Detailed Product Description

Radix Puerariae, Radix Rehmanniae, Radix Astragali, Radix Trichosanthis, Stylus Zeae Maydis, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae and Glibenclamide.

DESCRIPTION:

Black coated concentrated pills; sweet, sour and slightly astringent in taste.

ACTIONS AND INDICATIONS:

Nourish kidney-yin, benefit qi, promote generation of body fluid. Indicated for diabetes mellitus due to deficiency of qi and yin (non-insulin dependent diabetes) manifested as thirst, polydipsia, polyphagia, polyuria, polyorexia, emaciation, tiredness, fatigue, shortness of breath, indolent about speaking.

SPECIFICATION:

30g/Bottle, Per 10 pills weight 2.5g (contains glibenclamide 2.5mg).

USAGE AND DOSAGE:

For oral use before meals. 5-10 pills twice or thrice daily or by medical order.

ADVERSE REACTION: Still indefinite.

CONTRAINDICATIONS:

1.    Contraindicated for breast feeding women.

2.    Contraindicated for pregnant women, diabetes with insulin dependence, diabetes with non-insulin dependence accompanied with ketoacidosis, coma, severe burn and infection, severe trauma and major operation. Also contraindicated for hepatic insufficiency and renal insufficiency , cases with allergy of sulfonamide, and leucopenia.

3.    Cautiously use for debility, high fever, nausea, vomiting, aged, adrenocortical insufficiency or anterior pituitary hypofunction.

CAUTION:

The product is a Compound preparation of Chinese herbal drugs with western medicine. In view of shortage of clinical data, it is difficultly to prove that this compound preparation can reduce or eliminate the adverse reaction of chemical medicine. The following items list the correlative information about the chemical medicine to give attention to physician and patient.

1.      The product contains glibenclamide.  Glibenclamide belongs to sulfonylurea hypoglycemic agent for oral use, daily dose is 2.5mg in the initial stage, 1.25mg for mild cases, once before breakfast and lunch. According to the curative effect, the dose is regulated with an interval of one week. The general dose is 5_~10mg daily and the maximal dose is 15mg daily.

2.      The chief adverse reactions of glibenclamide: hypoglycemia. digestive reactions such as nausea, vomiting, diarrhea and metal taste in the mouth. allergic reactions such as skin rash, occasional exfoliative dermatitis. hematological disorder such as leukopenia, agranulemia, anemia, thrombocytopenia. hepatic injury such as jaundice, hepatic function injury.

3.      Interaction of glibenclamide: Increase the occurrence of hypoglycemia (1) probenecid, allopurin. (2) alcohol, cimetidine, ranitidine, chloramphenicol, miconazole, coumarins (anticoagulant), clofibrates ( decrease blood lipid agents). (3) salicylic acids, ismelin, monoamine oxidase inhibition agent, quinidine. (4) insulin, metformin, acarbose, insulin enhanced sensitivity agent. (5) β-Adrenal receptor blocking agent can interfere the increase of blood sugar during hypoglycemia and block the zymolysis of hepatic glycogen and cover the hypoglycemic symptoms sinultaneously. Increase the occurrence of hyperglycemin: (1)glucocorticoid, estrin, thiazide (diuretic), phenytoin sodium, lifampin. (2)  β-Adrenal receptor blocking agent can counteract the secretion of insulin by sulfonylurea medicine and lead to hyperglycemia.

4.      During the period of medication, periodic inspection of the blood sugar, glucose in Urine, Ketone in Urine, Urinary protein, hepatic and renal function, hemogram and ophthalmic examination should be done.

PHARMACOKINETICS:

The test of pharmacokinetics showed that the level of medicinal concentration in plasma increased after 30 minutes of administration and after 2-3 hours attained to the highest level.

STORAGE:

Hermetically sealed.

PACKAGE:

Plastic bottle, 120 pills in one bottle, one bottle in one box.

PERIOD OF VALIDITY:

36 months

Implement Standard:

The standards trial implementation of National Food and Drug Administration Bureau

CERTIFICATE NO.:

Guo Yao Zhun Zi Z44020045