Rupex 10

Indications

Rupex is indicated for the symptomatic management of Seasonal and Perennial Allergic Rhinitis and Urticaria.
Consult a registered healthcare professional before use.

Pharmacology

Rupex contains Rupatadine, a long-acting, non-sedative antihistamine that effectively blocks histamine H1-receptors and also inhibits platelet-activating factor (PAF). Both histamine and PAF contribute to bronchoconstriction, increased vascular permeability, and inflammation. By addressing both mechanisms, Rupatadine provides superior therapeutic benefits compared to standard antihistamines. It also inhibits mast cell degranulation and the release of inflammatory cytokines, including TNF-α in mast cells and monocytes, making it highly effective in treating allergic conditions.

Dosage & Administration

• Adults & Adolescents (12 years and older): The recommended dose is 10 mg once daily, with or without food.
• Children (2 to 11 years):
  • Children weighing 25 kg or more: 5 ml oral solution once daily.
  • Children weighing 10 kg to <25 kg: 2.5 ml oral solution once daily.

Consult a registered healthcare professional for personalized dosing recommendations.

Interactions

Concomitant use of Rupex (20 mg) with ketoconazole or erythromycin may increase its systemic exposure. Use with caution when co-administered with CYP3A4 inhibitors, statins, CNS depressants, or alcohol.
Avoid consuming grapefruit or grapefruit juice with Rupex, as it may affect drug metabolism.

Contraindications

• Hypersensitivity to Rupatadine or any of its components.

Side Effects

Common side effects may include fatigue, dizziness, and drowsiness. Uncommon effects include increased appetite, back pain, and gastrointestinal discomfort. Rarely, palpitations and tachycardia may occur.

Pregnancy & Lactation

• Pregnancy: Insufficient data is available regarding the safety of Rupex during pregnancy. It should only be used if the potential benefit outweighs the potential risk to the fetus.
• Lactation: No data on excretion in breast milk. Avoid use during breastfeeding unless absolutely necessary.

Precautions & Warnings

Rupex should be used with caution in patients with prolonged QT interval, hypokalemia, or proarrhythmic conditions (e.g., bradycardia or myocardial ischemia). It is not recommended for patients with renal or hepatic insufficiency.

Use in Special Populations

• Elderly: No dose adjustment is required, but use with caution.
• Children under 12: Safety and efficacy have not been established for this age group.

Overdose Effects

The most common symptom of overdose is somnolence. In case of overdose, provide symptomatic treatment and supportive care.

Therapeutic Class

Non-Sedating Antihistamines

Storage Conditions

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