Fexofenadine Hydrochloride Tablets

Pharmacological action: Fexofenadine hydrochloride is an antihistamine with selective peripheral H1 receptor antagonism. Fexofenadine inhibits the release of histamine from peritoneal mast cells in rats. In experimental animals, no anticholinergic, α1-adrenergic or β-adrenergic receptor blocking effects were observed, nor were sedation or other central nervous system effects observed. This product cannot pass the blood-brain barrier. Toxicological studies: Effect on QTc: Dogs were given fexofenadine hydrochloride orally twice a day at a dose of 30 mg/kg (the concentration of the original drug in plasma was equivalent to 9 times the maximum recommended adult oral dose), and rabbits were given an intravenous injection of 10 mg/kg (the concentration in plasma was equivalent to 20 times the maximum recommended adult oral dose). No QTc prolongation occurred after 1 hour of administration. Effect on calcium channel flow

The main ingredient of this product is fexofenadine hydrochloride, and its chemical name is ±4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-α,α-dimethylphenylacetic acid hydrochloride.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

Indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years and older, such as sneezing, runny nose, itchy nose, palate, throat, itchy, wet, red eyes.

Adults and children aged 12 years and over: Oral, once a day, 120 mg at a time. The recommended starting dose for patients with renal insufficiency is 60 mg, once a day.

Seasonal allergic rhinitis In a placebo-controlled clinical trial of seasonal allergic rhinitis, 2461 patients aged 12 years and older were treated with fexofenadine hydrochloride 20 mg to 240 mg twice a day. The adverse reactions of fexofenadine hydrochloride were similar to those of placebo. In a placebo-controlled clinical trial of seasonal allergic rhinitis, 570 patients aged 12 years and older were treated with fexofenadine hydrochloride 120 mg or 180 mg once a day. The adverse reactions of fexofenadine hydrochloride were similar to those of placebo. The above studies show that the incidence of adverse reactions, including drowsiness, is not dose-related and is similar among various age, gender, and racial groups. 60 mg, twice a day, orally

It is contraindicated for those who are allergic to the ingredients of this product.

Precautions for children: The safety and efficacy of fexofenadine hydrochloride for children under 6 years of age have not been established. Precautions for pregnancy and lactation: This product does not show obvious teratogenic effects on animals. When rats were given oral doses 3 times the maximum human dose, a dose-related decrease in weight gain and survival rate of pups was observed. However, since there have been no adequate, well-controlled studies on pregnant women, fexofenadine can only be used during pregnancy when the potential benefits far outweigh the risk to the fetus. There have been no adequate, well-controlled studies on lactating women. Because many drugs can be secreted through breast milk, fexofenadine hydrochloride should be used with caution in lactating women. Precautions for the elderly: It is not yet certain whether the response of elderly patients is different from that of young patients. However, since the drug is fully excreted by the kidneys, the risk of drug toxicity in patients with renal impairment may increase. Elderly patients are likely to have decreased renal function, so the dose should be selected with caution and renal function monitoring should be performed if necessary.

Although fexofenadine hydrochloride exhibits a low liver metabolism rate (approximately 5%), it can lead to increased plasma concentrations of fexofenadine hydrochloride when used in combination with erythromycin or ketoconazole. Fexofenadine hydrochloride has no effect on the pharmacokinetics of erythromycin and ketoconazole. In separate studies of fexofenadine hydrochloride in combination with erythromycin or ketoconazole, healthy volunteers (n=24 in each study) took fexofenadine hydrochloride 120 mg twice a day (twice the recommended twice a day dose) with erythromycin 500 mg every 8 hours or ketoconazole 400 mg once a day. The results showed that there was no difference in side effects or QTc intervals between patients taking fexofenadine hydrochloride alone or in combination with erythromycin or ketoconazole. The results of these studies are summarized in the following table:

Keep sealed. Validity period: tentatively 18 months.

60mg

36 months

Xi'an Wan Long Pharmaceutical Co., Ltd.

• Founded in:

  1995-05-26

• Address:

  No. 5, Chuangxin Road, New Industrial Park, Xi'an High-tech Zone

• Tax NO.:

  91610131294460976R

• Registered Funds:

  75 million yuan

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