Desloratadine Oral Solution .5 mg/mL
Desloratadine · SOLUTION · INA Pharmaceutics, Inc.
Desloratadine Oral Solution is a solution containing desloratadine at .5 mg/mL, taken oral. Manufactured by INA Pharmaceutics, Inc..
Key Facts
- Brand Name
- Desloratadine Oral Solution
- Generic Name
- Desloratadine
- NDC Code (Product)
74157-011- Manufacturer
- INA Pharmaceutics, Inc.
- Strength
- .5 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202936
- Drug Class
- Histamine-1 Receptor Antagonist [EPC]
- Marketing Start
- 07/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Desloratadine Oral Solution is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. (1.1) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. (1.2) Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 6 months of age and older. (1.3) 1.1 Seasonal Allergic Rhinitis Desloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older. 1.2 Perennial Allergic Rhinitis Desloratadine oral solution is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older. 1.3 Chronic Idiopathic Urticaria Desloratadine oral solution is indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Desloratadine oral solution may be taken without regard to meals. The age-appropriate dose of desloratadine oral solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon). Dosage (by age): Adults and Adolescents 12 Years of Age and Over: 2 teaspoonfuls (5 mg in 10 mL) once daily (2) Children 6 to 11 Years of Age: 1 teaspoonful (2.5 mg in 5 mL) once daily Children 12 Months to 5 Years of Age: ½ teaspoonful (1.25 mg in 2.5 mL) once daily (2) 2.1 Adults and Adolescents 12 Years of Age and Over The recommended dose of desloratadine oral solution is 2 teaspoonfuls (5 mg in 10 mL) once daily. 2.2 Children 6 to 11 Years of Age The recommended dose of desloratadine oral solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. 2.3 Children 12 Months to 5 Years of Age The recommended dose of desloratadine oral solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily. 2.4 Children 6 to 11 Months of Age The recommended dose of desloratadine oral solution is 2 mL (1 mg) once daily. 2.5 Adults with Hepatic or Renal Impairment Dosing recommendation for children with liver or renal…
Contraindications
4 CONTRAINDICATIONS Desloratadine oral solution is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. • Hypersensitivity (4, 6.2)
Drug Interactions
7 DRUG INTERACTIONS 7.1 Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).] 7.2 Fluoxetine In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).] 7.3 Cimetidine In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [See Clinical Pharmacology (12.3).]
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity reactions. [See Warnings and Precautions (5.1).] The most common adverse reactions (reported in ≥ 2% of adult and adolescent patients with allergic rhinitis and greater than placebo) were pharyngitis, dry mouth, myalgia, fatigue, somnolence, dysmenorrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults and Adolescents Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2,834 patients ages 12 years or older received desloratadine tablets at doses of 2.5 mg to 20 mg daily, of whom 1,655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between desloratad…
Frequently Asked Questions
What is Desloratadine Oral Solution used for?
Desloratadine Oral Solution contains Desloratadine. It is a solution taken oral. Consult your doctor for specific uses.
Is Desloratadine Oral Solution a controlled substance?
Desloratadine Oral Solution is not classified as a controlled substance by the DEA.
What is the generic name for Desloratadine Oral Solution?
The generic name for Desloratadine Oral Solution is Desloratadine. There are 11 other brand versions of Desloratadine.
What is the NDC code for Desloratadine Oral Solution .5 mg/mL?
The NDC (National Drug Code) for Desloratadine Oral Solution .5 mg/mL is 74157-011, listed by INA Pharmaceutics, Inc..