Description
What are Bigomet 500 Mg Tablets?
Bigomet 500 Mg Tablets are oral antidiabetic tablets manufactured by Aristo Pharmaceuticals Pvt. Ltd., an established Indian pharmaceutical company. Each tablet contains 500 mg of Metformin Hydrochloride as the active ingredient. Metformin is a biguanide class antidiabetic agent and is the most widely prescribed first-line oral medication for the management of type 2 diabetes mellitus (T2DM) worldwide.
Bigomet 500 helps lower blood glucose levels primarily by reducing the amount of glucose produced by the liver and by improving the body’s sensitivity to insulin. Unlike some other antidiabetic medications, metformin does not cause hypoglycaemia when used alone and is not associated with weight gain. Each pack contains 10 tablets.
Composition and Product Details
| Brand Name | Bigomet 500 |
|---|---|
| Generic Name | Metformin Hydrochloride |
| Strength | 500 mg per tablet |
| Dosage Form | Film-coated oral tablet |
| Pack Size | 10 tablets |
| Manufacturer | Aristo Pharmaceuticals Pvt. Ltd., India |
| Therapeutic Class | Biguanide / Oral Antidiabetic Agent |
| Prescription Required | Yes |
About Aristo Pharmaceuticals and the Bigomet Brand
Aristo Pharmaceuticals Pvt. Ltd. is a Mumbai-based pharmaceutical manufacturer with more than four decades of experience in formulation development and production. Aristo supplies generic and branded medicines across a broad therapeutic range including cardiovascular, endocrine, anti-infective, and central nervous system categories, serving both domestic Indian markets and international export destinations.
The Bigomet brand is Aristo’s metformin product line, offered across multiple strengths to support the range of metformin doses used throughout the management of type 2 diabetes — from initiation to established maintenance therapy. Bigomet 500 is the standard-strength tablet routinely used as the initial and maintenance dosing option for most adult patients with T2DM.
How Bigomet 500 Mg Works
Metformin works through three principal mechanisms that collectively lower blood glucose levels in patients with type 2 diabetes:
- Reduction of hepatic glucose production (gluconeogenesis): This is metformin’s primary mechanism. In type 2 diabetes, the liver produces excessive glucose, especially overnight. Metformin inhibits mitochondrial complex I in hepatocytes, reducing the energy substrate available for gluconeogenesis and thereby substantially lowering fasting blood glucose.
- Improved peripheral insulin sensitivity: Metformin enhances the uptake and utilisation of glucose in skeletal muscle and adipose tissue by improving insulin receptor signalling. This means that the same amount of circulating insulin is able to clear more glucose from the bloodstream.
- Slowed intestinal glucose absorption: Metformin reduces the rate at which glucose is absorbed from the gastrointestinal tract following meals, blunting post-prandial glucose peaks.
Because metformin works primarily by reducing hepatic glucose output and improving insulin sensitivity, it does not stimulate insulin secretion from the pancreas. This means it does not cause hypoglycaemia (dangerously low blood sugar) when used as monotherapy — a key safety advantage over some other antidiabetic agents such as sulphonylureas.
Indications and Uses
Bigomet 500 Mg Tablets are indicated for:
- Type 2 diabetes mellitus (T2DM) in adults: As first-line pharmacological therapy when diet and exercise alone have not provided adequate blood glucose control, either as monotherapy or in combination with other antidiabetic agents (sulphonylureas, DPP-4 inhibitors, SGLT-2 inhibitors, insulin, etc.)
- Type 2 diabetes in children and adolescents aged 10 years and over (under specialist supervision)
- Prevention of type 2 diabetes in high-risk individuals (pre-diabetes, impaired glucose tolerance) — in some clinical settings and guidelines
Metformin is recommended as the preferred initial oral glucose-lowering agent in most international guidelines, including those of the National Institute for Health and Care Excellence (NICE) in the UK, because of its efficacy, favourable safety profile, and evidence for reducing cardiovascular outcomes.
Dosage and Administration
Dosing must be directed by the prescribing physician. Bigomet 500 Mg Tablets should be taken with or immediately after meals to reduce gastrointestinal side effects.
- Initial dose (adults): 500 mg once or twice daily with meals. The dose is increased gradually (typically by 500 mg every 1–2 weeks) based on blood glucose response and tolerability.
- Standard maintenance dose: 1,500–2,000 mg per day in two to three divided doses (e.g., 500 mg three times daily or 1,000 mg twice daily)
- Maximum dose: 3,000 mg per day in divided doses (3 × 1,000 mg or equivalent), though doses above 2,000 mg are less well tolerated
- Tablets should be swallowed whole with a glass of water and not crushed or chewed unless a modified-release formulation permits this
Your doctor will advise on the appropriate dose for your individual needs. Do not adjust your dose without medical guidance.
Special Populations
Elderly (≥65 years)
Renal function typically declines with age. Since metformin is primarily eliminated unchanged by the kidneys, regular monitoring of eGFR (estimated glomerular filtration rate) is essential in elderly patients. Dose reduction or discontinuation may be required based on renal function. Metformin is generally not recommended if eGFR falls below 30 mL/min/1.73 m².
Renal Impairment
Metformin is contraindicated in patients with significantly impaired renal function (eGFR < 30 mL/min/1.73 m²) due to the risk of lactic acidosis — a rare but potentially life-threatening accumulation of metformin. Dose adjustment is required for eGFR 30–60 mL/min/1.73 m². Your doctor will assess renal function before starting and during treatment.
Hepatic Impairment
Metformin should be used with caution in hepatic impairment, as impaired lactate clearance by the liver increases the theoretical risk of lactic acidosis. It is generally avoided in severe hepatic impairment (Child-Pugh Class C).
Paediatric Use (10–17 years)
Metformin is licensed for use in children aged 10 years and above with type 2 diabetes under specialist supervision. Dosing is weight-based and individually determined. Bigomet 500 is an appropriate strength for this age group, subject to physician direction.
Precautions and Warnings
- Lactic acidosis: This is a rare but serious potential complication of metformin therapy. Risk is substantially increased in patients with renal failure, hepatic failure, dehydration, excessive alcohol use, sepsis, or during conditions causing tissue hypoxia. Symptoms include muscle pain, difficulty breathing, stomach discomfort, dizziness, and feeling cold. Seek urgent medical attention if these occur.
- Contrast media (iodinated dye): Metformin should be temporarily withheld for 48 hours before and after intravenous iodinated contrast media procedures (e.g., CT scans with contrast) due to the risk of contrast-induced nephropathy and secondary lactic acidosis. Always inform your radiologist or surgeon that you take metformin.
- Surgery: Metformin is generally withheld 24–48 hours before major surgery requiring general anaesthesia and restarted after adequate renal function is confirmed post-operatively.
- Alcohol: Excessive alcohol intake enhances the risk of lactic acidosis with metformin. Limit alcohol consumption.
- Vitamin B12 deficiency: Long-term metformin use has been associated with reduced vitamin B12 absorption. Periodic monitoring of B12 levels and supplementation if required is recommended, particularly in patients with symptoms of peripheral neuropathy.
- Hypoglycaemia: Metformin monotherapy rarely causes hypoglycaemia; however, when used in combination with insulin or sulphonylureas, the risk of hypoglycaemia increases. Patients should be educated on recognising and managing low blood sugar.
Contraindications
- Severely reduced renal function (eGFR < 30 mL/min/1.73 m²) — metformin accumulation and lactic acidosis risk
- Type 1 diabetes mellitus (insulin-dependent diabetes)
- Diabetic ketoacidosis
- Severe hepatic impairment
- Acute or chronic metabolic acidosis
- Dehydration, severe infection, shock, or any condition causing significant tissue hypoxia
- Excessive alcohol use
- Hypersensitivity to metformin hydrochloride or any excipient in the formulation
Possible Side Effects
Common (may affect up to 1 in 10 users — especially at treatment initiation)
- Nausea and vomiting
- Diarrhoea
- Abdominal pain or discomfort
- Loss of appetite
- Metallic taste in the mouth
Gastrointestinal side effects are most common at the start of treatment and typically improve within a few weeks. Taking tablets with food and starting with a low dose that is increased gradually significantly reduces these effects.
Uncommon
- Headache
- Skin reactions (rare rash)
Rare but Serious
- Lactic acidosis — rare with normal renal function; potentially life-threatening. Seek immediate medical attention if you develop unexplained muscle pain, breathing difficulties, abdominal pain, or feel unusually cold.
- Vitamin B12 deficiency — with prolonged use; may cause anaemia or peripheral neuropathy
- Severe hypoglycaemia — only when used with other glucose-lowering agents
Drug Interactions
- Iodinated contrast agents: Withhold metformin 48 hours before contrast procedures (see Precautions above).
- Alcohol: Increases the risk of lactic acidosis; limit intake.
- Insulin and sulphonylureas (e.g., glibenclamide, gliclazide): Concurrent use increases hypoglycaemia risk; dose of the sulphonylurea or insulin may need reduction.
- Cimetidine: Competes for renal tubular secretion, increasing metformin plasma concentrations; use with caution.
- Diuretics (especially loop diuretics) and NSAIDs: May cause dehydration and transient renal impairment, increasing metformin risk.
- ACE inhibitors and angiotensin receptor blockers: May reduce renal function; monitor regularly when combined with metformin.
- Corticosteroids, thiazide diuretics, sympathomimetics, and glucagon: May raise blood glucose, counteracting the effect of metformin.
Related Diabetes Products on IndoGenMed
IndoGenMed stocks a range of metformin products to support different stages of type 2 diabetes management:
- Bigomet 250 Mg Tablets — The 250 mg metformin formulation in the Bigomet range, used as a lower-dose initiation option or for patients who require a reduced dose due to tolerability or renal considerations.
Storage Instructions
- Store below 25°C in a cool, dry place away from direct sunlight and moisture
- Keep tablets in the original blister pack until use
- Store out of reach of children and pets
- Do not use tablets after the printed expiry date
- Do not store in a bathroom or near a sink where humidity is high
Frequently Asked Questions
Q: Why should I take Bigomet 500 with food?
A: Metformin commonly causes gastrointestinal side effects — particularly nausea, diarrhoea, and abdominal discomfort — especially when starting treatment. Taking the tablet with or immediately after a meal significantly reduces these effects by slowing absorption and reducing gastric irritation. The NHS recommends always taking metformin with a meal for this reason.
Q: Can Bigomet 500 cause low blood sugar (hypoglycaemia)?
A: When used as monotherapy (without other glucose-lowering drugs or insulin), metformin very rarely causes hypoglycaemia because it does not stimulate insulin secretion. However, if you take Bigomet 500 in combination with insulin or a sulphonylurea, your risk of low blood sugar increases. Your doctor will advise on symptoms to watch for and how to respond.
Q: Can I drink alcohol while taking Bigomet 500?
A: Occasional moderate alcohol consumption is generally acceptable, but regular or excessive alcohol intake is not recommended when taking metformin. Alcohol increases the risk of lactic acidosis, particularly in patients who are fasting or who have reduced kidney function. Discuss your alcohol intake with your doctor.
Q: What should I do if I am having a scan with contrast dye?
A: You must inform your doctor and the radiology team that you are taking metformin before any procedure involving intravenous iodinated contrast media (such as a CT scan with contrast). Metformin should generally be stopped 48 hours before the procedure and only restarted after kidney function has been confirmed to be normal. Failing to do this could increase the risk of a serious condition called lactic acidosis.
Q: Is Bigomet 500 the same as Glucophage?
A: Both Bigomet 500 and Glucophage (the original branded metformin by Merck) contain metformin hydrochloride as the active ingredient. Bigomet 500 is a generic equivalent that contains the same active substance at the same 500 mg dose. Generic medicines are required to demonstrate bioequivalence to the originator product and are considered therapeutically interchangeable. Always consult your doctor before switching between products.
References
- NHS. Metformin. NHS.uk. Available at: https://www.nhs.uk/medicines/metformin/
- MedlinePlus. Metformin. U.S. National Library of Medicine. Available at: https://medlineplus.gov/druginfo/meds/a696005.html
- U.S. Food and Drug Administration (FDA). Glucophage (metformin hydrochloride) Prescribing Information. Available at: FDA.gov
- National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management. NICE Guideline NG28. Available at: https://www.nice.org.uk/guidance/ng28
- Foretz M, et al. “Metformin: from mechanisms of action to therapies.” Cell Metabolism. 2014;20(6):953–966.
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