Desloratadine: profile and news

FDA Approves CLARINEX-D(R) 12 HOUR (desloratadine 2.5mg ... Feb 6, 2006
Schering-Plough Corporation (NYSE: SGP) today announced that the US Food and Drug Administration (FDA) has approved CLARINEX-D® 12 HOUR (desloratadine 2.5 mg ... - Medical News Today (press release),

FDA Approves Clarinex-D 12 Hour (Desloratadine/Pseudoephedrine) ... Feb 2, 2006
2, 2006 -- Schering-Plough Corporation today announced that the US Food and Drug Administration (FDA) has approved Clarinex-D® 12 hour (desloratadine 2.5 mg ... - DG News

FDA Approves CLARINEX-D(R) 12 HOUR (desloratadine 2.5mg ... Feb 1, 2006
Schering-Plough Corporation today announced that the US Food and Drug Administration (FDA) has approved CLARINEX-D(R) 12 HOUR (desloratadine 2.5 mg and ... - Finanzen.net,

FDA OKs Clarinex-D 12 Hour Feb 3, 2006
Clarinex (desloratadine) is a nonsedating antihistamine available by prescription for the treatment of seasonal allergy symptoms. ... - CBS News

Congestion for Use of Clarinex-D 12 Hour cleared – FDA Gives the ... Feb 4, 2006
Clarinex (desloratadine) , used for treatment of seasonal allergy symptoms, is a nonsedating antihistamine procured only by prescription . ... - MedIndia,

New Survey Shows Europeans' Allergy Symptoms Are Most Severe in ... Feb 14, 2006
AERIUS [NEOCLARITYN] (desloratadine) is a nonsedating prescription antihistamine for the treatment of symptoms associated with allergic rhinitis and chronic ... - PR Newswire UK (press release),

FDA approves CLARINEX-D 12 HOUR for seasonal allergic rhinitis Feb 6, 2006
...rhinitis. CLARINEX-D 12 HOUR is a drug containing a combination of desloratadine 2.5 mg and pseudoephedrine sulfate, USP 120 mg. ... - MedIndia,

FDA OKs Clarinex-D 12 Hour Feb 3, 2006
Clarinex (desloratadine) is a nonsedating antihistamine available by prescription for the treatment of seasonal allergy symptoms. ... - CBS News

Sepracor Announces Fourth Quarter and Full Year 2005 Results ... Jan 31, 2006
CLARINEX(R) brand desloratadine HCl - Marketed by Schering-Plough Corporation, Sepracor earns royalties on sales of all formulations of CLARINEX in the US ... - Genetic Engineering News,

Schering-Plough swings to profit in Q4 Jan 31, 2006
Global sales of the anti-allergy medicine Clarinex (desloratadine) dropped 14% to $139 million, as US revenues continued to feel the pinch of declining market ... - Pharma Times (subscription),

Diphenhydramine Has Decongestant Effect for Seasonal Allergies ... Nov 23, 2005
...diphenhydramine (Benadryl) appears to be as effective for nasal congestion as oral decongestant medication and superior to desloratadine (Clarinex) for nasal ... - DG News

PediaMed Recognized as One of Greater Cincinnati's Fastest-Growing ... Dec 6, 2005
...cough/cold and in promoting TAZORAC(R) (tazarotene) acne cream and gel, ZYMAR(R) (gatifloxacin ophthalmic solution), and CLARINEX(R) (desloratadine) Syrup and ... - Business Wire (press release),

Data Show Morning Is the Most Difficult Time for Allergic Rhinitis ... Nov 8, 2005
According to a clinical study presented at the meeting, CLARINEX(R) (desloratadine) significantly reduces morning symptoms of seasonal allergic rhinitis (SAR). ... - PharmaLive.com (press release),

Data Show Morning Is the Most Difficult Time for Allergic Rhinitis ... Nov 8, 2005
CLARINEX(R) (desloratadine) 5 mg Tablets significantly reduce morning symptoms of seasonal allergic rhinitis, according to study results presented at ACAAI ... - PR Newswire (press release),

Morepen keen on EU market; announces 52 DMF filings Sep 9, 2005
...cholesterol reducing drug Atorvastatin (Lipitor) for both the amorphous and the crystalline forms, antiasthmatic drug Desloratadine (Clarinex), antidiabetic ... - Express Pharma Pulse,

CIMA LABS' OraSolv(R) Technology Used in CLARINEX(R) ... Aug 25, 2005
CEPH), announced today that Schering-Plough Corporation plans to market an orally disintegrating version of CLARINEX(R) (desloratadine), its prescription ... - PR Newswire (press release),

Research Shows Patients With Allergic Rhinitis Prefer NASONEX(R) ... Sep 6, 2005
Products from the company's research efforts include the CLARITIN(R) (loratadine) family of nonsedating antihistamines, CLARINEX(R) (desloratadine) syrup and ... - PR Newswire (press release),

Morepen Laboratories declares 2 DMF filings for 6 products in EU Aug 26, 2005
...for cholesterol reducing Drug Atorvastatin (Lipitor) for both the amorphous and the crystalline forms Antiasthmatic Drug Desloratadine (Clarinex), Antidiabetic ... - Myiris.com,

Pediamed Appoints Chief Administrative Officer Aug 24, 2005
...of allergy/cough/cold and in promoting TAZORAC(r) acne cream and gel, ZYMAR(r) (gatifloxacin ophthalmic solution), and CLARINEX(r) (desloratadine) Syrup and ... - PharmaLive.com (press release),

PediaMed Appoints Chief Administrative Officer Aug 25, 2005
...of allergy/cough/cold and in promoting TAZORAC(R) acne cream and gel, ZYMAR(R) (gatifloxacin ophthalmic solution), and CLARINEX(R) (desloratadine) Syrup and ... - Genetic Engineering News,

Allergy symptoms rise with the sun Aug 24, 2005
Combination treatments include CLARINEX-D(r) 24 HOUR (desloratadine 5 mg/pseudoephedrine 240 mg) Extended Release Tablets, which can help seasonal allergy ... - El Dorado Times,

Orally Disintegrating Desloratadine for Convenient Control of ... Jul 16, 2005
Schering-Plough Corporation today announced that the US Food and Drug Administration (FDA) has approved re-formulated CLARINEX(R) (desloratadine 2.5 mg and 5 mg ... - RxPG NEWS

FDA Approves Re-Formulated CLARINEX(R) (desloratadine) REDITABS(R) ... Jul 15, 2005
Corporation (NYSE: SGP - News) today announced that the US Food and Drug Administration (FDA) has approved re-formulated CLARINEX® (desloratadine 2.5 mg and 5 ... - Yahoo News (press release)

FDA Approves Orally Disintegrating Prescription Antihistamine, Re ... Jul 19, 2005
Plough Corporation (NYSE: SGP) today announced that the US Food and Drug Administration (FDA) has approved re-formulated CLARINEX(R) (desloratadine 2.5 mg and ... - Medical News Today (press release)

Sepracor Announces Second Quarter 2005 Operating Results Jul 19, 2005
CLARINEX(R) brand desloratadine - Sepracor earns royalties from Schering-Plough Corporation on sales of all formulations of CLARINEX brand desloratadine in the ... - Genetic Engineering News

PediaMed Launches Mobile Compliance Program For TAZORAC(R); New ... Jul 26, 2005
...of allergy/cough/cold and in promoting TAZORAC(R) acne cream and gel, ZYMAR(R) (gatifloxacin ophthalmic solution), and CLARINEX(R) (desloratadine) Syrup and ... - Business Wire (press release)

Schering-Plough Plans Tutti-Frutti Clarinex Jul 15, 2005
...said Friday. The allergy medicine is available in two dosages, 2.5 milligrams and 5 milligrams of desloratadine. Schering-Plough ... - TheStreet.com <**results**>

NASONEX(R) (mometasone furoate monohydrate) Effective for Nasal ... Jun 29, 2005
Products from the company's research efforts include the CLARITIN® (loratadine) family of nonsedating antihistamines, CLARINEX® (desloratadine) syrup and ... - Yahoo News (press release)

Following Claritin's Lead, Second-Generation Antihistamines ... Jun 20, 2005
...switches in prescribing status of several oral second-generation antihistamines, including fexofenadine (Allegra/Telfast) and desloratadine (Clarinex/Aerius ... - Drug Newswire (press release),

Other information

Indication
For the relief of symptoms of seasonal allergic rhinitis, pruritus, reduction in the number of hives in patients with chronic idiopathic urticaria.

Pharmacology
Desloratadine is a long-lasting antihistamine. Desloratadine is a second-generation H₁-receptor antagonist which has a selective and peripheral H1-antagonist action. Histamine is a chemical that causes many of the signs that are part of allergic reactions, for example, swelling of tissues. Histamine is released from histamine-storing cells (mast cells) and attaches to other cells that have receptors for histamine. The attachment of the histamine to the receptors causes the cell to be "activated," releasing other chemicals which produce the effects that we associate with allergy. Desloratadine blocks one type of receptor for histamine (the H1 receptor) and thus prevents activation of cells by histamine. Unlike most other antihistamines, Desloratadine does not enter the brain from the blood and, therefore, does not cause drowsiness.

Mechanism Of Action
Like other H1-blockers, Desloratadine competes with free histamine for binding at H₁-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine.

Drug Category
Antihistamines; Antihistamines; ATC:R06AX27

Brand Names/Synonyms
Aerius; Alavert; Clarinex; Clarinex Reditabs; Claritin; Claritin Reditabs; Descarboethoxyloratadine; Descarboethoxyoratidine; Desloratadine; Desloratadine [Usan]; Desloratidine; Loratadine; Sch 34117

Dosage Forms
SYRUP; TABLET

Absorption
Not Available

Interactions
-->Interactions for Desloratadine:

In two controlled crossover clinical pharmacology studies in healthy male (n=12 in each study) a nd female (n=12 in each study) volunteers, desloratadine 7.5 mg (1.5 times the daily dose) once daily was coadministered with erythromycin 500 mg every 8 hours or ketoconazole 200 mg every 12 hours for 10 days. In three separate controlled, parallel group clinical pharmacology studies, desloratadine at the clinical dose of 5 mg has been coadministered with azithromycin 500 mg followed by 250 mg once daily for 4 days (n=18) or with fluoxetine 20 mg once daily for 7 days after a 23 day pretreatment period with fluoxetine (n=18) or with cimetidine 600 mg every 12 hours for 14 days (n=18) under steady state conditions to normal healthy male and female volunteers. Although increased plasma concentrations (C _max and AUC 0-24 hrs) of desloratadine and 3-hydroxydesloratadine were observed , there were no clinically relevant changes in the safety profile of desloratadine, as assessed by electrocardiographic parameters (including the corrected QT interval), clinical laboratory tests, vital signs, and adverse events.

Table 1 Changes in Desloratadine and 3-Hydroxydesloratadine Pharmacokinetics in Healthy Male and Female Volunteers
	Desloratadine		3-Hydroxydesloratadine
	C _max	AUC 0-24 hrs	C _max	AUC 0-24 hrs
Erythromycin
(500 mg Q8h)	+24%	+14%	+43%	+40%
Ketoconazole
(200 mg Q12h)	+45%	+39%	+43%	+72%
Azithromycin
(500 mg day 1, 250 mg QD × 4 days)	+15%	+5%	+15%	+4%
Fluoxetine
(20 mg QD)	+15%	+0%	+17%	+13%
Cimetidine
(600 mg Q12h)	+12%	+19%	-11%	-3%

Chemical IUPAC Name
Not Available

Chemical Formula
C19H19ClN2

Half Life
50 hours

Drug Type
Approved Drug

# Accession No
APRD00324

CAS Registry Number
100643-71-8