Rupafin

Rupafin

rupatadine

Manufacturer:

Hyphens

Distributor:

Pan-Malayan
Concise Prescribing Info
Contents
Rupatadine fumarate
Indications/Uses
Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) & urticaria in adults & adolescents ≥12 yr (tab) & childn 2-11 yr (oral soln).
Dosage/Direction for Use
Tab: 10 mg once daily. Oral soln: Childn 2-11 yr weighing ≥25 kg 5 mL once daily, ≥10 kg-<25 kg 2.5 mL once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Patients w/ known QT interval prolongation, uncorrected hypokalemia, ongoing proarrhythmic conditions (eg, clinically significant bradycardia, acute myocardial ischemia). Concomitant use w/ grapefruit juice. Renal or hepatic impairment. Concomitant use with potent or moderate CYP3A4 inhibitors. Concomitant use of CYP3A4 substrates. Glucose-galactose malabsorption. Tab: Not recommended in childn <12 yr. Galactose intolerance or Lapp lactase deficiency. Avoid during pregnancy. Lactation. Elderly ≥65 yr. Oral soln: Contains sucrose (may be harmful to teeth). Fructose intolerance, sucrase-isomaltase insufficiency. Methyl parahydroxybenzoate may cause allergic reactions (possibly delayed). Not recommended in childn <2 yr.
Adverse Reactions
Somnolence, headache. Tab: Dizziness; dry mouth; fatigue, asthenia.
Drug Interactions
Increased systemic exposure w/ ketoconazole, erythromycin, grapefruit juice, potent or moderate CYP3A4 inhibitors. Alcohol, CNS depressants, statins.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AX28 - rupatadine ; Belongs to the class of other antihistamines for systemic use.
Presentation/Packing
Form
Rupafin oral soln 1 mg/mL
Packing/Price
1's
Form
Rupafin tab 10 mg
Packing/Price
10's
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