Drugplain

Glipizide and Metformin Hydrochloride 5 mg/1

Glipizide and Metformin Hydrochloride · TABLET, FILM COATED · AvKARE

1 Recall on RecordCurrently in Shortage
Plain English

Glipizide and Metformin Hydrochloride is a tablet, film coated containing glipizide and metformin hydrochloride at 5 mg/1, taken oral. Manufactured by AvKARE.

Key Facts

Brand Name
Glipizide and Metformin Hydrochloride
Generic Name
Glipizide and Metformin Hydrochloride
NDC Code (Product)
42291-306
Manufacturer
AvKARE
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA077270
Drug Class
Sulfonylurea [EPC]
Marketing Start
07/08/2013

Recall History

1 Recall on Record
Class II03/25/2015

Heritage Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

abdominal discomfort1 reports
acute abdomen1 reports
bladder cancer1 reports
bladder discomfort1 reports
blood glucose increased1 reports
completed suicide1 reports
diarrhoea1 reports
diarrhoea haemorrhagic1 reports
drug dose omission1 reports
drug ineffective for unapproved indication1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient. With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to glipizide and metformin hydrochloride tablets and to identify the minimum effective dose for the patient. Thereafter, HbA 1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA 1c to normal or as near normal as possible. Ideally, the response to therapy shou…

Warnings

WARNINGS WARNING: LACTIC ACIDOSIS Postmarketing 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. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally > 5 mcg/mL [see PRECAUTIONS]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see PRECAUTIONS]. If metformin-associated lactic acidosis is susp…

Contraindications

CONTRAINDICATIONS Glipizide and metformin hydrochloride tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) (see WARNINGS and PRECAUTIONS ). 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.

Drug Interactions

Drug Interactions Glipizide and Metformin Hydrochloride Tablets 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 glipizide and metformin hydrochloride tablets, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving glipizide and metformin hydrochloride tablets, 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 non-steroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein-bound, salicylates, sulf…

Adverse Reactions

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 5 mg Tablets N = 170 Metformin 500 mg Tablets N = 177 Glipizide and Metformin Hydrochloride Tablets, 2.5 mg/250 mg N = 172 Glipizide and Metformin Hydrochloride Tablets, 2.5 mg/500 mg 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 glipizide and metformin hydrochloride tablets as second-line therapy,…

Frequently Asked Questions

What is Glipizide and Metformin Hydrochloride used for?

Glipizide and Metformin Hydrochloride contains Glipizide and Metformin Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Glipizide and Metformin Hydrochloride a controlled substance?

Glipizide and Metformin Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Glipizide and Metformin Hydrochloride?

The generic name for Glipizide and Metformin Hydrochloride is Glipizide and Metformin Hydrochloride. There are no other listed brand versions of Glipizide and Metformin Hydrochloride.

What is the NDC code for Glipizide and Metformin Hydrochloride 5 mg/1?

The NDC (National Drug Code) for Glipizide and Metformin Hydrochloride 5 mg/1 is 42291-306, listed by AvKARE.

Product NDC

42291-306

Package NDC

42291-306-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)