PROCET (Cetirizine) is a carboxylated derivative of the potent second generation antihistamine, Hydroxyzine. It is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonin effects. At pharmacologically active dose levels, it does not cause behavioural changes, which may be explained by the absence of passage through the blood-brain barrier. Cetirizine inhibits the histamine-mediated early phase of the allergic reactions and also reduces the migration of inflammatory cells and the release of mediators associated with the late allergic response.
PROCET Tablet: Each film coated tablet contains Cetirizine Hydrochloride BP 10 mg.
PROCET Syrup: Each 5 ml syrup contains Cetirizine Dihydrochloride BP 5 mg.
PROCET is indicated for the treatment of various allergic disorders including seasonal rhinitis, conjunctivitis, perennial allergic rhinitis, pruritus and urticaria.
DOSAGE AND ADMINISTRATION:
Usual adult and adolescent dose: Oral, 5 to 10 mg once a day.
Note: In patients with reduced creatinine clearance (<31 ml per min.) and with hepatic impairment, a dose of 5 mg once a day is recommended.
Usual pediatric dose:
Children up to 2 years of age: Safety and efficacy has not been established.
Children 2 to 6 years of age: Oral, 2.5 mg once a day. The dosage may be increased to a maximum daily dose of 5 mg given as once a day or 2.5 mg every 12 hours.
Children 6 years of age and older: Oral, 5 or 10 mg once a day.
Note: The dosage should be decreased in patients who have reduced renal function (Creatinine clearance of 11-13 ml per minute) or hepatic function impairment. In patients up to 6 years of age with renal or hepatic dysfunction, cetirizine use is not recommended. For children 6 years of age and older, the lower dosage of 5 mg once a day should be used.
PROCET (Cetirizine) is contraindicated in patients who have shown hypersensitivity, idiosyncrasy to it or its parent compound, Hydroxyzine.
Clinical studies of cetirizine at a dose up to 25 mg/day in healthy volunteers have not revealed effects on alertness or reaction time. Patients are advised not to exceed the recommended dose if they are engaged in skilled tasks like driving or operating machinery. At the therapeutic levels, cetirizine did not show any potentiation of alcohol. However, care should be exercised.
USE IN PREGNANCY AND LACTATION:
There is inadequate information about the safety of cetirizine during pregnancy. Hence its use in pregnant women is not recommended. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing mothers are advised not to take the medication since it is excreted in breast milk.
Use in elderly: Some dose reduction may be required if renal function is impaired.
Use in renal impairment: Dose amount and frequency will require modification in patients with impairment of renal function.
There are no known interactions of cetirizine with other drug till to date. Nevertheless caution should be excercised with concomitant use of sedatives.
Cetirizine has little or no effect on psychomotor function with the incidence of sedation being similar to that of placebo. There have been occasional reports of mild and transient side effects such as drowsiness, headache, dizziness, agitation, dry mouth and gastrointestinal discomfort.
INFORMATION TO THE PATIENT:
As with other antihistamines, patients are advised to avoid excessive consumption of alcohol.
PROCET Tablet: Each box contains 10 x 10 tablets in blister pack.
PROCET Syrup: Amber glass bottle containing 60 ml syrup.