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Metaglip

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Metaglip

Side Effects
Interactions

SIDE EFFECTS

Metaglip (glipizide and metformin)

In a double-blind 24-week clinical trial involving METAGLIP (glipizide and metformin) as initial therapy, a total of 172 patients received METAGLIP (glipizide and metformin) 2.5 mg/250 mg, 173 received METAGLIP (glipizide and metformin) 2.5 mg/500 mg, 170 received glipizide, and 177 received metformin. The most common clinical adverse events in these treatment groups are listed in Table 4.

Table 4: Clinical Adverse Events > 5% in any Treatment Group, by Primary Term, in Initial Therapy Study

Adverse Event Number (%) of Patients
Glipizide 5 mg tablets
N=170
Metformin 500 mg tablets
N=177
METAGLIP 2.5 mg/250 mg tablets
N=172
METAGLIP 2.5 mg/500 mg tablets
N=173
Upper respiratory infection 12 (7.1) 15 (8.5) 17 (9.9) 14 (8.1)
Diarrhea 8 (4.7) 15 (8.5) 4 (2.3) 9 (5.2)
Dizziness 9 (5.3) 2 (1.1) 3 (1.7) 9 (5.2)
Hypertension 17 (10.0) 10 (5.6) 5 (2.9) 6 (3.5)
Nausea/vomiting 6 (3.5) 9 (5.1) 1 (0.6) 3 (1.7)

In a double-blind 18-week clinical trial involving METAGLIP (glipizide and metformin) as second-line therapy, a total of 87 patients received METAGLIP (glipizide and metformin) , 84 received glipizide, and 75 received metformin. The most common clinical adverse events in this clinical trial are listed in Table 5.

Table 5: Clinical Adverse Events > 5% in any Treatment Group, by Primary Term, in Second- Line Therapy Study

Adverse Event Number (%) of Patients
Glipizide 5 mg tabletsa
N=84
Metformin 500 mg tabletsa
N=75
METAGLIP 5 mg/500 mg tabletsa
N=87
Diarrhea 11 (13.1) 13 (17.3) 16 (18.4)
Headache 5 (6.0) 4 (5.3) 11 (12.6)
Upper respiratory infection 11 (13.1) 8 (10.7) 9 (10.3)
Musculoskeletal pain 6 (7.1) 5 (6.7) 7 (8.0)
Nausea/vomiting 5 (6.0) 6 (8.0) 7 (8.0)
Abdominal pain 7 (8.3) 5 (6.7) 5 (5.7)
UTI 4 (4.8) 6 (8.0) 1 (1.1)
a The dose of glipizide was fixed at 30 mg daily; doses of metformin and METAGLIP were titrated.

 Hypoglycemia

In a controlled initial therapy trial of METAGLIP (glipizide and metformin) 2.5 mg/250 mg and 2.5 mg/500 mg the numbers of patients with hypoglycemia documented by symptoms (such as dizziness, shakiness, sweating, and hunger) and a fingerstick blood glucose measurement ≤ 50 mg/dL were 5 (2.9%) for glipizide, 0 (0%) for metformin, 13 (7.6%) for METAGLIP (glipizide and metformin) 2.5 mg/250 mg, and 16 (9.3%) for METAGLIP (glipizide and metformin) 2.5 mg/500 mg. Among patients taking either METAGLIP (glipizide and metformin) 2.5 mg/250 mg or METAGLIP (glipizide and metformin) 2.5 mg/500 mg, 9 (2.6%) patients discontinued METAGLIP (glipizide and metformin) due to hypoglycemic symptoms and 1 required medical intervention due to hypoglycemia. In a controlled second-line therapy trial of METAGLIP (glipizide and metformin) 5 mg/500 mg, the numbers of patients with hypoglycemia documented by symptoms and a fingerstick blood glucose measurement ≤ 50 mg/dL were 0 (0%) for glipizide, 1 (1.3%) for metformin, and 11 (12.6%) for METAGLIP (glipizide and metformin) . One (1.1%) patient discontinued METAGLIP (glipizide and metformin) therapy due to hypoglycemic symptoms and none required medical intervention due to hypoglycemia. (See PRECAUTIONS.)

Gastrointestinal Reactions

Among the most common clinical adverse events in the initial therapy trial were diarrhea and nausea/vomiting; the incidences of these events were lower with both METAGLIP (glipizide and metformin) dosage strengths than with metformin therapy. There were 4 (1.2%) patients in the initial therapy trial who discontinued METAGLIP (glipizide and metformin) therapy due to gastrointestinal (GI) adverse events. Gastrointestinal symptoms of diarrhea, nausea/vomiting, and abdominal pain were comparable among METAGLIP (glipizide and metformin) , glipizide and metformin in the second-line therapy trial. There were 4 (4.6%) patients in the second-line therapy trial who discontinued METAGLIP (glipizide and metformin) therapy due to GI adverse events.

Glipizide

Gastrointestinal Reactions

Cholestatic and hepatocellular forms of liver injury accompanied by jaundice have been reported rarely in association with glipizide; METAGLIP (glipizide and metformin) should be discontinued if this occurs.

Read the Metaglip (glipizide and metformin) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Metaglip (glipizide and metformin)

Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control. These drugs include thiazides 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 METAGLIP (glipizide and metformin) , the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving METAGLIP (glipizide and metformin) , the patient should be observed closely for hypoglycemia. Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid as compared to sulfonylureas, which are extensively bound to serum proteins.

Glipizide

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including nonsteroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein-bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents. When such drugs are administered to a patient receiving METAGLIP (glipizide and metformin) , the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving METAGLIP (glipizide and metformin) , the patient should be observed closely for loss of blood glucose control. In vitro binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. However, caution must be exercised in extrapolating these findings to the clinical situation and in the use of METAGLIP (glipizide and metformin) with these drugs.

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical, or vaginal preparations of miconazole is not known. The effect of concomitant administration of fluconazole and glipizide has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received glipizide alone and following treatment with 100 mg of fluconazole as a single oral daily dose for 7 days, the mean percent increase in the glipizide AUC after fluconazole administration was 56.9% (range: 35%- 81%).

Metformin Hydrochloride

Furosemide

A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that pharmacokinetic parameters of both compounds were affected by coadministration. Furosemide increased the metformin plasma and blood Cmax by 22% and blood AUC by 15%, without any significant change in metformin renal clearance. When administered with metformin, the Cmax and AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone, and the terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance. No information is available about the interaction of metformin and furosemide when coadministered chronically.

Nifedipine

A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers demonstrated that coadministration of nifedipine increased plasma metformin Cmax and AUC by 20% and 9%, respectively, and increased the amount excreted in the urine. Tmax and half-life were unaffected. Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine.

Cationic drugs

Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Such interaction between metformin and oral cimetidine has been observed in normal healthy volunteers in both single- and multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak metformin plasma and whole blood concentrations and a 40% increase in plasma and whole blood metformin AUC. There was no change in elimination half-life in the single-dose study. Metformin had no effect on cimetidine pharmacokinetics. Although such interactions remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment of METAGLIP (glipizide and metformin) and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system.

Other

In healthy volunteers, the pharmacokinetics of metformin and propranolol and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.

Read the Metaglip Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/28/2011
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Metaglip - User Reviews

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