GLUCOPHAGE 850/MG TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus: as monotherapy or in combination with other antidiabetic agents (including insulin); approved for adults and pediatric patients ≥10 years (per common labeling for immediate‑release metformin).

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults, immediate‑release): start 500 mg twice daily or 850 mg once daily with meals; increase by 500 mg weekly or 850 mg every 10-14 days as tolerated; usual effective dose 1500-2000 mg/day in divided doses; maximum 2550 mg/day. Pediatrics (10-16/17 years, immediate‑release): start 500 mg twice daily (or 850 mg once daily per some labels), titrate weekly; maximum 2000 mg/day in divided doses.

Initial Dose

500 mg twice daily or 850 mg once daily with meals

Maintenance Dose

1500-2000 mg/day in 2-3 divided doses with meals

Maximum Dose

2550 mg/day in adults; 2000 mg/day in children aged 10-17 years

Children's Dosage

Children 10-17 years: Initial 500 mg or 850 mg once daily with meals; titrate based on response; maximum 2000 mg/day in divided doses. Not approved for children under 10 years

How to Take

Swallow the film‑coated tablet whole with a glass of water, with or immediately after meals; do not crush or chew.

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, metallic taste, flatulence

Side Effect Frequency

Very common (>10%): gastrointestinal effects (diarrhea, nausea, vomiting, abdominal pain, loss of appetite). Common (1-10%): taste disturbance (metallic taste). Very rare (<0.01%): lactic acidosis. Frequency not known/very rare: decreased vitamin B12 absorption/deficiency with long-term use.

Safety & Warnings

Contraindications

Contraindicated in: severe renal impairment (eGFR <30 mL/min/1.73 m²), acute or chronic metabolic acidosis (including DKA), and hypersensitivity to metformin; temporarily stop around iodinated contrast in at-risk patients per eGFR/risk criteria (not a permanent contraindication).

Warnings & Precautions

Warnings/precautions: lactic acidosis risk-assess renal function before start and periodically; withhold during acute illness causing hypoxia/dehydration/sepsis, before major surgery as clinically appropriate, and around iodinated contrast in at-risk patients; avoid excessive alcohol; consider B12 monitoring with long-term therapy; not for type 1 diabetes or DKA; use extra caution in older adults due to renal function decline.

Age Restriction

Approved for adults and pediatric patients aged 10 years and older (type 2 diabetes); not established/approved under 10 years.

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporary discontinuation in at-risk patients), alcohol (increases lactic acidosis risk), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide-metabolic acidosis risk), cimetidine and other OCT2/MATE inhibitors (increase metformin exposure), and drugs that impair renal function (e.g., NSAIDs/diuretics/ACEi-monitor); insulin/sulfonylureas increase hypoglycemia risk when combined.

Interaction Severity

MAJOR: Iodinated contrast media (risk of AKI → metformin accumulation/lactic acidosis; temporarily withhold in at‑risk patients). MODERATE: Alcohol (increases lactic acidosis risk); carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) (metabolic acidosis risk); cationic drugs that reduce metformin renal clearance via OCT/MATE inhibition (e.g., cimetidine, ranolazine, dolutegravir, vandetanib) (↑ metformin exposure); insulin/sulfonylureas (↑ hypoglycemia risk).

Food Interaction

Take with food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Children 10-17 years: Initial 500 mg or 850 mg once daily with meals; titrate based on response; maximum 2000 mg/day in divided doses. Not approved for children under 10 years

Elderly

Start at lower dose, titrate slowly, and monitor renal function closely. Dose selection should be conservative due to greater frequency of decreased renal function. Regular assessment of eGFR required; contraindicated if eGFR <30 mL/min/1.73m²

Liver Impairment

Avoid use in hepatic impairment (especially severe hepatic disease) due to increased lactic acidosis risk; no dose-adjustment strategy is recommended-use is generally not advised rather than titrated.

Storage & Patient Advice

Overdose

Overdose can cause lactic acidosis (GI symptoms, malaise, respiratory distress/hyperventilation, hypothermia, hypotension, bradyarrhythmias, altered mental status); management is immediate cessation, urgent hospital care/supportive treatment, and hemodialysis to remove metformin and correct acidosis.

Patient Counseling

Take with or after meals; expect possible GI upset early and report persistent/severe symptoms; avoid excessive alcohol; maintain hydration and follow sick‑day rules (seek advice/temporarily stop if significant vomiting/diarrhea/dehydration); inform providers before surgery or iodinated contrast imaging; recognize and seek urgent care for lactic acidosis symptoms (e.g., rapid breathing, severe weakness, abdominal pain, unusual drowsiness); attend monitoring for kidney function, glucose control, and possible vitamin B12 deficiency.

Pharmacology

Mechanism of Action

Decreases hepatic glucose production (gluconeogenesis), decreases intestinal glucose absorption, and improves peripheral insulin sensitivity/increases glucose uptake; mediated in part via AMPK activation.

Onset of Action

Glucose-lowering effect begins within hours after the first dose; clinically meaningful reductions are usually seen within 24-48 hours, with full/steady effect typically in ~2-4 weeks after initiation or dose changes.

Half-Life

Apparent plasma elimination half-life: ~4-8.7 hours; whole-blood (erythrocyte) half-life: ~17.6 hours.

Metabolism

Not metabolized; excreted unchanged in urine (renal elimination).

Excretion

Eliminated renally as unchanged drug (>90%), primarily via active tubular secretion (OCT/MATE transport).

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 850 mg metformin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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