Indications of Rosela 10 mg

Rosela 10 mg is indicated for the symptomatic treatment of Seasonal and Perennial Allergic Rhinitis and Urticaria.

Theropeutic Class

Non-sedating antihistamines

Pharmacology

Rosela 10 mg is a second generation, non-sedating, long-acting histamine antagonist with selective peripheral H1 receptor antagonist activity. It further blocks the receptors of the platelet-activating factor (PAF) according to in vitro and in vivo studies.Rupatadine possesses anti-allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non-immunological stimuli, and inhibition of the release of cytokines, particularly of the tumor necrosis factors (TNF) in human mast cells and monocytes.

Dosage and Administration of Rosela 10 mg

Rupatadine Tablet: The recommended dosage is 10 mg once daily, with or without food. Rupatadine Oral Solution (Children aged 2 to 11 year): Children weighing 25 kg or more: 1 teaspoonful (5 ml) of oral solution once daily with or without food. Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.

Dosage of Rosela 10 mg

Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day. Rupatadine may be taken with or without food.Children aged 2 to 11 years: Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the oral solution once daily with or without food. Children weighing equal or more than 10 kg to less than 25 kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.

Interaction of Rosela 10 mg

With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine

Contraindications

Hypersensitivity to Rupatadine or to any of the excipients.

Side Effects of Rosela 10 mg

Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness, nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare: Palpitations, tachycardia.

Pregnancy and Lactation

Pregnancy category B2 (by TGA, Australia). There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine, unless the potential benefit outweighs the potential risk for the fetus. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.

Precautions and Warnings

Rosela 10 mg 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.

Overdose Effects of Rosela 10 mg

The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs, symptomatic treatment together with the required supportive measures should be given.

Storage Conditions

Store in cool and dry place below 30°C, protect from light and moisture. Keep out of reach of children.

Use In Special Populations

Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.

Drug Classes

Non-sedating antihistamines

Mode Of Action

Rosela 10 mg is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.

Pregnancy

There is no clinical data available on the exposure of Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine unless the potential benefit outweighs the potential risk for the infant. No information is available, whether Rupatadine is excreted in the mother's milk. Therefore, it should not be used during lactation, unless the potential benefits for the mother justify the potential risk to the infant.

Pediatric Uses

Elderly: Rupatadine should be used with caution in elderly. No information is available that indicates the requirement of any dose adjustment in this population.Children: Neither the safety nor the efficacy of Rupatadine has been established in patients less than 12 years of age.Patients with renal or hepatic insufficiency: Use of Rupatadine is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.