Rupatadine is a long-acting non-sedating histamine H1 receptor antagonist. It also antagonizes platelet activating factor (PAF). Both histamine and PAF can cause bronchoconstriction, increase vascular permeability, and act as mediators in the inflammatory process. Due to its dual mode of action, rupatadine shows better therapeutic effects than antihistamines alone. Rupatadine has other antiallergic properties, such as inhibiting mast cell degranulation caused by immune and non-immune stimuli and inhibiting the release of cytokines, especially tumor necrosis factor alpha (TNF alpha) in human mast cells and monocytes.
Dosage & Administration
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.
Combination with medication: Rupatadine 20 mg combined with ketoconazole or erythromycin will increase systemic exposure. Rupatadine should be used with caution when using these medications and other CYP3A4 isoenzyme inhibitors at the same time. Rupatadine should be used with caution when combined with statins, central nervous system depressants, or alcohol.
Take with food: Grapefruit and grapefruit juice should not be taken at the same time as rupatadine.
Allergic to rupatadine or any excipients.
Common: fatigue, dizziness, drowsiness. Uncommon: increased appetite, joint pain, back pain, inattention, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, dry nose, nausea, Sore mouth and throat, skin rash, thirst, vomiting, weight gain. Rare: palpitations, tachycardia.
There are no clinical data on exposure to rupatadine during pregnancy. Therefore, pregnant women should not use rupatadine unless the potential benefits outweigh the potential risks to the baby. There is no information available on whether rupatadine will be excreted in human milk. Therefore, it should not be used during breastfeeding unless the potential benefit to the mother justifies the potential risk to the baby.
For patients with a known long QT interval, patients with uncorrected hypokalaemia, and patients with persistent arrhythmia (such as clinically significant bradycardia or acute myocardial ischemia), rupatadine should be used with caution. Elderly patients (65 years or older) should use rupatadine with caution. As there is no clinical experience in patients with renal or hepatic impairment, the use of rupatadine 10 mg tablets is currently not recommended in these patients.
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.