Declarine

COMPOSITION :
Each f/c tablet contains : Desloratadine 5.0 mg .
Each 5 ml syrup (teaspoonful) contains : Desloratadine 2.5 mg .
DESCRIPTION :
Declarine (Desloratadine) is a long acting histamine antagonist, non-sedation. It also has selective peripheral
H1-receptor antagonist activity because the drug is effectively excluded from entry to the Central Nervous System
(CNS). In addition to antihistaminic activity of Declarine, it has demonstrated antiallergic and anti-inflammatory
activity . Desloratadine is well absorbed, not affected by the presence of food and it can be detected in plasma
within 30 minutes of its administration and its maximum concentration achieved after approximately 3 hours .
Desloratadine is moderately bound to plasma proteins (83 - 87%).
INDICATIONS :
Declarine is indicated in the following cases :
- Rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge, itching,
congestion and ocular itching, tearing and redness, itching of palate and coughing.
- Relief of symptoms associated with urticaria such as itching and the size and numbers of hives.
DOSAGE & ADMINISTRATION :
Declarine can be taken with or without meal, once daily as following :
- Adults (12 years and above) : 5 mg (one tablet or 10 ml syrup).

- Children (6 - 11 years) : 2.5 mg (5 ml syrup).
(1 - 5 years) : 1.25 mg (2.5 ml syrup).

RESTRICTIONS ON USE :
Contraindications
Hypersensitivity to Desloratadine or loratadine.
Precautions
- Desloratadine should be used with caution in case of severe renal insufficiency.
- Efficacy and safety of Desloratadine in children under 1 year have not been established.
Effect on the capacity to drive vehicles or use machines
Desloratadine does not affect the ability to drive vehicles or use machines.
Use in pregnancy and lactation
- Desloratadine is not to be used during pregnancy unless the potential benefits outweigh the risks.
- Desloratadine is not recommended in breast - feeding women because it is excreted into breast milk.
ADVERSE EFFECTS :
The most frequent adverse effects reported in excess of placebo include : fatigue, dry mouth, headache and
diarrhea.
In very rare cases include : hypersensitivity reactions, tachycardia, palpitations, elevations of liver enzymes and
increased bilirubin.
OVERDOSAGE :
In case of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and
supportive treatement is recommended.
Desloratadine is not eleminated by haemodialysis and it is not known if it is eliminated by peritoneal dialysis.
STORAGE INSTRUCTIONS :
Declarine Tablet : Store below 30°C , in a dry place.
Declarine Syrup : Store below 30°C , protect from light.
PRESENTATIONS :
Declarine Tablet : Blister pack of 20 tablets and hospital packs of different sizes.
Declarine Syrup : Bottle of 100 ml.