Desloratadine label

Desloratadine

Desloratadine Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Seasonal Allergic Rhinitis

Desloratadine Tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

1.2 Perennial Allergic Rhinitis

Desloratadine Tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.

1.3 Chronic Idiopathic Urticaria

Desloratadine Tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.

History

There is currently no drug history available for this drug.

Other Information

Desloratadine Tablets are light blue, round, tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine Tablets also contain the following inactive ingredients: microcrystalline cellulose NF, pregelatinized starch NF, croscarmellose sodium NF, talc USP, zinc stearate, USP and FD&C Blue #2 HT 11-14%.

Desloratadine is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C19H19ClN2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperdinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure:

Chemical Structure

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Desloratadine Manufacturers

Virtus Pharmaceuticals
No Recall
Desloratadine | Virtus Pharmaceuticals
Desloratadine Tablets may be taken without regard to meals.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of Desloratadine Tablets is one 5-mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Anesta Corporation
No Recall
Desloratadine | Anesta Corporation
There is currently no dosage information available for this product. We apologize for any inconvenience.
Virtus Pharmaceuticals
No Recall
Desloratadine | Virtus Pharmaceuticals
Desloratadine Tablets may be taken without regard to meals.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of Desloratadine Tablets is one 5 mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Sun Pharmaceutical Industries Limited
No Recall
Desloratadine | Sun Pharmaceutical Industries Limited

Desloratadine tablets may be taken without regard to meals.
2.1 Adults and Adolescents 12 Years of Age and Over
The recommended dose of desloratadine

tablets is one 5 mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Avkare, Inc.
No Recall
Desloratadine | Avkare, Inc.

Desloratadine Tablets may be taken without regard to meals.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of Desloratadine Tablets is one 5-mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Northstar Rx Llc
No Recall
Desloratadine | Northstar Rx Llc
Desloratadine tablets may be taken without regard to meals.
2.1 Adults and Adolescents 12 years of Age and Over
The recommended dose of desloratadine tablets is one 5 mg tablet once daily.

NOTE: Desloratadine tablets are not recommended for use in pediatric patients under 12 years of age as other dosage forms are better suited for younger patients.
2.2 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Belcher Pharmaceuticals,llc
No Recall
Desloratadine | Belcher Pharmaceuticals,llc

Desloratadine Tablets may be taken without regard to meals.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of Desloratadine Tablets is one 5-mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Dr. Reddy’s Laboratories Limited
No Recall
Desloratadine | Dr. Reddy's Laboratories Limited
Desloratadine orally disintegrating tablets may be taken without regard to meals. Place desloratadine orally disintegrating tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of desloratadine orally disintegrating tablets is one 5 mg tablet once daily.
2.2 Children 6 to 11 years of age
The recommended dose of desloratadine orally disintegrating tablet is one 2.5 mg tablet once daily.

NOTE: Desloratadine orally disintegrating tablets are not recommended for use in pediatric patients under 6 years of age as desloratadine syrup is better suited for these patients.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Paddock Laboratories, Llc
No Recall
Desloratadine | Paddock Laboratories, Llc
Desloratadine tablets 5 mg may be taken without regard to meals. Take tablet immediately after opening the blister.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of desloratadine tablets is one 5-mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Bryant Ranch Prepack
No Recall
Desloratadine | Bryant Ranch Prepack
Desloratadine Tablets may be taken without regard to meals.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of Desloratadine Tablets is one 5 mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Lupin Pharmaceuticals, Inc.
No Recall
Desloratadine | Hi-tech Pharmacal Co., Inc.
Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is contraindicated for children under 2 years of age (see WARNINGS - Black Box Warning and Use in Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.

Children 6 years to under 12 years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 20 mL in 24 hours.

Children 2 years to under 6 years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours, not to exceed 10 mL in 24 hours.
Sandoz Inc
No Recall
Desloratadine | Sandoz Inc
Desloratadine tablets may be taken without regard to meals.
2.1 Adults and Adolescents 12 Years of Age and Over
The recommended dose of desloratadine tablets is one 5-mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see CLINICAL PHARMACOLOGY (12.3)].
Mylan Pharmaceuticals Inc.
No Recall
Desloratadine | Mylan Pharmaceuticals Inc.
Desloratadine tablets may be taken without regard to meals.
2.1 Adults and Adolescents 12 Years of Age and Over
The recommended dose of desloratadine tablets is one 5 mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Avpak
No Recall
Desloratadine | Avpak

Desloratadine Tablets may be taken without regard to meals.
2.1 Adults and adolescents 12 years of age and over
The recommended dose of Desloratadine Tablets is one 5-mg tablet once daily.
2.5 Adults with Hepatic or Renal Impairment
In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].