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Loratadine / Pseudoephedrine Sulfate

Pronunciation: lore-AT-uh-DEEN/SUE-doe-eh-FED-rin
Class: Antihistamine, Decongestant

Trade Names

Claritin-D 12 Hour
- Tablets 120 mg pseudoephedrine sulfate and 5 mg loratadine

Claritin-D 24 Hour
- Tablets 240 mg pseudoephedrine sulfate and 10 mg loratadine

Claritin Allergy and Sinus (Canada)
Claritin Allergy and Sinus Extra Strength (Canada)

Pharmacology

Loratadine

Competitively antagonizes histamine at the H 1 receptor.

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Pseudoephedrine

Causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, promoting nasal drainage.

Indications and Usage

Relief of symptoms of seasonal allergic rhinitis.

Contraindications

Hypersensitivity to any ingredient of product; patients with narrow-angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease; MAOI therapy or within 14 days of stopping MAOI; idiosyncratic reactions to adrenergic agents.

Dosage and Administration

Adults and Children older than 12 yr of age

PO 1 tablet every day ( Claritin-D 24 Hour ) or 1 tablet bid ( Claritin-D 12 Hour ).

General Advice

  • Do not break, chew, or crush tablets.
  • Patients with reduced renal function (Ccr less than 30 mL/min) should be started on 1 tablet q other day ( Claritin-D 24 Hour ) or 1 tablet every day ( Claritin-D 12 Hour ).

Storage/Stability

Store tablets at controlled room temperature (59° to 77°F). Keep container tightly closed. Protect unit-dose hospital pack from light.

Drug Interactions

Loratadine Cimetidine, erythromycin, ketoconazole

May increase loratadine plasma levels.

Pseudoephedrine Antihypertensive agents that interfere with sympathetic activity (eg, beta-blockers, mecamylamine, methyldopa, reserpine, veratrum alkaloids)

Antihypertensive effect of these agents may be reduced.

Digitalis

Increased ectopic pacemaker activity may occur.

MAOIs

Contraindicated in patients taking MAOIs and for 14 days after stopping use of an MAOI.

Laboratory Test Interactions

May diminish or prevent positive reactions to skin tests.

Adverse Reactions

Cardiovascular

Hypertension; hypotension; palpitations; peripheral edema; syncope; tachycardia; ventricular extrasystoles.

CNS

Headache (19% for 12-h tablet); insomnia (16% for 12-h tablet; 5% for 24-h tablet); somnolence (approximately 7%); nervousness, dizziness, fatigue (approximately 4%); aggressive reaction; agitation; anxiety; apathy; confusion; convulsions; decreased libido; depression; dysphonia; emotional lability; euphoria; hyperkinesia; hypertonia; impaired concentration; irritability; migraine; paresthesia; paroniria; tremors; vertigo.

Dermatologic

Acne; bacterial skin infection; dry skin; eczema; epidermal necrolysis; erythema; flushing; hematoma; increased sweating; pruritus; rash; urticaria.

EENT

Pharyngitis (approximately 4%); abnormal lacrimation; abnormal vision; blurred vision; conjunctivitis; earache; ear infection; eye pain; mydriasis; photophobia; tinnitus.

GI

Dry mouth (14% for 12-h tablet; 8% for 24-h tablet); nausea (3%); anorexia (2%); dyspepsia (3% for 12-h tablet); abdominal distension, distress, pain; altered taste; constipation; diarrhea; eructation; flatulence; gastritis; gingival bleeding; hemorrhoids; increased appetite; stomatitis; taste loss; tongue discoloration; tongue ulceration; toothache; vomiting.

Genitourinary

Dysmenorrhea (2%); dysuria; impotence; intermenstrual bleeding; micturition frequency; nocturia; oliguria; polyuria; urinary retention; UTI; vaginitis.

Hepatic

Cholelithiasis; hepatic function abnormal.

Metabolic

Dehydration; edema; thirst; weight gain.

Respiratory

Coughing (3%); bronchitis; bronchospasm; chest congestion; dry throat; dyspnea; epistaxis; halitosis; hemoptysis; nasal congestion; nasal irritation; pleurisy; pneumonia; sinusitis; sneezing; sputum increased; upper respiratory infection; wheezing.

Miscellaneous

Thirst (2%); abscess; arthralgia; asthenia; back pain; chest pain; facial edema; fever; flu-like symptoms; hypoesthesia; leg cramps; lymphadenopathy; malaise; musculoskeletal pain; myalgia; rigors; tendinitis; torticollis; viral infection.

Precautions

Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Special Risk Patients

Use with caution in patients with hypertension, hyperthyroidism, diabetes, cardiovascular disease, increased intraocular pressure, renal impairment, hepatic impairment, or prostatic hypertrophy.

Swallowing difficulty

Esophageal obstruction and perforation has been reported with product; therefore, should not be used by patients with history of difficulty in swallowing tablets or who have known upper GI narrowing or abnormal esophageal peristalsis.

Sympathomimetic amines (eg, pseudoephedrine)

May cause CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Overdosage

Symptoms

Somnolence, tachycardia, headache, giddiness, nausea, vomiting, sweating, thirst, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, insomnia, toxic psychosis with delusions and hallucinations, cardiac arrhythmias, circulatory collapse, convulsions, coma, respiratory failure.

Patient Information

  • Advise patient to take with a full glass of water.
  • Advise patient to take last dose late in the afternoon or early evening to reduce chance of drug causing sleeplessness.
  • Caution patient not to break, chew, or crush tablet and to swallow whole.
  • Advise patient that if allergy symptoms are not controlled not to increase the dose of medication but to inform health care provider.
  • Caution patient not to take any OTC antihistamines or decongestants while taking this medication unless advised by health care provider.
  • If patient is to have allergy skin testing, advise patient not to take the medication for at least 6 days before the skin testing.
  • Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: nervousness, dizziness, sleeplessness.

Copyright © 2009 Wolters Kluwer Health.

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