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Allergies

CLARINEX (DESLORATADINA) SYRUP 60ML
 
 

CLARINEX (DESLORATADINA) SYRUP 60ML
SKU: 7501050616973



In stock: 1000 units
Price: $ 24.11 USD*
Sale: $ 19.95 USD*
* United States Dollars


THERAPEUTIC INDICATIONS: Antihistamine.
AZOMYR ® Solution is indicated for rapid relief of symptoms associated with allergic rhinitis and other allergic conditions, including sneezing, rhinorrhea, nasal congestion and itching, as well as itching, tearing and redness, itching of the palate and coughing; to after 6 months.
AZOMYR ® Solution is also indicated for the relief of symptoms and signs of acute and chronic urticaria and other allergic skin conditions from 6 months.
Pharmacokinetics in Humans:
Desloratadine is an antagonist of histamine non-sedating, long acting, with potent peripheral H1-receptor antagonist. Desloratadine has demonstrated antiallergic activity, antihistamine and anti-inflammatory.
Desloratadine plasma concentrations can be detected within 30 minutes after administration. The agent is well absorbed, achieving maximum concentrations after approximately 3 hours, the terminal phase half-life is approximately 27 hours.
The degree of accumulation of desloratadine was correlated with the half-life and his administration once a day. The bioavailability of desloratadine is proportional to the dose between 5 and 20 mg.
Desloratadine is moderately bound (83 to 87%)
to plasma proteins. No evidence of clinically significant drug accumulation after administration once daily (at doses of 5 to 20 mg) for 14 days.
The enzyme responsible for the metabolism of desloratadine has not been identified, so some drug interactions can not be completely excluded. In vivo studies with specific inhibitors of CYP3A4 and CYP2D6 have shown that these enzymes are important in the metabolism of desloratadine. Desloratadine does not inhibit CYP3A4 or CYP2D6 and not a substrate or inhibitor of P-glycoprotein
In a single-dose study using a dose of 7.5 mg of desloratadine, food (high fat breakfast, rich in calories) did not change the absorption parameters of desloratadine. In another study, grapefruit juice had no effect on the bioavailability of desloratadine.
In a single dose crossover study, formulations and solution AZOMYR ® Tablets were bioequivalent, and are not affected by the presence of food (rich in fat and calories).
In separate single dose studies in approved doses, pediatric patients had AUC and Cmax of desloratadine comparable to those reported in adults receiving AZOMYR ® Solution 5 mg per day.
After oral administration, desloratadine specifically blocks peripheral histamine receptors H1 because the agent does not penetrate the central nervous system (CNS).
In addition to antihistaminic activity, desloratadine has demonstrated antiallergic and antiinflammatory activity in numerous in vitro studies (mostly conducted in human cells) and in vivo. These studies have shown that desloratadine inhibits the wide cascade of events that initiate and propagate allergic inflammation, among which are included:
The release of proinflammatory cytokines such as:
IL-4, IL-6, IL-8, IL-13.
The release of proinflammatory chemokines important as the activator and regulator of normal T-cell expressed and secreted (RANTES, for its acronym in English).
Superoxide anion production by activated polymorphonuclear neutrophils.
Adhesion and chemotaxis of eosinophils.
The expression of adhesion molecules such as
P-selectin.
Release of histamine, prostaglandin PGD2 and leukotriene LTC4, IgE dependent.
The acute allergic bronchoconstrictor response and allergic cough in animal models.
AZOMYR ® security solution was demonstrated in 3 clinical studies in pediatric populations. Pediatric patients 6 months to 11 years who were candidates for antihistamine therapy received a daily dose of 1 mg (6 to 11 months), 1.25 mg (1 to 5 years) or 2.5 mg (6 to 11 years). Treatment was well tolerated as documented by laboratory tests, monitoring of vital signs and ECG data, including analysis of QTc. The plasma concentration of desloratadine was comparable in adult and pediatric patients, when administered at recommended doses. Because the natural history of allergic rhinitis and urticaria and the profile of desloratadine is similar in pediatric and adult patients, the efficacy data in adults can be extrapolated to the pediatric population.
In a multiple dose clinical study, which were administered as 20 mg of desloratadine for 14 days, no significant cardiovascular effects statistically or clinically significant. In a clinical pharmacology study in which desloratadine was administered at a dose of 45 mg daily (nine times the clinical dose) for ten days, there was no QTc interval prolongation.
Desloratadine does not penetrate into the central nervous system. At the recommended dose of 5 mg daily, the incidence of somnolence was comparable to placebo. In clinical studies with doses up to 7.5 mg daily, AZOMYR ® solution did not affect psychomotor performance.
A dose of desloratadine 5 mg did not affect standard measures of flight ability of pilots including exacerbation of subjective sleepiness or processes related to pilotage.
No changes in plasma concentrations of desloratadine, clinically significant, drug-drug interaction studies of multiple doses, made with ketoconazole, erythromycin, azithromycin, fluoxetine, and cimetidine.
In clinical pharmacology studies, concomitant administration of alcohol did not increase the effect of reduction in psychomotor performance induced by alcohol or increase drowsiness. There were no significant differences in the psychomotor test results between the groups receiving desloratadine and placebo were administered either by themselves or with alcohol.
AZOMYR ® Solution and Tablets was effective in relieving symptoms such as sneezing, postnasal discharge and itching, nasal congestion and itchy eyes and palate, watery and red eyes. AZOMYR ® Solution and Tablets effectively relieved symptoms for 24 hours.
In addition to the classification of seasonal and perennial allergic rhinitis can alternatively be classified in intermittent allergic rhinitis and persistent allergic rhinitis according to the duration of symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms for less than 4 days a week or less than 4 weeks. Persistent allergic rhinitis is defined as the presence of symptoms for 4 days or more per week and over 4 weeks.
In two trials of 4 weeks on patients with seasonal allergic rhinitis and asthma, desloratadine was effective in reducing symptoms of seasonal allergic rhinitis (sneezing, rhinorrhea, nasal congestion and itching, and itching, tearing and redness of the eyes, itching of the palate and ears) and asthma (cough, wheezing, difficulty breathing), and decreased beta-agonist medication use. FEV1 did not change in the groups receiving desloratadine and placebo.
In studies conducted in adults and adolescents with chronic idiopathic urticaria, desloratadine was effective in relieving pruritus and decreasing the size and number of lesions at 24 hours of starting treatment.
In each study, the effects lasted for 24 hours interval of dosage. Treatment with desloratadine also improved sleep quality and daytime activity, as demonstrated by the decrease in the interference of sleep quality and daytime activities.
We have seen that AZOMYR ® Solution is effective in relieving ocular discomfort of seasonal allergic rhinitis as demonstrated in the questionnaire on quality of life for the total score in rhinoconjunctivitis. The best therapeutic response is associated with increased ratings of the domain to solve practical problems in performing daily activities limited by symptoms.
CONTRAINDICATIONS: Hypersensitivity to the active substance or any excipients, during pregnancy and lactation.
Not established the safety and efficacy of AZOMYR ® Solution in pediatric patients below 6 months.
Special Precautions: No adverse effects were observed on the ability to guide vehicles and using machinery.
The appropriate dose should be administered by the graduate dispenser included in the package.
Use in Pregnancy and Lactation: No effects of desloratadine on fertility in rats at an exposure 34 times the human exposure resulting from the administration of the agent at the recommended clinical dose.
No teratogenic or mutagenic effects in animal studies with the use of desloratadine. As there is no clinical data on pregnancies with exposure to desloratadine, the safe use of AZOMYR ® Solution during pregnancy has not been established.
AZOMYR ® solution should not be used during pregnancy unless formally establish the benefit / risk.
Desloratadine is excreted in breast milk, so that should make the decision to discontinue nursing or discontinue the drug.
Pediatric Use: See Dosage and administration.
It has been established AZOMYR ® security solution in 246 subjects aged 6 months to 11 years in three controlled clinical trials. Has not been established below this range.
ADVERSE REACTIONS: In clinical studies in pediatric population AZOMYR ® solution was administered in 246 children 6 months to 11 years. The incidence of adverse effects was similar to placebo in patients 2 to 11 years treated with AZOMYR ® Solution. In pediatric patients 6 to 23 months, adverse events most frequently reported placebo were diarrhea (3.7%), fever (2.3%) and insomnia (2.3%).
In clinical studies in a range of indications included allergic rhinitis and chronic idiopathic urticaria recommended dose of 5 mg daily, undesirable effects were reported AZOMYR ® Solution 3% more of patients receiving placebo. Adverse effects reported more frequently compared to placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).
Since marketing began AZOMYR ® Solution, have been reported as an exception, hypersensitivity reactions including anaphylaxis and rash. In addition, cases of tachycardia, palpitations, psychomotor hyperactivity, seizures, elevated liver enzymes, hepatitis and increased bilirubin have been reported very rarely.
DRUG INTERACTIONS AND OTHER GENDER: In clinical studies there were no clinically important drug interactions with AZOMYR ® Solution (see Pharmacokinetics and pharmacodynamics in humans).
Another study showed that grapefruit juice has no effect on the bioavailability of desloratadine.
AZOMYR ® Solution taken concomitantly with alcohol did not increase the effect of reduction in psychomotor performance induced by alcohol. In a single-dose study using a dose of 7.5 mg of desloratadine, food (high fat breakfast, rich in calories) did not change the absorption parameters of desloratadine.
No changes in plasma concentrations of desloratadine, clinically significant, drug-drug interaction studies of multiple doses, made with ketoconazole, erythromycin, azithromycin, fluoxetine, and cimetidine.
CHANGES IN RESULTS OF LABORATORY TESTS: None reported to date.
PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, TERATOGÉNE-SIS AND FERTILITY: Desloratadine has no carcinogenic risk in humans, according to data available in the original studies of loratadine. Desloratadine showed no mutagenic effects on mutagenesis studies in vitro and in vivo.
Desloratadine was not teratogenic in rats or rabbits at exposures 228 and 864 times greater, respectively, human exposure at the recommended clinical dose.
Desloratadine is the primary active metabolite of loratadine. Preclinical studies conducted with desloratadine and loratadine demonstrated that there were no significant differences in the toxicity profile of both exposure levels comparative with desloratadine. Preclinical data with desloratadine reveal no special hazard for humans on conventional studies of safety pharmacology, repeated dose toxicity, genetic toxicity and reproductive toxicity.
The lack of carcinogenic potential was demonstrated in studies conducted with loratadine.
DOSAGE AND ADMINISTRATION: Oral.
Children 6 months to 11 months: Take 2 ml (1.0 mg) of AZOMYR ® solution once daily, with or without meals, for relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria acute and chronic.
Children 12 months to 5 years: Take 2.5 ml (1.25 mg) of AZOMYR ® solution once daily, with or without meals, for relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria acute and chronic.
Children 6 to 11 years: Take 5 ml (2.5 mg) of AZOMYR ® solution once daily, with or without meals, for relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria acute and chronic.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or less than 4 weeks) should be managed according to the evaluation of the patient, their disease, and treatment can be discontinued after symptoms been resolved and restarted when the last resort. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and over 4 weeks), continued treatment can be proposed to patients during periods of exposure to allergens.
The appropriate dose should be administered by the graduate dispenser included in the package.
REPRESENTATIONS AND MANAGEMENT Overdosage: In case of overdose, consider standard measures to remove the active substance has not been absorbed. We recommend symptomatic treatment and supportive.
Based on clinical studies in adolescents and adults with multiple doses, which was administered 45 mg of desloratadine (9 times the recommended clinical dose), we determined the absence of relevant side effects.
Desloratadine is not eliminated by hemodialysis; not know if it can be removed by peritoneal dialysis

  • Name of medicine: Azomyr
  • Comparable patent medicine: Clarinex
  • Active ingredient: Desloratadine
  • Presentation: Solution
  • Concentration: 50mg/100ml
  • Extended-release tablets: No
  • Lab: Schering-Plough, SA de CV
  • Bottle with 60 ml graduated dropper
  • Made in: Mexico.
  • Pharmacies online, Rx online, Drugs online, Pharmacy online, Drugs online, prescription online, Drug store online, Brand Name drugs and generic drugs, all located in Pharmacy Del Niño



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