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01 Type 2 diabetes
1.1
Adult (domestic usage)
▎1.1.1 Indications
In conjunction with dietary control, it is used to:
Type 2 Diabetes
Reduces postprandial blood glucose in people with reduced glucose tolerance.
▎1.1.2 Dosage
Swallow the tablets in their entirety immediately before a meal or chew them with the first few bites of food, at doses that vary from person to person.
The general recommended dose is: the initial dose is 50 mg once, 3 times a day, and then gradually increased to 100 mg once, 3 times a day. In individual cases, it can be increased to 200 mg once, 3 times a day. Or as directed by a physician.
If the patient does not respond significantly after 4-8 weeks of taking the drug, the dose can be increased. If the patient is still uncomfortable adhering to a strict diabetic diet, the dose cannot be increased, and sometimes the dose needs to be reduced appropriately, averaging 100 mg at a time and three times a day [1-3].
1.2
Adult (FDA Usage)
▎2.1.1 Indications
Can be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
▎2.1.2 Dosage
There is no fixed-dose regimen for the treatment of diabetes with this product or any other medication. The dosage of this product must be individually adjusted according to the effectiveness and drug resistance, and shall not exceed the maximum recommended dose of 100mg 3 times a day.
This product should be swallowed immediately before meals or chewed with the first bite of food 3 times a day. This product should be started at a low dose and gradually increased to reduce gastrointestinal side effects and reach the minimum dose required to ensure that the patient has adequate control over blood sugar.
If you do not follow your doctor's prescription for a regulated diet, side effects in the intestines may be exacerbated. If severe painful symptoms still occur while adhering to a diabetic diet, it is necessary to consult a doctor and temporarily or permanently reduce the dose.
At the beginning of treatment and the dose adjustment stage, blood glucose 1 hour after a meal can be used to determine the patient's response to the treatment of this product and determine the minimum effective dose. HbD is measured approximately every 3 months thereafter.
The goal of treatment should be to reduce postprandial blood glucose and glycosylated hemoglobin levels to normal or near-normal levels by using the lowest effective dose of this product, as a single agent or in combination with sulfonylureas, insulin, or metformin.
■Initial dose:
25 mg orally, 3 times a day, at the beginning of each meal (first bite). For some patients who need to minimize gastrointestinal side effects, it is recommended to gradually increase the dose, starting with 25 mg orally once a day, and then gradually increasing the frequency of administration to 25 mg orally 3 times a day.
■Maintenance dose:
After reaching a dosage regimen of 25 mg orally 3 times a day, its dose should be adjusted at intervals of 4-8 weeks according to the level and tolerability of blood glucose or glycosylated hemoglobin 1 hour after a meal.
The dose can be increased from 25 mg 3 times a day to 50 mg 3 times a day. Some patients benefited after a further increase in the dose to 100 mg 3 times a day.
The maintenance dose range is 50 mg, 3 to 100 mg 3 times a day. However, due to the increased risk of developing elevated serum aminotransferases in patients with low body weight, only patients with a body weight > 60 kg can be considered at doses greater than 50 mg 3 times a day.
If no further decrease in the level of postprandial glucose or glycosylated hemoglobin is observed after 100 mg 3 times a day, a reduction in the dose administered with this product should be considered. Once the effective and tolerated dose of this product is determined, the dose should be maintained.
■Maximum dose:
The maximum recommended dose for patients with a body weight ≤ 60 kg is 50 mg 3 times a day. The maximum recommended dose for patients weighing >60 kg is 100 mg three times daily [4].
02 Medication for special populations
2.1
Adults (renal impairment)
The plasma concentration of this product in volunteers with kidney injury is directly proportional to the degree of renal insufficiency. Long-term clinical trials have not been conducted in patients with diabetes mellitus with significant renal insufficiency (serum creatinine > 2.0 mg/dL). Therefore, the use of this product is not recommended for such patients [4].
2.2
Adults (liver damage)
/
2.3
Children's Usage
Safety and efficacy in pediatric patients have not been established [4].
2.4
Elderly usage
In the United States, among the subjects in the clinical study of this product, 27% were patients aged 65 years and older, and 4% were patients aged 75 years and older. No overall differences in safety and efficacy were observed between these subjects and younger subjects. The steady-state area (AUC) and the maximum concentration of this product under the average curve in older adults are about 1.5 times that of young people; however, these differences are not statistically significant [4].
2.5
Patients receiving sulfonylureas or insulin therapy
Sulfonylureas or insulin can cause hypoglycemia.
Acarbose in combination with sulfonylurea or insulin will lead to a further decrease in blood glucose and may increase the incidence of hypoglycemia. Once hypoglycemia occurs, the dose of these drugs should be adjusted appropriately [4].
2.6
Medication during pregnancy
The safety of acarbose in pregnant women has not been established. There are currently no adequate and good controlled studies on the use of acarbose in pregnant women. At present, sufficient and controllable research data on pregnant women as the main body are not sufficient.
Animal reproduction studies cannot fully predict human responses, so this product should only be used during pregnancy if there is a clear need for it.
Current information clearly states that abnormalities in blood glucose levels during pregnancy are associated with a high incidence of congenital anomalies and an increase in neonatal morbidity and mortality, and most experts recommend the use of insulin during pregnancy to keep blood glucose levels as close to normal as possible.
2.7
Medication during lactation
After administration of radiolabeled product, a small amount of radioactivity was found in the milk of lactating rats. It is unclear whether the drug is excreted through breast milk. Because many drugs are excreted through breast milk, they should not be given to lactating women [4].
bibliography:
[2] Drug information: Beshi, acarbose capsules, National Medicines H20020391
[3] Drug information: Chewable acarbose tablets, National Medicines H20150012
[4] Product Information: PRECOSE,acarbose tablets, Bayer HealthCare Pharmaceuticals Inc. 2015/3/11.
This article was first published: Clinical Pharmacy Channel of the Medical Community
Author: Jie Xiao Yao
Editor-in-Charge: Little Dangdang
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