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Cetrizet D

Composition
Each film coated tablet of Cetrizet D contains:

Cetirizine Hydrochloride BP .................... 5mg

Pseudoephedrine Hydrochloride BP ........ 120mg

(As extended release)


Product Description
A yellow coloured, circular, film coated tablet with break line marked on one side and plain on the other side.

Description
Combination of antihistamine and decongestant used to relieve allergic rhinitis.

ACTION AND MODE OR MECHANISMS OF ACTION
Pharmacodynamic

Cetirizine is a potent antihistamine with a low potential for drowsiness at pharmacologically active doses and with additional anti-allergic properties. It is selective H,-antagonist with negligible effects on other receptors and so is virtually free from anti-cholinergic and antiserotonin effects. At pharmacologically active doses, it induces neither sedation nor behaviour changes. This may be explained by the fact that cetirizine does not cross the blood-brain barrier.


It was shown in human pharmacology studies that cetirizine inhibits certain effects produced by exogenous histamine. This activity appears rapidly. Cetirizine also inhibits the effects produced by endogenous histamine released in vivo by any agent. It also inhibits the cutaneous reaction induced by VIP (Vasoactive Intestinal Polypeptide) and substance P, neuropeptides, which are believed to take part in the allergic reaction.


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 the 'late' allergic response.
Cetirizine markedly reduces bronchial hyper-reactivity to histamine in the asthmatic patient. It also reduces the allergic reaction induced by specific allergens. These effects are obtained without any central effects being demonstrated either by psychometric tests or by quantified EEG.


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.

Pharmacokinetic
Cetirizine
After oral administration, cetirizine is rapidly and almost completely absorbed. Under fasting conditions, Cmax is about 1 hour. The extent of absorption is not reduced by food; however, the rate of absorption is reduced and the peak levels are expected about 3 hrs after dosing. Cetirizine does not undergo any appreciable first-pass metabolism. After repeated oral administration, the daily urinary excretion of unchanged cetirizine is approximately 65% of the dose. The absorption and the elimination of cetirizine are independent of the dose. Inter and infra subject variations are low. The plasma half-life of cetirizine is approximately 9 hours. This value is increased in patients with reduced renal function. Cetirizine is strongly bound to plasma proteins.

Pseudoephedrine
Pseudoephedrine is rapidly and completely absorbed after oral administration. Pseudoephedrine, given as a sustained-release formulation, provides maximum plasma levels 8 hrs after administration. About 1/4-1/2 of the administered dose of pseudoephedrine is transformed by the liver into inactive metabolite through N-de-methylation. This metabolite and the remaining non-metabolized pseudoephedrine are excreted via the kidneys.


The rate of urinary excretion is increased when the urine is acidic, and reduced in case of alkalinization of urine. The absorption of pseudoephedrine is not affected by fatty meals. After repeated oral administration (every 12 hrs), the steady state is obtained within 6 days and the effective half-life is estimated to 15 hrs.


There was no evidence for a relevant pharmacokinetic interaction between cetirizine and pseudoephedrine.

Indications
Treatment of symptoms associated with seasonal allergy or hay fever, perennial allergic rhinitis and common cold e.g., nasal congestion, sneezing, rhinorrhea, nasal and ocular pruritus.


Cetrizet-D should be administered when both the antiallergic properties of cetirizine HCI and the nasal decongestant activity of pseudoephedrine HCI are desired.


Recommended Dosage, Dosage Schedule
Adult and children ≥ 12 years:
The recommended dosage is 1 tablet, twice daily. Do not take more often than one tablet every twelve hours.


The tablet should preferably be swallowed with some liquid and should not chewed.


Treatment should normally not exceed the symptomatic period. When adequate relief from nasal symptoms is obtained, treatment with an antihistaminic drug should be continued, if appropriate.

Symptoms and Treatment For Overdosage
Cetirizine hydrochloride
Drowsiness can be a symptom of overdosage, occurring from administration of 50 mg of Cetirizine dihydrochloride as a single dose. In the case of massive overdosage, gastric lavage should be performed together with the usual supportive measures. To date, there is no specific antidote. Apart from the usual supportive measures, all vital parameters have to be monitored regularly.

Pseudoephedrine Hydrochloride
Symptoms of overdosage include irritability, restless, tremor, convulsions, palpitations, hypertension, difficulty in micturition, tachycardia, arrhythmia, signs of CNS depression (sedation, apnea, unconsciousness, cyanosis and cardiovascular collapse) or stimulation (insomnia, hallucination, tremor, seizures) which can be fatal.

Treatment preferably in a hospital setting, should be symptomatic and supportive, taking into account any concomitantly ingested medication. Necessary steps should be taken to maintain the support respiration and control convulsions. Gastric lavage should be performed if indicated. After vomiting, the drug still remaining in the stomach can be absorbed using a suspension of charcoal in water. Apart from the usual supportive measures, all vital parameters have to be monitored regularly. There are no known antidotes. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid duress or by dialysis. Sympathomimetic amines should not be used.

Hypertension can be controlled with alpha-blockers and tachycardia with beta-blockers. Seizures can be treated with 10mg of IV diazepam or 0.5mg/kg of diazepam given rectally in the case of children.

Mode of Administration

Oral

1    2

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