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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|
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.
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.
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.
Respiratory System: Bronchitis, bronchospasm, chest congestion, coughing, dry throat, dyspnea, epistaxis, halitosis, nasal congestion, nasal irritation, sinusitis, sneezing, sputum increased, upper respiratory infection, wheezing.
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)|
Adverse events occurring in greater than or equal to 2% of loratadine; pseudoephedrine sulfate 24 hour extended release tablets-treated patients, but that were more common in the placebo-treated group, include headache.
Adverse events did not appear to significantly differ based on age, sex, or race, although the number of nonwhites was relatively small.
In addition to those adverse events reported above, the following adverse events have been reported in fewer than 2% of patients who received loratadine; pseudoephedrine sulfate 24 hour extended release tablets.
Autonomic Nervous System: Altered lacrimation, flushing, increased sweating, mydriasis, thirst.
Body as a Whole: Abnormal vision, asthenia, back pain, chest pain, conjunctivitis, earache, eye pain, facial edema, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, rigors, tinnitus.
Cardiovascular System: Hypertension, palpitation, tachycardia.
Central and Peripheral Nervous System: Convulsions, dysphonia, hyperkinesis, hypertonia, migraine, paresthesia, tremor.
Gastrointestinal System: Abdominal distension, altered taste, constipation, diarrhea, dyspepsia, flatulence, gastritis, stomatitis, tongue ulceration, toothache, vomiting.
Liver and Biliary System: Cholelithiasis.
Musculoskeletal System: Arthralgia, musculoskeletal pain, myalgia, tendinitis.
Psychiatric: Agitation, depression, emotional lability, irritability.
Reproductive System: Vaginitis.
Skin and Appendages: Acne, pruritus.
Additional adverse events reported with the combination of loratadine and pseudoephedrine include abnormal hepatic function, aggressive reaction, anxiety, apathy, confusion, euphoria, paroniria, postural hypotension, syncope, urticaria, vertigo, weight gain.
There have been postmarketing reports of mechanical upper gastrointestinal tract obstruction and esophageal perforation in patients taking a previously marketing formulation of loratadine; pseudoephedrine sulfate 24 hour extended release tablets. In some, but not all, of these cases, patients have had known upper gastrointestinal narrowing or abnormal esophageal peristalsis. It is not known whether this reformulation of loratadine; pseudoephedrine sulfate 24 hour extended release tablets has the potential for this adverse event (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
12 and 24 Hour Extended Release Tablets
The Following Additional Adverse Events Have Been Reported With Loratadine; Pseudoephedrine Sulfate Tablets: Alopecia, altered salivation, amnesia, anaphylaxis, angioneurotic edema, blepharospasm, breast enlargement, breast pain, dermatitis, dry hair, erythema multiforme, laryngitis, menorrhagia, nasal dryness, photosensitivity reaction, purpura, seizures, sneezing, supraventricular tachyarrhythmias, urinary discoloration. Additional Adverse Events for 24 Hour Extended Release Tablets Only: Abdominal distress, altered micturition, bronchitis, decreased libido, dry skin, hypoesthesia, impaired concentration, impotence, increased appetite, peripheral edema, rash, and upper respiratory infection.
Pseudoephedrine may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects, such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.
DRUG ABUSE AND DEPENDENCE
There is no information to indicate that abuse or dependency occurs with loratadine. Pseudoephedrine, like other central nervous system stimulants, has been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable, and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal.
Read the Claritin D (loratadine and pseudoephedrine) Side Effects Center for a complete guide to possible side effects
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|
|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
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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