Rufecta 10mg is a tablet containing 10 mg of Rupatadine Fumarate . It is manufactured by Biopharma Limited .
Indications:
Rufecta 10mg is indicated for the symptomatic treatment of:
- Seasonal allergic rhinitis (hay fever)
- Perennial allergic rhinitis (year-round allergies)
- Urticaria (hives)
Pharmacology:
Rupatadine is a second-generation, non-sedating antihistamine. It works by selectively blocking peripheral H1 receptors, which reduces the effects of histamine, a chemical the body releases during an allergic reaction. Rupatadine also inhibits the platelet-activating factor (PAF), another mediator involved in allergic and inflammatory processes.
Dosage and Administration:
- Adults and adolescents (over 12 years): The recommended dose is 10 mg once daily , with or without food.
Contraindications:
Rufecta 10mg is contraindicated in patients with:
- Hypersensitivity to rupatadine or any of the excipients.
Side Effects:
Common:
- Asthenia (weakness)
- Dizziness
- Drowsiness
Uncommon:
- Increased appetite
- Arthralgia (joint pain)
- Back pain
- Impaired concentration
- Constipation
- Cough
- Diarrhea
- Dry throat
- Epistaxis (nosebleed)
- Fever
- Gastrointestinal discomfort
- Increased risk of infection
- Irritability
- Malaise (general feeling of discomfort)
- Myalgia (muscle pain)
- Nasal dryness
- Nausea
- Oropharyngeal pain (pain in the mouth and throat)
- Rash
- Thirst
- Vomiting
- Weight increased
Rare:
- Palpitations (fast or irregular heartbeat)
- Tachycardia (increased heart rate)
Pregnancy and Lactation:
- Pregnancy: There is limited clinical data on the use of rupatadine in pregnant women. It should only be used if the potential benefit outweighs the potential risk to the fetus.
- Lactation: It is not known whether rupatadine is excreted in breast milk. Therefore, it is not recommended for use during breastfeeding unless the potential benefits for the mother justify the potential risk to the infant.
Precautions and Warnings:
Rufecta 10mg should be used with caution in patients with:
- Known prolongation of the QT interval on an ECG.
- Uncorrected hypokalemia (low potassium levels).
- Ongoing proarrhythmic conditions (e.g., clinically significant bradycardia, acute myocardial ischemia).
- Elderly patients (65 years and older).
- Impaired kidney or liver function (use is currently not recommended due to lack of clinical experience).
Drug Interactions:
- The concomitant administration of rupatadine with ketoconazole or erythromycin (CYP3A4 inhibitors) increases systemic exposure to rupatadine and should be used with caution.
- Caution should be exercised when rupatadine is co-administered with statins, CNS depressants, or alcohol.
- Grapefruit and grapefruit juice should not be taken simultaneously with rupatadine as they can increase the levels of rupatadine in the body.
Storage Conditions:
Store in a cool and dry place below 30°C, protected from light and moisture. Keep out of reach of children.
Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication.
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