Gloryl-M® 500/ 2

Gloryl-M® 500/ 2
Potent Antidiabetic

Indication
- Gloryl-M®: is used as oral antidiabetic medicine, it is recommended as an adjunct to diet and physical exercise for the treatment of non-insulin dependent diabetes mellitus (Type 2).
- Gloryl-M®: is used when the monotherapy with glimepiride or metformin dose not result in adequate glycemic control.
- Gloryl-M®: is used in the replacement of the free combination therapy of glimepiride and metformin.

Composition
Each film coated tablet of Gloryl-M® 500/ 4 contains :
- Metformin Hydrochloride 500 mg
- Glimepiride 4 mg
Each film coated tablet of Gloryl-M® 500/ 2 contains :
- Metformin Hydrochloride 500 mg
- Glimepiride 2 mg

Dosage
- Gloryl-M® should be administered once or twice daily ,immediately before or with meals.
- The tablet should be swallowed whole with about half a glass of water.
Gloryl-M® is a medicine which contains two components: Metformin Hydrochloride and Glimepiride.
- Metformin Hydrochloride is an oral antidiabetic (biguanide) agent. Its mechanism of action is differ from those of sulfonylurea, where it decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity ( increase peripheral glucose uptake and utilization). It doesn’t produce hypoglycemia and doesn’t change from insulin secretion.
- Glimepiride is a sulfonylurea hypoglycemic agent and act by stimulation of insulin release from functioning pancreatic beta cells and increases sensitivity of peripheral tissues to insulin.
Absorption:
- Metformin hydrochloride is slowly and incompletely absorbed from the gastrointestinal tract, inverse Glimepiride where it completely absorbed from the gastrointestinal tract.The peak plasma concentrations for both is occur between 2- 6 hours, and bioavailability from 50- 60% for metformin.
Plasma protein binding:
- Metformin’s plasma protein binding is negligible, and it excreted unchanged in urine, where the plasma elimination half life range from about 2 -6 hours.
- Glimepiride is highly bound to plasma proteins and is completely metabolized. The half life after multiple doses is about 9 hours and( 60%) of dose is eliminated in the urine and 40% in the feces.
Each film coated tablet of Gloryl-M® 500/ 4 contains :
- Metformin Hydrochloride 500 mg
- Glimepiride 4 mg
Each film coated tablet of Gloryl-M® 500/ 2 contains :
- Metformin Hydrochloride 500 mg
- Glimepiride 2 mg
- Gloryl-M®: is used as oral antidiabetic medicine, it is recommended as an adjunct to diet and physical exercise for the treatment of non-insulin dependent diabetes mellitus (Type 2).
- Gloryl-M®: is used when the monotherapy with glimepiride or metformin dose not result in adequate glycemic control.
- Gloryl-M®: is used in the replacement of the free combination therapy of glimepiride and metformin.
Gloryl-M® is contraindicated in the following cases:
- Insulin dependent diabetes (Type 1- diabetes requiring lnsulin therapy).
- Diabetic ketoacidosis.
- Hypersensitivity to Gloryl-M®, or any of its ingredients,and other Sulfonylureas and biguanides.
- Lactic acidosis.
- Renal diseases or renal dysfunction.
- Heart failure.
- Recently heart attack, severe circulatory problems or breathing difficulty.
- Liver diseases.
- Severe infections or any dehydration.
- X-ray with iodinated contrast materials administered IV stop tacking Gloryl-M® at the time of and for a few days after the procedure.
- If you are not eating sufficiently, if you are debilitated or suffering from pituitary or adrenal insufficiency.
- Gloryl-M® hypoglycemic effects may potentiated when administered with the following drugs: ( insulin and other oral antidiabetics, ACE inhibitors , allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatiues, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAO inhibitors, miconazole, para- aminosalicylic acid, pentoxifylline, phenylbutazone, azapropazone, oxyphenbutazone, probenecide, quinolines, salicylates, sulfinpurazone, sulfonamides, tetracyclines, tritoqualine, and trofosfamide) .
- Weaking of blood sugar lowring effect and thus raised blood sugar levels may occur when the following medicines is taken, for example: (Acetazolamide, barbiturates, corticosteroides, diazoxide, diuretics, epinephrine, and other sympathomimetic agents, glocagon, laxatives, nicotinic acid, estrogens and progestogens, phenothiazines, phenytoin, rifampicin and thyroid hormones).
- H2 receptor antagonists, clonidine and reserpine may` potentiate or decrease the Gloryl-M® effects.
- Beta- blockers decrease glucose tolerance. In patients with diabetes melitus this may lead to deterioration of metabolic control, in addition, beta blockers may be potentiate or weaken the blood sugar lowering action of Gloryl-M® unpredictably.
- coumarin derivatives may increase or decrease the activity of Gloryl-M®.
- Lactic acidosis may occur by concomitant. with Gloryl-M® administration of the following drugs : Iodinated contrast materials and antibiotics having strong renal toxicity (for example gentamycin).
- Gloryl-M® should not be used during pregnancy, if there is planning for pregnancy or Breast feeding.
- Hypoglycemia.
- Lactic acidosis practically those who have renal dysfunction.
- Temporary visual impairment may occur due to change in blood Sugar levels.
- Occasionally, gastrointestinal symptoms may occur, most frequently during initiation of therapy and resolve spontaneously in most cases: ( Nausea, vomiting, sensation of pressure or fullness in the epigastria, flatulence, abdominal pain, and diarrhea. In rare cases, liver enzyme levels may increase. In isolated cases, impairment of liver function (e.g with cholestasis and jaundice) and hepatitis may develop, possibly leading to liver failure) .
- Severe changes in blood picture may occur, rarely, thrombopenia and in isolated cases, leucopenia, hemolytic anemia, erythrocytopenia and agranulocytosis, and pancytopenia may develop.
- A decrease in vit B12 levels can be observed, therefore, serum B12 levels should be appropriately monitored.
- Allergic or pseudo allergic reactions may occur e.g.:(in the form of itching, urticaria or rashes), such reactions may be mild, but may become more serious and may be complained by dyspnoea, and fall in blood pressure, sometimes progressing to shock. In isolated cases, a decrease in serum sodium , inflammation of blood vessels and hypersensitivity of the skin to light may occur.
Over dosage:
- If an excessive dose is taken ,this may lead to severe and sometimes life-threatening hypoglycemia and may require hospitalization even as precautionary measure.
- Gloryl-M® should be administered once or twice daily ,immediately before or with meals.
- The tablet should be swallowed whole with about half a glass of water.
- Please follow closely the instructions for dosage monitoring (blood and urine tests), diet and physical activity ( physical work and exercise) as discussed with your doctor.
- Inform your doctor in event of the following : surgery, fever, infection, difficulty in eating.
- In the first weeks of treatment, the risk of developing hypoglycaemia may be increased, and you may need to be closely monitored.
- Vision, alertness and reactions during driving or machine operation may be impaired when treatment for diabetes is not properly balanced or in the case of hypoglycemia.
- Blister contains 10 tablets, pack contains three blister.
- Store in a dry place, away from light and temperature below 30 °C.