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Fulaihe (repaglinide and metformin hydrochloride tablets (I))
repaglinide and metformin hydrochloride tablets (I)

English Name: Repaglinide and Metformin Hydrochloride Tablets (I)

Chinese Pinyin: Ruigelienai Erjiashuanggua Pian (I)

The product is a combination of Repaglinide and Metformin Hydrochloride.

Chemical Name: S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid

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【Name】

Common Name: Repaglinide and Metformin Hydrochloride Tablets (I)

English Name: Repaglinide and Metformin Hydrochloride Tablets (I)

Chinese Pinyin: Ruigelienai Erjiashuanggua Pian (I)

【Ingredients】

The product is a combination of Repaglinide and Metformin Hydrochloride.

Structural formula of repaglinide: 

Chemical Name: S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid

Molecular formula: C27H36N2O4

Molecular weight: 452.59

Structural formula of metformin 

hydrochloride:


Chemical Name: N,N-dimethylimidodicarbonimidic diamide hydrochloride

Molecular formula:  C4H11N5·HC1

Molecular weight: 165.6

【Description】

The product is white film-coated tablets, and it is white or off-white after removal of the film coating

【Indications】

This product is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a glinide and metformin or who have inadequate glycemic control on a glinide alone or metformin alone.

It is should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis

【Strength】

Each tablet contains 1 mg repaglinide and 0.5 g metformin hydrochloride

【Dosage and Administration】

Recommended Dosage and Administration

The individualized dosing regimen of this product should be determined based on the patient's current treatment regimen, efficacy, and tolerability.

It can be administered 2 to 3 times a day up to a maximum daily dose of 8 mg repaglinide/2000 mg metformin hydrochloride. Not more than 4 mg repaglinide / 1000 mg metformin hydrochloride should be taken per meal. When using this product for combination therapy, the individualized initial dose and maintenance dose should be established by the doctor according to the patient's condition. Blood glucose should be monitored regularly to determine the patient's response to treatment with this product.

Instruct patients to take this product within 15 minutes before meals, at meal or within 30 minutes before meals are also accepted. In patients who skip meals, instruct patients to skip the scheduled dose of this product.

Patients Inadequately Controlled with Metformin Monotherapy

For the patients inadequately controlled with metformin monotherapy but suit for being treated with repaglinide and metformin hydrochloride concomitantly, the recommended starting dose for this product is 1 mg repaglinide / 500 mg metformin hydrochloride twice a day with meals and gradually increase the dose based on glycemic response to reduce the risk of hypoglycemia with repaglinide.

Patients Inadequately Controlled with Glinide Monotherapy

For the patients inadequately controlled with glinide monotherapy but suit for being treated with repaglinide and metformin hydrochloride concomitantly, the recommended starting dose for metformin hydrochloride is 500 mg twice a day. Gradually increased dose based on glycemic response to reduce the risk of gastrointestinal side effects associated with metformin hydrochloride.

Patients Currently Using Repaglinide and Metformin Concomitantly

Initial this product at the dose of repaglinide and metformin hydrochloride similar to (but not exceeding) the patient’s current doses. Titrate as needed to achieve glycemic control up to the maximum daily dose.

Patients Previously Using other Oral Antidiabetic Drugs 

The safety and efficacy study has not been performed when converting to this product from other antidiabetic drugs. The glycemic control may have change. Any treatment changes should be implemented with care and appropriate monitoring.

2014: First-to-market generic drug in China


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