Glipizide and metformin hcl 5 mg/1
Glipizide and metformin hcl · TABLET, FILM COATED · Chartwell RX, LLC
Glipizide and Metformin HCl is a prescription tablet that combines two medications to help manage type 2 diabetes by lowering blood sugar levels. This combination drug works through two different mechanisms: glipizide is a sulfonylurea that stimulates insulin release, while metformin helps reduce glucose production in the liver.
Key Facts
- Brand Name
- Glipizide and metformin hcl
- Generic Name
- Glipizide and metformin hcl
- NDC Code (Product)
62135-733- Manufacturer
- Chartwell RX, LLC
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078728
- Drug Class
- Sulfonylurea [EPC]
- Marketing Start
- 06/29/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Glipizide and Metformin HCl Tablets 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 HCl 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 HCl 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 HCl 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 should be evaluated using HbA 1c ,…
Warnings
WARNINGS SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to 1 of 4 treatment groups ( Diabetes 19 (Suppl. 2):747-830, 1970). UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these res…
Contraindications
CONTRAINDICATIONS Glipizide and Metformin HCl Tablets are contraindicated in patients with: 1. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 )(see WARNINGS and PRECAUTIONS ). 2. Known hypersensitivity to glipizide or metformin hydrochloride. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Adverse Reactions
ADVERSE REACTIONS Glipizide and Metformin HCl Tablets In a double-blind 24-week clinical trial involving Glipizide and Metformin HCl Tablets as initial therapy, a total of 172 patients received Glipizide and Metformin HCl Tablets 2.5 mg/250 mg, 173 received Glipizide and Metformin HCl 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 HCl 2.5 mg/250 mg tablets N=172 Glipizide and Metformin HCl 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 Glipizide and Metformin HCl Tablets as second-line therapy, a total of 87 patients received Glipizide and Metformin HCl Tablets, 84 received g…
Frequently Asked Questions
What is Glipizide and metformin hcl used for?
Glipizide and Metformin HCl is a prescription tablet that combines two medications to help manage type 2 diabetes by lowering blood sugar levels. This combination drug works through two different mechanisms: glipizide is a sulfonylurea that stimulates insulin release, while metformin helps reduce glucose production in the liver.
Is Glipizide and metformin hcl a controlled substance?
Glipizide and metformin hcl is not classified as a controlled substance by the DEA.
What is the generic name for Glipizide and metformin hcl?
The generic name for Glipizide and metformin hcl is Glipizide and metformin hcl. There are 4 other brand versions of Glipizide and metformin hcl.
What is the NDC code for Glipizide and metformin hcl 5 mg/1?
The NDC (National Drug Code) for Glipizide and metformin hcl 5 mg/1 is 62135-733, listed by Chartwell RX, LLC.