Mepaphage for diabetes type 2

Tablets, XR Film Coated Tablets

Composition :

Mepaphage 500 mg tablets:
Each tablet contains:
Active ingredients:
Metformin HCI                          500 mg
Equivalent to Metformin          390 mg
Inactive ingredients:
-PoVidone K25, ACdisol, Avicel and Magnesium stearate.
Mepaphage 850 mg XR film coated tablets
Each XR film coated tablet contains:
Active ingredients:
Metformin HCI                           850 mg
Equivalent to Metformin          662.9 mg
Inactive ingredients:
Carboxy methyl cellulose sodium, stearic acid, magnesium stearate, hydroxy propyl methyl cellulose 1S CPS, titanium dioxide and macrogols (PEG 6000).
Mepaphage 1000 mg XR film coated tablets
Each XR film coated tablet contains:
Active ingredients:
Metformin HCI                           1000 mg
Equivalent to Metformin           780 mg
Inactive ingredients:
Carboxy methyl cellulose-sodium, stearic acid, magnesium stearate hydroxy propyl methyl cellulose 15 CPS, titanium dioxide and macrogols (PEG 6000).

Pharmacological action :

Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucoseproduction, decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see precautions) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

Pharmacokinetics :

The appearance of metformin in plasma from extended release tablet is slower and more prolonged compared to immediate- release metformin. Metformin absorption increased by approximately 60% when given with food. Metformin is negligibly bound to plasma proteins.

Indications :

Diabetes type 2.

Dosage and administration :

Initially SOD mg with breakfast for 1 week then SOD mg with breakfast and evening meal for 1 week then 500 mg with breakfast ,lunch and evening meal, maximum 3 g. daily in divided doses.

Contraindications :

Mepaphage is contra-indicated in patients with:
– Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels >/= 1.5 mg/dL [males], >/= 1.4 mg/dL [females) or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute
myocardial infarction and septicemia. Congestive heart failure requiring pharmacologic treatment.
– Known hypersensitivity to metformin hydrochloride.
– Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
– Mepaphage should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because , use of such products may result in acute alteration of renal function.

Side effects :

Vomiting, abdominal pain accompanied by muscle cramps and tor general feeling of malaise with severe fatigue occurring during therapy may be signs of serious destabilization of your diabetes.

Drug interaction :

Inform your doctor or pharmacist if you are taking or have recently taken another drug i.e corticosteroids, antihypertensive agents of ACE inhibitor class, diuretics, ritodrin, salbutamol or terbutanine iodised contrast media or medications containing alcohol.

Pregnancy and lactation :

The treatment with Mepaphage (Metformin) should be replaced with insulin during pregnancy and breast feeding.

Precautions and warnings :

Lactic Acidosis:
• Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Mepaphage or Mepaphage XR; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in
association with a number of pathophysiologic conditions, including diabetes mellitus .
• Monitoring of renal function: Metformin is known to be substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal for their age should not receive Mepaphage (metformin hydrochloride tablets) or Mepaphage XR (metformin hydrochloride extended release tablets).
• Use of concomitant medications that may affect renal function or metformin disposition.
• Radiologic studies involving the use of intravascular iodinated contrast materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials.

Package and Storage :

Each box of Mepaphage 500 mg tablets contains:
3 strips (PVC/Aluminium) each of 10 tablets and inner leaflet.
Each box of Mepaphage 1000 mg (XR) Film coated tablets contains:
3 strips (PVC/Aluminium) each of 10 tablets and inner leaflet.
Each box of Mepaphage 850 mg (XR) Film coated tablets contains:
3 strips (PVC/Aluminium) each of 10 tablets and inner leaflet.
Store in a dry place at temperature not exceeding 30 ·C.
Keep out of reach of children

Produced by :

Arab Company for Pharmaceuticals and Medicinal Plants
Enshas El Raml- Sharkeya – Egypt.

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