Fexofenadine Hydrochloride Capsules

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-[1-hydroxy-4-[4-(hydroxybenzhydryl)-1-piperidinyl]butyl]-α,α-dimethylphenylacetic acid hydrochloride.

The contents of this product are white or off-white granules and powder.

1. Seasonal allergic rhinitis is suitable for relieving the symptoms associated with seasonal allergic rhinitis in adults and children aged 6 years and over. Such as sneezing, runny nose, itchy nose, palate, throat, itchy, wet, and red eyes. 2. Chronic idiopathic urticaria is suitable for the treatment of skin symptoms of chronic idiopathic urticaria in adults and children aged 6 years and over, and can reduce itching and the number of wheals.

1Seasonal allergic rhinitis For adults and children aged 12 years and over, the recommended dose of fexofenadine hydrochloride is 60 mg twice a day, or 180 mg once a day. The recommended starting dose for patients with renal insufficiency is 60 mg once a day. For children aged 6 to 11 years, the recommended dose of fexofenadine hydrochloride is 30 mg twice a day, and the recommended starting dose for children with renal insufficiency is 30 mg once a day. 2Chronic idiopathic urticaria For adults and children aged 12 years and over, the recommended dose of fexofenadine hydrochloride is 60 mg twice a day. The recommended starting dose for patients with renal insufficiency is 60 mg once a day. 6 to 11 years old

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 old have not been established. Precautions for pregnancy and lactation: In animal experiments, in the study of rat implantation ability, it was observed that oral administration of 150 mg/kg of terfenadine can cause a dose-dependent decrease in the number of implantations and post-implantation loss. When rats or rabbits were given oral terfenadine up to 300 mg/kg (the resulting fexofenadine exposure was equivalent to 4 times and 31 times the exposure of the maximum daily recommended dose of fexofenadine hydrochloride for adults, respectively), no teratogenicity was observed. However, it is worth noting that the non-teratogenicity of fexofenadine hydrochloride does not mean that it has no effect on the fetus. Studies have shown that oral administration of 150 mg/kg of terfenadine to rats can cause a dose-dependent decrease in the weight gain and survival of offspring. Due to the lack of information on the use of drugs in pregnant women, pregnant women should not use it unless the benefits outweigh the potential risks to the fetus. 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:

Store in a sealed, dry place. Validity period: 12 months.

60mg

24 months

Zhe JIANG HUA HAI Pharmaceutical Co., Ltd.

• Founded in:

  2001-02-28

• Address:

  Xunqiao, Linhai City, Zhejiang Province

• Tax NO.:

  91330000147968817N

• Registered Funds:

  1.491754938 yuan

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