Desloratadine

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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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.

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History

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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:

Sources

Desloratadine Manufacturers

Virtus Pharmaceuticals

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)].

No Recall
Anesta Corporation

Desloratadine | Anesta Corporation

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

No Recall
Virtus Pharmaceuticals

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)].

No Recall
Sun Pharmaceutical Industries Limited

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)].

No Recall
Avkare, Inc.

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)].

No Recall
Northstar Rx Llc

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)].

No Recall
Belcher Pharmaceuticals,llc

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)].

No Recall
Dr. Reddy’s Laboratories Limited

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)].

No Recall
Paddock Laboratories, Llc

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)].

No Recall
Bryant Ranch Prepack

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)].

No Recall
Lupin Pharmaceuticals, Inc.

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.

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Sandoz Inc

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)].

No Recall
Mylan Pharmaceuticals Inc.

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)].

No Recall
Avpak

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)].

No Recall