Glipizide And Metformin Hydrochloride

Generic Name: glipizide and metformin hydrochloride

Sulfonylurea [EPC]Over-the-Counter (OTC)

Brand Names:

Glipizide And Metformin Hydrochloride

DESCRIPTION Glipizide and metformin hydrochloride tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[ p -[2-(5-methylpyrazinecarboxamido)ethyl]phenyl] sulfonyl]urea.

Overview

DESCRIPTION Glipizide and metformin hydrochloride tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[ p -[2-(5-methylpyrazinecarboxamido)ethyl]phenyl] sulfonyl]urea.

Uses

INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage

DOSAGE AND ADMINISTRATION General Considerations: Dosage of glipizide and metformin hydrochloride tablets must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glipizide/2000 mg metformin. Glipizide and metformin hydrochloride tablets should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glipizide), to reduce GI side effects (largely due to metformin), and to permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.

Side Effects

ADVERSE REACTIONS Glipizide and Metformin Hydrochloride Tablets: In a double-blind 24-week clinical trial involving glipizide and metformin hydrochloride tablets as initial therapy, a total of 172 patients received glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg, 173 received glipizide and metformin hydrochloride tablets, 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 Tablets 5 mg N = 170 Metformin Tablets 500 mg N = 177 Glipizide and Metformin Hydrochloride Tablets 2 .

Interactions

Drug Interactions:

Warnings

WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death,hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. WARNINGS Metformin Hydrochloride: WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death,hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. CONTRAINDICATIONS Glipizide and metformin hydrochloride tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mlL/min/1.73 m 2 ) Known hypersensitivity to glipizide or metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Pregnancy

Pregnancy:

Storage

STORAGE AND HANDLING Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Frequently Asked Questions

What is Glipizide And Metformin Hydrochloride used for?

INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

What are the side effects of Glipizide And Metformin Hydrochloride?

ADVERSE REACTIONS Glipizide and Metformin Hydrochloride Tablets: In a double-blind 24-week clinical trial involving glipizide and metformin hydrochloride tablets as initial therapy, a total of 172 patients received glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg, 173 received glipizide and metformin hydrochloride tablets, 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 Tablets 5 mg N = 170 Metformin Tablets 500 mg N = 177 Glipizide and Metformin Hydrochloride Tablets 2 .

Can I take Glipizide And Metformin Hydrochloride during pregnancy?

Pregnancy:

What are the important warnings for Glipizide And Metformin Hydrochloride?

WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death,hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. WARNINGS Metformin Hydrochloride: WARNING: LACTIC ACIDOSIS Post-marketing cases of metformin-associated lactic acidosis have resulted in death,hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. CONTRAINDICATIONS Glipizide and metformin hydrochloride tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mlL/min/1.73 m 2 ) Known hypersensitivity to glipizide or metformin hydrochloride. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.