COMPOSITION :
Delosdin® Film coated tablet 5 mg, each film coated tablet contains : Desloratadine 5 mg.
DESCRIPTIONS :
Delosdin® contains Desloratadine as active ingredient available in film coated tablet 5 mg.
INDICATIONS :
- Allergic rhinitis : To relief of the nasal and non-nasal symptoms of allergic rhinitis (including intermittent and persistent allergic rhinitis) in patients 12 years of age and older.
- Urticaria : Symptomatic relief of pruritus, reduction in the number of hives and size of hives, in patients with urticaria 12 years of age and older.
DOSAGE AND ADMINISTRATIONS :
In adults and children 12 years of age and over : 1 tablet (5 mg) once daily.
In patients with liver or renal impairment : A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data.
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 allergen exposure periods.
OVERDOSAGE :
- Information regarding acute overdose is limited. Sleepiness is reported at a dose of 10 mg and 20 mg/day.
- In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended.
- Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.
CONTRAINDICATIONS :
Hypersensitivity to this medication or to any of its ingredients or to Loratadine.
WARNINGS AND PRECAUTIONS :
- Nursing mothers : Desloratadine 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.
- Pediatric use : The safety and effectiveness of Desloratadine tablet in pediatric patients under 12 years of age have not been established.
- Geriatric use : In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
- Patients should be instructed to use Desloratadine tablets as directed. As there are no food effects on bioavailability, patients can be instructed that Desloratadine tablets may be taken without regard to meals.
- Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur.
ADVERSE REACTIONS :
- Allergic rhinitis : Pharyngitis, dry mouth, myalgia, fatigue, somnolence, dysmenorrhea.
- Chronic idiopathic urticaria : Headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia, myalgia, tachycardia and rarely hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea and anaphylaxis), psychomotor hyperactivity, seizures, hepatitis and elevated liver enzymes including bilirubin.
PRESENTATIONS :
Delosdin® Film coated tablet 5 mg Box, 3 strips @ 10 film coated tablets
Reg. No. DKL1702356617A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
