METFORMIN HYDROCHLORIDE EXTENDED RELEASE 750 mg/1
METFORMIN HYDROCHLORIDE · TABLET, EXTENDED RELEASE · Proficient Rx LP
Metformin hydrochloride extended release is an oral prescription medication used to help control blood sugar levels in people with type 2 diabetes. This extended release tablet allows for once-daily dosing and is designed to provide steady medication levels throughout the day.
Key Facts
- Brand Name
- METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Generic Name
- METFORMIN HYDROCHLORIDE
- NDC Code (Product)
82804-148- Manufacturer
- Proficient Rx LP
- Strength
- 750 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090295
- Marketing Start
- 05/12/2016
Recall History
Teva Pharmaceuticals USA
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
A-S Medication Solutions LLC
Presence of Foreign Tablets/Capsules.
Marksans Pharma Limited
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Marksans Pharma Limited
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Nostrum Laboratories Inc
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lupin Pharmaceuticals Inc.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
The Harvard Drug Group
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Amneal Pharmaceuticals of New York, LLC
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Dosage & Administration
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride extended-release tablets or any other pharmacologic agent. Dosage of metformin hydrochloride extended-release tablets must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride extended-release tablets in adults is 2000 mg. Metformin hydrochloride extended-release tablets should generally be given once daily with the evening meal. Metformin hydrochloride extended-release tablets should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride extended-release tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of appr…
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. Metforminassociated 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 DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and PRECAUTIONS). If metfo…
Frequently Asked Questions
What is METFORMIN HYDROCHLORIDE EXTENDED RELEASE used for?
Metformin hydrochloride extended release is an oral prescription medication used to help control blood sugar levels in people with type 2 diabetes. This extended release tablet allows for once-daily dosing and is designed to provide steady medication levels throughout the day.
Is METFORMIN HYDROCHLORIDE EXTENDED RELEASE a controlled substance?
METFORMIN HYDROCHLORIDE EXTENDED RELEASE is not classified as a controlled substance by the DEA.
What is the generic name for METFORMIN HYDROCHLORIDE EXTENDED RELEASE?
The generic name for METFORMIN HYDROCHLORIDE EXTENDED RELEASE is METFORMIN HYDROCHLORIDE. There are 12 other brand versions of METFORMIN HYDROCHLORIDE.
What is the NDC code for METFORMIN HYDROCHLORIDE EXTENDED RELEASE 750 mg/1?
The NDC (National Drug Code) for METFORMIN HYDROCHLORIDE EXTENDED RELEASE 750 mg/1 is 82804-148, listed by Proficient Rx LP.
Other Metformin Brands
See all →- Metformin hydrochloride ER750 mg/172789-106
- Metformin Hydrochloride850 mg/10615-8577
- Metformin Hydrochloride1000 mg/183301-0010
- Riomet500 mg/5mL10631-206
- Metformin Hydrochloride500 mg/111788-037
- Metformin Hydrochloride850 mg/125000-131
- Metformin hydrochloride1000 mg/133342-143
- Metformin hydrochloride500 mg/133342-239
- Metformin Hydrochloride500 mg/143063-527
- Metformin Hydrochloride750 mg/150090-5246
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)