Glumetza

— THERAPEUTIC CATEGORIES —
  • Diabetes

Glumetza Generic Name & Formulations

General Description

Metformin HCl 500mg, 1000mg; ext-rel tabs.

Pharmacological Class

Biguanide.

How Supplied

Tabs 500mg—100; 1000mg—90

Generic Availability

YES

Glumetza Indications

Indications

Adjunct to diet and exercise in type 2 diabetes.

Glumetza Dosage and Administration

Adult

Swallow whole. Take with evening meal. Initially 500mg once daily; may increase by 500mg increments at 1-2 week intervals; max 2g once daily.

Children

Not established.

Glumetza Contraindications

Contraindications

Severe renal impairment (eGFR <30mL/min/1.73m2). Metabolic acidosis, diabetic ketoacidosis, with or without coma.

Glumetza Boxed Warnings

Boxed Warning

Lactic acidosis.

Glumetza Warnings/Precautions

Warnings/Precautions

Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis occurs. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR 30–60mL/min/1.73m2, history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Suspend therapy if dehydration occurs or before surgery. Avoid if clinical or lab evidence of hepatic disease. Assess renal function prior to starting and periodically thereafter; more frequently in elderly or if eGFR <60mL/min/1.73m2. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication: increased risk of hypoglycemia. Monitor hematology annually and Vit. B12 every 2–3yrs. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Pregnancy. Nursing mothers.

Glumetza Pharmacokinetics

See Literature

Glumetza Interactions

Interactions

Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels; consider benefits/risks. Avoid excessive alcohol intake (potentiates effects of metformin on lactate). Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, calcium channel blockers, isoniazid, nicotinic acid, others may cause hyperglycemia; monitor. May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia.

Glumetza Adverse Reactions

Adverse Reactions

Hypoglycemia, diarrhea, nausea; Vit. B12 deficiency; rare: lactic acidosis (may be fatal).

Glumetza Clinical Trials

See Literature

Glumetza Note

Not Applicable

Glumetza Patient Counseling

See Literature