DELOSDIN Syrup

Desloratadine 0.5 mg / ml

COMPOSITION :

Delosdin® Syrup 0.5 mg/ml, each ml contains : Desloratadine 0.5 mg.

 

DESCRIPTIONS : 

Delosdin® contains Desloratadine as active ingredient available in syrup 0.5 mg/ml.

 

INDICATIONS : 

Delosdin® is indicated for the relief of symptoms associated with :

  • Allergic rhinitis (AR, including intermittent and persistent allergic rhinitis).
  • Urticaria.

 

DOSAGE AND ADMINISTRATIONS  : 

  • Children 6 – 11 years of age : 5 ml (2.5 mg) once a day, with or without a meal.
  • Children 1 – 5 years of age : 2.5 ml (1.25 mg) once a day, with or without a meal.
  • In adults and adolescents (≥ 12 years of age) : 10 ml (5 mg) once a day, with or without a meal.

Intermittent allergic rhinitis (presence of symptoms for less then 4 days per week or for less then 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 then 4 weeks), continued treatment may be proposed to the patients during allergen exposure periods.

 

OVERDOSAGE : 

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 and it is not known if it is eliminated by peritoneal dialysis.

 

CONTRAINDICATIONS : 

Hypersensitivity to the active substance or to any of the excipients, or to Loratadine.

 

WARNINGS AND PRECAUTIONS : 

  • Efficacy and safety of Desloratadine syrup in children under 1 year of age have not been established. In the case of severe renal insufficiency, Desloratadine syrup should be used with caution. This medicinal product contains sucrose and sorbitol; thus, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
  • Effect on ability to drive and use machines : No effect on the ability to drive and use machines have been observed (see Pharmacodynamic).
  • Usage during pregnancy and lactation : Since no clinical data on exposed pregnancies are available with Desloratadine, the safe use of Desloratadine during pregnancy has not been established. Desloratadine is not to be used during pregnancy unless the potential benefits outweigh the risks. Desloratadine is excreted into breast milk, therefore the use of Desloratadine is not recommended in breast-feeding women.

 

DRUG INTERACTIONS : 

  • There was no effect of food or grapefruit juice on the disposition of Desloratadine.
  • Desloratadine taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.

 

ADVERSE REACTIONS : 

  • Most frequent : Fatigue, dry mouth and headache.
  • Very rare :
  • Cardiac disorders : Tachycardia, palpitations, psychomotor hyperactivity, seizures.
  • Gastrointestinal disorders : Abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
  • Hepato-biliary disorders : Hepatitis, elevations of liver enzymes, increased bilirubin.
  • General disorders : Hypersensitivity reactions (such as anaphylaxis, angioedema, pruritus, rash and urticaria).

 

PRESENTATIONS :

Delosdin® Syrup 0.5 mg/ml Box, 1 bottle @ 60 ml

Reg. No. DKL1702355937A1

 

STORAGE :

STORE  BELOW 30ºC, PROTECT FROM LIGHT

 

After packaging is opened, the solution is stable for 30 days at storage below 30ºC.

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by : 

BERNOFARM

Sidoarjo – Indonesia