Dinox^® (Tablets) Instructions for Use

ATC Code

R06AX26 (Fexofenadine)

Active Substance

Fexofenadine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker. Fexofenadine is a pharmacologically active metabolite of terfenadine. It does not have a sedative effect.

The antihistamine effect appears within 1 hour, reaches a maximum in 6 hours, and lasts for 24 hours. No tolerance was observed after 28 days of administration.

It has been established that when taken orally in the dose range from 10 mg to 130 mg, the efficacy of fexofenadine is dose-dependent.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract. T_max is reached within 1-3 hours. The mean C_max after a 180 mg dose is approximately 494 ng/ml, and after a 120 mg dose – 427 ng/ml. Plasma protein binding is 60-70%. T_1/2 after multiple doses is 11-15 hours. It is excreted in breast milk. 5% of the dose undergoes partial extrahepatic metabolism. It is excreted mainly with bile (80%), 10% is excreted by the kidneys unchanged.

Indications

Relief of symptoms associated with seasonal allergic rhinitis, symptomatic treatment of chronic urticaria.

ICD codes

Dosage Regimen

For adults and children over 12 years of age, administer 120 mg to 180 mg orally once daily.

Take the tablet with water. For consistent absorption, administer the dose separately from antacid medications containing aluminum or magnesium hydroxide; maintain a minimum 2-hour interval.

For patients with moderate to severe renal impairment, initiate therapy at the lower end of the dosage range. Exercise caution and consider dose adjustment based on clinical response and tolerability.

The total daily dose must not exceed 180 mg. Do not crush or chew the tablet. The duration of treatment is determined by the physician based on the indication and symptom control.

Adverse Reactions

The following are possible headache, drowsiness, dizziness, fatigue, nausea, lethargy, increased fatigue.

Contraindications

Pregnancy, lactation period, children under 6 years of age, hypersensitivity to fexofenadine.

Use in Pregnancy and Lactation

Fexofenadine is contraindicated for use during pregnancy and during the lactation period (breastfeeding).

Fexofenadine passes into breast milk. If it is necessary to use fexofenadine during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Use with caution in patients with hepatic insufficiency.

Use in Renal Impairment

Use with caution in patients with renal insufficiency.

Pediatric Use

Use of the drug in children under 6 years of age is not recommended.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in elderly patients, in patients with renal or hepatic insufficiency.

The efficacy and safety of fexofenadine in children under 6 years of age have not been studied.

Effect on the ability to drive vehicles and mechanisms

Based on the pharmacodynamic profile and known side effects, it can be assumed that the effect of fexofenadine on the ability to drive a car and engage in activities requiring increased concentration is unlikely. Objective studies have shown that Fexofenadine does not have a significant effect on CNS functions. Nevertheless, it is recommended to check the individual reaction before driving a car or engaging in other potentially hazardous activities.

Drug Interactions

Fexofenadine is not biotransformed in the liver and therefore does not interact with other drugs undergoing hepatic metabolism.

It has been shown that with the simultaneous use of fexofenadine with erythromycin or ketoconazole, the plasma concentration of fexofenadine increases by 2-3 times, which is apparently associated with an increase in absorption from the gastrointestinal tract and with a reduction in either bile excretion or gastrointestinal secretion. No changes in the QT interval were observed.

When taking antacids containing aluminum or magnesium 15 minutes before taking fexofenadine, a decrease in its bioavailability was observed, most likely due to binding in the gastrointestinal tract. The recommended time interval between taking fexofenadine and antacids containing aluminum or magnesium hydroxide is 2 hours.

Does not interact with omeprazole, with drugs metabolized in the liver.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.