Drugplain

Glyburide and Metformin Hydrochloride 2.5 mg/1

Glyburide and Metformin Hydrochloride · TABLET, FILM COATED · A-S Medication Solutions

1 Recall on RecordCurrently in Shortage
Plain English

Glyburide and Metformin Hydrochloride is a tablet, film coated containing glyburide and metformin hydrochloride at 2.5 mg/1, taken oral. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
Glyburide and Metformin Hydrochloride
Generic Name
Glyburide and Metformin Hydrochloride
NDC Code (Product)
50090-0887
Manufacturer
A-S Medication Solutions
Strength
2.5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA077870
Drug Class
Sulfonylurea [EPC]
Marketing Start
11/14/2007

Recall History

1 Recall on Record
Class II03/24/2014

Teva Pharmaceuticals USA

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

blood glucose increased22 reports
hypoglycaemia19 reports
diarrhoea18 reports
drug ineffective15 reports
dyspnoea13 reports
nausea13 reports
renal failure13 reports
pain12 reports
asthenia11 reports
cardiac failure congestive11 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Adult Dosage: Give glyburide and metformin hydrochloride tablets in divided doses, twice daily, with meals. ( 2.1 ) For patients not treated with either glyburide (or another sulfonylurea) or metformin HCl, initiate treatment with another formulation with a dose of 1.25 mg glyburide and 250 mg metformin HCl orally, once or twice daily with meals. ( 2.1 ) For patients not adequately controlled on either glyburide (or another sulfonylurea) or metformin HCl alone, the recommended starting dose is 2.5 mg/500 mg or 5 mg/500 mg orally twice daily with meals. ( 2.1 ) For patients previously treated with a combination therapy of glyburide (or another sulfonylurea) and metformin HCl, the starting dose should not exceed the daily dose of glyburide (or equivalent dose of another sulfonylurea) and metformin HCl already being taken. ( 2.1 ) Increase the dose gradually on the basis of glycemic control and tolerability, up to a maximum to a maximum dose of 20 mg glyburide/2,000 mg metformin HCl daily. ( 2.1 ) Renal Impairment: Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.4 ) Do not use in patients with eGFR below 30 mL…

Contraindications

4 CONTRAINDICATIONS Glyburide 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 ( 5.1 ) ]. Hypersensitivity to metformin or glyburide. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Concomitant administration of bosentan [see Drug Interactions ( 7 ) ]. Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) ( 4 , 5.1 ) Hypersensitivity to metformin or glyburide. ( 4 ) Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. ( 4 ) Concomitant administration of bosentan. ( 4 , 7 )

Drug Interactions

7 DRUG INTERACTIONS Table 3 presents clinically significant drug interactions with glyburide and metformin hydrochloride. Table 3: Clinically Significant Drug Interactions with Glyburide and Metformin Hydrochloride Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with glyburide and metformin hydrochloride may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide and dichlorphenamide. Drugs that Reduce Metformin Clearance Clinical Impact: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [ see Clinical Pharmacology ( 12.3 ) ]. Intervention: Consider the benefits and risks of concomitant use with glyburide and metformin hydrochloride. Examples: Ranolazine,…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions ( 5.1 ) ] Hypoglycemia [see Warnings and Precautions ( 5.2 ) ] Cardiovascular mortality [see Warnings and Precautions ( 5.3 ) ] Hemolytic anemia [see Warnings and Precautions ( 5.4 )] Vitamin B 12 Deficiency [ see Warnings and Precautions ( 5.5 ) ] Most common (>5%) adverse reactions to glyburide and metformin hydrochloride tablets diarrhea, headache, nausea/vomiting, abdominal pain, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In double-blind clinical studies with glyburide and metformin hydrochloride as initial therapy or as second-line therapy of 20 and 14 weeks, respectively (see section 14), a …

Frequently Asked Questions

What is Glyburide and Metformin Hydrochloride used for?

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

Is Glyburide and Metformin Hydrochloride a controlled substance?

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

What is the generic name for Glyburide and Metformin Hydrochloride?

The generic name for Glyburide and Metformin Hydrochloride is Glyburide and Metformin Hydrochloride. There are 4 other brand versions of Glyburide and Metformin Hydrochloride.

What is the NDC code for Glyburide and Metformin Hydrochloride 2.5 mg/1?

The NDC (National Drug Code) for Glyburide and Metformin Hydrochloride 2.5 mg/1 is 50090-0887, listed by A-S Medication Solutions.

Product NDC

50090-0887

Package NDC

50090-0887-0

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

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