Generic

Rupatadine Fumarate

Indications

Rupatadine is indicated for the symptomatic treatment of Seasonal & Perennial Allergic Rhinitis and Urticaria

Pharmacology

Rupatadine is a long-acting, non-sedative antagonist of histamine H1-receptors. It also antagonizes the platelet-activating factor (PAF). Both histamine and PAF cause broncho constriction which leads to an increase in the vascular permeability and act as a mediator in the inflammatory process. With the dual mode of action, Rupatadine shows better therapeutic effect than an isolated antihistamine. Rupatadine possesses other anti-allergic properties such as the inhibition of the degranulation of mast cells induced by immunological and non-immunological stimuli and inhibition of the release of cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human mastocytes and monocytes.

Dosage & Administration

Adults and adolescents (over 12 years): The recommended dose is 10 mg once a day.
Route of administration: Oral. Minista® (Rupatadine) may be taken with or without food.

Interaction

With medicine: The concomitant administration of Rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure. Rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4. Rupatadine should be used with caution when it is co-administered with statins, CNS depressants or alcohol.

With food: Grapefruit and Grapefruit juice should not be taken simultaneously with Rupatadine.

Contraindications

Hypersensitivity to Rupatadine or to any of the excipients.

Side Effects

Common: Asthenia, dizziness, drowsiness.
Uncommon: Appetite increased, arthralgia, back pain, concentration impaired, constipation, cough, diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased risk of infection, irritability, malaise, myalgia, nasal dryness,
nausea, oropharyngeal pain, rash, thirst, vomiting, weight increased.
Rare: Palpitations, tachycardia

Pregnancy & Lactation

No adequate data available. It is preferable to avoid the use of Rupatadine during pregnancy & lactation. It is unknown whether Rupatadine is excreted into breast milk.

Precautions & Warnings

Rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia or acute myocardial ischemia. Rupatadine should be used with caution in elderly patients (65 years and older). As there is no clinical experience in patients with impaired kidney or liver function, the use of Rupatadine 10 mg tablets is at present not recommended in these patients.

Therapeutic Class

Antihistamines that do not cause drowsiness

Storage Conditions

Store in cool & dry place below 30°C, protect from light & moisture.
Keep out of reach of children.

Phamaceutical Name

Radiant Pharmaceuticals Ltd.