CLARINEX-D 12 HOUR

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE

Manufacturer: Organon LLC

Score: 141.0

Quick Summary

CLARINEX-D 12 HOUR is a combination product containing desloratadine and pseudoephedrine, used for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years of age and older. The recommended dose is one tablet twice a day, administered approximately 12 hours apart and with or without a meal. CLARINEX-D 12 HOUR is contraindicated in patients with hypersensitivity to any of its ingredients, narrow-angle glaucoma, urinary retention, and those receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen days of stopping such treatment. The most common adverse reactions include insomnia, headache, mouth dry, fatigue, somnolence, pharyngitis, dizziness, nausea, and anorexia.

Key Clinical Findings and Indications

Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis
Nasal congestion in adults and adolescents 12 years of age and older

Important Safety Information

Warning

Cardiovascular and Central Nervous System effects, increased intraocular pressure, urinary retention, and hypersensitivity reactions

Contraindications

Hypersensitivity to any of the ingredients
Narrow-angle glaucoma
Urinary retention
Monoamine oxidase (MAO) inhibitor therapy or within fourteen days of stopping such treatment
Severe hypertension or severe coronary artery disease

Adverse Reactions

Insomnia
Headache
Mouth dry
Fatigue
Somnolence
Pharyngitis
Dizziness
Nausea
Anorexia

Dosing Recommendations

General Guidance

No dose adjustment is recommended in elderly patients

Seasonal allergic rhinitis

Adult Dose

One tablet twice a day, administered approximately 12 hours apart and with or without a meal

Pediatric Dose

Not indicated for use in pediatric patients under 12 years of age

Special Population Considerations

Pregnancy

Limited available data with CLARINEX-D 12 HOUR in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

No information available

Pediatric Use

Not indicated for use in pediatric patients under 12 years of age

Geriatric Use

No dose adjustment is recommended in elderly patients
Elderly patients are more likely to have decreased renal function, care should be taken in dose selection