Dianorm-M microphone treatment for diabetes (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Metformin, Gliclazide

Ingredient

Composition information	Content
Metformin	500mg
Gliclazide	80mg

Uses

Indications

Dianorm - M is indicated in cases: diabetes without insulin, diabetes with or without obesity in adults.

Pharmacokic

Gliclazide reduces blood glucose levels with both mechanisms, adjusting insulin secretion and peripheral insulin resistance. This mechanism is performed by the closing of potassium channels in the beta cells of the pancreas that opened the calcium channel that causes intracellular hypercalcium and causes insulin release. Gliclazide also increases cell sensitivity to glucose.

Gliclazide restores insulin sensitivity such as reducing glucose formation in the liver and increasing glucose clearance. Gliclazide has anti -platelet adhesion and reduces free radicals, thus preventing vascular complications. Gliclazide is also reported to reduce cholesterol and plasma triglycerides after repeated use.

metformin acts as a blood glucose anti -tank due to improving the sensitivity of liver and peripheral tissue for insulin. The drug proved to have a positive influence on serum lipid concentration and fibrin -decomposing activity. Metformin treatment does not increase the weight.

Sulfonylurea and Biguanide have mutual support. Both compounds have the effect of lowering blood glucose without increasing the adverse effects of each active group according to pharmacological classification.

Gliclazide works through stimulation of the beta cells of the pancreatic cell release insulin and it also increases peripheral sensitivity to insulin. Metformin works through intentional enhancement and use of glucose. In addition, metformin also reduces glucose production in the liver thus reducing insulin resistance.

There are many reports on the combination treatment of sulfonylurea with metformin to achieve satisfaction of blood glucose control for several years. This combination is reported to be effective in comparative studies that sulfonylurea treatment has failed. This combination can enhance blood glucose control levels (effectively reducing blood glucose) and thus reducing insulin demand in some patients.

Gliclazide is less tend to cause hypoglycemia and weight gain compared to other sulfonylurea. Metformin has a more dominant external mechanism so it has no assimilation effects like sulfonylurea and does not increase weight.

Gliclazide proved to be useful for complications in large vessels and capillaries or caused by hyperglycemia, hypertension, hyperglycemia, hyperlipidemia, or plateletic collection. Metformin reduces plasma insulin when hungry and after eating and reduces triglycerides, increases HDL - cholesterol levels, increases plasminogen activation in tissue, reducing platelet aggregation. Pharmacokinetic, two drugs are compatible because metformin does not attach plasma proteins and is not metabolized in the liver. Therefore, the interaction with Gliclazide (attaching plasma proteins 80 - 90% and metabolism in the liver) is impossible. Therefore, the combination of Metformin and Gliclazide is very useful in the treatment of Niddm and prevents complications in large circuits and capillaries.

pharmacokinetics

Gliclazide's oral dosage, 40 to 120mg causes CMAX from 2.2 to 8mg/1 within 2 to 8 hours. Stable concentration achieved after 2 days of use 40 - 120 mg Gliclazide. Drink Gliclazide along with food reduces CMAX and slow TMAX. Low distribution voltage due to high serum protein (85 - 97%).

The half -cancellation time of Gliclazide varies from 8.1 to 20.5 hours after the single dose. Gliclazide is converted mainly into 7 metabolites and excreted mainly through urine. Most metabolites are derivatives of carboxylic acid, 60 - 70% of the dose is eliminated through the urine and 10-20% excreted through feces.

Metformin has absolute bioavailability when drinking is 50 - 60%. Absorption in the stomach - intestines completely after 6 hours and Metformin quickly distributed in the body after absorption.

metformin is eliminated through the kidneys in two phases. 95% of the absorption metformin is excreted in the first phase with a half -life of 6 hours, the remaining 5% is slowly eliminated at the end phase with the half -life of 20 hours. Metformin does not attach plasma proteins, 40-60% of the dose detected in the form of unchanged urine and 30% is detected in the form of non -change in the feces.

Before taking Dianorm-M microphone treatment for diabetes (10 blisters x 10 tablets)

How to use

Dianorm - M used oral.

Dosage

recommended dose: The starting dose for patients who are not using Metformin is 1 tablet, once/day. If the patient does not have a harmful reaction to the gastrointestinal tract and need to increase the dose, one additional tablet can be used after each treatment period from 1 to 2 weeks. The dose of Metformin should be considered for adjustments on each specific patient based on the effectiveness and tolerance of the patient and not exceeding the maximum dose recommended as 4 tablets/day.

Recommended the use of drugs in patients with renal impairment: Review kidney function before starting treatment with metformin and periodic assessment.

Contraindicated Metformin in patients with EGFR is less than 30ml/min/1.73 m2.

There is no recommendation to start treatment with Metformin in patients with EGFR in the range of 30 - 45ml/minute/1.73m2. In patients who are using Metformin and have EGFR drops below 45ml/min/1.73m2, assess risk - benefits when continuing treatment.

Stop using Metformin if the patient has EGFR drops below 30ml/minute/1.73m2 [see the contraindication, warning and cautious section].

Stop using metformin when performing an image diagnostic test using contrast drug containing IOD.

On patients with EGFR is in the range of 30 - 60ml/minute/1.73m2, in patients with a history of liver, alcoholic or heart failure, or on patients who will use iodine contrast drugs through artery lines, stop metformin before or at the time of testing testing tests using iodine containing iodine. Reassess the EGFR after a 48 -hour projection, reuse Metformin if the kidney function is stable [see the warning and caution].

What to do when overdose? When an overdose of the complications should be performed, the stomach should be tried to have an intravenous injection with hypertonic glucose (10 or 30%) and continue to control blood glucose levels.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

Stomach -intestinal disorders: Nausea, diarrhea, stomach pain, constipation, vomiting, metal flavor in the mouth. Effects on the skin: rash, itching, urticaria, erythema and redness.

headache and dizziness. Gliclazide proved to have low hypoglycemia. Gliclazide may have a risk of side effects on the cardiovascular system. However, Gliclazide has been used to treat insulin -induced diabetes patients for many years without side effects on the cardiovascular system. Reducing the absorption of vitamin B12 and folic acid that occurred when used for prolonged metformin.

Notify the doctor with unwanted effects when using the drug.

Warnings

Contraindicated

diabetes dependent insulin, liver failure or kidney failure, alcoholism, diabetes with non -dependent insulin with serious complications due to ceton or acidic infection, coma or diabetes due to diabetes, patients who have just undergone surgery, trauma or bacterial infection, chronic pulmonary disease, cylinder disease, inferiority Feel with any ingredients of the preparation.

Patients with severe renal failure (EGFR below 30ml/min/1.73m2 [see warning and caution]).

Patients have a history of hypersensitivity to metformin.

Patients with acute or chronic metabolic acidosis, including diabetes cetonic acidosis.

Precautions when taking drugs

Warning: Hypoglycemia may occur if the patient has a diet reduction, after an overdose due to accidental or intentional or after severe exercise, injury and stress. Symptoms of hypoglycemia can be treated by prescribing according to the meal plan of diabetes. It is necessary to stop the drug as soon as there are signs and symptoms of hypoglycemia.

Precautions: Adjust the combined dose according to blood glucose concentrations in the blood and urine in the first few months. However, there are several reports on lactic acid infections in patients with liver or kidney disease.

Used in pediatrics: Safety and validity in children have not been published.

Lactic acidosis: The after -sales monitoring process has recorded lactic acidosis related to metformin, including death, body temperature reduction, prolonged slow pulse, prolonged slow arrhythmia. The onset of lactic acidic acidosis related to Metformin is often not easy to detect, accompanied by typical symptoms such as discomfort, muscle pain, respiratory failure, drowsiness and abdominal pain. Lactic acidic acidosis related to metformin is characterized by increased lactate levels in the blood (> 5mmol/l), anion space (no evidence of keto urine or blood keto), increasing lactate/pyruvate ratio and plasma metformin levels in general increases> 5μg/ml.

Risk factors of lactic acidic acidosis related to Metformin include renal failure, simultaneous use with certain drugs (for example, carbonic inhibitors such as Topiramat), from 65 years of age and older, performing screens using contrast drugs, surgery and performing other tricks, reducing inhaled oxygen (eg acute congestion), drinking a lot of alcohol and liver failure.

Measures to minimize the risk and management of lactic acidic acidosis related to metformin in a group of high -risk patients are detailed in the instruction sheet of drug use (Dosage and usage, contraindications, warning and caution, drug interaction and drug use on special objects).

If there is suspicion of lactic acidosis related to Metformin, Metformin should stop using Metformin, quickly take patients to the hospital and take treatment measures. In patients who have been treated with metformin, have been diagnosed with lactic acidosis or doubts that are likely to have lactic acidosis, quickly recommend filtering to adjust acidosis and remove the accumulated metformin part (metformin hydrochloride can be separated with 170ml/minute clearance under good dynamics). Dialysis can reverse symptoms and recovery.

Instructions for patients and family members about acidic symptoms and if these symptoms occur, it is necessary to stop the drug and report these symptoms to the doctor.

For factors that increase the risk of lactic acidosis related to metformin, recommendations to minimize the risk and handle lactic acidosis related to metformin, specifically as follows:

Renal failure: Lactic acidosis related to metformin during after -sales drug monitoring occurs mainly in patients with severe renal impairment. The risk of cumulative metformin and lactic acidosis is related to metformin increases with the severity of renal failure because metformin is excreted mainly through the kidneys. Clinical recommendations based on the patient's kidney function include [see the dose and usage section, clinical pharmacology]:

Before the beginning of treatment with Metformin, it is estimated that the level of glomerular filtration (EGFR) of the patient.

Contraindicated Metformin in patients with EGFR is less than 30ml/min/1.73m2 [see the section contraindicated].

It is not recommended to start treatment with Metformin in patients with EGFR in the range of 30 - 45ml/minute/1.73m2.

Data income on EGFR at least once a year in all patients using Metformin, in patients who are likely to increase the risk of kidney failure (such as the elderly), the kidney function should be evaluated more often.

In patients using Metformin and having EGFR drops below 45ml/min/1.73m2, assessing risks - benefits of continuing the regimen.

Medication interaction: Concomitant use of metformin with some drugs may increase the risk of lactic acidosis related to metformin: Patients with impaired renal function leads to significant hemodynamic changes, affecting base acid balance or increasing metformin accumulation [see drug interaction items]. Therefore, considering monitoring patients more often.

Patients aged 65 and over: The risk of lactic acidosis is related to Metformin increases with the age of patients because the elderly patients are likely to have liver failure, kidney failure, heart failure than younger patients. Need to evaluate kidney function more often for older patients.

Perform diagnostic tests using contrast drugs: Injecting contrast drugs into the intravascular disease in patients who are being treated metformin can lead to impaired renal function and cause lactic acidosis. Stop using Metformin before or at the time of performing a scan using iodine -containing contrast drugs in patients with EGFR in the range of 30 - 60ml/min/1.73m2, patients with a history of liver failure, alcoholism, heart failure or patients will use IOD contrast drugs in artery. Reassess EGFR 48 hours after screening and reuse Metformin if the kidney function is stable.

Surgery or other procedures: food storage and fluid during surgery or performing other procedures may increase the risk of decreased volume, hypotension and kidney failure. Metformin should be temporarily stopped temporarily when the patient has a limited amount of food and deposits.

Inhalation oxygen reduction: after -sales monitoring process has recorded a number of lactic acidosis related to metformin occurring in acute congestive heart failure (especially when accompanied by reduced perfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, bacterial infection and other diseases related to hypoxemia are associated with lactic acidosis and may also cause nitrogen nitrogen before the kidneys. When these events occur, stop Metformin.

Alcohol: Alcohol has the ability to affect the impact of metformin on lactate metabolism and thereby increases the risk of lactic acidosis associated with metformin. Warning patients do not drink alcohol when using Metformin.

Hepatic failure: Patients with hepatic impairment may progress to lactic acidosis related to metformin due to lactate excretion reduction leading to increased lactate levels in the blood. Therefore, avoid using Metformin in patients who have been diagnosed with liver disease through tested or clinical evidence.

The ability to drive and operate machinery

Because the drug can cause hypoglycemia, be careful when driving or operating machinery.

Pregnancy

Contraindications.

Breastfeeding period

Contraindications.

Other special subjects

Safety and effectiveness in children have not been published.

Drug interaction

Diuretics, barbiturate, phenytoin, rifampicin, corticosteroids, estrogen, estroprogestogen and pure progestogen can reduce blood sugar control levels. The hypoglycemic effect of the drug can be enhanced by salicylate, phenylbutazone, sulphonamide, beta blockers, clofibric acid, vitamin K antagonist, Allopurinol, theophyllline, caffeine and Mao inhibitors.

Simultaneous use of miconazole, perhexiline or cimetidine with glyclazide can cause hypoglycemia. Glyclazide should not be used with drugs that may increase blood glucose levels without closely monitoring blood glucose levels to avoid hyperglycemia. Acarbose and Guar gums have shown significantly reduced oral bioavailability of Metformin.

Storage

Store in a cool place, avoid light. Expiry date: 36 months from the date of production.

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