Glucophage: Effective First-Line Type 2 Diabetes Management
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Glucophage, with its active ingredient metformin hydrochloride, stands as a cornerstone in the pharmacological management of type 2 diabetes mellitus. As a biguanide-class antihyperglycemic agent, it is universally recognized by leading endocrinological associations as the first-line oral therapy for newly diagnosed patients. Its primary mechanism of action involves reducing hepatic glucose production and improving insulin sensitivity in peripheral tissues, thereby addressing core pathophysiological defects of the disease. This product card provides a comprehensive, evidence-based overview for healthcare professionals to support informed clinical decision-making.
Features
- Active Pharmaceutical Ingredient: Metformin hydrochloride.
- Available Formulations: Immediate-release tablets (500 mg, 850 mg, 1000 mg) and extended-release tablets (500 mg, 750 mg).
- Pharmacologic Class: Biguanide antihyperglycemic agent.
- Primary Mechanism: Decreases hepatic gluconeogenesis and enhances peripheral glucose uptake and utilization.
- Administration: Oral, with meals to minimize gastrointestinal discomfort.
- Bioavailability: Approximately 50-60% under fasting conditions; food decreases the extent and slightly delays absorption.
Benefits
- Achieves significant and sustained reductions in both fasting and postprandial plasma glucose levels.
- Promotes modest weight loss or weight neutrality, a distinct advantage over many other antidiabetic agents that cause weight gain.
- Demonstrates a very low risk of hypoglycemia when used as monotherapy, as its action is glucose-dependent.
- Improves lipid profiles, often resulting in reduced levels of triglycerides and LDL cholesterol.
- Offers potential cardiovascular protective benefits, as evidenced by long-term outcome studies.
- Provides a cost-effective therapeutic option with a well-established efficacy and safety profile spanning decades of use.
Common use
Glucophage (metformin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. It is used as monotherapy or in combination with other oral antihyperglycemic agents (e.g., sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors) or with insulin. Its use is also well-established in the management of polycystic ovary syndrome (PCOS) to address insulin resistance and support ovulation induction, though this is an off-label application.
Dosage and direction
Dosage must be individualized based on efficacy and tolerability, with a gradual titration to minimize gastrointestinal side effects.
- Adults (Immediate-Release): The usual starting dose is 500 mg twice daily or 850 mg once daily, taken with the morning and evening meals. Dosage may be increased by 500 mg weekly or 850 mg every two weeks. The maximum recommended daily dose is 2550 mg administered in divided doses. A commonly used effective dose is 2000 mg daily.
- Adults (Extended-Release): The usual starting dose is 500 mg once daily with the evening meal. Dose may be increased by 500 mg weekly. The maximum recommended daily dose is 2000 mg (2500 mg for some formulations, per specific manufacturer guidelines) taken once daily with the evening meal.
- Pediatric Patients (10-16 years): The usual starting dose for immediate-release tablets is 500 mg twice daily. Dose may be increased by 500 mg weekly up to a maximum of 2000 mg per day.
- Administration: Tablets must be swallowed whole and never crushed or chewed. Extended-release tablets may appear in stool as a soft mass resembling the original tablet; this is the empty shell (ghost matrix) and is not a sign of improper absorption.
Precautions
- Lactic Acidosis: Although a rare occurrence (approximately 0.03 cases per 1000 patient-years), metformin-associated lactic acidosis is a serious metabolic complication that can be fatal. Risk factors include renal impairment, congestive heart failure requiring pharmacologic management, advanced age, dehydration, excessive alcohol intake, hepatic impairment, and acute conditions that can affect renal function or hemodynamics (e.g., radiocontrast procedures, surgery, hypoxemia, sepsis).
- Vitamin B12 Deficiency: Long-term use of metformin has been associated with decreased vitamin B12 absorption and lower serum levels. Periodic measurement of hematological parameters is advised.
- Surgery and Radiologic Procedures: Glucophage should be temporarily discontinued at the time of, or prior to, any surgical procedure or intravascular iodinated contrast imaging and withheld for 48 hours afterwards, only to be reinstated after renal function has been re-evaluated and found to be normal.
- Hepatic Impairment: Use with caution, as impaired liver function may significantly impair lactate clearance.
Contraindications
- Severe renal impairment (eGFR below 30 mL/min/1.73m²) or renal disease.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- History of a hypersensitivity reaction to metformin hydrochloride or any ingredient in the formulation.
- Acute or chronic conditions which may cause tissue hypoxia (e.g., cardiac or respiratory failure, recent myocardial infarction, shock).
Possible side effect
The most common adverse reactions are gastrointestinal in nature and often transient.
- Very Common (>10%): Diarrhea, nausea, vomiting, abdominal discomfort, flatulence.
- Common (1-10%): Asthenia, indigestion, headache, taste disturbance.
- Uncommon (0.1-1%): Decreased vitamin B12 levels (see Precautions).
- Rare (<0.1%): Lactic acidosis (see Precautions), erythema, pruritus, urticaria.
- Very Rare: Hepatitis, isolated reports of liver enzyme elevations.
Drug interaction
- Drugs that impair renal function: Concomitant use with drugs that may affect renal function (e.g., diuretics, NSAIDs, ACE inhibitors) or compete for tubular secretion may increase the risk of lactic acidosis and metformin accumulation.
- Alcohol: Alcohol potentiates the effect of metformin on lactate metabolism. Excessive alcohol intake is contraindicated.
- Cationic drugs: Drugs that are eliminated by renal tubular secretion (e.g., cimetidine, digoxin, amiloride, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin) may interact with metformin by competing for common renal tubular transport systems, potentially increasing metformin plasma levels.
- Glucose-lowering agents: When used in combination with insulin or other oral antidiabetic drugs (e.g., sulfonylureas), the hypoglycemic effect may be additive, increasing the risk of hypoglycemia.
Missed dose
Instruct the patient to take the next dose at the usual time. Do not take a double dose to make up for the missed one. Maintaining a consistent daily schedule is important for optimal glycemic control.
Overdose
Hypoglycemia has not been seen with metformin overdose in the absence of concomitant glucose-lowering agents. However, metformin overdose is associated with a high risk of lactic acidosis. Signs and symptoms are primarily those of lactic acidosis (e.g., vomiting, diarrhea, malaise, hyperventilation, somnolence). In the event of an overdose, hospitalization is immediately required. Hemodialysis is an effective means of removing accumulated metformin and correcting the acidosis and should be considered promptly.
Storage
- Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
- Keep the bottle tightly closed to protect from moisture and light.
- Keep out of reach of children and pets.
- Do not use after the expiration date printed on the packaging.
Disclaimer
This information is intended for educational purposes for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. The prescribing physician remains solely responsible for determining the appropriateness of therapy for an individual patient, considering the patient’s unique clinical situation and the official prescribing information. Always consult the full manufacturer’s prescribing information and relevant clinical guidelines before initiating or modifying any treatment regimen.
Reviews
“Glucophage remains the foundational therapy in my type 2 diabetes treatment algorithm. Its efficacy, safety profile, cardiovascular neutrality/benefit, and cost-effectiveness are unmatched. The GI side effects are usually manageable with slow titration and taking with food.” – Endocrinologist, 15 years of practice.
“For the majority of my newly diagnosed patients, metformin is where we start. It effectively tackles insulin resistance, and the weight-neutral aspect is a significant benefit that patients appreciate. Patient education on gradual dose initiation is key to adherence.” – Primary Care Physician, 10 years of practice.
“The extended-release formulation has been a game-changer for patient tolerability. It significantly reduces the frequency of gastrointestinal adverse events, which was the primary reason for discontinuation in the past. This has improved long-term adherence in my practice.” – Diabetes Specialist Nurse, 8 years of practice.