Rupatadine Fumarate
Therapeutic Class: Anti Histamine (Non-sedating antihistamines)
Presentation:
Rupatadine tablet: Each tablet contains Rupatadine Fumarate INN equivalent to Rupatadine 10 mg.
Rupatadine syrup: Each 5 ml syrup contains Rupatadine Fumarate INN equivalent to Rupatadine 5 mg.
Description:
Rupatadine is a preparation of Rupatadine. Rupatadine is a new selective histamine H1 receptor and platelet-activating factor (PAF) antagonist. Rupatadine has a dual mechanism of action. It acts as a long-acting, non-sedative antagonist at histaminergic H1-receptor and also antagonizes the platelet-activating factor (PAF). This dual mechanism of action gives Rupatadine a major clinical efficacy.
Indications:
Rupatadine is indicated for the symptomatic treatment of seasonal & perennial allergic rhinitis and idiopathic urticaria.
Dosage & Administration:
Adults and adolescents (above 12 years): 10 mg (one tablet) once daily, with or without food.
Elderly (above 65 years): Rupatadine should be used with caution in the elderly. No information is available that indicates the requirement of any dose adjustment for this group of patient.
Children: Use of Rupatadine is not recommended in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended.
Rupatadine Syrup:
Children aged 2 to 11 years:
Children weighing 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) syrup once a day with or without food.
Children weighing 25 kg or more: 1 teaspoonful (5ml) of syrup once a day with or without food.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended.
Side Effects:
Rupatadine is a non-sedating antihistamine. However, as in other non-sedating second-generation antihistamines, the most common side effects may be somnolence, headache and fatigue.
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B2. Available limited data showed no adverse effect of Rupatadine on pregnancy or the fetus/newborn child. Since data are not sufficient, pregnant women should use Rupatadine if the expected benefits outweigh the potential risk to the mother and child.
Lactation: No information is available, whether Rupatadine is excreted in the mother\'s milk. Therefore, it should be used during lactation if the potential benefits outweigh the potential risk to the mother and child.
Interaction:
Inhibitors of CYP3A4 may decrease the metabolism of Rupatadine. As in the case of other anti-histamines, the interactions with CNS depressants cannot be excluded.
Overdose:
Accidental consumption of a very high dose should be treated symptomatically together with the necessary supportive measures.
Storage:
Store in a cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Presentation:
Rupatadine tablet: Each tablet contains Rupatadine Fumarate INN equivalent to Rupatadine 10 mg.
Rupatadine syrup: Each 5 ml syrup contains Rupatadine Fumarate INN equivalent to Rupatadine 5 mg.
Description:
Rupatadine is a preparation of Rupatadine. Rupatadine is a new selective histamine H1 receptor and platelet-activating factor (PAF) antagonist. Rupatadine has a dual mechanism of action. It acts as a long-acting, non-sedative antagonist at histaminergic H1-receptor and also antagonizes the platelet-activating factor (PAF). This dual mechanism of action gives Rupatadine a major clinical efficacy.
Indications:
Rupatadine is indicated for the symptomatic treatment of seasonal & perennial allergic rhinitis and idiopathic urticaria.
Dosage & Administration:
Adults and adolescents (above 12 years): 10 mg (one tablet) once daily, with or without food.
Elderly (above 65 years): Rupatadine should be used with caution in the elderly. No information is available that indicates the requirement of any dose adjustment for this group of patient.
Children: Use of Rupatadine is not recommended in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended.
Rupatadine Syrup:
Children aged 2 to 11 years:
Children weighing 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) syrup once a day with or without food.
Children weighing 25 kg or more: 1 teaspoonful (5ml) of syrup once a day with or without food.
Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended.
Side Effects:
Rupatadine is a non-sedating antihistamine. However, as in other non-sedating second-generation antihistamines, the most common side effects may be somnolence, headache and fatigue.
Use in Pregnancy & Lactation:
Pregnancy: Pregnancy category B2. Available limited data showed no adverse effect of Rupatadine on pregnancy or the fetus/newborn child. Since data are not sufficient, pregnant women should use Rupatadine if the expected benefits outweigh the potential risk to the mother and child.
Lactation: No information is available, whether Rupatadine is excreted in the mother\'s milk. Therefore, it should be used during lactation if the potential benefits outweigh the potential risk to the mother and child.
Precautions:
Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.
Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.
Interaction:
Inhibitors of CYP3A4 may decrease the metabolism of Rupatadine. As in the case of other anti-histamines, the interactions with CNS depressants cannot be excluded.
Overdose:
Accidental consumption of a very high dose should be treated symptomatically together with the necessary supportive measures.
Store in a cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
0 Comments
if you have any doudts.please let me know