Duo-Anglucid 500mg 5.0 mg 30 Tabs, Metformin Glibenclamide

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Duo-Anglucid 500mg 5.0 mg 30 Tabs, Metformin Glibenclamide

INDICATIONS:

Oral Hypoglycemic : Diabetes mellitus non-insulin dependent diabetes mellitus ( II ) not cetoacidósica when dietary measures and monotherapy with sulphonylureas not sufficient to achieve a satisfactory adaptation of blood glucose.

In type II diabetes under diet and hypoglycemic fails to monotherapy with sulfonylureas or biguanides . In patients with type II diabetes mellitus in combination therapy with sulfonylurea and biguanide that require a greater stimulus for the production of insulin by the pancreas by increasing the dose of sulfonylurea.

Pharmacokinetics:

Metformin : Intestinal absorption of metformin can extend around 6 hours. The maximum concentration in plasma in a stable condition after an oral dose is reached between 27 to 48 minutes with an average of 40 ± 5.3 minutes and goes from 2 to 4 ml .
Plasma half-life is 1.25 to 2.6 hours with an average of 1.8 ± 0.6 hours. The plasma protein binding is negligible .

Therapeutic doses bioavailability reaches 50 to 60%.

Metabolism is biotransformed very little , its main metabolite is hidroximetilbiguanida ( hydroxylation ) and this happens in the liver microsomal level .

Elimination or excretion : Mainly by the kidneys ( 90 % ) the elimination of this drug in healthy subjects and in diabetic patients with normal renal function is approximately 4 times the elimination of creatine which suggests that active tubular secretion is an important mechanism removal . This drug is also eliminated by the salivary glands .

Glibenclamide Glibenclamide partially absorbed orally and binds to plasma proteins 97%. Its half-life is approximately 5 hours. Its peak is reached at 2 or 4 hours after

Administration.

Two metabolites have been identified hydroxylated and a third unidentified lacking significant hypoglycemic activity . It is excreted in the urine half being excreted within 24 hours.

Is also excreted in feces and bile.

Pharmacodynamics

Metformin : Metformin reduces glucose levels in diabetic patients while Unlike sulfonylureas not cause a reduction of glucose levels normoglycaemic . Antihyperglycemic action is mainly due to their mechanism of action of extrapancreatic sites . The main action

Metformin is the result of potentiation of the metabolic effects of insulin in the peripheral tissues.

This results in an increased transport of glucose into the cell an increase in glucose oxidation and an increase in the incorporation into glycogen. Metformin in liver also inhibits gluconeogenesis increased sensitivity to insulin. Postprandial hyperglycemia is reduced as a result of glucose uptake mechanism in the gastrointestinal tract delayed by metformin.

These properties of metformin action mean that its presence depends on the degree of plasma insulin either endogenous or exogenous origin . Added to its antihyperglycemic effect of metformin has favorable effects on fat metabolism . High levels of triglyceride and cholesterol reducing treatment.

Anorexic activity of metformin promotes weight loss and therefore supports the reduction measures and / or weight maintenance . The spectrum of action of metformin makes particularly suitable for treating non-insulin dependent diabetic patients with overweight in whom hyperglycemia is usually caused by peripheral insulin resistance and associated disorders who hyperlipoproteinemias . Lowers total cholesterol triglycerides and increases LDL - cholesterol HDL - cholesterol.

Increases fibrinolytic activity. This effect is produced by a decrease in the plasma levels of plasminogen activator inhibitor -1 ( PAI-1) .

Glibenclamide stimulates sulfonylurea Like any insular tissue to secrete insulin. Cause beta cell degranulation phenomenon associated with increased insulin secretion. It is ineffective in pancreatectomized patients and insulin-dependent diabetics .

During chronic administration peripheral tissues become more sensitive to insulin, probably due to an increase in the number of receptors for the hormone.

The hypoglycemic activity of 5 mg of glibenclamide is equivalent to 1 g of tolbutamide chlorpropamide or 250 mg . This drug is effective in patients with non-insulin that retain the ability to secrete insulin.

CONTRAINDICATIONS :

Hypersensitivity to glyburide and metformin gestational diabetes insulin dependent diabetes diabetic ketoacidosis coma and pre-coma serum creatinine levels greater than

12 mg / l ; propensity to lactic acidosis , severe alterations in liver function and renal diabetic patients likely to produce impaired renal or hepatic function , severe cardiovascular disease (heart failure cardiogenic shock septic shock impaired peripheral arterial circulation ) ; chronic alcoholism ; been prolonged calorie diet do fasting , pregnancy gangrene acute bleeding two days before or after an operation or performance of excretory urography and severe dystrophic diseases .

Special precautions for use :

There are several reports related to the use of biguanides as a factor that can promote the lactic acidosis potentially fatal metabolic disorder characterized by elevated levels of lactate lactatopiruvato ratio increase and decreased blood pH.

Although most of these reports refer to the therapeutic use of other biguanides that ANGLUCID DUO is made ??of metformin ( a biguanide ) necessary to take into account the following precautions for use : Do not use in patients with impaired capable to increase the risk of lactic acidosis and renal and hepatic heart failure ischemic vascular diseases respiratory failure acute myocardial infarction and other conditions characterized by hypoxemia .

If symptoms such as abdominal pain nausea vomiting and malaise hyperventilation this situation must be reported immediately to your doctor .

RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING

As with any oral anti-diabetic drug metformin and glyburide is contraindicated during pregnancy and lactation. Patients should be treated with insulin for optimal metabolic control.

ADVERSE REACTIONS :

The all sulfonylurea glibenclamide lowers blood glucose levels and may lead to hypoglycaemia (sometimes prolonged and severe ) . This happens when there is a disproportion between the dosage diet exercise and other factors that influence the metabolism .

Mainly the start of treatment with glyburide may be changes in ocular refraction due to the normalization of blood glucose . Cutaneous hypersensitivity reactions possible cross-allergy reactions to sulfonamides and sulfonamide derivatives decreased tolerance to alcohol. Hematopoietic system rarely changes (decreased platelet count erythrocytes and leukocytes ) and hemolytic anemia (rare) that in principle are reversible to the suspension of glyburide . Glyburide and metformin may cause gastrointestinal intolerance as anorexia nausea vomiting stomach pain and diarrhea. Metformin in very rare cases can lead to lactic acidosis in patients with predisposing factors such as kidney failure and circulatory collapse.

DRUG INTERACTIONS AND OTHER GENDER

The hypoglycemic action of sulfonylureas may be increased by dicumarol and its derivatives phenylbutazone MAOI sulfonamides and salicylates feniramidol probenecid , and sulfinpyrazone perexilina by oral miconazole and by ingesting large amounts of alcohol , whereas adrenaline can be decreased by oral contraceptives corticosteroids thiazide diuretics and barbiturates .

Also keep caution when co-administered beta blockers. Metformin potentiates the effect of anticoagulants and fibrinolytics. Inhibits the absorption of vitamin B12.

CHANGES IN RESULTS OF LABORATORY TESTS

Glyburide can cause elevation of liver enzymes . In rare cases there may be malabsorption of vitamin B12 can lead to megaloblastic anemia .

Parameter decreases total and LDL cholesterol triglycerides . You can modify the HDL . Exceptionally there may be increased serum lactate levels in predisposed patients .

PRECAUTIONS IN RELATION TO EFFECTS OF Carcinogenesis Mutagenesis Impairment of Fertility:

Studies aimed at the search for such alterations in animals such as rabbits, dogs and monkeys rats showed no alteration of this type .

DOSAGE AND ADMINISTRATION:

Oral .

The daily dose and method of administration will be recommended by the doctor depending on the patient's metabolic state .

The dose is 1 tablet per day will increase gradually to half tablet mid tablet according to the patient's metabolic control not to exceed 4 tablets daily.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION

Symptoms of overdose include gastrointestinal irritation depending on the severity of hypoglycemia if glucose should be administered orally or intravenously and hospitalize the patient hypovolemia lactic acidosis metabolic acidosis respiratory depression seizures oliguria and anuria . The steps to correct this accidental ingestion gastric lavage required .

Compared with sulfonylurea overdose biguanides not cause hypoglycemia. However, hypoglycemia can occur if you are managing other hypoglycaemic agents have been ingested concomitantly or alcohol. Symptoms of poisoning are similar to the adverse reactions .

Keep in mind the risk of lactic acidosis. The diagnosis should be confirmed by measurements of serum lactate and metformin. When metformin is implicated as the cause of lactic acidosis metformin plasma levels should be above 5 ug / ml.

If you suspect poisoning with metformin , the patient should be referred to a hospital for intensive management support for the risk of lactic acidosis. In poisoning hemodialysis therapy is the most effective way of removing lactate and metformin. Symptomatic measures should be taken to stabilize the movement correct acidosis and hypoxia .

PRESENTATIONS :

Box of 15 30 and 60 mg tablets 500/2.5 and 500 /

5.0 mg in bubble pack for sale.

Box of 20 and 40 tablets of 1000/5 mg in bubble pack for sale.

Bottle with 15 30 60 and 100 tablets 500/2.5 and 500 /

5 mg for sale.

Bottle of 20 and 40 tablets of 1000/5 mg for sale.

STORAGE RECOMMENDATIONS

Store at room temperature and protect from light . Store at room temperature not more than 30 ° C and dry .

Drug Name: Duo-Anglucid
Comparable drug patent: Glucovance
Active substance: Metformin-Glibenclamide
Presentation: Tablets
Concentration: 500/5.0 mg
Extended-release tablets: No
Laboratory: Collins S. A. DE CV
Bottle with 30 pills
Made In: Mexico