Rupex

Indications

Rupex is indicated for the effective management of Seasonal & Perennial Allergic Rhinitis and Urticaria (Hives).
Use this medication as advised by a registered healthcare provider.

Pharmacology

Rupatadine is a long-acting, non-sedating antihistamine that works by blocking histamine H1 receptors. Additionally, it inhibits the Platelet Activating Factor (PAF), which contributes to bronchoconstriction and increases vascular permeability, both of which are involved in the inflammatory response. By targeting both histamine and PAF, Rupatadine offers superior therapeutic benefits compared to single-action antihistamines.

Beyond its dual mechanism, Rupatadine has other anti-allergic properties. It prevents the degranulation of mast cells triggered by both immunological and non-immunological factors. Additionally, it inhibits the release of cytokines such as Tumor Necrosis Factor Alpha (TNF-α) in human mast cells and monocytes.

Dosage & Administration

For Adults and Adolescents (over 12 years):
The recommended dose is 10 mg once daily, with or without food.

For Children Aged 2-11 Years:

• Children weighing 25 kg or more: 5 ml (1 teaspoonful) of the oral solution once daily, with or without food.
• Children weighing between 10 kg and 25 kg: 2.5 ml (1/2 teaspoonful) of the oral solution once daily, with or without food.

Use as per the guidance of a registered healthcare professional.

Drug Interactions

With Medicines:
Concomitant use of Rupex (20 mg) with Ketoconazole or Erythromycin may increase systemic exposure. Use with caution when co-administered with other CYP3A4 inhibitors, statins, CNS depressants, or alcohol.

With Food:
Avoid consuming grapefruit or grapefruit juice while taking Rupatadine, as it may affect its efficacy.

Contraindications

Do not use Rupex if you have a known hypersensitivity to Rupatadine or any of its ingredients.

Side Effects

Common: Asthenia (weakness), dizziness, drowsiness.
Less Common: Increased appetite, arthralgia, back pain, impaired concentration, constipation, dry throat, epistaxis (nosebleeds), fever, gastrointestinal discomfort, irritability, malaise, muscle pain, nausea, oropharyngeal pain, rash, thirst, weight gain, vomiting.
Rare: Palpitations, tachycardia (increased heart rate).

Pregnancy & Lactation

Pregnancy:
There is insufficient clinical data regarding Rupatadine during pregnancy. It should only be used if the benefits outweigh potential risks to the fetus.

Lactation:
The excretion of Rupatadine in breast milk is not known. It should not be used during breastfeeding unless the potential benefit to the mother justifies the potential risk to the infant.

Precautions & Warnings

Rupex should be used cautiously in individuals with prolonged QT interval, uncorrected hypokalemia, or conditions like bradycardia or acute myocardial ischemia. Special caution is required for elderly patients (65+ years) and those with kidney or liver impairments, as clinical data for these populations is limited. The use of Rupex 10 mg tablets is not currently recommended for patients with renal or hepatic insufficiency.

Use in Special Populations

• Elderly: Use cautiously in older adults. No specific dose adjustments are recommended based on age.
• Children: Rupex has not been studied for safety or effectiveness in children under 12 years.
• Renal/Hepatic Insufficiency: Use is not recommended in patients with impaired kidney or liver function due to lack of relevant clinical data.

Overdose Effects

Overdose may cause drowsiness. In case of accidental ingestion of large amounts, provide symptomatic treatment and supportive care as needed.

Therapeutic Class

Non-sedating antihistamines.

Storage Conditions

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