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Fexofenadine (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. Tmax is reached within 1-3 hours. The mean Cmax 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%. T1/2 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

ICD-10 code Indication
J30.1 Allergic rhinitis due to pollen
L50 Urticaria
ICD-11 code Indication
CA08.00 Allergic rhinitis due to pollen

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For adults and children over 12 years of age, the recommended dosage for seasonal allergic rhinitis is 120 mg or 180 mg taken orally once daily.

For the symptomatic treatment of chronic idiopathic urticaria, the recommended dosage is 180 mg taken orally once daily.

Administer the tablet with a full glass of water.

Take the dose on an empty stomach or without food, as a high-fat meal can reduce absorption and decrease efficacy.

For patients with renal impairment, initiate therapy at a reduced dose of 60 mg once daily.

Do not take aluminum- or magnesium-containing antacids within 2 hours of fexofenadine administration, as they significantly reduce bioavailability.

The maximum recommended daily dose is 180 mg. Do not exceed this dose.

The safety and efficacy of fexofenadine in children under 6 years of age have not been established; use in this population is contraindicated.

For children 6 to 11 years of age, a specific pediatric formulation is available; the recommended dose is 30 mg twice daily.

Adverse Reactions

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

Contraindications

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

Use in Pregnancy and Lactation

Fexofenadine is contraindicated for use during pregnancy and lactation (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 machinery

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 biliary excretion or gastrointestinal secretion. No changes in the QT interval were observed.

When taking aluminum- or magnesium-containing antacids 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Advanced Pharma, LLC (Russia)

Dosage Forms

Bottle OTC Icon Fexofenadine-Advanced Film-coated tablets, 120 mg: 10 or 30 pcs.
Film-coated tablets, 180 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from yellow-pink to yellow-pink with a brownish tint, round, biconvex; the tablet core is from white to white with a yellowish or grayish tint.

1 tab.
Fexofenadine hydrochloride 120 mg

Excipients : lactose monohydrate – 82.6 mg, pregelatinized starch – 12 mg, hypromellose – 5 mg, sodium starch glycolate – 14.4 mg, sodium lauryl sulfate – 1.2 mg, colloidal silicon dioxide – 2.4 mg, magnesium stearate – 2.4 mg.

Shell composition film coating WT-19022P pink – 10 mg (polyvinyl alcohol – 40-50%, polyethylene glycol 4000 – 10-20%, soy lecithin – 0.5-0.8%, titanium dioxide – 15-25%, talc – 15-25%, iron oxide red dye – 0.01-0.3%).

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.

Film-coated tablets from yellow-pink to yellow-pink with a brownish tint, round, biconvex; the tablet core is from white to white with a yellowish or grayish tint.

1 tab.
Fexofenadine hydrochloride 180 mg

Excipients : lactose monohydrate – 123.9 mg, pregelatinized starch – 18 mg, hypromellose – 7.5 mg, sodium starch glycolate – 21.6 mg, sodium lauryl sulfate – 1.8 mg, colloidal silicon dioxide – 3.6 mg, magnesium stearate – 3.6 mg.

Shell composition film coating WT-19022P pink – 15 mg (polyvinyl alcohol – 40-50%, polyethylene glycol 4000 – 10-20%, soy lecithin – 0.5-0.8%, titanium dioxide – 15-25%, talc – 15-25%, iron oxide red dye – 0.01-0.3%).

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Forms

Bottle OTC Icon Fexofenadine-SZ Film-coated tablets 30 mg
Film-coated tablets 120 mg
Film-coated tablets 180 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

1 tab.
Fexofenadine hydrochloride 30 mg

10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – jars – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – bottles – cardboard packs (30 pcs.) – Over-the-Counter

Film-coated tablets

1 tab.
Fexofenadine hydrochloride 120 mg

10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – jars – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – bottles – cardboard packs (30 pcs.) – Over-the-Counter

Film-coated tablets

1 tab.
Fexofenadine hydrochloride 180 mg

10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – jars – cardboard packs (30 pcs.) – Over-the-Counter
30 pcs. – bottles – cardboard packs (30 pcs.) – Over-the-Counter

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Forms

Bottle OTC Icon Fexofenadine-Akrikhin Film-coated tablets, 120 mg: 10 or 30 pcs.
Film-coated tablets, 180 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from yellow-pink to yellow-pink with a brownish tint, round, biconvex; the tablet core is from white to white with a yellowish or grayish tint.

1 tab.
Fexofenadine (as hydrochloride) 120 mg

Excipients : lactose monohydrate – 82.6 mg, pregelatinized starch – 12 mg, hypromellose – 5 mg, sodium starch glycolate – 14.4 mg, sodium lauryl sulfate – 1.2 mg, colloidal silicon dioxide – 2.4 mg, magnesium stearate – 2.4 mg.

Film coating composition hypromellose-2910 – 3.6 mg, hypromellose – 1.2 mg, macrogol-6000 – 1.2 mg, glycerol – 1 mg, talc – 2.1 mg, titanium dioxide – 0.862 mg, iron oxide red dye – 0.014 mg, iron oxide yellow dye – 0.024 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Film-coated tablets from yellow-pink to yellow-pink with a brownish tint, round, biconvex; the tablet core is from white to white with a yellowish or grayish tint.

1 tab.
Fexofenadine (as hydrochloride) 180 mg

Excipients : lactose monohydrate – 123.9 mg, pregelatinized starch – 18 mg, hypromellose – 7.5 mg, sodium starch glycolate – 21.6 mg, sodium lauryl sulfate – 1.8 mg, colloidal silicon dioxide – 3.6 mg, magnesium stearate – 3.6 mg.

Film coating composition hypromellose-2910 – 5.4 mg, hypromellose – 1.8 mg, macrogol-6000 – 1.8 mg, glycerol – 1.5 mg, talc – 3.15 mg, titanium dioxide – 1.293 mg, iron oxide red dye – 0.021 mg, iron oxide yellow dye – 0.036 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

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