Description
Release form
film-coated tablets.
Packing
10 pcs.
Pharmacological action
Pharmacodynamics.
Fexofenadine hydrochloride is a blocker of H1-histamine receptors, almost devoid of sedation. Fexofenadine is a pharmacologically active metabolite of terfenadine.
The antihistamine effect of the drug appears 1 hour after administration, reaches a maximum after 6 hours and lasts for 24 hours. After 28 days of admission, there is no development of tolerance. With oral doses of 10 mg to 130 mg, there is a linear dose-response relationship. For the 24-hour effectiveness of the drug (for allergic rhinitis), a dose of 120 mg is sufficient. At a dose of up to 240 mg, the drug does not cause changes in the QT interval.
Pharmacokinetics
Fexofenadine hydrochloride after oral administration is rapidly absorbed from the gastrointestinal tract, the time to reach the maximum concentration (TCmax) is 1-3 hours. The average maximum concentration (Cmax) after a dose of 120 mg is 289 ng / ml, and after administration doses of 180 mg are approximately 494 ng / ml. Communication with plasma proteins – 60 70% (mainly with albumin and alpha1-glycoprotein). Does not cross the blood-brain barrier. Fexofenadine undergoes partial (5% of the dose) metabolism.
Biphasic elimination. The half-life (T1 / 2) after repeated administration is from 11 to 15 hours. In patients with moderate (creatinine clearance 41 80 ml / min) and severe (11 40 ml / min) renal failure, T1 / 2 increases by 59 and 72%, respectively, in patients on hemodialysis, T1 / 2 increases by 31% . The pharmacokinetics with single and multiple use of fexofenadine (up to 120 mg twice a day) is linear.
It is excreted mainly (80%) with bile, up to 10% of the dose taken is excreted unchanged in the urine.
Indications
Seasonal allergic rhinitis: sneezing, itching, rhinitis, redness of the mucous membranes of the eyes and other symptoms of hay fever – tablets, 120 mg
Chronic idiopathic urticaria: redness, skin itching and other symptoms of urticaria – tablets, 180 mg.
Contraindications
Hypersensitivity to any of the components of the drug, pregnancy, lactation, children’s age (up to 12 years), chronic renal failure.
Special instructions
In older patients or patients with hepatic insufficiency, fexofenadine should be used with caution due to lack of data. It is recommended that the time interval between taking fexofenadine hydrochloride and antacids containing aluminum or magnesium hydroxide is 2 hours.
Influence on the ability to drive a car and perform work requiring concentration attention
When taking Fexadin, it is possible to perform work that requires a high concentration of attention and speed of psychomotor reactions (with the exception of people who have an unusual reaction to drugs). Thus, before starting to perform these works (driving vehicles, controlling machinery), you must first check the individual reaction to the drug.
Composition
Each tablet, film-coated contains:
active ingredient:
Fexofenadine hydrochloride 180 mg
Auxiliary ingredients:
Croscarmellose sodium – 30.00 mg, microcrystalline cellulose – 266.13 mg, gelatinized starch – 87.00 mg, silicon dioxide 21 colloid mg, povidone – 9.0 mg, magnesium stearate – 6.00 mg, purified water * – up to 600.00 mg.
Film coat:
Dye Opadra pink (OY-54957) – 23.40 mg: (hypromellose, titanium dioxide, macrogol-400, dye iron oxide red (CI No. 77491), purified water *.
Printing ink:
Opakod S-1-17823 black – qs:
glazed shellac-45% (20% esterified) in ethanol, iron dye black oxide, N-butyl alcohol, propylene glycol, isopropanol, 28% ammonium hydroxide.
(* -vaporates during production).
Dosage and administration
Tablets are for oral administration.
The recommended dose of fexofenadine for seasonal allergic rhinitis for adults and children 12 years of age and older is 120 mg once a day.
The recommended dose of fexofenadine in chronic urticaria for adults and children 12 years of age and older is 180 mg once a day.
Side effects
Headache, drowsiness, nausea, dyspepsia, dizziness.
Rarely (less than 1 case per 1000 appointments): feeling tired, insomnia, nervousness, sleep disturbance.
In some cases: skin rash, urticaria, skin itching, other hypersensitivity reactions: angioedema, shortness of breath.
Drug interaction
When combined with erythromycin or ketoconazole, the concentration of fexofenadine in the plasma increases by 2-3 times. There is no significant effect on increasing the QT interval. The intake of aluminum or magnesium-containing antacids 15 minutes before taking fexofenadine leads to a decrease in the bioavailability of the latter (the time interval between their intake should be at least 2 hours). Does not interact with omeprazole.
Overdose
Symptoms: dizziness, drowsiness, and dry mouth. In case of an overdose, it is recommended that standard measures be taken to remove the non-absorbed drug from the gastrointestinal tract. Symptomatic and supportive therapy is recommended. Hemodialysis is ineffective.
Storage Conditions
In a dry place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Expiration
3 years.
active substance
fexofenadine
lekarstvennaja form
tablets
Indications
Indications
Allergy, Allergic rhinitis, hay fever, allergic conjunctivitis, urticaria
Ranbaxy Laboratoriz Limited, India
