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Glucovance (glyburide/metformin hydrochloride)

BOXED WARNING

Lactic acidosis may occur due to metformin accumulation; risk increases with CHF, degree of renal dysfunction, and patient's age. Regularly monitor renal function and use the minimum effective dose of metformin. Do not initiate in patients ≥80 yrs of age unless measurement of CrCl demonstrates that renal function is not reduced. Promptly withhold therapy in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Avoid with clinical or lab evidence of hepatic disease. Caution against excessive alcohol intake; alcohol potentiates the effects of metformin on lactate metabolism. Temporarily d/c therapy prior to any intravascular radiocontrast study and for any surgical procedure. D/C use immediately and promptly institute general supportive measures if lactic acidosis occurs. Prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin.

THERAPEUTIC CLASS

Biguanide/sulfonylurea

DEA CLASS

RX

INDICATIONS

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

ADULT DOSAGE

Type 2 Diabetes Mellitus

Currently on Diet and Exercise:
Initial: 1.25mg/250mg qd w/ a meal; may use 1.25mg/250mg bid w/ the am and pm meals if baseline HbA1c >9% or FPG >200mg/dL
Titrate: Increase by 1.25mg/250mg/day every 2 weeks
Max: 20mg/2000mg/day

Currently on a Sulfonylurea and/or Metformin:
Initial: 2.5mg/500mg or 5mg/500mg bid w/ the am and pm meals; starting dose should not exceed daily doses of the sulfonylurea or metformin already being taken
Titrate: Increase by no more than 5mg/500mg/day
Max: 20mg/2000mg/day

Addition of Thiazolidinediones:
Continue current dose of Glucovance and initiate thiazolidinedione at its recommended starting dose

DOSING CONSIDERATIONS

Concomitant Medications
Colesevelam: Administer Glucovance at least 4 hrs prior to colesevelam

Elderly
Initial/Maint: Dose conservatively; do not titrate to max dose

Adverse Reactions
Hypoglycemia w/ Glucovance/Thiazolidinedione Combination: Consider reducing the dose of the glyburide component; consider adjusting the dosages of the other components of the regimen as clinically warranted

Other Important Considerations
Debilitated/Malnourished Patients: Do not titrate to max dose

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: (Glyburide/Metformin) 1.25mg/250mg, 2.5mg/500mg, 5mg/500mg

CONTRAINDICATIONS

Renal disease or dysfunction (eg, SrCr ≥1.5mg/dL [males], ≥1.4mg/dL [females], or abnormal CrCl), acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Coadministration with bosentan. Temporarily d/c in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.

WARNINGS/PRECAUTIONS

May be associated with increased cardiovascular (CV) mortality. May cause hypoglycemia; increased risk when caloric intake is deficient; when strenuous exercise is not compensated by caloric supplementation; with renal/hepatic insufficiency, adrenal/pituitary insufficiency, alcohol intoxication; or in elderly, debilitated, or malnourished patients. Not recommended during pregnancy. Caution in elderly. Glyburide: May cause hemolytic anemia; caution with G6PD deficiency. Metformin: Assess renal function before initiation of therapy and at least annually thereafter; d/c with evidence of renal impairment. Temporarily d/c at the time of or prior to radiologic studies involving the use of intravascular iodinated contrast materials, withhold for 48 hrs subsequent to the procedure, and reinstitute only if renal function is normal. D/C promptly if CV collapse (shock), acute CHF, acute MI and other conditions characterized by hypoxemia occur. Temporarily suspend for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids); restart when oral intake is resumed and renal function is normal. May decrease serum vitamin B12 levels; monitor hematologic parameters annually. Caution in patients predisposed to developing subnormal vitamin B12 levels (eg, those with inadequate vitamin B12 or Ca2+ intake or absorption). Evaluate patients previously well controlled on therapy who develop lab abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis; d/c if acidosis occurs.

ADVERSE REACTIONS

Lactic acidosis, upper respiratory infection, N/V, abdominal pain, headache, dizziness, diarrhea.

DRUG INTERACTIONS

See Boxed Warning, Dosage, Dose Modification, and Contraindications. Increased risk of hypoglycemia with other glucose-lowering agents or ethanol. May be difficult to recognize hypoglycemia with β-blockers. Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid may produce hyperglycemia and may lead to loss of glycemic control; monitor closely for loss of control during coadministration and for hypoglycemia during withdrawal of these drugs. Weight gain observed with the addition of rosiglitazone to therapy. Monitor LFTs during coadministration with a thiazolidinedione. Metformin: Caution with drugs that may affect renal function or result in significant hemodynamic change or may interfere with the disposition of metformin (eg, cationic drugs eliminated by renal tubular secretion). Furosemide, nifedipine, and cimetidine may increase levels. May decrease furosemide levels. Cationic drugs that are eliminated by renal tubular secretion (eg, cimetidine, amiloride, digoxin, morphine, quinidine, vancomycin) may potentially produce an interaction; monitor and adjust dose of therapy and/or the interfering drug. Glyburide: Hypoglycemic effects may be potentiated by NSAIDs and other highly protein-bound drugs, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, MAOIs, and β-blockers; monitor closely for hypoglycemia during coadministration and for loss of glycemic control during withdrawal of these drugs. Possible interaction with ciprofloxacin (a fluoroquinolone antibiotic), resulting in potentiation of hypoglycemic action. Potential interaction leading to severe hypoglycemia reported with oral miconazole. Colesevelam may reduce levels.

PREGNANCY AND LACTATION

Category B, not for use in nursing.

MECHANISM OF ACTION

Glyburide: Sulfonylurea; lower blood glucose acutely by stimulating release of insulin from the pancreas. Metformin: Biguanide; decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

PHARMACOKINETICS

Absorption: Glyburide: Tmax=4 hrs. Metformin: Absolute bioavailability (50-60%) (500mg); Cmax=1.48mcg/mL (850mg single-dose); Tmax=3.32 hrs (850mg single-dose). Distribution: Glyburide: plasma protein binding (extensive). Metformin: Vd=654L (850mg single-dose). Metabolism: Glyburide: metabolites: 4-trans-hydroxy derivative (major) and 3-cis hydroxy derivative. Elimination: Glyburide: Bile (50%, metabolites), urine (50%, metabolites); T1/2=10 hrs. Metformin: Urine (90%); T1/2=6.2 hrs (plasma), 17.6 hrs (blood).

ASSESSMENT

Assess for metabolic acidosis, diabetic ketoacidosis, risk factors for lactic acidosis, renal/hepatic impairment, presence of malnourishment or debilitation, adrenal/pituitary insufficiency, alcoholism, G6PD deficiency, hypoxemia, inadequate vitamin B12 or Ca2+ intake/absorption, previous hypersensitivity to the drug, pregnancy/nursing status, and possible drug interactions. Assess if patient is planning to undergo any surgical procedure, or radiologic studies involving the use of intravascular iodinated contrast materials. Obtain baseline FPG and HbA1c levels, and hematologic parameters.

MONITORING

Monitor for signs/symptoms of lactic acidosis, CV effects, hypoglycemia, hemolytic anemia, and other adverse reactions. Monitor for changes in clinical status. Monitor renal function, especially in elderly, at least annually. Monitor hematologic parameters annually. Perform routine serum vitamin B12 measurements at 2- to 3-yr intervals in patients predisposed to developing subnormal vitamin B12 levels. Monitor FPG and HbA1c levels periodically.

PATIENT COUNSELING

Inform of the risks, benefits, and alternative modes of therapy. Advise on the importance of adherence to dietary instructions, regular exercise program, and regular testing of blood glucose, HbA1c, renal function, and hematologic parameters. Inform of the risk of lactic acidosis; instruct to d/c therapy immediately and notify physician if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Inform of the risk of hypoglycemia. Counsel against excessive alcohol intake.

STORAGE

Up to 25°C (77°F).

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