Desloratadine is indicated for the relief of symptoms associated with:
- Allergic rhinitis (see section 5.1),
- Urticaria (see section 5.1).

Adults and adolescents (12 years of age and over)
The recommended dose of Desloratadine is one tablet once a day.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4
weeks) should be managed in accordance with the evaluation of patient's disease history and the
treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4
weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Paediatric population
There is limited clinical trial efficacy experience with the use of Desloratadine in adolescents 12
through 17 years of age (see sections 4.8 and 5.1).

The safety and efficacy of Desloratadine film-coated tablets in children under the age of 12 years
have not been established. No data are available.
Method of administration
Oral use.
The dose can be taken with or without food.

In the case of severe renal insufficiency, Desloratadine should be used with caution (see section 5.2).

No clinically relevant interactions were observed in clinical trials with Desloratadine tablets in which
erythromycin or ketoconazole were co-administered (see section 5.1).
Paediatric population
Interaction studies have only been performed in adults.
In a clinical pharmacology trial, Desloratadine tablets taken concomitantly with alcohol did not
potentiate the performance impairing effects of alcohol (see section 5.1). However, cases of alcohol
intolerance and intoxication have been reported during post-marketing use. Therefore, caution is
recommended if alcohol is taken concomitantly.

Pregnancy Category C
Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no
malformative nor foeto/ neonatal toxicity of Desloratadine. Animal studies do not indicate direct or
indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary
measure, it is preferable to avoid the use of Desloratadine during pregnancy.

Breast-feeding
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of
Desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue
breast-feeding or to discontinue/abstain from Desloratadine therapy taking into account the benefit of
breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no data available on male and female fertility.

Desloratadine has no or negligible influence on the ability to drive and use machines based on clinical
trials.
Patients should be informed that most people do not experience drowsiness. Nevertheless, as there is
individual variation in response to all medicinal products, it is recommended that patients are advised
not to engage in activities requiring mental alertness, such as driving a car or using machines, until
they have established their own response to the medicinal product.

Summary of the safety profile
In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at
the recommended dose of 5 mg daily, undesirable effects with Desloratadine were reported in 3 % of
patients in excess of those treated with placebo. The most frequent of adverse events reported in
excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %).
Pediatric Population
In a clinical trial with 578 adolescent patients, 12 through 17 years of age, the most common adverse
event was headache; this occurred in 5.9 % of patients treated with Desloratadine and 6.9 % of
patients receiving placebo.

Tabulated list of adverse reaction
The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable
effects reported very rarely during the post-marketing period are listed in the following table.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥
1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000) and not known (cannot
be estimated from the available data).

Paediatric population
Other undesirable effects reported during the post-marketing period in paediatric patients with an
unknown frequency included QT prolongation, arrhythmia, and bradycardia.
To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

The adverse event profile associated with over dosage, as seen during post-marketing use, is similar
to that seen with therapeutic doses, but the magnitude of the effects can be higher.
Treatment
In the event of overdose, consider standard measures to remove unabsorbed active substance.
Symptomatic and supportive treatment is recommended.
Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal
dialysis.
Symptoms
Based on a multiple dose clinical trial, in which up to 45 mg of Desloratadine was administered
(nine times the clinical dose), no clinically relevant effects were observed.
Paediatric population
The adverse event profile associated with over dosage, as seen during post-marketing use, is similar
to that seen with therapeutic doses, but the magnitude of the effects can be higher.

Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X27
Mechanism of action
Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1
receptor antagonist activity. After oral administration, Desloratadine selectively blocks peripheral
histamine H1-receptors because the substance is excluded from entry to the central nervous system.
Desloratadine has demonstrated antiallergic properties from in vitro studies. These include inhibiting
the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast
cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on
endothelial cells. The clinical relevance of these observations remains to be confirmed.
Clinical efficacy and safety
In a multiple dose clinical trial, in which up to 20 mg of Desloratadine was administered daily for
14 days, no statistically or clinically relevant cardiovascular effect was observed. In a clinical
pharmacology trial, in which Desloratadine was administered at a dose of 45 mg daily (nine times the
clinical dose) for ten days, no prolongation of QTc interval was seen.
No clinically relevant changes in Desloratadine plasma concentrations were observed in multipledose
ketoconazole and erythromycin interaction trials.
Desloratadine does not readily penetrate the central nervous system. In controlled clinical trials, at the
recommended dose of 5 mg daily, there was no excess incidence of somnolence as compared to
placebo. Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance
in clinical trials. In a single dose study performed in adults, Desloratadine 5 mg did not affect
standard measures of flight performance including exacerbation of subjective sleepiness or tasks
related to flying.
In clinical pharmacology trials, co-administration with alcohol did not increase the alcohol-induced
impairment in performance or increase in sleepiness. No significant differences were found in the
psychomotor test results between Desloratadine and placebo groups, whether administered alone or
with alcohol.

In patients with allergic rhinitis, Desloratadine was effective in relieving symptoms such as sneezing,
nasal discharge and itching, as well as ocular itching, tearing
Paediatric population
The efficacy of Desloratadine tablets has not been clearly demonstrated in trials with adolescent
patients12 through 17 years of age.
In addition to the established classifications of seasonal and perennial, allergic rhinitis can
alternatively be classified as intermittent allergic rhinitis and persistent allergic rhinitis according to
the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for
less than 4 days per week or for less than 4 weeks. Persistent allergic rhinitis is defined as the
presence of symptoms for 4 days or more per week and for more than 4 weeks.
Desloratadine was effective in alleviating the burden of seasonal allergic rhinitis as shown by the
total score of the rhino-conjunctivitis quality of life questionnaire. The greatest amelioration was seen
in the domains of practical problems and daily activities limited by symptoms.
Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the
underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be
more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases,
Desloratadine is expected to be effective in providing symptomatic relief for other urticarial
conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Desloratadine
was effective in relieving pruritus and decreasing the size and number of hives by the end of the
first dosing interval. In each trial, the effects were sustained over the 24 hour dosing interval. As with
other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified
as non-responsive to antihistamines was excluded. An improvement in pruritus of more than 50 %
was observed in 55 % of patients treated with desloratadine compared with 19 % of patients treated
with placebo. Treatment with Desloratadine also significantly reduced interference with sleep and
daytime function, as measured by a four-point scale used to assess these variables.

Absorption
Desloratadine plasma concentrations can be detected within 30 minutes of administration.
Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours;
the terminal phase half-life is approximately 27 hours. The degree of accumulation of Desloratadine
was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The
bioavailability of Desloratadine was dose proportional over the range of 5 mg to 20 mg.
In a pharmacokinetic trial in which patient demographics were comparable to those of the general
seasonal allergic rhinitis population, 4 % of the subjects achieved a higher concentration of
Desloratadine. This percentage may vary according to ethnic background. Maximum Desloratadine
concentration was about 3-fold higher at approximately 7 hours with a terminal phase half-life of
approximately 89 hours. The safety profile of these subjects was not different from that of the general
population.
Distribution
Desloratadine is moderately bound (83 % - 87 %) to plasma proteins. There is no evidence of
clinically relevant medicine accumulation following once daily dosing of Desloratadine (5 mg to 20
mg) for 14 days.
Biotransformation
The enzyme responsible for the metabolism of Desloratadine has not been identified yet, and
therefore, some interactions with other medicinal products cannot be fully excluded. Desloratadine
does not inhibit CYP3A4 in vivo and in vitro studies have shown that the medicinal product does not
inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Elimination
In a single dose trial using a 7.5 mg dose of Desloratadine, there was no effect of food (high-fat, high
caloric breakfast) on the disposition of Desloratadine. In another study, grapefruit juice had no effect
on the disposition of Desloratadine.

Renally impaired patients
The pharmacokinetics of Desloratadine in patients with chronic renal insufficiency (CRI) was
compared with that of healthy subjects in one single-dose study and one multiple dose study. In the
single-dose study, the exposure to Desloratadine was approximately 2 and 2.5-fold greater in subjects
with mild to moderate and severe CRI, respectively, than in healthy subjects. In the multiple-dose
study, steady state was reached after Day 11, and compared to healthy subjects the exposure to
Desloratadine was ~1.5-fold greater in subjects with mild to moderate CRI and ~2.5-fold greater in
subjects with severe CRI. In both studies, changes in exposure (AUC and Cmax) of Desloratadine
and 3-hydroxydesloratadine were not clinically relevant.

Desloratadine is the primary active metabolite of Loratadine. Non-clinical studies conducted with
Desloratadine and Loratadine demonstrated that there are no qualitative or quantitative differences in
the toxicity profile of Desloratadine and Loratadine at comparable levels of exposure to Desloratadine.
Non-clinical data with Desloratadine reveal no special hazard for humans based on conventional
studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.
The lack of carcinogenic potential was demonstrated in studies conducted with Desloratadine and
Loratadine.

Tablet Core Containing:
1. Dibasic Calcium Phosphate Dihydrate (DC Grade)
2. Microcrystalline Cellulose -PH102
3. Maize Starch
4. Crospovidone NF
5. Magnesium Stearate
6. Talc
Film Coating Containing
1. Opadry White 03H28604
2. Propylene Glycol
3. Purified Water

Not applicable.

 Do not store above 30°C.
 Store in a dry place.
 Keep out the sight and reached of children.

Deslor 5mg Film Coated Tablet is packed as Alu-PVC/Aclar blisters containing 20 (2x10) tablets in
outer carton with Patient Information Leaflet.

No special requirements.