Metformin HCl 1000 mg/1
Metformin HCl · TABLET · QPharma, Inc.
Metformin HCl is a tablet containing metformin hcl at 1000 mg/1, taken oral. Manufactured by QPharma, Inc..
Key Facts
- Brand Name
- Metformin HCl
- Generic Name
- Metformin HCl
- NDC Code (Product)
42708-018- Manufacturer
- QPharma, Inc.
- Strength
- 1000 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090564
- Marketing Start
- 02/06/2017
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Moisture Limits: Out of specification for water content
Takeda Development Center Americas, Inc.
Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Bristol-myers Squibb Company
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Preferred Pharmaceuticals, Inc.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Aidapak Services, LLC
Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD32742_1, EXP: 5/1/2014.
Bristol-myers Squibb Company
Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.
PD-Rx Pharmaceuticals, Inc.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
PD-Rx Pharmaceuticals, Inc.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Dosage & Administration
DOSAGE & ADMINISTRATION There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride or any other pharmacologic agent. Dosage of metformin hydrochloride 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 is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age). Metformin hydrochloride should be given in divided doses with meals. Metformin hydrochloride 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 and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting pl…
Warnings
WARNINGS Lactic Acidosis: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Metformin Hydrochloride Tablets USP; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found. The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic r…
Contraindications
CONTRAINDICATIONS Metformin Hydrochloride Tablets USP are contraindicated in patients with: 1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS ). 2. Known hypersensitivity to metformin hydrochloride 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. Metformin Hydrochloride Tablets USP should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS .)
Drug Interactions
DRUG INTERACTIONS (Clinical Evaluation of Drug Interactions Conducted with Metformin Hydrochloride Tablets USP) Glyburide —In a single-dose interaction study in type 2 diabetes patients, coadministration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics. Decreases in glyburide AUC and C max were observed, but were highly variable. The single-dose nature of this study and the lack of correlation between glyburide blood levels and pharmacodynamic effects, makes the clinical significance of this interaction uncertain (see DOSAGE AND ADMINISTRATION: Concomitant Metformin Hydrochloride Tablets USP and Oral Sulfonylurea Therapy in Adult Patients ). Furosemide —A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that pharmacokinetic parameters of both compounds were affected by coadministration. Furosemide increased the metformin plasma and blood C max by 22% and blood AUC by 15%, without any significant change in metformin renal clearance. When administered with metformin, the C max and AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone, and the term…
Adverse Reactions
ADVERSE REACTIONS In a US double-blind clinical study of Metformin Hydrochloride Tablets USP in patients with type 2 diabetes, a total of 141 patients received Metformin Hydrochloride Tablets USP therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the Metformin Hydrochloride Tablets USP patients, and that were more common in Metformin Hydrochloride Tablets USP- than placebo-treated patients, are listed in Table 9 . Table 9: Most Common Adverse Reactions (>5.0 Percent) in a Placebo-Controlled Clinical Study of Metformin Hydrochloride Tablets Monotherapy * Adverse Reaction Metformin Hydrochloride Tablets Monotherapy (n=141) Placebo (n=145) % of Patients Diarrhea 53.2 11.7 Nausea/Vomiting 25.5 8.3 Flatulence 12.1 5.5 Asthenia 9.2 5.5 Indigestion 7.1 4.1 Abdominal Discomfort 6.4 4.8 Headache 5.7 4.8 * Reactions that were more common in metformin hydrochloride tablets than placebo-treated patients. Diarrhea led to discontinuation of study medication in 6% of patients treated with Metformin Hydrochloride Tablets USP. Additionally, the following adverse reactions were reported in ≥1.0 to ≤5.0% of Metformin Hydrochloride Table…
Frequently Asked Questions
What is Metformin HCl used for?
Metformin HCl contains Metformin HCl. It is a tablet taken oral. Consult your doctor for specific uses.
Is Metformin HCl a controlled substance?
Metformin HCl is not classified as a controlled substance by the DEA.
What is the generic name for Metformin HCl?
The generic name for Metformin HCl is Metformin HCl. There are 1 other brand versions of Metformin HCl.
What is the NDC code for Metformin HCl 1000 mg/1?
The NDC (National Drug Code) for Metformin HCl 1000 mg/1 is 42708-018, listed by QPharma, Inc..
Other Metformin HCl Dosages
- Metformin HCl1000 mg/150090-3579
- Metformin HCl1000 mg/180425-0435
- Metformin HCl500 mg/150090-4891
- Metformin HCl1000 mg/155700-669
- Metformin HCl850 mg/171335-1983
- Metformin HCl1000 mg/171205-548
- Metformin HCl1000 mg/150090-4892
- Metformin HCl850 mg/167877-562
- Metformin HCl500 mg/170882-124
- Metformin HCl850 mg/171205-567
Other Metformin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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