Rupatadine fumarate
Active Pharmaceutical Ingredients 2025-03-03
Catalog ID80071761
CAS NO.182349-12-8
Purity 95%
MDL Number MFCD00926499
Colecular FormulaC26H26ClN3.C4H4O4
Molecular Weight532.03
Melting point: 58~61°C
| Item | Information |
|---|---|
| Mechanism of Action | Rupatadine fumarate is a potent, selective, and long-acting dual antagonist of histamine H1 receptors and platelet-activating factor (PAF) receptors, with Ki values of 0.1 μM and 0.55 μM, respectively. |
| Indications | – Treatment of intermittent and persistent allergic rhinitis in adults and adolescents (≥12 years of age).<br>- Treatment of chronic idiopathic urticaria. |
| Dosage Forms | Tablets (e.g., 10 mg) for oral administration. |
| Common Side Effects | – Drowsiness (9.5%).<br>- Headache (6.9%).<br>- Fatigue (3.2%).<br>- Dry mouth.<br>- Gastrointestinal disturbances (e.g., nausea, diarrhea). |
| Uncommon Side Effects | Increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough, dry throat, rhinitis, nausea, abdominal pain, diarrhea, indigestion, vomiting, constipation, rash, back pain, joint pain, muscle pain, thirst, general discomfort, fever, abnormal liver function test, and increased weight. |
| Rare Side Effects | Palpitations, increased heart rate, and allergic reactions (itching, hives, swelling of the face, lips, tongue, or throat). |
| Drug Interactions | Avoid concurrent use with known CYP3A4 inhibitors (e.g., ketoconazole, erythromycin). It does not interact significantly with azithromycin, fluoxetine, or lorazepam. |
| Special Precautions | – Not recommended for patients with hepatic or renal impairment.<br>- Avoid grapefruit juice, as it may increase plasma levels of rupatadine.<br>- Use with caution in elderly patients.<br>- Not recommended during pregnancy or breastfeeding due to insufficient clinical data.<br>- Avoid in patients with known allergies to any component of the drug. |
| Storage Conditions | Store at room temperature, protected from moisture |
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