Batlor is indicated in adults and adolescents aged 12 years or older for the relief of symptoms associated
with: - allergic rhinitis (see section 5.1), - urticaria (see section 5.1).
 

Posology
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.
 

Pediatric population
There is limited clinical trial efficacy experience with the use of desloratadine in adolescent s 12 through 17
years of age (see sections 4.8 and 5.1).
The safety and efficacy of desloratadine film-coated tablets in children below the age of 12 years have not
been established.

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).

Batlor should be administered with caution in patients with medical or familial history of seizures, and
mainly young children (see section 4.8), being more susceptible to develop new seizures under
desloratadine treatment. Healthcare providers may consider discontinuing desloratadine in patients who
experience a seizure while on treatment.
 

No clinically relevant interactions were observed in clinical trials with desloratadine tablets in which erythromycin
or ketoconazole were co-administered (see section 5.1).

Pediatric 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
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
Batlor 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.
 

Batlor 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 reactions 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 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), 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 pediatric patients with an unknown
frequency included QT prolongation, arrhythmia, bradycardia, abnormal behavior, and aggression.
A retrospective observational safety study indicated an increased incidence of new-onset seizure in patients 0
to 19 years of age when receiving desloratadine compared with periods not receiving desloratadine. Among
children 0-4 years old, the adjusted absolute increase was 37.5 (95% Confidence Interval (CI) 10.5-64.5) per
100,000 person years (PY) with a background rate of new onset seizure of 80.3 per 100,000 PY. Among
patients 5-19 years of age, the adjusted absolute increase was 11.3 (95% CI 2.3-20.2) per 100,000 PY with a
background rate of 36.4 per 100,000 PY. (See section 4.4.)

To report any side effect(s):
x Saudi Arabia:

x United Arab Emirates

x Other GCC states

The adverse event profile associated with overdosage, 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 hemodialysis; 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.
 

Pediatric population
The adverse event profile associated with overdosage, 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.
It has demonstrated antiallergic properties from in vitro studies.

These include inhibiting the release of proinflammatory cytokines such as IL4, 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 multiple- dose
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 and redness, and itching of palate. Desloratadine
effectively controlled symptoms for 24 hours.

Paediatric population
The efficacy of desloratadine tablets has not been clearly demonstrated in trials with adolescent patients 12
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 nonresponsive 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 halflife 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 reveal no special hazard for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and
development. The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine
and loratadine.
 

Maize starch,Calcium phosphate dibasic dihydrate, Microcrystalline cellulose, Purified talc, Opadry II
32B205000 Blue ,Hypromellose 6 cps and PEG 400.
 

Not applicable.
 

Store below 30oC
Keep out of the sight and reach of children.
Do not use Batlor after the expiry date (EXP) which is stated on the box.
 

Primary Packaging; Every 10 units of Batlor 5 mg film-coated tablets are packed into a blister package
consisting of clear transparent PVC/Aclar® and aluminium lidding foil; each blister contains ten tablets.
Secondary Packaging; Every three blisters, each containing ten Batlor 5 mg film-coated tablets are
packed into a carton box with an insert leaflet. Each pack contains 30 tablets.
 

No special requirements for disposal.