Metformin Hydrochloride 750 mg Tablet, Extended Release, 60-count
Other active recalls for Metformin Hydrochloride (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Biguanide class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Metformin works in three ways: it lowers the amount of sugar your liver dumps into your bloodstream, slows how much sugar your gut absorbs from food, and helps your body respond to...
- What exactly is metformin doing for my diabetes?
- Yes, this is very common — diarrhea, nausea, and stomach discomfort are the most frequently reported side effects, and they're often worst when you first start or when your dose go...
- My stomach has been a mess since I started metformin. Is that normal? Will it get better?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metformin Hydrochloride — tap one for details:
Metformin Hydrochloride may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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UNII D9C330MD8B
Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1129 | $6.77 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metformin Hydrochloride 750 mg 29300-0399-01 | Unichem | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin Hydrochloride 750 mg 42385-0978-01 | Laurus | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin Hydrochloride 750 mg 42806-0633-01 | Epic | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin Hydrochloride Extended Release 750 mg 49483-0624-01 | TIME | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin Hydrochloride 750 mg 50268-0551-15 | AvPAK | 1 tablet | $0.053 | AB1 | Availability likely | — |
| Metformin Hydrochloride 750 mg 67877-0414-01 | Ascend | 100 tablets | $0.053 | AB | Availability likely | — |
| Metformin Hydrochloride 750 mg 68094-0804-50 | Precision | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin 750 mg 70010-0492-01 | Granules | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin Hydrochloride 750 mg 72578-0036-01 | Viona | 100 tablets | $0.053 | AB | Availability likely | — |
| Metformin hydrochloride ER 750 mg 76385-0129-01 | UNICHEM | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin ER 750 mg 82009-0118-01 | Quallent | 100 tablets | $0.053 | AB1 | Availability likely | — |
| Metformin Hydrochloride 750 mg 82009-0181-01 | Quallent | 100 tablets | $0.053 | AB | Availability likely | — |
| Metformin Hydrochloride 750 mg 62756-0143-01 | Sun | 100 tablets | $0.054 | — | Discontinued | — |
| Metformin hydrochloride 750 mg 33342-0240-11 | Macleods | 100 tablets | $0.067 | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 51224-0107-50 | TAGI | 100 tablets | $0.067 | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 10135-0824-05 | Marlex | 500 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 25000-0102-03 | MARKSANS | 30 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride ER 750 mg 42291-0824-10 | AvKARE | 1000 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 750 mg 43063-0902-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 50090-5246-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 750 mg 50090-6839-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metformin 750 mg 50090-7372-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin 750 mg 50090-7373-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 50090-7534-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 50090-7535-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 51655-0077-26 | Northwind | 90 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 750 mg 51655-0368-52 | Northwind | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 59651-0549-01 | Aurobindo | 100 tablets | — | AB1 | FDA listed | — |
| Metformin ER 750 mg 62207-0492-40 | Granules | 3500 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 63629-9147-01 | Bryant | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 65162-0179-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride 750 mg 65841-0039-01 | Zydus | 100 tablets | — | AB | Discontinued | — |
| Metformin Hydrochloride 750 mg 67046-1556-03 | Coupler | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 68788-7205-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 69238-2126-01 | Amneal | 100 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride 750 mg 70518-2709-00 | REMEDYREPACK | 30 tablets | — | AB1 | Discontinued | — |
| Metformin Hydrochloride 750 mg 70518-4163-00 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mgthis 71205-0141-60 | Proficient | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 71335-0776-01 | Bryant | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 750 mg 71335-0889-01 | Bryant | 30 tablets | — | AB1 | Discontinued | — |
| Metformin Hydrochloride 750 mg 71335-2504-01 | Bryant | 30 tablets | — | AB1 | FDA listed | — |
| Metformin 750 mg 71335-2524-01 | Bryant | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 71335-9752-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Metformin hydrochloride ER 750 mg 71610-0666-60 | Aphena | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 71610-0740-53 | Aphena | 60 tablets | — | — | FDA listed | — |
| Metformin hydrochloride ER 750 mg 71610-0867-53 | Aphena | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 72162-1293-01 | Bryant | 100 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride ER 750 mg 72789-0106-01 | PD-Rx | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 72789-0451-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 750 mg 72789-0472-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 750 mg 72789-0548-93 | PD-Rx | 180 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 750 mg 82804-0148-00 | Proficient | 100 tablets | — | AB1 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71205-0141-00 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-141-00) | 2018-10-01 | Active |
| 71205-0141-20 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-141-20) | 2018-10-01 | Active |
| 71205-0141-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-141-30) | 2018-10-01 | Active |
| 71205-0141-60 You're viewing this | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-141-60) | 2018-10-01 | Active |
| 71205-0141-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-141-90) | 2018-10-01 | Active |
You're viewing one of 5 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71205-0141-60?
What is the difference between NDC 71205-0141-60 and NDC 71205-0141-20?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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. Metformin-associated 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 metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see PRECAUTIONS ).
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
⏱️ Dosage and Administration ▾
DOSAGE AND 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 2,000 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 approximately 3 months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride extended-release tablets, either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
Short-term administration of metformin hydrochloride extended-release tablets may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Metformin hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of metformin hydrochloride extended-release tablets will be eliminated in the feces as a soft, hydrated mass.
(See Patient Information printed below.) Recommended Dosing Schedule Adults The usual starting dose of metformin hydrochloride extended-release tablets is 500 mg once daily with the evening meal. In general, clinically significant responses are not seen at doses below 1,500 mg per day. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2,000 mg once daily with the evening meal.
The dosage of metformin hydrochloride extended-release tablets must be individualized on the basis of both effectiveness and tolerability. If glycemic control is not achieved on metformin hydrochloride extended-release tablets 2,000 mg once daily, a trial of metformin hydrochloride extended-release tablets 1,000 mg twice daily should be considered. If higher doses of metformin are required, metformin hydrochloride tablets should be used at total daily doses up to 2,550 mg administered in divided daily doses, as described above.
(See CLINICAL PHARMACOLOGY: Clinical Studies . ) Patients receiving metformin hydrochloride tablets treatment may be safely switched to metformin hydrochloride extended-release tablets once daily at the same total daily dose, up to 2,000 mg once daily. Following a switch from metformin hydrochloride tablets to metformin hydrochloride extended-release tablets, glycemic control should be closely monitored and dosage adjustments made accordingly (see CLINICAL PHARMACOLOGY: Clinical Studies ). Pediatrics Safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established.
Recommendations for Use in Renal Impairment Assess renal function prior to initiation of metformin hydrochloride ext…
⛔ Contraindications ▾
CONTRAINDICATIONS Metformin hydrochloride extended-release 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 metformin hydrochloride. 3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
⚠️ Warnings ▾
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. Metformin-associated 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 metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see PRECAUTIONS ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with metformin hydrochloride extended-release tablets in placebo- and active-controlled studies. In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets and 195 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release tablets patients, and that were more common in metformin hydrochloride extended-release tablets- than placebo-treated patients, are listed in Table 6 .
Table 6: Most Common Adverse Reactions (>
5.0Percent) in Placebo-Controlled Studies of Metformin Hydrochloride Extended-Release Tablets Reactions that were more common in metformin hydrochloride extended-release tablets- than placebo-treated patients. Adverse Reaction Metformin Hydrochloride Extended-Release Tablets (n = 781) Placebo (n = 195) % of Patients Diarrhea 9.6
2.6Nausea/Vomiting 6.5
1.5Diarrhea led to discontinuation of study medication in 0.6% of patients treated with metformin hydrochloride extended-release tablets. Additionally, the following adverse reactions were reported in ≥ 1.0% to ≤ 5.0% of metformin hydrochloride extended-release tablets patients and were more commonly reported with metformin hydrochloride extended-release tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.
Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
🔄 Drug Interactions ▾
Drug Interactions (Clinical Evaluation of Drug Interactions Conducted with Metformin Hydrochloride Tablets) 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 Extended-Release Tablets 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 terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance.
No information is available about the interaction of metformin and furosemide when coadministered chronically. Nifedipine A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers demonstrated that coadministration of nifedipine increased plasma metformin C max and AUC by 20% and 9%, respectively, and increased the amount excreted in the urine. T max and half-life were unaffected.
Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine. Drugs that reduce metformin clearance 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 such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis.
Consider the benefits and risks of concomitant use. Such interaction between metformin and oral cimetidine has been observed in normal healthy volunteers in both single- and multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak metformin plasma and whole blood concentrations and a 40% increase in plasma and whole blood metformin AUC. There was no change in elimination half-life in the single-dose study.
Metformin had no effect on cimetidine pharmacokinetics. In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies. Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.
Other Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving metformin hydrochloride extended-release tablets, the patient should be closely observed for loss of blood glucose control.
When such drugs are withdrawn from a patient receiving metformin hydrochloride extended-release tablets, the patient should be observed closely for hypoglycemia. Carbonic anhydrase inhibitors Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently…
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category B Recent information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible. Because animal reproduction studies are not always predictive of human response, metformin hydrochloride extended-release tablets should not be used during pregnancy unless clearly needed.
There are no adequate and well-controlled studies in pregnant women with metformin hydrochloride extended-release tablets. Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This represents an exposure of about 2 and 6 times the maximum recommended human daily dose of 2,000 mg based on body surface area comparisons for rats and rabbits, respectively.
Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of metformin hydrochloride extended-release tablets in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use Controlled clinical studies of metformin hydrochloride extended-release tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of lactic acidosis.
Assess renal function more frequently in elderly patients (see WARNINGS , PRECAUTIONS , and DOSAGE AND ADMINISTRATION ).
🆘 Overdosage ▾
OVERDOSAGE Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see WARNINGS ).
Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease. Pharmacokinetics Absorption and Bioavailability Following a single oral dose of metformin hydrochloride extended-release tablets, C max is achieved with a median value of 7 hours and a range of 4 to 8 hours.
Peak plasma levels are approximately 20% lower compared to the same dose of metformin hydrochloride tablets, however, the extent of absorption (as measured by AUC) is similar to metformin hydrochloride tablets. At steady state, the AUC and C max are less than dose proportional for metformin hydrochloride extended-release tablets within the range of 500 to 2,000 mg administered once daily. Peak plasma levels are approximately 0.6, 1.1, 1.4, and 1.8 mcg/mL for 500, 1,000, 1,500, and 2,000 mg once-daily doses, respectively.
The extent of metformin absorption (as measured by AUC) from metformin hydrochloride extended-release tablets at a 2,000 mg once-daily dose is similar to the same total daily dose administered as metformin hydrochloride tablets 1,000 mg twice daily. After repeated administration of metformin hydrochloride extended-release tablets, metformin did not accumulate in plasma. Within-subject variability in C max and AUC of metformin from metformin hydrochloride extended-release tablets is comparable to that with metformin hydrochloride tablets.
Although the extent of metformin absorption (as measured by AUC) from the metformin hydrochloride extended-release tablets increased by approximately 50% when given with food, there was no effect of food on C max and T max of metformin. Both high and low fat meals had the same effect on the pharmacokinetics of metformin hydrochloride extended-release tablets. Distribution The apparent volume of distribution (V/F) of metformin following single oral doses of metformin hydrochloride tablets 850 mg averaged 654 ± 358 L.
Metformin is negligibly bound to plasma proteins, in contrast to sulfonylureas, which are more than 90% protein bound. Metformin partitions into erythrocytes, most likely as a function of time. At usual clinical doses and dosing schedules of metformin hydrochloride tablets, steady state plasma concentrations of metformin are reached within 24 to 48 hours and are generally < 1 mcg/mL.
During controlled clinical trials of metformin hydrochloride tablets, maximum metformin plasma levels did not exceed 5 mcg/mL, even at maximum doses. Metabolism and Elimination Intravenous single-dose studies in normal subjects demonstrate that metformin is excreted unchanged in the urine and does not undergo hepatic metabolism (no metabolites have been identified in humans) nor biliary excretion. Renal clearance (see Table 1 ) is approximately 3.5 times greater than creatinine clearance, which indicates that tubular secretion is the major route of metformin elimination.
Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours, suggesting that the erythrocyte mass may be a compartment of distribution. Specific Populations Patients with Type 2 Diabetes…
🧬 Mechanism of Action ▾
Mechanism of Action Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS ) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Metformin hydrochloride extended-release tablets USP, 750 mg are white, capsule shaped tablets, with "OE" debossed on one side and "585" debossed on the other side. They are available as follows: Bottles of 20 NDC 71205-141-20 Bottles of 30 NDC 71205-141-30 Bottles of 60 NDC 71205-141-60 Bottles of 90 NDC 71205-141-90 Bottles of 100 NDC 71205-141-00 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in well-closed, light-resistant containers.
📦 Storage and Handling ▾
Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in well-closed, light-resistant containers.
📋 Description ▾
DESCRIPTION Metformin hydrochloride extended-release tablets, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride ( N,N -dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 ∙ HCl and a molecular weight of 165.63.
Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride as the active ingredient. In addition, each tablet contains the following inactive ingredients: copovidone, carboxymethylcellulose sodium, hypromellose, microcrystalline cellulose and magnesium stearate. The USP dissolution test is pending.
Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients should be informed of the potential risks and benefits of metformin hydrochloride extended-release tablets and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose, glycosylated hemoglobin, renal function, and hematologic parameters. The risks of lactic acidosis, its symptoms, and conditions that predispose to its development, as noted in the WARNINGS and PRECAUTIONS sections, should be explained to patients.
Patients should be advised to discontinue metformin hydrochloride extended-release tablets immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur. Once a patient is stabilized on any dose level of metformin hydrochloride extended-release tablets, gastrointestinal symptoms, which are common during initiation of metformin therapy, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.
Patients should be counselled against excessive alcohol intake, either acute or chronic, while receiving metformin hydrochloride extended-release tablets. Metformin hydrochloride extended-release tablets alone do not usually cause hypoglycemia, although it may occur when metformin hydrochloride extended-release tablets are used in conjunction with oral sulfonylureas and insulin. When initiating combination therapy, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members.
(See Patient Information printed below.) Patients should be informed that metformin hydrochloride extended-release tablets must be swallowed whole and not crushed or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.