CETIRIZINE ORAL DROPS

Description

PROPERTIES:
Cetirizine oral drops contains cetirizine hydrochloride which is a potent selective H1-antagonist with negligible anticholinergic and antiserotonergic activity. Cetirizine is classified as a non-sedating antihistaminic because it produces minimal sedation and psychomotor impairment due to its limited penetration of the blood-brain barrier. The once daily intake of cetirizine is adequate to provide 24 hours symptomatic relief of allergic manifestations such as runny nose, sneezing, itching of the nose, itchy watery eyes and urticaria.

Pharmacokinetics:
″ In case of adult and children over 6 years: After oral administration of 10 mg cetirizine, the peak plasma concentration is reached in 1 hour.
In case of children older than 2 years: The peak plasma concentration is reached in more than 1 hour.
The plasma half-life is 11 hours in adults, 6 hours in children more than 6 years and 5 hours in children form 2 to 6 years.
″ The elimination is essentially by kidney.
″ Cetirizine is highly bound to plasma protein.

INDICATIONS:
″ Symptoms of seasonal allergic rhinitis and conjunctivitis.
″ Perennial allergic rhinitis.
″ Chronic urticaria and pruritus.

DOSAGE:
Adult & children 12 years and older: 10 mg (20 drops) per day as single dose.
Children from 6 to 11 years: 10 mg (20 drops) per day as single dose or divided into 2 doses.
Children from 2 to 5 years: 5 mg (10 drops) per day as single dose or divided into 2 doses.

CONTRAINDICATIONS:
″ Hypersensitivity to cetirizine hydrochloride.
″ Renal insufficiency.
″ Children less than 2 years.

SIDE EFFECTS:
Vertigo, Somnolence may occur, fatigue, cutaneous eruption and urticarea rarely occur. Psychotic agitation specially in children, digestive troubles, dryness of mouth, hepatic disorders, tachycardia.

Drug interactions:
None.

Pregnancy & lactation:
″ The use of cetirizine during pregnancy should be only if necessary.
″ The use of cetirizine during lactation is not recommended.

Precautions & warning:
″ Activities requiring mental alertness.
″ Caution should be taken when driving a motor vehicle or operating machinery.
″ In case of epileptic patients or having a risk of convulsions, the administration of cetirizine should be with great care.

PACKING:
A dropper bottle containing 15 ml.

STORAGE:
Keep at a temperature below 30C.
Keep out of reach of children.

instruction to patients:
None.