Rupex is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria.
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.
Rupatadine 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.
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.
Hypersensitivity to Rupatadine or to any of the excipients.
Rupex 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. Rupex 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 Rupex 10 mg tablets is at present not recommended in these patients.
Elderly
Rupex 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 Rupex has been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency
Use of Rupex is not recommended in patients with renal or hepatic insufficiency. As no relevant clinical data is available.
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.
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.
With medicine: The concomitant administration of Rupex 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupex should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupex 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
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Rupex 5 mg/5 ml Solution is H1-receptors antagonist. It also antagonizes the platelet activating factor (PAF).
Rupex 5 mg/5 ml Solution is commonly used to treat seasonal & perennial allergic rhinitis and urticaria.
Rupex 5 mg/5 ml Solution is maybe unsafe to use during pregnancy.
Unknown. Human and animal studies are not available. Please consult your doctor.
There is no data available. Please consult doctor before consuming the drug.
Caution should be advised in patients with renal impairment.
There is no data available. Please consult doctor before consuming Rupex 5 mg/5 ml Solution.
The action is initiated in the first 75 minutes after administration.
The duration of action of Rupex 5 mg/5 ml Solution is in between 8 to 10 hrs.
Always consult a registered physician before taking any medicine. Prices shown are MRP and may vary by pharmacy.