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, alpha;1-adrenergic or beta;-adrenergic receptor blocking effects were observed, nor were sedation or other central nervous system effects observed. This product cannot pass the blood-brain barrier.

The main ingredient of this product is fexofenadine hydrochloride, and its chemical name is plusmn;4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-hydroxybutyl]-alpha;,alpha;-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, and 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, and 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.

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 old have not been established. Precautions for pregnancy and lactation: Due to the lack of information on the use of drugs in pregnant women, pregnant women should not take this product unless the benefits outweigh the potential risks to the fetus. Effects on lactation: Although adequate and well-controlled studies have not been conducted on lactating women, many drugs are secreted in human milk, so lactating women should use it with caution. 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 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 is required when necessary.

Drug interactions with erythromycin and ketoconazole: Co-administration of ketoconazole and erythromycin increases the gastrointestinal absorption of fexofenadine. In vivo animal studies have also shown that in addition to increased absorption, ketoconazole reduces the gastrointestinal secretion of fexofenadine hydrochloride, while erythromycin may also reduce biliary excretion. Fexofenadine hydrochloride has no significant effect on the pharmacokinetics of erythromycin and ketoconazole. Drug interactions with antacids: Administration of 120 mg of fexofenadine hydrochloride (2 times; 60 mg capsules) within 15 minutes with an antacid containing aluminum and magnesium (Maalox) reduced the AUC of fexofenadine by 41% and Cmax by 43%. Fexofenadine hydrochloride should not be administered at the same time as antacids containing aluminum and magnesium.

Keep sealed. Validity period: tentatively 18 months.

30mg

24 months

Yunnan Yufeng Pharmaceutical Co., Ltd.

• Founded in:

  2018-01-09

• Address:

  Zhuangdian Medical Area, Chuxiong Development Zone, Yunnan Province

• Tax NO.:

  91532300MA6MY5XD30

• Registered Funds:

  62.2 million yuan

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