Allegra pills 120 mg 10 pcs
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Active ingredients
Fexofenadine
Release form
Pills
Composition
1 tablet contains: fexofenadine hydrochloride 120 mg. Adjuvants: croscarmellose sodium - 24 mg, pregelatinized starch - 120 mg, microcrystalline cellulose - 133 mg, magnesium stearate - 3 mg.
Pharmacological effect
Histamine H1 receptor blocker. Fexofenadine (a pharmacologically active metabolite of terfenadine) is an antihistamine agent with selective antagonistic activity to histamine H1 receptors without anticholinergic and alpha-adrenergic blocking action. In addition, fexofenadine does not show a sedative effect and other effects on the CNS side. and lasts for 24 hours after taking it. Even after 28 days of taking fexofenadine, no tolerance to the drug was detected. With a single dose of fexofenadine, a dose-dependent increase in the antihistamine effect is observed with an increase in dose from 10 mg to 130 mg. When using the same model of antihistamine action, it was found that a dose of at least 130 mg was necessary for a constant action over 24 hours. The maximum suppression of blistering and hyperemia of the skin is more than 80%. In patients with seasonal allergic rhinitis who received up to 240 mg of Fexofenadine 2 times / day for 2 weeks, the duration of the QTc interval (QT adjusted) did not differ from that taken with placebo. Also not observed QTc changes when taking fexofenadine by healthy volunteers 60 mg 2 times / day for 6 months, 400 mg 2 times / day for 6.5 days, and 240 mg / day for 1 year compared with the duration of QTc for placebo. Even with plasma At a concentration of 32 times the therapeutic concentration in humans, fexofenadine did not affect the potassium channels of the delayed straightening in the human heart.
Pharmacokinetics
Absorption and distribution of Fexofenadine after oral administration is rapidly absorbed, Tmax is approximately 1-3 h.The average Cmax when taking 120 mg / day is about 289 ng / ml, and when you take 180 mg / day - about 494 ng / ml. . At a dose of 240 mg, 2 times / day there is a slightly greater than proportional (by 8.8%) increase in AUC, which indicates that the pharmacokinetics of fexofenadine is almost linear in the dose range from 40 to 240 mg per day. 60-70%. Metabolism Fexofenadine is slightly metabolized in the liver and outside it, as evidenced by the fact that it is the only substance detected in significant quantities in the urine and feces of humans and animals. Excretion Nia fexofenadine biexponential plasma decreases, and the final T1 / 2 of 11-15 ch.Soglasno currently available data most of the dose in unchanged form excreted in the bile and 10% - in the urine.
Indications
- seasonal allergic rhinitis (to reduce symptoms) - 120 mg pills; - chronic idiopathic urticaria (to reduce symptoms) - 180 mg pills.
Contraindications
- hypersensitivity to any of the components of the drug; - pregnancy; - lactation period; - children under 12 years old. With caution: - in patients with chronic renal and hepatic insufficiency, as well as in elderly patients (lack of clinical experience in this category patients); - in patients with cardiovascular diseases, incl. in history (antihistamines can cause palpitations and tachycardia).
Use during pregnancy and lactation
There is not enough data on the use of fexofenadine in pregnant women. Limited animal studies have shown no signs of adverse effects on pregnancy, fetal development, childbirth, and postnatal development. Fexofenadine should not be used during pregnancy. There are no data on the content of fexofenadine in breast milk when it is taken by women during the breastfeeding period. However, it has been shown that terfenadine is excreted in breast milk in women.Therefore, the use of fexofenadine during breastfeeding is not recommended.
Dosage and administration
The drug is intended for oral administration. The recommended dose of fexofenadine for seasonal allergic rhinitis for adults and children 12 years and older is 120 mg 1 time / day before meals. The recommended dose of fexofenadine for chronic urticaria for adults and children 12 years and older is 180 mg 1 time / day before meals. Studies in special risk groups (elderly patients, patients with renal and hepatic insufficiency) showed that they do not require correction dosing regimen.
Side effects
In placebo-controlled clinical trials, the most frequent (≥1% - less than 10%) were observed: headache (7.3%), drowsiness (2.3%), dizziness (1.5%) and nausea (1.5%). When taking fexofenadine, the incidence of the above adverse effects was similar to that taken with placebo. In placebo-controlled studies with a frequency of less than 1% (equally with taking fexofenadine and placebo) and with post-marketing use, weakness, insomnia, nervousness, and sleep disorders or unusual dreams ( paronyria), such as nightmares; tachycardia, palpitations; diarrhea. In rare cases (≥0.01% - less than 0.1%): rash, urticaria, pruritus and other hypersensitivity reactions, such as angioedema, difficulty breathing, shortness of breath, skin hyperemia, systemic anaphylactic reactions.
Overdose
Symptoms: dizziness, drowsiness and dry mouth. Healthy volunteers took single doses up to 800 mg and course doses up to 690 mg 2 times / day for 1 month or 240 mg 2 times / day for 1 year without any significant adverse effects compared to placebo. The maximum tolerated dose for fexofenadine has not been established. Treatment: in the case of overdose, it is recommended to carry out gastric lavage, taking activated charcoal, and if necessary symptomatic and supportive therapy. Hemodialysis is ineffective.
Interaction with other drugs
When combined with fexofenadine erythromycin or ketoconazole, the concentration of fexofenadine in plasma increases by 2-3 times, but this is not accompanied by a significant lengthening of the QTc interval.There were no significant differences in the incidence of adverse effects when using these drugs as monotherapy and as part of combination therapy. Animal studies have shown that the aforementioned increase in plasma concentrations of fexofenadine is probably associated with improved absorption of fexofenadine and a decrease in its biliary excretion or secretion into the lumen of the gastrointestinal tract. magnesium antacids 15 minutes before taking fexofenadine leads to a decrease in the bioavailability of the latter as a result, apparently, of binding in the gastrointestinal tract.
special instructions
It is recommended that the time interval between taking fexofenadine and antacids containing aluminum or magnesium hydroxide is at least 2 hours. Use in pediatricsFor use in children from 6 to 11 years old, pills of 30 mg are produced. Effect on ability to drive vehicles and control mechanismsWhen taking the drug it is possible to perform work requiring high concentration of attention and quickness of psychomotor reactions (except for patients with non-standard reaction). Therefore, it is recommended to check the individual response to fexofenadine before engaging in such activities.