Glumetza- Once-daily dosing effective for type 2 diabetes control

Companies:

Depomed and King

Pharmacologic class:

Antihyperglycemic (biguanide)

Active ingredient:

Metformin HCl 500 mg; extended-release tabs.

Indication:

Adjunct to diet and exercise in type 2 diabetes as monotherapy, or with a sulfonylurea or insulin.

Pharmacology:

Glumetza extended-release tablets are designed to deliver metformin HCl to the upper GI tract, which may reduce GI side effects often seen with immediate-release products.

Clinical trials:

In a randomized, double-blind study, three Glumetza regimens were evaluated in the treatment of patients with type 2 diabetes. Patients were given Glumetza 1.5 g once daily, Glumetza 1.5 g per day in divided doses (500 mg in the am and 1 g in the pm), Glumetza 2 g once daily, or immediate-release metformin 1.5 g per day in divided doses (500 mg in the am and 1 g in the pm). Each of the Glumetza regimens were at least as effective as immediate-release metformin in all measures of glycemic control. The once-daily dosing regimen was shown to be as effective as the twice-daily dosing regimen of the immediate-release metformin formulation.

Adults:

Swallow whole. Take with evening meal. ≥18 years: Monotherapy: Initially 1 g once daily; may increase by 500 mg/day at one-week intervals; maximum 2 g once daily. If glycemic control not achieved: consider giving 1 g twice daily. Adding to insulin: Initially 500 mg once daily; may increase by 500 mg/day at one-week intervals; maximum 2 g/day. Reduce insulin dose by 10%–25% as needed. Concomitant sulfonylureas: see literature. Elderly, debilitated, malnourished: avoid maximum doses.

Children:

<18 years: not recommended.

Contraindications:

Renal disease or dysfunction. Metabolic acidosis, ketoacidosis. Concomitant intravascular iodinated contrast agents (suspend during and for 48 hours after use).

Precautions:

Confirm normal renal function before starting and monitor (especially in patients ≥80 years). Avoid if clinical or lab evidence of hepatic disease. Discontinue if lactic acidosis, ketoacidosis, renal impairment, shock, acute MI, sepsis, acute CHF, or hypoxemia occurs. Suspend therapy if dehydration occurs or before surgery. Monitor hematology (especially serum vitamin B12 in susceptible patients). Secondary failure. Elderly, debilitated, uncompensated strenuous exercise, stress, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Pregnancy (Cat. B), nursing mothers: not recommended; consider using insulin instead.

Interactions:

Cationic drugs eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin), furosemide, nifedipine, cimetidine: may increase metformin levels. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Diuretics, steroids, phenothiazines, phenytoin, niacin, sympathomimetics, calcium channel blockers, isoniazid, others that may cause hyperglycemia. Increased risk of hypoglycemia with alcohol, sulfonylureas, insulin. Beta blockers may mask hypoglycemia.

Adverse reactions:

GI disturbances, lactic acidosis (rare, half of the cases are fatal).

How supplied:

Tabs — 100.

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