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| Delarex |
Delarex Desloratadine 5 mg
Each film-coated Delarex tablet contains desloratadine 5 mg.
Inactive ingredients:
Diabasic calcium phosphate dehydrate, Starch maize,
Microcrystalline Cellulose, Talc.
Each 5 ml Delarex syrup contains 2.5 mg desloratadine.
Inactive ingredients:
Propylene Glycol, Sodium Citrate Anhydrous, Citric Acid
Anhydrous, Sodium Benzoate, Edetate Disodium, Sucrose,
Strawberry Essence, Banana Essence, Sorbitol Solution 70%. Delorex, desloratadine, is a long-acting tricyclic histamine antagonist with selective Hl -receptor histamine antagonist activity. It is a metabolite of loratadine. It does not cross the blood brain barrier. It inhibited histamine release from human mast cells in vitro.
Inactive ingredients:
Diabasic calcium phosphate dehydrate, Starch maize,
Microcrystalline Cellulose, Talc.
Each 5 ml Delarex syrup contains 2.5 mg desloratadine.
Inactive ingredients:
Propylene Glycol, Sodium Citrate Anhydrous, Citric Acid
Anhydrous, Sodium Benzoate, Edetate Disodium, Sucrose,
Strawberry Essence, Banana Essence, Sorbitol Solution 70%. Delorex, desloratadine, is a long-acting tricyclic histamine antagonist with selective Hl -receptor histamine antagonist activity. It is a metabolite of loratadine. It does not cross the blood brain barrier. It inhibited histamine release from human mast cells in vitro.
Following oral administration of desloratadine 5 mg, mean peak plasma concentrations are reached within 3 hours. Neithgrfhod nogapçsitjuice had an effect on the bioavailability of desloratadine tablet and syrup.
Deslorstadine and 3-hydroxydesloratadine are approximately 85%protein bound.
Desioratadine is metabolised to an active metabolite, 3- hydroxydesloratadine. This metabolite subsequently undergoes glucuronidation.
Half-life of desloratadine is 27 hours. A recovery of approximately 87% of a 14C-desloratadine dose is equally distributed in the urine and faeces as metabolic products. aItdiflfl... - Relief of nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis in patients 6 months of age and older. - Symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older. - Symptoms of allergic conjunctivitis.
Frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in desloratadine and placebo-treated patients.
Rare side effects of the syrup form may occur such as fever, diarrhoea, appetite increase, emotional lability, pharyngitia, somnolence, insomnia.
N.B: Overdosage of desloratadine: little increase in QT with no clinically relevant adverse events was reported.
In patients who are hyprsensitive to desloratadine, to any of the product ingredients, or to loratadine.
No adequate and well-controlled studies in pregnant women are documented, therefore, desloratadine should be used during pregnancy only if clearly needed.
As deslorstadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.
Dosage adjustment for patients with renal or hepstic impairment is recommended.
Safety of tablets and syrup have not been demonstrated in paediathc patients less than 6 months of age.
Adults and children 12 years of age and over: Delarex tablet: one tablet to be taken once daily or Delarex syrup: two teaspoonfuls (5mg in 10 ml) to be taken once daily.
Children 6 to II years of agei One tesapoonfislof-Delarexsyrup (2.5 mg in 5 ml) to be given once daily. Children 12 months to 5 years of age: HaIfa teaspoonful of Delarex syrup (1.25mg in 2.5 ml) to be given once daily. Children 6 to 11 months of age:2 ml (1 mg) to be given once daily with a special measuring device.
Patients with hepatic or renal impairment should be given desloratadine 5 mg on alternate days initially. Delarex tablets are supplied in boxes of 20 tablets each.
Delarex syrup is supplied in bottles of 60 ml each. Store at temperature not exceeding 3OnC, in dry place. Keep out of reach of children
Deslorstadine and 3-hydroxydesloratadine are approximately 85%protein bound.
Desioratadine is metabolised to an active metabolite, 3- hydroxydesloratadine. This metabolite subsequently undergoes glucuronidation.
Half-life of desloratadine is 27 hours. A recovery of approximately 87% of a 14C-desloratadine dose is equally distributed in the urine and faeces as metabolic products. aItdiflfl... - Relief of nasal and non-nasal symptoms of seasonal and perennial allergic rhinitis in patients 6 months of age and older. - Symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older. - Symptoms of allergic conjunctivitis.
Frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in desloratadine and placebo-treated patients.
Rare side effects of the syrup form may occur such as fever, diarrhoea, appetite increase, emotional lability, pharyngitia, somnolence, insomnia.
N.B: Overdosage of desloratadine: little increase in QT with no clinically relevant adverse events was reported.
In patients who are hyprsensitive to desloratadine, to any of the product ingredients, or to loratadine.
No adequate and well-controlled studies in pregnant women are documented, therefore, desloratadine should be used during pregnancy only if clearly needed.
As deslorstadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the importance of the drug to the mother.
Dosage adjustment for patients with renal or hepstic impairment is recommended.
Safety of tablets and syrup have not been demonstrated in paediathc patients less than 6 months of age.
Adults and children 12 years of age and over: Delarex tablet: one tablet to be taken once daily or Delarex syrup: two teaspoonfuls (5mg in 10 ml) to be taken once daily.
Children 6 to II years of agei One tesapoonfislof-Delarexsyrup (2.5 mg in 5 ml) to be given once daily. Children 12 months to 5 years of age: HaIfa teaspoonful of Delarex syrup (1.25mg in 2.5 ml) to be given once daily. Children 6 to 11 months of age:2 ml (1 mg) to be given once daily with a special measuring device.
Patients with hepatic or renal impairment should be given desloratadine 5 mg on alternate days initially. Delarex tablets are supplied in boxes of 20 tablets each.
Delarex syrup is supplied in bottles of 60 ml each. Store at temperature not exceeding 3OnC, in dry place. Keep out of reach of children
Pharyngitis, dry mouth, myalgia, fatigue, somnolence, dysmenorrhoea, incidence of sedation and low antimuscarinic effects.
Other side effects have been reported such as tachycardia, palpitations and rarely anhythmias and hypersensitivity reactions (such as rash, pruritus, urticaria, oedema, dyspnea, and anaphylaxis), extrapyramidal effects, blood disorders and elevated liver enzymes including bilimbin and very rarely hepatitis.
Other side effects have been reported such as tachycardia, palpitations and rarely anhythmias and hypersensitivity reactions (such as rash, pruritus, urticaria, oedema, dyspnea, and anaphylaxis), extrapyramidal effects, blood disorders and elevated liver enzymes including bilimbin and very rarely hepatitis.
GLOBAL NAPI PHARWCEUTICALS 2 ndst6o ZoneNo.40 8 8 6
GLOBAL NAPI ANTIHISTAMINE
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