Alexodiab 1000 mg Tablets
Metformin HCl 1000 mg/tab.
Company Name
Alexandria
Therapeutic Group
BIGUANIDE A-DIABS PLAIN
Pharmaceutical form
Tablets
Package
3 or 100 strips x 10 tab.
Indications
"Alexodiab as monotherapy, is indicated as an adjunct to diet to lower blood glucose in patients with type II Diabetes mellitus whose hyperglycemia can not be satisfactorily managed on diet alone.
Alexodiab may be used concomitantly with a sulphonylurea or insulin to improve glycemic control. In initiating treatment for type II Diabetes Mellitus, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patients. If this treatment program fails to reduce symptoms and/or blood glucose, the use of Metformin alone or plus a sulphonylurea should be considered
Warning & Precautions
"Precautions: Lactic Acidosis: Lactic Acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Alexodiab , 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 ,and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L) ,decreased blood pH ,electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio, When metformin is implicated as the cause of lactic acidosis, metformin plasma levels > 5 g/ml are generally found. 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 Metformin. In patients with advanced age, Metformin should be carefully titrated to establish the minimum dose for adequate glycemic effect, because aging is associated with reduced renal function. Hypoxic states: Cardiovascular collapse (shock) from whatever cause, acute congestive heart failure, acute myocardial infarction and other conditions characterized by hypoxemia have been associated with lactic acidosis. When such events occur in patients on Metformin therapy, the drug should be promptly discontinued. Surgical procedures: Metformin should be temporarily suspended for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids) and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal. Alcohol intake: Alcohol is known to potentiate the effect of metformin on lactate metabolism. Patients, therefore, should be warned against excessive alcohol intake, acute or chronic, while receiving Metformin. Impaired hepatic function: Since impaired hepatic function has been associated with some cases of lactic acidosis, Metformin should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Vitamin B12 levels: A decrease to subnormal levels of previously normal serum vitamin B12 levels, without clinical manifestations, is observed. Such decrease, possibly due to interference with B12 absorption from the B12-intrinsic factor complex, is however very rarely associated with anemia and appears to be rapidly reversible with discontinuation of Metformin or vitamin B12 supplementation. Hypoglycemia: It does not occur in patients receiving Metformin alone or under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulphonylureas and insulin) or ethanol. Elderly, debilitated or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs. Loss of control of blood glucose: When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a temporary loss of glycemic control may occur. At such times, it may be necessary to withhold Metformin and temporarily administer insulin. Metformin may be re-instituted after the acute episode is resolved. Warning: This drug can be useful in some diabetic patients and must not be used except under medical supervision and should only be dispensed with a medical prescription."
Product Type
Human
Dosage
"As recommended by the physician or as follows:
There is no fixed dosage regimen for the management of hyperglycemia in Diabetes Mellitus with Alexodiab or any other pharmacologic agent. Dosage of Alexodiab must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose of 2550 mg.
Alexodiab should be given in divided doses with meals and should be started at a low dose with gradual dose escalation, both to reduce gastro-intestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
Recommended dosing schedule: The usual starting dose of Alexodiab is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a total of 2000 mg per day given in divided doses.
Adverse Reactions
"Gastro-intestinal reactions: Diarrhea, nausea, vomiting, abdominal bloating, flatulence and anorexia. These symptoms are generally transient and resolve spontaneously during continued treatment. Because gastrointestinal symptoms during therapy initiation appear to be dose-related, they may be decreased by gradual dose escalation and by having patients take Metformin with meals.
Special senses: Unpleasant or metallic taste which usually resolves spontaneously.
Dermatologic reactions: Rash, dermatitis.
Hematologic: Asymptomatic subnormal serum vitamin B12 levels; serum folic acid levels did not decrease significantly. However, only five cases of megaloblastic anemia have been reported with metformin administration. Therefore, serum B12 levels should be appropriately monitored or periodic parenteral B12 supplementation considered.
Contra Indications
"Metformin is contra-indicated in patients with:
1- Known hypersensitivity to metformin hydrochloride or any of other drug components.
2- Renal disease or renal dysfunction (abnormal creatinine clearance) which may result from conditions such as cardiovascular collapse (shock), acute myocardial infarction and septicemia.
3- Congestive heart failure requiring pharmacologic treatment.
4- Metformin 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.
5- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
6- In patient of chronic alcohol intake. "
Drug Interactions
"Glyburide: Co-administration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics.
Furosemide: Furosemide increased the plasma & blood metformin without any significant change in metformin renal clearance when administered with metformin. No information is available about the interaction of metformin and furosemide when co-administered chronically.
Nifedipine: Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine.
Cationic drugs: Cationic drugs (e.g. amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems.
Other: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include thiazide and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving Metformin, the patient should be closely observed to maintain adequate glycemic control.
Metformin is negligibly bound to plasma proteins and is , therefore , less likely to interact with highly protein-bound drugs such as salicylates, sulphonamides, chloramphenicol and probenecid, as compared to sulphonylureas, which are extensively bound to serum proteins.
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