Rosela Tablet 10 mg
Rosela Tablet 10 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Trade Name | Rosela Tablet 10 mg |
Generic | Rupatadine Fumarate |
Weight | 10 mg |
Type | Tablet |
Therapeutic Class | Non-sedating antihistamines |
Manufacturer | Healthcare Pharmaceuticals Ltd. |
Available Country | Bangladesh |
Last Updated: | October 19, 2023 at 6:27 am |
Uses
Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.Dosage
Rosela Tablet 10 mg dosage
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.Side Effects
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.Precaution
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
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 RupatadinePregnancy & Breastfeeding use
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.Contraindication
Hypersensitivity to Rupatadine or to any of the excipients.Special Warning
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.Acute Overdose
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 Condition
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.Innovators Monograph
You find simplified version here Rosela Tablet 10 mg