Class: Antihistamine and decongestant

Manufacturer: Sun Pharma, Sun Pharma House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai-400 063, Maharashtra, India.

Dosage Form: Tablet

Similar Brands:

Uses:

Seasonal allergy or hay fever.

Dosage:

For seasonal allergy or hay fever the recommended dosage is 1 tablet, twice daily. Do not take more often than one tablet every twelve hours

Side Effects:

Cetrizine hydrochloride

In objective tests of psychomotor function, the incidence of sedation with cetrizine was similar to that of placebo. There have been occasional reports of mild and transient side effects such as headache, dizziness, drowsiness, agitation, dry mouth and gastro-intestinal discomfort. If desired the dose may be taken 5mg in the morning and 5mg in the evening.

Pseudoephedrine hydrochloride

Serious adverse effects associated with the use of pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, including sleep disturbances and rarely, hallucinations have been reported.

Skin rashes, with or without irritation, have occasionally been reported. Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement could have been an important predisposing factor.

Warnings & Precautions:

Cetrizine hydrochloride

Studies in healthy volunteers at 20 and 25mg/day have not revealed effects on alertness or reaction time, however, patients are advised not to exceed the recommended dose if driving or operating machinery.

Pseudoephedrine hydrochloride

Pseudoephedrine hydrochloride should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants, other sympathomimetic agents such as decongestants, appetite suppressants and amphetamine-like psychostimulants. Caution should be exercised in the present of severe renal or hepatic impairment, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. There is no information on the effect of pseudoephedrine on human fertility.

Pregnancy & Lactation:

There is no specific data on the use of cetrizine or pseudoephedrine during pregnancy. Therefore, Cetrizet D should be given only if the potential benefit justifies the potential risks to the fetus/neonate. Cetrizine and pseudoephedrine are excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known.

Drug Interactions:

Cetrizine hydrochloride

As cetrizine is the only minimally metabolized, being excreted unchanged primarily via the kidneys, it may have a low potential for adverse drug reactions involving induction or inhibition of metabolic enzyme systems.

Potentially hazardous interactions

There are no reports of hazardous interactions with other drugs to date. Concomitant administration with alcohol or diazepam does not impair psychomotor performance any more than the impairment of performance produced by alcohol alone.

Pseudoephedrine hydrochloride

Concomitant use of pseudoephedrine with other sympathomimetic agents such as decongestants, trycyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may occasionally cause rise in blood pressure.

The effect of antihypertensive agents which interfere with sympathetic activity may be partially reversed by pseudoephedrine e.g. bretylium, bethadine, guanethidine, debrisoquine, methyldopa, alpha and beta-adrenergic blocking agents.

Contraindications:

1. In patients with a history of hypersensitivity to any of the constituents
2. In lactating women since it is excreted in breast milk
3. In patients who had previous intolerance to pseudoephedrine
4. In patients with severe hypertension or severe coronary artery disease.
5. In patients who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure.
6. Concurrent administration of furazolidone and pseudoephedrine.

Price: Ksh 4500

Notes:

Pack Size: 100s

Mechanism of action

Cetrizine is a potent antihistamine with low potential for drowsiness at pharmacologically active dosed and with additional anti-allergic properties. It is selective H1-antagonist with negligible effects on other receptors and so is virtually free from anti-cholinergic and anti-serotonin effects. Cetrizine 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 the “late” allergic response. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30ml/minute and the excretion half-life is approximately nine hours. Cetrizine is strongly bound to plasma proteins.

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory tract decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

Overdosage

Cetrizine hydrochloride

Drowsiness can be a symptom of over dosage, occurring from administration of 50mg of cetrizine dihydrochloride as a single dose. In the case of massive over dosage, gastric lavage should be performed together with the usual supportive measures. To date there is no specific antidote.

Pseudoephedrine hydrochloride

Symptoms of over dosage include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty micturition. Necessary steps should be taken to maintain the support respiration and control convulsions. Gastric lavage should be performed if indicated. Catheterization of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid dieresis or by dialysis.

Ref: PXPI2247