Indications

Cetirizine is indicated for symptomatic treatment of perennial and seasonal allergic rhinitis, idiopathic urticaria in adults and children over 12 years of age, allergic conjunctivitis.

Present

Blister of 15 film– coated tablets. Box of 2 blisters.

Composition

Cetirizine dihydrochloride …………………………………………..10mg
Excipients s.q. for ……………………………………………………1 tablet
(Corn starch, lactose, povidone, magnesium stearate, methacrylic acid copolymer, hypromellose, titanium
dioxide, polyethylene glycol 6000, talc, polysorbate 80, ethanol 96%).

Actions

– Cetirizine is a potent antihistamine with a low potential for drowsiness at pharmacologically active doses and with additional anti– allergic properties.
– Cetirizine inhibits the histamine– mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with late phase allergic response.

Contra-Indications

Patients with history of allergy to cetirizine, hydroxyzine or hypersensitivity to any ingredient of the drug.

Side effect

– Common: drowsiness, fatigue, dryness of mouth, pharyngitis, dizziness, headache, nausea.
– Less common: loss of appetite or increased appetite, dysuria, facial flushing, increased salivation.
– Rare: hemolytic anemia, thrombocytopenia, severe hypotension, anaphylactic shock, hepatitis, cholestasis, glomerulonephritis.
– Inform your doctor about side– effects when using this medicine.

Precaution

– The dosage should be adjusted in patients with hepatic impairment, in patients with moderate to severe renal impairment, patients on hemodialysis.
– Patients should be warned that cetirizine may cause somnolence and caution should be exercised in taking the drug while driving or operating machinery.
– Avoid concomitant administration of cetirizine with alcohol and other CNS depressants, since cetirizine may increase the effects of these drugs.
PREGNANCY & LACTATION:
Pregnant women and nursing mothers should not use this medicine.

Interaction

– To date, there are no known interactions with other drugs. Nevertheless, MEKOZITEX 10 should be used with caution if sedatives are also being taken.
– A mild decrease in the clearance of cetirizine was observed when 400mg theophylline was administration concomitantly with cetirizine.
OVERDOSAGE & MANAGEMENT:
– In acute cetirizine overdosage the manifestations include somnolence in adults, restlessness and irritability followed by drowsiness in children. In case of severe overdosage, the stomach should be emptied by gastric lavage or by induced emesis, and other symptomatic and supportive measures should be used as needed.
– If overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place, not exceeding 3^oC. Protect from light.

Dosage

– Take orally without regard to meal.
– As prescribed by the physician.
– Recommended dosage:
* Adults and children > 6 years of age: 1 tablet once daily or divided into 2 doses daily.
* In patients with renal insufficiency (creatinine clearance 11 – 31mL/min), patients on hemodialysis (creatinine learance less than 7mL/min) and in hepatically impaired patients: ½ tablet once daily.