Metformin 500 mg Tablet, Extended Release, 60-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Biguanide class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 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
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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 B1QE5P712K
Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
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UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
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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 U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
4 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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.029 | $1.73 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.0571 | $3.43 / 60 tablets |
| 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 500 mg 29300-0389-01 | Unichem | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 42385-0977-01 | Laurus | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 42806-0632-01 | Epic | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride Extended Release 500 mg 49483-0623-01 | TIME | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 50268-0550-15 | AvPAK | 1 tablet | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 67877-0159-01 | Ascend | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 67877-0413-01 | Ascend | 100 tablets | $0.029 | AB | Availability likely | — |
| Metformin Hydrochloride 500 mg 68094-0904-50 | Precision | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin 500 mgthis 68645-0595-59 | Legacy | 60 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride Er 500 mg 69315-0410-01 | Leading | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin 500 mg 70010-0491-01 | Granules | 100 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin ER 500 mg 82009-0117-10 | Quallent | 1000 tablets | $0.029 | AB1 | Availability likely | — |
| Metformin Hydrochloride 500 mg 82009-0180-05 | Quallent | 500 tablets | $0.029 | AB | Availability likely | — |
| Metformin Hydrochloride 500 mg 62756-0142-01 | Sun | 100 tablets | $0.029 | — | FDA listed | +1% |
| Metformin hydrochloride 500 mg 33342-0239-11 | Macleods | 100 tablets | $0.031 | AB1 | FDA listed | +8% |
| Metformin Hydrochloride 500 mg 51224-0007-50 | TAGI | 100 tablets | $0.031 | AB1 | FDA listed | +8% |
| Metformin Hydrochloride 500 mg 00615-8289-39 | NCS | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 10135-0823-05 | Marlex | 500 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended-Release 500mg 500 mg 17224-0311-28 | Calvin | 28 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 25000-0101-03 | MARKSANS | 30 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 42291-0825-10 | AvKARE | 1000 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 42708-0201-60 | QPharma | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-1494-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-5396-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-5397-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Metformin 500 mg 50090-6515-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Metformin 500 mg 50090-6516-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7116-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7576-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7577-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7579-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 50090-7918-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 51655-0555-96 | Northwind | 180 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 51655-0559-25 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 51655-0853-25 | Northwind | 60 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride 500 mg 59651-0548-25 | Aurobindo | 25000 tablets | — | AB1 | FDA listed | — |
| Metformin ER 500 mg 62207-0491-31 | Granules | 5000 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 63187-0779-00 | Proficient | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 65162-0178-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride 500 mg 65841-0027-01 | Zydus | 100 tablets | — | AB1 | Discontinued | — |
| Metformin Hydrochloride 500 mg 65841-0809-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Metformin 500 mg 67046-0437-03 | Coupler | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 67296-1701-06 | RedPharm | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 68071-3111-02 | NuCare | 120 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 68788-8814-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 68788-8866-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 68788-8903-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 69238-2125-01 | Amneal | 100 tablets | — | — | FDA listed | — |
| Metformin 500 mg 70518-4370-00 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71205-0186-20 | Proficient | 20 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71205-0686-30 | Proficient | 30 tablets | — | AB | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 71335-0293-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-0720-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-0886-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin 500 mg 71335-2354-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-2568-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71335-9683-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0447-30 | Aphena | 30 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 71610-0454-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0533-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 71610-0554-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0578-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Metformin hydrochloride 500 mg 71610-0587-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin 500 mg 71610-0613-60 | Aphena | 90 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0652-30 | Aphena | 30 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride 500 mg 71610-0837-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 71610-0858-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Metformin 500 mg 72162-2424-00 | Bryant | 1000 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 72189-0064-30 | direct | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72189-0150-30 | direct | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72578-0035-01 | Viona | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72664-0227-01 | VGYAAN | 100 tablets | — | — | FDA listed | — |
| Metformin Hydrochloride Extended Release 500 mg 72789-0009-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 72789-0105-01 | PD-Rx | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72789-0400-01 | PD-Rx | 100 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72789-0454-60 | PD-Rx | 60 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 72789-0455-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| Metformin hydrochloride 500 mg 76385-0128-01 | UNICHEM | 100 tablets | — | AB1 | FDA listed | — |
| Metformin 500 mg 82804-0147-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Metformin Hydrochloride 500 mg 82804-0195-60 | Proficient | 60 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?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 68645-0595-59 You're viewing this | 60 TABLET in 1 BOTTLE (68645-595-59) | 2022-03-10 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients 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, USP or any other pharmacologic agent. Dosage of metformin hydrochloride extended-release tablets, USP 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, USP in adults is 2000 mg.
Metformin hydrochloride extended-release tablets, USP should generally be given once daily with the evening meal. Metformin hydrochloride extended-release tablets, USP 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, USP 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, USP 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, USP may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone. Metformin hydrochloride extended-release tablets, USP must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of metformin hydrochloride extended-release tablets, USP will be eliminated in the feces as a soft, hydrated mass.
(See Patient Information printed below.) Recommended Dosing Schedule Adults In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms. The usual starting dose of metformin hydrochloride extended-release tablets, USP is 500 mg once daily with the evening meal.
Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on metformin hydrochloride extended-release tablets, USP 2000 mg once daily, a trial of metformin hydrochloride extended-release tablets, USP 1000 mg twice daily should be considered. (See CLINICAL PHARMACOLOGY: CLINICAL STUDIES.) In a randomized trial, patients currently treated with metformin hydrochloride tablets were switched to metformin hydrochloride extended-release tablets.
Results of this trial suggest that 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 2000 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, USP in pediatric patients have not been established.
Recommendations for Use in Renal Impairment Assess renal function…
⛔ Contraindications ▾
CONTRAINDICATIONS Metformin hydrochloride extended-release tablets, USP are contraindicated in patients with: 1. Severe Renal Impairment (eGFR below 30mL/min/1.73m2) (see WARNINGS and PRECAUTIONS). 2.Known hypersensitivity to metformin hydrochloride, USP. 3.Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
⚠️ Warnings ▾
WARNINGS 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 evidenceof 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, concamitent 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 extend release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see PRECAUTIONS ).
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In A US double blind clinical study of metformin hydrochloride tablets in patients with type 2 diabetes, a total of 141 patients received metformin hydrochloride tablets therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride tablets patients, and that were more common in metformin hydrochloride tablets than placebo treated patients, are listed in Table 6. Table 6: Most Common Adverse Reactions (>5 Percent) in a Placebo-Controlled Clinical Study of Metformin Hydrochloride Tablets Monotherapy* Diarrhea 53.2
11.7Nausea/Vomiting 25.5
8.3Flatulence 12.1
5.5Asthenia 9.2
5.5Indigestion 7.1
4.1Abdominal Discomfort 6.4
4.8Headache 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. Additionally, the following adverse reactions were reported in ≥1 - ≤5% of metformin hydrochloride tablets patients and myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, and palpitation.
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 trails, 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 7.
Table 7: Most Common Adverse Reactions (>5 Percent) in Placebo-Controlled Studies of Metformin Hydrochloride Extended-Release Tablets* Metformin Hydrochloride Extended-Release Tablets(N=781) Placebo (N=195) Adverse Reactions % 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 - ≤5% 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.*Reactions that were more common in metformin hydrochloride extended-release tablets than placebo treated patients.
🆘 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 2000 mg administered once daily. Peak plasma levels are approximately 0.6, 1.1, 1.4, and 1.8 mcg/mL for 500, 1000, 1500, and 2000 mg once-daily doses, respectively. The extent of metformin absorption (as measured by AUC) from metformin hydrochloride extended-release tablets at a 2000 mg once-daily dose is similar to the same total daily dose administered as metformin hydrochloride tablets 1000 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 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 In the presence…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Metformin Hydrochloride Extended-Release Tablets, USP 500 mg tablets are white to off-white uncoated, modified capsule shaped tablets debossed with “G7” on one side and plain on the other side. Unit of Use Bottles of 60 Tablets - 500mg - 68645-595-59 Storage Store at 20° to 25° C (68° to 77° F); excursions permitted within 15° to 30° C (59° to 86° F). [See USP Controlled Room Temperature.] Dispense in light-resistant containers. Dispense with Patient Information available at: https://granulespharma.com/product/metformin-er-tab-500-750/ Manufactured by: Granules India Limited Hyderabad-500 081, India Manufactured for: Granules Pharmaceuticals Inc.
Chantilly, VA 20151. Distributed by: Wal-Mart Bentonville, AR 72716 Packaged by: Legacy Pharmaceutical Packaging, LLC Earth City, MO 63045 Revision date: May 2023
📋 Description ▾
DESCRIPTION Metformin Hydrochloride Extended-Release Tablets, USP Metformin hydrochloride extended-release tablets, USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride, USP (N,Ndimethyl- monohydrochloride,Imidodicarbonimidic diamide) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride, USP is a white or almost white, crystalline powder with a molecular formula of C4H11N5•HCl and a molecular weight of 165.62.
Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in Methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.35.
Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Metformin hydrochloride extended-release tablets, USP 500 mg and 750 mg tablets contain the inactive ingredients hypromellose, magnesium stearate, and polyvinyl pyrrolidone. Dissolution Method: Test 10 System Components and Performance - Metformin hydrochloride extended-release tablets, USP comprises a dual hydrophilic polymer matrix system.
Metformin hydrochloride, USP is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essentially independent of pH.
The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass. DESCRIPTION
💬 Patient Medication Information ▾
SPL PATIENT PACKAGE INSERT Patient Information Metformin Hydrochloride Extended-Release Tablets, USP Read this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of your doctor’s advice.
Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine. What are Metformin Hydrochloride Extended-Release Tablets? Metformin Hydrochloride Extended-Release Tablets are used to treat type 2 diabetes.
This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood.
This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.
High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take metformin hydrochloride extended-release tablets, try to control your diabetes by exercise and weight loss. While you take your diabetes medicine, continue to exercise and follow the diet advised for your diabetes.
No matter what your recommended diabetes management plan is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness. Metformin hydrochloride and Metformin hydrochloride extended-release tablets have the same active ingredient. However, metformin hydrochloride extended-release tablets works longer in your body.
Both of these medicines help control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin hydrochloride extended-release tablets do not cause your body to make more insulin.
Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain. Tell your doctor if you are pregnant or plan to become pregnant.
Metformin hydrochloride extended-release tablets may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.
Can Metformin hydrochloride extended-release tablets be used in children? Metformin hydrochloride extended-release tablets has not been studied in children. How should I take Metformin hydrochloride extended-release tablets?
Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled.
You should take metformin hydrochloride extended-release tablets with meals. Your doctor may have you take other medicines along with metformin hydrochloride extended-release tablets to control your blood sugar. These medicines may include insulin shots.
Taking metformin hydrochloride extended-release tablets with insulin may help you better control your blood sugar while reducing the insulin dose. Continue your exercise and diet program and test your blood sugar regularly while taking metformin hydrochloride extended-release tablets. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally.
There is no evidence that metformin hydrochloride extended-release tablets causes harm to the liver or kidneys. Tell your doctor if you: • have an illness that causes severe vomiting, diarrhea or fever,…