metformin may be switched to Glipizide and Metformin HCl Tablets 2.5 mg/500 mg or 5 mg/500 mg; the starting dose should not exceed the daily dose of Glipizide (or equivalent dose of another sulfonylurea) and metformin already being taken. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of Glipizide and Metformin HCl Tablets should be titrated as described above to achieve adequate control of blood glucose.
Specific Patient Populations
Glipizide and Metformin HCl Tablets is not recommended for use during pregnancy or for use in pediatric patients. The initial and maintenance dosing of Glipizide and Metformin HCl Tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of Glipizide and Metformin HCl Tablets to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS.)
HOW SUPPLIED
Glipizide and Metformin HCl Tablets USP
Glipizide and Metformin HCl Tablet 2.5 mg/250 mg is a pink coloured, capsule shape, film-coated tablet with "U 787" debossed on one side and plain on the other side.
Glipizide and Metformin HCl Tablet 2.5 mg/500 mg is a white to off white, capsule shape, film-coated tablet with "U 785" debossed on one side and plain on the other side.
Glipizide and Metformin HCl Tablet 5 mg/500 mg is a pink coloured, capsule shape, film-coated tablet with "U 786" debossed on one side and plain on the other side.
Glipizide and Metformin HCl Tablets NDC 24724-xxx-xx for unit of use
USP
Glipizide (mg) Metformin HCl (mg) Bottle of 100’s Bottle of 1000’s
2.5 250 006-01 006-10
2.5 500 007-01 007-10
5.0 500 008-01 008-10
Storage
Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). [See USP Controlled Room Temperature.]
GLUCOPHAGE® is a registered trademark of Merck Santé S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.
GLUCOTROL® is a registered trademark of Pfizer Inc.
Manufactured for:
Heritage Pharmaceuticals, Inc.
Edison, NJ 08837
1-866-901-DRUG (3784)
Manufactured by :
USV Limited
H-17/H-18, OIDC,
Mahatma Gandhi Udyog Nagar,
Dabhel, Daman 396210, India
Revised: 03/2010
PATIENT INFORMATION ABOUT
Glipizide and Metformin HCl Tablets USP
Rx Only
WARNING: A small number of people who have taken metformin hydrochloride have developed a serious condition called lactic acidosis. Properly functioning kidneys are needed to help prevent lactic acidosis. Most people with kidney problems should not take Glipizide and Metformin HCl Tablets. (See Question Nos. 9-13.)
Q1. Why do I need to take Glipizide and Metformin HCl Tablets?
Your doctor has prescribed Glipizide and Metformin HCl Tablets to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus.
Q2. What is type 2 diabet