DESLOREX TABLET & SYRUP

Description

PROPERTIES:
DESLOREX is a non–sedating long-acting antihistaminic product in the form of tablets and syrup. DESLOREX contains desloratadine (the major active metabolite of loratadine) which has high efficacy in the symptomatic relief of allergic conditions including rhinitis and urticaria. DESLOREX (desloratadine) abolishes the major actions of histamine in the body by bloking histamine H1-receptors. DESLOREX (desloratadine) blocks selectively peripheral histamine H1-receptors as it does not readily penetrate into the central nervous system (CNS). DESLOREX, therefore, does not cause sedation or drowsiness and does not act synergistically with CNS depressants. In addition, DESLOREX does not cause significant antimuscarinic effects, as compared with many other antihistamines. DESLOREX provides marked long-lasting relief of the manifestations commonly associated with allergic conditions such as nasal itching, rhinorrhea, sneezing, excessive lacrimation, swelling of eyelids and skin itching. DESLOREX, in the form of tablets or syrup, is well tolerated by adults and children with excellent patient compliance as it is effective in a once daily dosage regimen without causing sedation or affecting the performance of daytime activities.
PHARMACOKINETICS:
Following oral administration of DESLOREX tablets or syrup, desloratadine is well absorbed from the gastrointestinal tract (GIT). Peak plasma concentrations of the drug are achieved within 2-3 hours. Desloratadine is distributed in body tissues and fluids but does not appear to cross the blood-brain barrier to a significant extent. The drug is excreted from the body in the urine and faeces. The mean elimination half-life of desloratadine from plasma is about 28 hours.

INDICATIONS:
DESLOREX , in the form of tablets and syrup, is used for the symptomatic relief of allergic conditions as in:
– Seasonal and perennial allergic rhinitis or rhinosinusitis with manifestations such as sneezing, nasal itching and rhinorrhea.
– Cases of urticaria with symptoms such as pruritus , skin rash and angioedema.
– Other pruritic skin conditions such as eczema and atopic dermatitis.
– Allergic conjunctivitis with eye itching, excessive lacrimation and eyelid swelling.

DOSAGE:
– Adults and children 12 years or older: one DESLOREX tablet (5 mg) once daily.
– Children
• 2-5 years old: a half teaspoonful (2.5 ml) of DESLOREX syrup once daily.
• 6-11 years old: one teaspoonful (5 ml) of DESLOREX syrup once daily.

CONTRAINDICATIONS:
Hypersensitivity to any component of the product.
Not to be used for children less than 2 years.

SIDE EFFECTS:
DESLOREX, in the form of tablets or syrup, is safe and well tolerated in the recommended doses. Mild side effects, e.g. nausea, dyspepsia, fatigue, myalgia and rarely hypersensitivity reactions and transient elevation of liver enzymes may occur.

DRUG INTERACTIONS:
Erythromycin, ketoconazole, azithromycin, fluoxetine and cimetidine increase the plasma concentration of desloratadine.

PREGNANCY & LACTATION:
– Desloratadine should be used during pregnancy only if clearly needed.
– The use of the drug should be avoided during lactation.

PRECAUTIONS & WARNINGS:
Patients with hepatic or renal impairment should be given the dose of desloratadine (5 mg) on alternate days initially.

PACKING:
A box containing 10 DESLOREX tablets in PVC/Aluminium strips.
A brown glass bottle Type III containing 120 ml Deslorex syrup.

STORAGE:
Syrup:Keep at a temperature not exceeding 30C.
Tablet:Keep at a temperature not exceeding 30C, in dry place.
Keep out of reach of children.

INSTRUCTIONS TO THE PATIENT:
Patients should be advised not to increase the recommended dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses but somnolence may occur.