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Components:
Fexofenadine
Method of action:
Antiallergic, Antihistamines For Systemic Use
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Medically reviewed by Fedorchenko Olga Valeryevna, Pharmacy-Provisor. Last updated on 2019.12.06

Name of the medicinal product

Lai Duo Fei

Qualitative and quantitative composition

Fexofenadine

Therapeutic indications

The information provided in Therapeutic indications of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Substance-powder

Lai Duo Fei 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis.

Lai Duo Fei 180mg is indicated in adults and children 12 years and older for the relief of symptoms associated with chronic idiopathic urticaria.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Posology

Adults

The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal.

Fexofenadine is a pharmacologically active metabolite of terfenadine.

Paediatric population

- Children aged 12 years and over

The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg one daily taken before a meal.

- Children under 12 years of age

The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12.

In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet is the appropriate formulation for administration and dosing in this population.

Special populations

Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.

Posology

Adults

The recommended dose of Lai Duo Fei for adults is 180 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine.

Paediatric population

- Children aged 12 years and over

The recommended dose of Lai Duo Fei for children aged 12 years and over is 180 mg once daily taken before a meal.

- Children under 12 years of age

The efficacy and safety of Lai Duo Fei 180 mg has not been studied in children under 12.

Special populations

Studies in special risk groups (older people, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Lai Duo Fei in these patients.

Contraindications

The information provided in Contraindications of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups.

Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations.

As with most new medicinal products there is only limited data in the older people and renally or hepatically impaired patients. Lai Duo Fei should be administered with care in these special groups.

Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Lai Duo Fei has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.

On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that Lai Duo Fei tablets will produce an effect on the ability to drive or use machines.

In objective tests, Lai Duo Fei has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.

Undesirable effects

The information provided in Undesirable effects of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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The following frequency rating has been used, when applicable:

Very common >1/10; Common >1/100 and <1/10; Uncommon >1/1,000 and <1/100; Rare >1/10,000 and <1/1,000; Very rare <1/10,000 and not known (frequency cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo:

Nervous system disorders

Common: headache, drowsiness, dizziness

Gastrointestinal disorders

Common: nausea

General disorders and administration site conditions

Uncommon: fatigue

In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (can not be estimated from available data):

Immune system disorders

hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis

Psychiatric disorders

insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria)

Cardiac disorders

tachycardia, palpitations

Gastrointestinal disorders

diarrhoea

Skin and subcutaneous tissue disorders

rash, urticaria, pruritus

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

The following frequency rating has been used, when applicable:

Very common >1/10;

Common >1/100 and <1/10;

Uncommon >1/1,000 and <1/100;

Rare >1/10,000 and <1/1,000;

Very rare <1/10,000

and not known (frequency cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo:

Nervous system disorders

Common: headache, drowsiness, dizziness

Gastrointestinal disorders

Common: nausea

General disorders and administration site conditions

Uncommon: fatigue

In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (can not be estimated from available data):

Immune system disorders

hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis

Psychiatric disorders

insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria)

Cardiac disorders:

tachycardia and, palpitations

Gastrointestinal disorders

diarrhoea

Skin and subcutaneous tissue disorders

rash, urticaria, pruritus

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

Website: https://yellowcard.mhra.gov.uk/

Overdose

The information provided in Overdose of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established.

Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.

Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of Lai Duo Fei. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of Lai Duo Fei has not been established.

Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove Lai Duo Fei from blood.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Antihistamines for systemic use, ATC code: R06A X26

Mechanism of action

Fexofenadine hydrochloride is a non-sedating H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.

Clinical efficacy and safety

Human histamine wheal and flare studies following single and twice daily doses of fexofenadine hydrochloride demonstrate that the medicinal product exhibits an antihistaminic effect beginning within one hour, achieving maximum at 6 hours and lasting 24 hours. There was no evidence of tolerance to these effects after 28 days of dosing. A positive dose-response relationship between doses of 10 mg to 130 mg taken orally was found to exist. In this model of antihistaminic activity, it was found that doses of at least 130 mg were required to achieve a consistent effect that was maintained over a 24 hour period. Maximum inhibition in skin wheal and flare areas were greater than 80%. Clinical studies conducted in seasonal allergic rhinitis have shown that a dose of 120 mg is sufficient for 24 hour efficacy.

No significant differences in QTc intervals were observed in seasonal allergic rhinitis patients given fexofenadine hydrochloride up to 240 mg twice daily for 2 weeks when compared to placebo. Also, no significant change in QTc intervals was observed in healthy subjects given fexofenadine hydrochloride up to 60 mg twice daily for 6 months, 400 mg twice daily for 6.5 days and 240 mg once daily for 1 year, when compared to placebo. Fexofenadine at concentrations 32 times greater than the therapeutic concentration in man had no effect on the delayed rectifier K+ channel cloned from human heart.

Fexofenadine hydrochloride (5-10 mg/kg po) inhibited antigen induced bronchospasm in sensitised guinea pigs and inhibited histamine release at supratherapeutic concentrations (10-100 μM) from peritoneal mast cells.

Pharmacotherapeutic group: Antihistamines for systemic use, ATC code: R06A X26

Mechanism of action

Lai Duo Fei is a non-sedating H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.

Clinical efficacy and safety

Human histamine wheal and flare studies following single and twice daily doses of Lai Duo Fei demonstrate that the medicinal product exhibits an antihistaminic effect beginning within one hour, achieving maximum at 6 hours and lasting 24 hours. There was no evidence of tolerance to these effects after 28 days of dosing. A positive dose-response relationship between doses of 10 mg to 130 mg taken orally was found to exist. In this model of antihistaminic activity, it was found that doses of at least 130 mg were required to achieve a consistent effect that was maintained over a 24 hour period. Maximum inhibition in skin wheal and flare areas were greater than 80%.

No significant differences in QTc intervals were observed in seasonal allergic rhinitis patients given Lai Duo Fei up to 240 mg twice daily for 2 weeks when compared to placebo. Also, no significant change in QTc intervals was observed in healthy subjects given Lai Duo Fei up to 60 mg twice daily for 6 months, 400 mg twice daily for 6.5 days and 240 mg once daily for 1 year, when compared to placebo. Fexofenadine at concentrations 32 times greater than the therapeutic concentration in man had no effect on the delayed rectifier K+ channel cloned from human heart.

Lai Duo Fei (5-10 mg/kg po) inhibited antigen induced bronchospasm in sensitised guinea pigs and inhibited histamine release at supratherapeutic concentrations (10-100 μM) from peritoneal mast cells.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Substance-powder

Absorption

Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/ml following the administration of a 120 mg dose once daily.

Distribution

Fexofenadine is 60-70% plasma protein bound.

Biotransformation and elimination

Fexofenadine undergoes negligible metabolism (hepatic or non-hepatic), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear for oral doses up to 120 mg BID. A dose of 240 mg BID produced slightly greater than proportional increase (8.8%) in steady state area under the curve, indicating that fexofenadine pharmacokinetics are practically linear at these doses between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine.

Absorption

Lai Duo Fei is rapidly absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 494 ng/ml following the administration of a 180 mg dose once daily.

Distribution

Fexofenadine is 60-70% plasma protein bound.

Biotransformation and elimination

Fexofenadine undergoes negligible metabolism (hepatic or non-hepatic), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear for oral doses up to 120 mg BID. A dose of 240 mg BID produced slightly greater than proportional increase (8.8%) in steady state area under the curve, indicating that fexofenadine pharmacokinetics are practically linear at these doses between 40 mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Antihistamines for systemic use, ATC code: R06A X26

Preclinical safety data

The information provided in Preclinical safety data of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Substance-powder

Dogs tolerated 450 mg/kg administered twice daily for 6 months and showed no toxicity other than occasional emesis. Also, in single dose dog and rodent studies, no treatment-related gross findings were observed following necropsy.

Radiolabelled fexofenadine hydrochloride in tissue distribution studies of the rat indicated that fexofenadine did not cross the blood brain barrier.

Fexofenadine hydrochloride was found to be non-mutagenic in various in vitro and in vivo mutagenicity tests.

The carcinogenic potential of fexofenadine hydrochloride was assessed using terfenadine studies with supporting pharmacokinetic studies showing fexofenadine hydrochloride exposure (via plasma AUC values). No evidence of carcinogenicity was observed in rats and mice given terfenadine (up to 150 mg/kg/day).

In a reproductive toxicity study in mice, fexofenadine hydrochloride did not impair fertility, was not teratogenic and did not impair pre- or postnatal development.

Dogs tolerated 450 mg/kg administered twice daily for 6 months and showed no toxicity other than occasional emesis. Also, in single dose dog and rodent studies, no treatment-related gross findings were observed following necropsy.

Radiolabelled Lai Duo Fei in tissue distribution studies of the rat indicated that fexofenadine did not cross the blood brain barrier.

Lai Duo Fei was found to be non-mutagenic in various in vitro and in vivo mutagenicity tests.

The carcinogenic potential of Lai Duo Fei was assessed using terfenadine studies with supporting pharmacokinetic studies showing Lai Duo Fei exposure (via plasma AUC values). No evidence of carcinogenicity was observed in rats and mice given terfenadine (up to 150 mg/kg/day).

In a reproductive toxicity study in mice, Lai Duo Fei did not impair fertility, was not teratogenic and did not impair pre- or postnatal development.

Incompatibilities

The information provided in Incompatibilities of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Film-coated tablet; Film-coated tablets (for children)
Substance-powder

Not applicable

Not Applicable

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Lai Duo Fei is based on data of another medicine with exactly the same composition as the Lai Duo Fei of the medicine (Fexofenadine). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Lai Duo Fei directly from the package or from the pharmacist at the pharmacy.
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Film-coated tablet; Film-coated tablets (for children)
Substance-powder

No special requirements.

No special requirements.

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