GLUCOPHAGE XR 750/MG PR TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults, as monotherapy or in combination with other antidiabetic agents (including insulin), as an adjunct to diet and exercise.

Off-Label Uses

Common off-label uses include polycystic ovary syndrome (PCOS), prevention/delay of type 2 diabetes in high-risk (prediabetes) patients, and mitigation of antipsychotic-associated weight gain; gestational diabetes use occurs but is typically specialist-directed and varies by guideline/label.

Dosage & Administration

Dosing by Condition

Type 2 diabetes (XR): typically start 500 mg once daily with the evening meal and increase by 500 mg weekly (or every 1-2 weeks) as tolerated; usual max 2000 mg/day (some labels allow up to 2000 mg once daily).

Maintenance Dose

1500mg to 2000mg once daily or in divided doses

Maximum Dose

2000mg per day (XR formulation); 3000mg per day (immediate-release formulation)

Children's Dosage

Immediate-release metformin is approved for children ≥10 years; Glucophage XR 750mg prolonged-release tablet is not approved for use in children under 18 years

Dose Adjustment Notes

Titrate gradually to minimize GI adverse effects; assess renal function (eGFR) before initiation and periodically; do not initiate if eGFR 30-44 mL/min/1.73 m² and discontinue if eGFR <30; temporarily withhold around iodinated contrast in at-risk patients and around major surgery per perioperative guidance.

How to Take

Swallow the prolonged-release tablet whole with the evening meal (or immediately after); do not crush, chew, or split.

Side Effects

Common Side Effects

Diarrhea, nausea, vomiting, abdominal bloating, flatulence, anorexia, metallic taste in mouth.

Side Effect Frequency

Very common (≥10%): gastrointestinal effects (diarrhea, nausea, vomiting, abdominal pain, loss of appetite). Common (1-10%): taste disturbance/metallic taste. Rare/very rare: lactic acidosis; hepatic abnormalities (abnormal LFTs/hepatitis); skin reactions (e.g., erythema, pruritus, urticaria). Vitamin B12 decrease/deficiency: frequency not known (risk increases with long-term use).

Safety & Warnings

Contraindications

Contraindicated in: severe renal impairment (eGFR <30 mL/min/1.73m²), acute or chronic metabolic acidosis (including DKA), and hypersensitivity to metformin; temporarily discontinue for iodinated contrast in at‑risk patients per labeling.

Warnings & Precautions

Major warnings/precautions: lactic acidosis risk (assess renal function before and periodically; avoid/withhold in hypoxia, dehydration, sepsis, acute illness), temporary discontinuation around iodinated contrast in at‑risk patients, caution in elderly due to renal decline, monitor for vitamin B12 deficiency with long‑term use, and not indicated for type 1 diabetes/DKA.

Age Restriction

Not recommended/approved for pediatric use (<18 years) for this prolonged‑release (XR) formulation; use is established in adults.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (AKI/lactic acidosis risk-temporary hold in at‑risk patients), alcohol (↑ lactic acidosis risk), carbonic anhydrase inhibitors e.g., topiramate (↑ acidosis risk), cationic drugs reducing renal tubular secretion/clearance e.g., cimetidine/ranolazine (↑ metformin exposure), and hyperglycemia‑inducing drugs (corticosteroids, thiazides/diuretics) that may worsen control; insulin/secretagogues increase hypoglycemia risk when combined.

Interaction Severity

MAJOR: Iodinated contrast media (risk of AKI and lactic acidosis-temporarily withhold in appropriate patients). MODERATE: Alcohol (increases lactic acidosis risk), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide; metabolic acidosis risk), cimetidine and other OCT2/MATE inhibitors (increase metformin exposure), ranolazine (can increase metformin levels).

Food Interaction

Take with food

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Use with caution; low levels in breast milk, generally considered compatible but monitor infant

Children

Immediate-release metformin is approved for children ≥10 years; Glucophage XR 750mg prolonged-release tablet is not approved for use in children under 18 years

Elderly

Start at lower dose, titrate slowly, and monitor renal function regularly. Contraindicated if eGFR <30 mL/min/1.73m². Use with caution in patients ≥65 years due to age-related decline in renal function

Kidney Impairment

eGFR ≥60: no adjustment; eGFR 45-59: continue/monitor more frequently; eGFR 30-44: do not initiate-if already on, consider dose reduction and close monitoring; eGFR <30: contraindicated.

Liver Impairment

Avoid use in hepatic impairment (no dose adjustment recommended because use is generally not advised).

Storage & Patient Advice

Stopping the Medicine

Do not stop without clinician guidance; if discontinued, monitor glucose as glycemic control may worsen.

Overdose

Overdose can cause severe lactic acidosis (GI symptoms, malaise, myalgias, respiratory distress/hyperventilation, hypothermia, hypotension, bradyarrhythmias, altered mental status); management is emergency discontinuation, hospitalization/supportive care, and consider hemodialysis to remove metformin and correct acidosis.

Patient Counseling

Take once daily with the evening meal; swallow whole (do not crush/chew/split). GI upset is common initially-dose is usually increased gradually. Avoid excessive alcohol. Tell providers before surgery or contrast imaging as temporary interruption may be needed. Seek urgent care for symptoms of lactic acidosis (e.g., severe weakness, muscle pain, abdominal pain, rapid breathing, unusual sleepiness). Monitor kidneys and glucose regularly; long-term use may lower vitamin B12. Seeing a tablet “shell” in stool can occur with some XR formulations and can be normal.

Monitoring Requirements

Monitor renal function (eGFR) before starting and at least annually (more often if elderly/at risk), glycemic control (HbA1c every ~3 months until stable then every 3-6 months; SMBG as appropriate), and vitamin B12 periodically with long-term use; assess for lactic acidosis risk factors and consider hepatic function if clinically indicated.

Pharmacology

Mechanism of Action

Decreases hepatic glucose production (gluconeogenesis), decreases intestinal glucose absorption, and improves insulin sensitivity/increases peripheral glucose uptake; AMPK activation is a key proposed mediator.

Onset of Action

Glucose-lowering begins within days (typically within 48-72 hours); maximal glycemic effect may take about 2-4 weeks.

Duration of Effect

Glucose-lowering effect persists for approximately 24 hours per dose with the extended-release formulation; full therapeutic effect may take 2-4 weeks.

Half-Life

Approximately 6.2 hours (plasma); ~17.6 hours in whole blood/erythrocytes.

Bioavailability

Oral bioavailability is approximately 50-60% (immediate-release); XR has slower, more prolonged absorption and food may alter the rate/extent of absorption depending on formulation.

Metabolism

Not metabolized; excreted unchanged in urine (no hepatic metabolism).

Excretion

Eliminated primarily by the kidneys as unchanged drug (via tubular secretion), with the vast majority excreted unchanged in urine.

Protein Binding

Negligible.

Product Information

Available Dosage Forms

Metformin is available as immediate-release tablets, prolonged/extended-release tablets, and oral solution; this specific product is a prolonged-release tablet (750 mg).

Composition per Dose

Each prolonged-release tablet: 750mg metformin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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