Sil-Norboral (Glyburide, Metformin)

Active Ingredient: Glyburide, Metformin
Dosage: 5/500 mg
Route of Administration: Oral
Dosage Form: Tablets
Quantity per package: 40 pills

Sil-Norboral is a combination medication (glyburide + metformin) which is used to control glucose level in type 2 diabetes. This type of diabetes is also called as non-insulin dependent diabetes mellitus.

Sil-Norboral is no longer available in the store but you can order a similar product  for type 2 diabetes on this page.

Indications

Sil-Norboral is indicated as a treatment attached to diet and exercise to control hyperglycemia in patients with type 2 diabetes mellitus (not insulin-dependent). The drug is specifically indicated in the following cases: type 2 diabetic, overweight or normal weight, with failure to dietary regimen and no tendency to ketosis; type 2 diabetic with overweight or normal weight, with lipid disorders secondary to diabetes; type 2 diabetic under dietary regimen and with failure secondary to sulfonylureas or biguanides; type 1 diabetic (insulin-dependent) under dietary regimen and insulin, to reduce the doses of the latter, never to replace it.

Dosage and administration

The drug is administered orally. The dose of Sil-Norboral should be individualized according to the effectiveness and tolerance of glyburide and metformin, as long as they do not exceed the recommended daily maximum of 20 mg for glyburide and 3000 mg for metformin. The tablets should be administered with food. Start with the lowest dose and make gradual adjustments to avoid hypoglycemia. It is necessary to determine the minimum effective dose for adequate glycemic control in each patient. It is recommended to monitor the response through the determination of glycosylated hemoglobin since this is a better indicator of long-term glycemic control than fasting blood glucose. The drug does not replace the diet, therefore, it should always accompany the administration of the medication. Sil-Norboral is not a substitute for insulin, but it can be associated with it to decrease doses and/or daily applications, together with a dietary plan.

Type of diabetic patient	Therapeutic scheme
Newly diagnosed who has not responded to diet and exercise and is taking an HbA1c = 9% or fasting plasma blood glucose = 200 mg / dl	Continue with diet and exercise by administering 1 tablet of 2.5 mg / 500 mg every 12 hours with food or 1 tablet of 5 mg / 500 mg every 24 hours with the main food
Newly diagnosed who has not responded to diet and exercise and is taking an HbA1c> 9% or fasting plasma blood glucose> 200 mg / dl	Continue with diet and exercise by administering 1 tablet of 5 mg / 500 mg every 12 hours with food or 1 tablet of 5 mg / 1,000 mg every 24 hours with the main food
Patient under therapy who has not responded to diet, exercise, sulfonylurea or biguanide, with HbA1c = 7% or fasting plasma glycemia = 150 mg / dl	Continue with diet and exercise by administering 1 tablet of 5 mg / 500 mg every 12 hours with food or 1 tablet of 5 mg / 1,000 mg every 12 hours with the main food
Patient who has not responded to diet, exercise, combination of sulfonylurea and biguanide at low doses	Continue with diet and exercise by administering 5 mg / 1,000 mg distributed with food, without exceeding the maximum dose

Always consult a doctor before taking this medication!

Contraindications

• Hypersensitivity to glibenclamide, metformin, as well as other sulfonylureas or biguanides;
• Diabetic ketosis;
• Hypoglycemic states;
• Hepatic and / or renal failure;
• Intake of alcoholic beverages;
• Type 1 diabetes as an insulin substitute;
• Surgical interventions;
• All those pathologies that present or cause a state of hypoxia, dehydration, sepsis, or hypermetabolic states such as advanced age, cardiovascular, cardiovascular-respiratory disorders, serious infections (bacteremias, septicemias, pneumopathies), traumas, fever, adrenal insufficiency or pregnancy;
• Radiological studies using contrast media I.V.

It is recommended to suspend the administration of the drug 48 hours before carrying out the radiological study and to resume its administration 48 hours after having finished it, in order to prevent lactoacidosis.

Side effects

Sil-Norboral is a well-tolerated medication. Side effects are directly related to the dose, they are transient and respond to dose reduction or drug suspension. However, there are reports that some side effects due to hypersensitivity can be severe. The most common gastrointestinal reactions are diarrhea and abdominal pain. Other effects reported: fullness, heartburn, anorexia and bitter or metallic taste, which are often corrected by dividing the daily dose into two doses and are reduced by taking the medication with food. Rarely, cholestatic jaundice may occur. In this case, treatment with this drug should be suspended. Metabolic reactions are hypoglycemia and lactoacidosis. The risk of hypoglycemia is increased in patients with renal, hepatic or pituitary insufficiency, as well as in the elderly. Dermatological reactions include pruritus, erythema, urticaria and maculopapular lesions. In sporadic cases, it is necessary to suspend the medication. Hematological reactions: decreased platelet aggregation and increased clotting time. In rare cases, the drug caused leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia and pancytopenia, mainly due to its sulfonylureic component. Cardiac reactions: hypoglycemia, angor attacks and arrhythmias.

Overdose

An overdose of Sil-Norboral in diabetic patients causes hypoglycemia and / or lactic acidosis. Accidental intake of excessive doses of the drug by a non-diabetic person can cause hypoglycemia of varying intensity. Hypoglycemia is characterized by hunger, anxiety, profuse sweating, tremor, irritability, restlessness, confusional state, vertigo, palpitations, paleness, paraesthesia, and hyperesthesias of the lips, nose, fingers, nausea, vomiting, seizures and other neurological disorders. Hypoglycemia is confirmed by usual laboratory methods or with test strips. Hypoglycemia is treated by administering food or drinks rich in glucose or a 50% glucose solution. Close monitoring is required for 48 hours after normalizing blood levels to prevent relapse.

An overdose can also cause lactic acidosis or lactoacidosis. The picture is characterized by nausea, vomiting, abdominal discomfort, feeling of fullness, heartburn, anorexia, myalgia and lactoacidemia above 5 mmol / L and elevation of serum creatinine. In this case, stop the medication and establish intensive symptomatic therapy and close monitoring.

Hemodialysis effectively removes metformin and can correct metformin-induced lactic acidosis.

Interaction

The drug interactions that occur with Sil-Norboral are not exclusive to this medicine since they are shared by all sulfonylureas and by biguanides.

Medicines that potentiate the hypoglycemic action: thiotic acid, non-steroidal anti-inflammatory drugs, beta-blockers, biguanides, bezafibrate, clofibrate, chloramphenicol, cyclophosphamide, anabolic steroids, fenfluramine, phosphamide, fluconazole, phenylbutazone, fluoroquinolones, fluoroquinolones, fluoroquinolones, insulin, fluoroquinolones, insulin, fluoroquinolones, insulin, fluoroquinolones, insulin, itraconazole, ACE inhibitors, miconazole, parenteral pentoxifylline (high doses), probenecid, hypoglycemic sulfonylureas, sulfamethoxazole, sulfathiazole, sulfisoxazole, sulfadiazine, sulfonamide, sulfinpyrazone, salicylates and tetracyclines.

Medicines that reduce hypoglycemic action: nicotinic acid (high doses), acetazolamide, calcium channel inhibitors, barbiturates, corticosteroids, clonidine, estrogens, phenothiazine and derivatives, glucagon, gestagens, thyroid hormones, isoniazid, laxatives (high doses), rifampin, sympathomimetics, thiazides and other saluretics.

Other drug interactions: cationic drugs compete with metformin for tubular renal secretion (cimetidine, ranitidine, amiloride, digoxin, morphine, quinine, quinidine, triamterene, trimethoprim and vancomycin) increasing the concentration of metformin. Histamine H2 receptor inhibitors may potentiate or decrease the hypoglycemic effect. The intake of alcoholic beverages with sulphonylureic or biguanidic drugs can cause a disulfiramic reaction, regardless of whether they can potentiate or diminish their hypoglycemic effect. The effect of anticoagulants and fibrinolytics are potentiated by metformin. Nutritional interactions: foods do not alter the absorption of Sil-Norboral so they can be administered before, with or after ingesting food. Due to the pharmacological characteristics of Sil-Norboral, it is recommended to administer the tablets with food or immediately after it.