female conception rates, occurred at approximately 64 mg/kg of loratadine (approximately 50 times the maximum recommended human daily oral dose of the 24 hour extended release tablet based on mg/m2) and was reversible with cessation of dosing. Loratadine had no effect on male or female fertility or reproduction in the rat at doses approximately 24 mg/kg (approximately 20 times the maximum recommended human daily oral dose of the 24 hour extended release tablet based on mg/m2).

Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets Only: Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Programs (NTP) uncovered no evidence of carcinogenic potential of ephedrine sulfate at doses up to 10 and 27 mg/kg, respectively (approximately 16% and 100% of the maximum recommended human daily oral dose of pseudoephedrine sulfate on a mg/m2 basis).

In mutagenicity studies with loratadine alone, there was no evidence of mutagenic potential in reverse (Ames) or forward point mutation (CHO-HGPRT) assays, or in the assay for DNA damage (Rat Primary Hepatocyte Unscheduled DNA Assay) or in two assays for chromosomal aberrations (Human Peripheral Blood Lymphocyte Clastogenesis Assay and the Mouse Bone Marrow Erythrocyte Micronucleus Assay). In the Mouse Lymphoma Assay, a positive finding occurred in the nonactivated but not the activated phase of the study.

Pregnancy Category B

Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets: There was no evidence of animal teratogenicity in reproduction studies performed on rats and rabbits with this combination at oral doses up to 150 mg/kg (885 mg/m2 or 5 times the recommended daily human dosage of 250 mg or 185 mg/m2), and 120 mg/kg (1416 mg/m2 or 8 times the recommended daily human dosage), respectively.

Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets: The combination product loratadine; pseudoephedrine sulfate was evaluated for teratogenicity in rats and rabbits. There was no evidence of teratogenicity in reproduction studies with this combination of the same clinical ratio (1:24) at oral doses up to 150 mg/kg (approximately 5 times the maximum recommended daily human dose on a mg/m2 basis) in rats, and 120 mg/kg (approximately 8 times the maximum recommended daily human dose on a mg/m2 basis) in rabbits. Similarly, no evidence of animal teratogenicity in rats and rabbits was reported at oral doses up to 96 mg/kg of loratadine alone (approximately 75 and 150 times, respectively, the maximum human daily oral dose on a mg/m2 basis).

Loratadine; Pseudoephedrine Sulfate 12 and 24 Hour Extended Release Tablets: There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, loratadine; pseudoephedrine sulfate extended release tablets should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known if this combination product is excreted in human milk. However, loratadine when administered alone 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 the parent and active metabolite, respectively. Following a single oral dose of 40 mg, a small amount of loratadine and metabolite was excreted into the breast milk (approximately 0.03% of 40 mg over 48 hours). Pseudoephedrine administered alone also distributes into breast milk of the lactating human female. Pseudoephedrine concentrations in milk are consistently higher than those in plasma. The total amount of drug in milk as judged by the area under the curve (AUC) is 2 to 3 times greater than in plasma. The fraction of a pseudoephedrine dose excreted in milk is estimated to be 0.4% to 0.7%. 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; pseudoephedrine sulfate 12 and 24 hour extended release tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 years have not been established.

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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