Loratadine / Pseudoephedrine Sulfate
Pronouncation: (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
Trade Names:
Claritin-D 24 Hour
- Tablets 240 mg pseudoephedrine sulfate and 10 mg loratadine
Claritin Extra (Canada)
Claritin Liberator (Canada)
Pharmacology
Feedback for Loratadine/Pseudoephedrine Sulfate
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Competitively antagonizes histamine at the H 1 receptor.
PseudoephedrineCauses 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 agePO 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, ketoconazoleMay 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.
DigitalisIncreased ectopic pacemaker activity may occur.
MAOIsContraindicated 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.
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