Product Overview
【Drug Ingredients】
Fexofenadine Hydrochloride
【Chemical Composition】
Main Ingredient: Fexofenadine Hydrochloride Chemical Name: (±)4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethylphenylacetic acid hydrochloride Molecular Formula: C32H39NO4·HCl Molecular Weight: 538.13
【Properties】
The contents of this product are white or off-white granules and powder.
【Indications】
Seasonal Allergic Rhinitis: For relief of symptoms associated with seasonal allergic rhinitis in adults and children aged 6 years and older, such as sneezing, runny nose, itchy nose, palate, throat, itchy, moist, and red eyes. Chronic Idiopathic Urticaria: For the treatment of skin symptoms of chronic idiopathic urticaria in adults and children aged 6 years and older, reducing itching and the number of wheals.
【Dosage and Administration】
Seasonal Allergic Rhinitis: The recommended dose of fexofenadine hydrochloride for adults and children aged 12 years and older is 60 mg twice daily, or 180 mg once daily. For patients with renal impairment, the recommended starting dose is 60 mg once daily. For children aged 6 to 11 years, the recommended dose of fexofenadine hydrochloride is 30 mg twice daily; for children with renal impairment, the recommended starting dose is 30 mg once daily. Chronic Idiopathic Urticaria: The recommended dose of fexofenadine hydrochloride for adults and children aged 12 years and older is 60 mg twice daily. For patients with renal impairment, the recommended starting dose is 60 mg once daily. For children aged 6 to 11 years, the recommended dose of fexofenadine hydrochloride is 30 mg twice daily; for children with renal impairment, the recommended starting dose is 30 mg once daily.
【Adverse Reactions】
Common adverse reactions include drowsiness, dry mouth, and fatigue. The incidence of adverse reactions, including drowsiness, was not dose-related and was similar across age, sex, and ethnic groups. Literature reports that in a US placebo-controlled trial of seasonal allergic rhinitis, the following adverse reactions occurred in patients aged 12 years and older with an incidence greater than 1%: Fexofenadine Hydrochloride Capsules (twice daily) Adverse Reactions with Incidence Greater than 1% Fexofenadine 60 mg twice daily (n=679) Placebo twice daily (n=671) Viral Infection (Cold, Influenza) 2.5% 1.5% Nausea 1.6% 1.5% Dysmenorrhea 1.5% 0.3% Drowsiness 1.3% 0.9% Indigestion 1.3% 0.6% Fatigue 1.3% 0.9% Adverse reactions with an incidence greater than 2% in once-daily oral fexofenadine hydrochloride tablets: Fexofenadine 180 mg once daily (n=283) Placebo (n=293) Headache 10.6% 7.5% Upper respiratory tract infection 3.2% 3.1% Back pain 2.8% 1.4% The frequency and number of laboratory abnormalities were similar in the fexofenadine hydrochloride group and the placebo treatment group. In placebo-controlled trials of seasonal allergic rhinitis conducted in the United States and Canada, the following adverse reactions occurred in children aged 6-11 years: Side effects: Fexofenadine 30 mg twice daily (n=209) Placebo (n=229) Headache 7.2% 6.6% Accidental injury 2.9% 1.3% Cough 3.8% 1.3% Fever 2.4% 0.9% Pain 2.4% 0.4% Otitis media 2.4% 0.0% Upper respiratory tract infection 4.3% 1.7%
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to any component of this product.
【Precautions】
No dose reduction is required for patients with hepatic impairment; the dose should be halved for patients with renal impairment.
【Overdosage】
Reports of fexofenadine hydrochloride overdose are rare, and information in this area is limited. However, dizziness, drowsiness, and dry mouth have been reported. No clinically significant adverse reactions were observed with a single dose of fexofenadine hydrochloride up to 800 mg (6 healthy volunteers), 690 mg twice daily for one month (3 healthy volunteers), or 240 mg once daily for one year (234 healthy volunteers) compared to placebo. In case of overdose, standard measures should be considered to remove unabsorbed drug. Symptomatic and supportive therapy is recommended. Data indicate that hemodialysis is not effective in removing fexofenadine hydrochloride from the blood after terfenadine administration (only 1.7% was removed).
【Population】
It is not yet certain whether there is a difference in response between elderly and younger patients. However, because this drug is fully excreted by the kidneys, patients with impaired renal function may be at increased risk of drug toxicity. Elderly patients are likely to have decreased renal function; therefore, dosage selection should be cautious, and renal function monitoring may be necessary. The safety and efficacy of fexofenadine hydrochloride in children under 6 years of age have not been established. This product has not shown significant teratogenic effects in animals. When rats were orally administered three times the maximum human dose, a dose-related decrease in pup weight gain and survival was observed. Because adequate, well-controlled studies in pregnant women have not been conducted, fexofenadine should only be used during pregnancy when the potential benefits significantly outweigh the risks to the fetus. Adequate, well-controlled studies in lactating women have not been conducted. Because many drugs are excreted in breast milk, fexofenadine hydrochloride should be used with caution in lactating women.
FDA Pregnancy Drug Classification:
Category C:
【Drug Interactions】
Drug interactions with erythromycin and ketoconazole: Concomitant administration of ketoconazole and erythromycin increases the gastrointestinal absorption of fexofenadine. In vivo animal studies have also shown that, in addition to increasing absorption, ketoconazole decreases the gastrointestinal secretion of fexofenadine hydrochloride, while erythromycin may also decrease bile excretion. Fexofenadine hydrochloride has no significant effect on the pharmacokinetics of erythromycin and ketoconazole. Drug interactions with antacids: Administration of 120 mg fexofenadine hydrochloride (2 x 60 mg capsules) within 15 minutes and an aluminum and magnesium-containing antacid (Maalox) reduced fexofenadine's AUC by 41% and Cmax by 43%. Fexofenadine hydrochloride should not be administered at approximately the same time as aluminum and magnesium-containing antacids.
【Manufacturer】
Guangdong Global Pharmaceutical Co., Ltd., China National Pharmaceutical Group Co., Ltd.
