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Medicines and generics searching. Query must consist minimum of 3 characters:. Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. LV is not responsible for any damage to your health as the result of self treatment. Maximum allowed state defined price from ZVA webpage Euro: Tablets also contain as inactive ingredients: The molecular weight is Cetirizine hydrochloride is a white, crystalline powder and is water-soluble. The chemical structure is shown below:. Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in chloroform. Cetirizine, a metabolite of hydroxyzine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors. The antihistaminic activity of cetirizine has been clearly documented in a variety of animal and human models. In vivo and Ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In clinical trials, however, dry mouth was more common with cetirizine than with placebo. In vitro receptor binding studies have shown no measurable affinity for other than H 1 receptors. Autoradiographic studies with radiolabeled cetirizine in the rat have shown negligible penetration into the brain. Ex vivo experiments in the mouse have shown that systemically administered cetirizine does not significantly occupy cerebral H 1 receptors. Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects. The bioavailability of cetirizine hydrochloride and pseudoephedrine hydrochloride from ZYRTEC-D 12 HOUR Extended Release Tablets is not significantly different from that achieved with separate administration of a cetirizine 5 mg tablet and a pseudoephedrine mg extended release caplet. Co-administration of cetirizine and pseudoephedrine does not significantly affect the bioavailability of either component. Food had no significant effect on the extent of cetirizine absorption AUC , but Tmax was delayed by 1. Food had no significant effect on the pharmacokinetics of pseudoephedrine. No plasma protein binding data in humans are available. Most of the rapid increase in peak plasma radioactivity was associated with parent drug, suggesting low first pass metabolism. Cetirizine is metabolized to a limited extent by oxidative O-dealkylation to a metabolite with negligible antihistaminic activity. The enzyme or enzymes responsible for this metabolism have not been identified. One to seven percent of the pseudoephedrine dose appeared to be metabolized to norpseudoephedrine by N-demethylation after a single dose. It was reported that 0. Pharmacokinetic interaction trials with cetirizine in adults were conducted with pseudoephedrine, antipyrine, ketoconazole, erythromycin and azithromycin. No interactions were observed. The disposition of theophylline was not altered by concomitant cetirizine administration. The decrease in cetirizine clearance in these elderly volunteers may be related to decreased renal function. The effect of gender on cetirizine or pseudoephedrine pharmacokinetics has not been adequately studied. The effect of race on cetirizine or pseudoephedrine pharmacokinetics has not been adequately studied. The pharmacokinetics of cetirizine were similar in patients with mild impairment and normal volunteers. Therefore, pseudoephedrine may accumulate in patients with renal insufficiency. Trials in 69 adult normal volunteers aged 20—61 years showed that cetirizine at doses of 5 and 10 mg inhibited the skin wheal and flare caused by the intradermal injection of histamine. The effects of intradermal injection of various other mediators or histamine releasers were also inhibited by cetirizine. In mildly asthmatic subjects, cetirizine at 5 to 20 mg blocked bronchoconstriction due to nebulized histamine, with virtually total blockade after a 20 mg dose. In trials conducted for up to 12 hours following cutaneous antigen challenge, the late phase recruitment of eosinophils, neutrophils and basophils, components of the allergic inflammatory response, was inhibited by cetirizine at a dose of 20 mg. The clinical significance of these findings is not known. In four clinical trials in healthy adult males, no clinically significant mean increases in QTc were observed in cetirizine treated subjects. In the first study, a placebo-controlled crossover trial, cetirizine was given at doses up to 60 mg per day, 6 times the maximum clinical dose, for 1 week, and no significant mean QTc prolongation occurred. In the second study, a crossover trial, cetirizine 20 mg and erythromycin mg every 8 hours were given alone and in combination. There was no significant effect on QTc with the combination or with cetirizine alone. In the third trial, also a crossover study, cetirizine 20 mg and ketoconazole mg per day were given alone and in combination. Cetirizine caused a mean increase in QTc of 9. Ketoconazole also increased QTc by 8. The combination caused an increase of Thus, there was no significant drug interaction on QTc with the combination of cetirizine and ketoconazole. In the fourth study, a placebo-controlled parallel trial, cetirizine 20 mg was given alone or in combination with azithromycin mg as a single dose on the first day followed by mg once daily. There was no significant increase in QTc with cetirizine 20 mg alone or in combination with azithromycin. In a six-week, placebo-controlled study of patients aged 12—64 years with allergic rhinitis and mild to moderate asthma, cetirizine 10 mg once daily improved rhinitis symptoms and did not alter pulmonary function. This study supports the safety of administering cetirizine to allergic rhinitis patients with mild to moderate asthma. In the two trials, patients were aged 12 to 17 years. The primary efficacy measure in both trials was the mean change from baseline in the subject-rated Total Symptom Severity Complex TSSC score, which included the following symptoms: Nine multicenter, randomized, double-blind, clinical trials comparing cetirizine 5 to 20 mg to placebo in patients 12 years and older with seasonal or perennial allergic rhinitis were conducted in the United States. Five of these showed significant reductions in symptoms of allergic rhinitis, 3 in seasonal allergic rhinitis 1 to 4 weeks in duration and 2 in perennial allergic rhinitis for up to 8 weeks in duration. In general, the 10 mg dose was more effective than the 5 mg dose and the 20 mg dose gave no added effect. Some of these trials included pediatric patients aged 12 to 16 years. It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include insomnia, dizziness, weakness, tremor, or arrhythmias. Sympathomimetic amines may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly are more likely to have adverse reactions to sympathomimetic amines. Cetirizine hydrochloride and pseudoephedrine hydrochloride do not influence the pharmacokinetics of each other when administered concomitantly. No clinically significant drug interactions have been found with cetirizine and theophylline at a low dose, azithromycin, ketoconazole, or erythromycin. There was a small decrease in the clearance of cetirizine caused by a mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect. Concomitant use with antihypertensive drugs that interfere with sympathetic activity e. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis. There are no carcinogenicity trials of pseudoephedrine and cetirizine in combination. Cetirizine was not mutagenic in the Ames test or mouse lymphoma test and not clastogenic in the human lymphocyte assay or the in vivo rodent micronucleus test. Likewise, the combination of cetirizine and pseudoephedrine in a 1: However, the Ames and mouse lymphoma assays did not strictly adhere to test standards. These effects were not observed at 1. This effect was not observed at 1. For pseudoephedrine administered alone, 0. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, although the elderly are more likely to have adverse reactions to sympathomimetic amines. In general, dosing in an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Of the total number of subjects in clinical trials of cetirizine alone, were 65 years and over, while 39 were 75 years and over. No overall differences in safety were observed between these subjects and younger subjects, and other reported experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. With regard to efficacy, clinical trials of cetirizine for each approved indication did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger patients. This dose of pseudoephedrine exceeds the recommended dose for pediatric patients under 12 years of age. Controlled and uncontrolled clinical trials of cetirizine conducted in the United States and Canada included more than patients aged 12 years and older, with more than receiving cetirizine at doses of 5 to 20 mg per day. The duration of treatment ranged from 1 week to 6 months, with a mean exposure of 30 days. Most adverse reactions reported during therapy with cetirizine were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving cetirizine 5 mg or 10 mg was not significantly different from placebo 2. The most common adverse reaction in patients aged 12 years and older that occurred more frequently on cetirizine than placebo was somnolence. Discontinuations due to somnolence for cetirizine were uncommon 1. Fatigue and dry mouth also appeared to be treatment-related adverse reactions. There were no differences by age, race, gender or by body weight with regard to the incidence of adverse reactions. Table 2 lists adverse experiences in patients aged 12 years and older that were reported for cetirizine 5 and 10 mg in controlled clinical trials in the United States and were more common with cetirizine than placebo. A causal relationship of these infrequent events with cetirizine administration has not been established. Central and Peripheral Nervous Systems: Body as a Whole: Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of cetirizine has been reported. In foreign marketing experience or experience in the post market period, the following additional rare, but potentially severe adverse events have been reported: Pseudoephedrine hydrochloride may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, nausea, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse. Information regarding acute overdosage is limited to experience with cetirizine alone and the marketing history of pseudoephedrine hydrochloride. Overdosage has been reported with cetirizine. In one adult patient who took mg of cetirizine, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an month-old pediatric patient who took an overdose of cetirizine approximately mg , restlessness and irritability were observed initially; this was followed by drowsiness. Should overdose occur, treatment should be symptomatic or supportive, taking into account any concomitantly ingested medications. There is no known specific antidote to cetirizine. Cetirizine is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested. In rodents, the target of acute toxicity was the central nervous system, and the target of multiple-dose toxicity was the liver. In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma and respiratory failure. Norwegian Institute of Public Health - \\\\\\\\\\\\\\[Nov\\\\\\\\\\\\\\]. Unreasonable use of drugs is harmful to your health! Please consult with your doctor or pharmacist. Carefully read medicine application instructions! Query must consist minimum of 3 characters: Queues for medical examinations. Lists of compensated medicines. Please enable JavaScript to contact.

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