Merichom®

Diabetes Type 2

Adults

Initial dose: 500 to 1000 mg orally once a day with the evening meal.
Dose titration: Increase in 500 mg weekly increments as tolerated up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on 2000 mg once daily, a trial of 1000 mg twice daily should be considered. If higher doses are required, may switch to immediate-release product.
Maintenance dose: 2000 mg daily
Maximum dose: 2000 mg daily

Children:

Safety and effectiveness of metformin extended-release has not been established in pediatric patients less than 18 years of age.

Administration advice:
-Metformin ER tablets must be swallowed whole and never split, crushed, or chewed. Occasionally, the inactive ingredients of the 500 mg ER tablets will be eliminated in the feces as a soft, hydrated mass, while the1000 mg ER tablets will leave an insoluble shell

-Take with a full glass of water once daily with the evening meal.

Contraindications:

• Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [men] and ≥ 1.4 mg/dL [women] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia
• Known hypersensitivity to metformin hydrochloride.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
• 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.

Interactions:

• Glyburide: Following coadministration of Metformin and glyburide, decreases in glyburide C max were observed, but were highly variable; the clinical significance of this interaction is uncertain.
• Furosemide: If furosemide and metformin must be used together, Patients should be advised to monitor their blood glucose and to promptly notify their physician if they experience possible signs of lactic acidosis such as malaise, myalgia, respiratory distress, hyperventilation, slow or irregular heartbeat, somnolence, abdominal upset, or other unusual symptoms.
• Nifedipine: Nifedipine may increase plasma concentrations of metformin by increasing the extent of absorption. Increased metformin levels may increase the risk of lactic acidosis.
• Cationic drugs: Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin). careful patient monitoring and dose adjustment of Metformin and/or the interfering drug is recommended in patients.
• Cimetidine: Particularly slow and cautious titration of metformin dosage is recommended if these drugs must be used together. The maximal dose of metformin should also be reduced. Patients should be advised to monitor their blood glucose and to promptly notify their physician if they experience possible signs of lactic acidosis such as nausea, vomiting, malaise, myalgia, weakness, respiratory distress, slow or irregular heartbeat, dizziness, lightheadedness, or other unusual symptoms.
• Other: Certain drugs (for example thiazides, other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid) tend to produce hyperglycemia and may lead to loss of glycemic control. When such drugs are withdrawn from a patient receiving Metformin, the patient should be observed closely for hypoglycemia.

Pregnancy and Lactation:

Pregnancy Category B

There are no adequate and well-controlled studies in pregnant women with Metformin. Metformin should not be used during pregnancy unless clearly needed.

Breast-feeding: Metformin is excreted into milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If Metformin is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Warning and Precaution:

►Monitoring of renal function: Before initiation of Metformin therapy and at least annually thereafter, renal function should be assessed and verified as normal. In patients in whom development of renal dysfunction is anticipated, renal function should be assessed more frequently and Metformin discontinued if evidence of renal impairment is present.

► Lactic Acidosis: Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking Metformin hydrochloride tablets, the drug should be discontinued immediately and general supportive measures promptly instituted.

►Iodinated contrast materials: Intravascular contrast studies with iodinated materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials) can lead to acute alteration of renal function and have been associated with lactic acidosis in patients receiving Metformin. Therefore, Metformin should be temporarily discontinued at the time of or prior to the procedure, and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been re-evaluated and found to be normal.

►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 therapy 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: In controlled clinical trials of Metformin hydrochloride tablets, a decrease of normal serum vitamin B 12 levels, without clinical manifestations, was observed. Such decrease very rarely associated with anemia and appears to be rapidly reversible with discontinuation of Metformin hydrochloride tablets or vitamin B 12 supplementation.

►Hypoglycemia- Hypoglycemia does not occur in patients receiving Metformin alone 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 sulfonylureas and insulin) or ethanol.

►Elderly: Metformin treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced.

►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 reinstituted after the acute episode is resolved.

Adverse Reactions:

Diarrhea, vomiting, abdominal pain, constipation, abdomen distention, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.

Storage:

Store below 30 and protect from light and moisture.