Stark Tablet Rupatadine 10mg

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PRESENTATION:
Stark® Tablet : Each tablet contains Rupatadine Fumarate
equivalent to Rupatadine 10mg.
PHARMACOLOGY:
Rupatadine is a non-sedating, long-acting antagonist of
histamine H1 Receptors. It also antagonizes the Platelet
Activating Factor (PAF). Both histamine and PAF cause
bronchoconstriction which leads to an increase in the
vascular permeability and act as a mediator in the
inflammatory process. 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 TNFα (Tumor Necrosis Factor
Alpha) in the human mast cells and monocytes.
INDICATIONS & USAGE:
Stark® (Rupatadine) is indicated for the symptomatic relief of
seasonal & perennial Allergic Rhinitis and Urticaria in
patients with Adults and Children of 2 years of age and older.
DOSAGE & ADMINISTRATION:
Stark® Tablet: Adults and Adolescents (Over 12 years of
age): The recommended dose is 10mg (1 tablet) once a day,
with or without food.
SIDE EFFECTS:
Stark® is a non-sedating antihistamine. However, the most
common undesirable side effects are sleepiness, general
weakness & fatigue. Other uncommon side effects include
dyspepsia, rash and increased appetite.
DRUG INTERACTION:
The concomitant administration of Rupatadine 20mg and
Ketoconazole or Erythromycin increases the systemic
exposure to Rupatadine 10 times and 2-3 times respectively.
Co-administration of Rupatadine with Erythromycin and
other moderate CYP3A4 inhibitors (i.e. Azithromycin,
Fluconazole, Diltiazem) should be avoided. Also,
Rupatadine should be used with caution when it is
co-administered with statins or CNS depressants or Alcohol.
CONTRAINDICATION:
Rupatadine is contraindicated in patients with known
hypersensitivity to any of its ingredients.
PRECAUTIONS:
Administration of a dose of 10mg daily of Rupatadine has not
shown significant effects on the function of the Central
Nervous System as seen in specific studies done for
psychomotor function. Nevertheless, the patient should take
precaution in driving or managing machines.
USE IN PREGNANCY & LACTATION:
No adequate data is available. Caution should be exercised
when prescribing Rupatadine to pregnant or lactating
women; it is unknown whether Rupatadine is excreted into
breast milk.
PEDIATRIC USE:
Rupatadine should not be used in children under 2 years of
age or weighing less than 10kg.
USE IN RENAL & HEPATIC INSUFFICIENCY:
As there is no clinical experience in patients with impaired or
liver functions, use of Rupatadine is not recommended in
these patients.
STORAGE:
Store in a cool & dry place, away from light & children.
PACKAGE QUANTITIES:
Stark® Tablet : Each box containing 3×10’s tablets in blister
strips.

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Stark Tablet Rupatadine 10mg