Amlexanox oral patch

In vitro studies have shown that amlexanox is an effective inhibitor of the formation and/or release of inflammatory mediators (histamine and leukotrienes) in mast cells, neutrophils, and monocytes. Carcinogenicity, mutagenicity, and reproductive damage: Amlexanox was not carcinogenic when taken orally for two years in rats and for 18 months in mice. The results of bacterial mutagenesis tests, mouse lymphoma cell tests, and mouse micronucleus tests were negative. At 70 times the human dose, amlexanox had no significant effect on the reproduction and fertility of rats.

The main ingredient of this product is Amlexanox. Its chemical name is: 2-amino-7-isopropyl-5-oxo-5H-[1]benzopyranyl-[2,3-b]pyridine-3-carboxylic acid

This product is a double-layer tablet with blue and off-white upper and lower layers.

Indicated for the treatment of oral ulcers in adults with normal immune systems and adolescents over 12 years old

This product should be used as soon as ulcers are found, 4 times a day, preferably 80 minutes after breakfast, lunch, dinner and before going to bed, after cleaning the mouth.

In foreign clinical trials, adverse reactions experienced by patients (n=409) included pain at the site of medication (7.1%), burning sensation (2.7%), irritation (1.5%), non-specific reaction (1.2%), and strange sensation (0.7%). Systemic adverse reactions included nausea (1.0%), headache (1.5%), sore throat (0.2%), and abnormal liver function in some patients (2.0%). According to reports on post-marketing applications, 9.8% of patients experienced pain and burning sensation at the medication site after medication, and less than 2% of patients experienced irritation and strange sensation at the medication site.

It is contraindicated for patients who are allergic to Amlexanox or other ingredients in this product.

Precautions for children: This product has no experience with children under 12 years of age. Due to the risk of aspiration, this product is not recommended for use in patients under 12 years of age. Precautions for pregnancy and lactation: Doses of up to 300 mg/kg/day given to rats and rabbits (approximately 70 and 45 times the human dose, respectively, based on body surface area) showed that amlexanox did not impair fertility in rats and rabbits, and was not harmful to the fetus. However, adequate and well-controlled studies have not been conducted in pregnant women. Because animal reproduction studies are not always representative of humans, women should use this product only when necessary during pregnancy. Amlexanox appears in the milk of rats, so use it with caution in lactating women. Precautions for the elderly: The safety and effectiveness of this product for elderly patients have not been established.

Not yet clear.

Sealed, stored in a cool and dry place

2 mg

24 months

Sichuan Qiyun Pharmaceutical Co., Ltd.

• Founded in:

  2002-03-07

• Address:

  Xieshengba, Dongxiang Town, Xuanhan County, Dazhou City, Sichuan Province

• Tax NO.:

  915117227090762134

• Registered Funds:

  9 million yuan

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