Allegra Table n / 120mg film about 10 pc

$13.87

Allegra Table n / 120mg film about 10 pc

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SKU: 994436833 Categories: , Tags: ,

Description

Composition
Active substance:
Fexofenadine hydrochloride 120.0 mg or 180.0 mg.
Excipients:
Croscarmellose sodium, pregelatinized starch, microcrystalline cellulose, magnesium stearate, hypromellose E-15, E-5, hypromellose, povidone, titanium dioxide, colloidal silicon dioxide, macrogol, iron oxide colorant (pink mixture), iron oxide colorant (yellow mixture). – pink mixture of iron oxide pigment is a mixture of red iron oxide (E 172) and titanium dioxide (E 171). – iron oxide yellow dye mixture is a mixture of yellow iron oxide (E 172) and titanium dioxide (E 171).
Description:
Oblong, biconvex tablets, film-coated light pink color, one side of engraving “012” or “018”, on the other – a stylized “e”.
Product form:
Tablets, film-coated 120 mg and 180 mg.
10 tablets in blister PVC / aluminum foil. 1 blister together with instructions for use placed in a cardboard box.
Contraindications
– hypersensitivity to any component of the drug. – Pregnancy. – Lactation. – Children’s age (12 years).
Precautions: – in patients with chronic renal and hepatic failure, as well as in elderly patients (lack of clinical application experience in these patients); – in patients with cardiovascular disease, including a history (antihistamines can cause palpitations and tachycardia).
Dosage
120 mg
Indications
Seasonal allergic rhinitis (to reduce symptoms) – tablets of 120 mg.
Chronic idiopathic urticaria (to reduce symptoms) – tablets of 180 mg.
Interaction with other drugs
In a joint application fexofenadine with erythromycin or ketoconazole concentrations of fexofenadine in plasma increases by 2-3 times, but it is not associated with a significant prolongation of the QTc interval. There were no significant differences in the incidence of adverse effects with these drugs in monotherapy and in combinations. Animal studies have shown that the above increase plasma concentrations of fexofenadine is probably due to improved absorption of fexofenadine and a decrease in biliary excretion or its secretion into the lumen of the gastrointestinal tract.
Interaction between fexofenadine and omeprazole was observed.
It does not interact with drugs metabolized in the liver.
Receiving containing aluminum or magnesium antacids 15 minutes before receiving fexofenadine reduces the bioavailability of the latter as a result, presumably, the binding in the gastrointestinal tract.
Overdose
In case of overdose observed dizziness, drowsiness and dry mouth. Healthy volunteers received single doses up to 800 mg, and course doses up to 690 mg 2 times a day for 1 month or 240 mg 2 times a day for 1 year without any significant adverse effects compared with placebo. The maximum tolerated dose has not been established for fexofenadine.
In case of overdose is recommended that a gastric lavage, administration of activated charcoal, if necessary symptomatic and supportive therapy. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
Antiallergic agent – H1-histamine receptor blocker.
Pharmacodynamics:
Fexofenadine (the pharmacologically active metabolite of terfenadine) is an antihistamine with selective antagonistic activity for H1- receptor without blocking anticholinergic and alpha1-adrenergic receptor actions. In addition, at the fexofenadine is not observed sedation and other effects on the central nervous system.
In studies in humans to evaluate the histamine wheals induced hyperemia and antihistaminic action fexofenadine ingestable once or twice a day, manifested through 1 hour reaches a maximum after 6 hours and continued for 24 hours after administration. Even after 28 days of fexofenadine is not revealed the development of tolerance to the drug. In single dose of fexofenadine inwardly observed a dose-dependent increase antihistaminic effect in increasing doses from 10 mg to 130 mg. Using the same model antihistaminic action it has been found that for constant for 24 hours was necessary action dose not less than 130 mg. Maximum suppression of blistering and redness of the skin is greater than 80%.
In patients with seasonal allergic rhinitis, treated with 240 mg of fexofenadine 2 times a day for 2 weeks, the duration of the interval QTc (QT ‘corrected) was not different from that of placebo.
Also, changes in QTc was observed when receiving fexofenadine healthy volunteers to 60 mg 2 times a day for 6 months with 400 mg 2 times a day for 6.5 days and 240 mg daily for one year as compared to the duration of at QTc placebo.
Even when the plasma concentration is 32 times greater than the therapeutic concentrations in man, fexofenadine no effect on the delayed rectifier potassium channel in human heart.
Pharmacokinetics:
Fexofenadine after ingestion is rapidly absorbed, time to maximum concentration (T max.) Is about 1-3 hours. The mean value of the maximum concentration (Cmax) of approximately 289 ng / ml when receiving 120 mg per day, and when receiving 180 mg per day – about 494 ng / ml.
Fexofenadine 60-70% bound to plasma proteins.
Fexofenadine significantly metabolized in the liver and it is, as evidenced by the fact that it is the only substance detectable in significant amounts in the urine and feces of man and animals.
At course curve taking the drug elimination from plasma fexofenadine biekspotentsialno reduced, and terminal half-life is 11 – 15 hours.
The pharmacokinetics in single and course intake fexofenadine (up to 120 mg twice 3
day orally) is linear. The dose of 240 mg twice a day gives a slightly more than proportional (8.8%) increase in the area under the curve “concentration-time”, which indicates that the pharmacokinetics of fexofenadine is substantially linear over a dose range from 40 to 240 mg day.
According to available data to date most of the dose unchanged excreted in the bile and 10% of the drug – the urine.
Pregnancy and breast-feeding
There is not enough data on the use of fexofenadine for pregnant women. Limited animal studies have shown no evidence of the presence of adverse effects on pregnancy, prenatal development, childbirth and postnatal development.
Fexofenadine should not be used during pregnancy.
Data on the content of fexofenadine in breast milk at his admission lactating women are not available. However, when taking terfenadine seen its penetration in the breast milk of lactating women. Therefore, the use of fexofenadine during the period of breast-feeding is not recommended.
Conditions of supply of pharmacies
Without recipe.
side effects
In placebo-controlled clinical trials, the most frequently (more than 1% – less than 10%) observed adverse effects were headache (7.3%), somnolence (2.3%), dizziness (1.5%) and nausea 1.5 %. When receiving the above-mentioned fexofenadine frequency of adverse effects was similar to that of placebo.
In a placebo-controlled studies, with a frequency of less than 1% (when receiving equally fexofenadine and placebo) and post-marketing drug application were fatigue, insomnia, anxiety and sleep disorders or abnormal dreams (paroniriya) such as nightmares; tachycardia, palpitations; diarrhea.
In rare cases (more than 0.01% – less than 0.1%) were observed exanthema, urticaria, pruritus and other hypersensitivity reactions such as angioedema, difficulty breathing, dyspnea, flushing of the skin, systemic anaphylactic reaction.
special instructions
It is recommended that the time interval between reception of fexofenadine and antacids containing aluminum or magnesium hydroxide, was at least 2 hr.
For use in children 6 to 11 years are available tablets 30 mg.
Effects on ability to drive and perform tasks requiring concentration.
Before the drug is possible to perform the work requiring high concentration and psychomotor speed of reactions (except for patients having irregular reaction). Therefore it is recommended to pursue such activities to check the individual response to the reception of fexofenadine.
Storage conditions
3 years.
At the end of the shelf life of the drug can not be used.
Dosing and Administration
The tablets are for oral use.
The recommended dose of fexofenadine in seasonal allergic rhinitis for adults and children 12 years and older is 120 mg once a day before meals.
The recommended dose of fexofenadine with chronic hives for adults and children 12 years and older is 180 mg once a day before meals.
Patients at risk 4
Studies in special risk groups (elderly patients, patients with renal and hepatic impairment) have shown that they do not require a correction mode.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

SANOFI AVENTIS GROUP

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