GLUCOPHAGE 500/MG TAB 50/TAB

Indications

Approved Uses

Type 2 diabetes mellitus as an adjunct to diet and exercise, used as monotherapy or in combination with other antidiabetic agents (including insulin); approved for adults and pediatric patients ≥10 years (per common metformin labeling).

Dosage & Administration

Dosing by Condition

Type 2 diabetes (immediate‑release adults): start 500 mg twice daily with meals (or 500 mg once daily then increase), titrate by 500 mg weekly (or every 1-2 weeks) as tolerated; usual effective dose 1500-2000 mg/day in divided doses; maximum 2550 mg/day. Pediatrics ≥10 years: start 500 mg once daily with meals, titrate by 500 mg weekly; maximum 2000 mg/day in divided doses.

Initial Dose

500 mg twice a day or 850 mg once a day with meals.

Maintenance Dose

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

Maximum Dose

2550 mg per day.

Children's Dosage

For children 10 years and older: Initial dose is 500 mg twice a day. The dose may be increased in 500 mg increments weekly up to a maximum of 2000 mg per day in divided doses.

Dose Adjustment Notes

Titrate gradually to improve GI tolerability (e.g., increase by 500 mg about weekly or every 1-2 weeks); assess renal function before initiation and periodically-do not initiate if eGFR 30-45 mL/min/1.73 m², contraindicated if eGFR <30, and reduce/reevaluate dose if eGFR falls <45.

How to Take

Swallow the 500 mg film‑coated tablet whole with water, taken with or immediately after meals; do not crush or chew unless specifically directed.

Side Effects

Common Side Effects

Gastrointestinal effects are most common: diarrhea, nausea, vomiting, abdominal pain/discomfort, decreased appetite, and metallic taste; flatulence/bloating/indigestion may occur; headache can occur.

Side Effect Frequency

Very common (>10%): Diarrhea (53%), nausea/vomiting (26%), flatulence (12%), asthenia (9%). Common (1-10%): Indigestion (7%), abdominal discomfort (6%), headache (6%), metallic taste, loss of appetite. Uncommon (<1%): Lactic acidosis, skin reactions. Vitamin B12 deficiency observed in approximately 7% of patients in 29-week clinical trials

Safety & Warnings

Contraindications

Contraindications: eGFR <30 mL/min/1.73 m²; acute or chronic metabolic acidosis (including DKA); hypersensitivity to metformin.

Warnings & Precautions

Warnings/precautions: lactic acidosis risk (higher with renal impairment, age ≥65, hypoxic states, excessive alcohol, and interacting drugs); assess renal function before and during therapy; temporarily withhold for iodinated contrast in at-risk patients and around major surgery/acute illness causing hypoxia or dehydration; monitor for and periodically assess vitamin B12 with long-term use; not for type 1 diabetes or DKA.

Age Restriction

Approved for use in adults and pediatric patients aged 10 years and older (not established <10 years).

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporary interruption in at-risk patients and reassess renal function before restarting); alcohol/excessive intake (↑ lactic acidosis risk); carbonic anhydrase inhibitors (e.g., topiramate) (↑ acidosis risk); cationic drugs that reduce renal tubular secretion/clearance of metformin (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim) (↑ metformin exposure); drugs that raise glucose (e.g., corticosteroids, some diuretics) may reduce glycemic control.

Interaction Severity

MAJOR: Iodinated contrast media in patients with reduced renal function or other risk factors-temporarily discontinue metformin at/around the procedure and reassess renal function before restarting; Excessive alcohol intake increases lactic acidosis risk. MODERATE: Carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) increase metabolic acidosis risk; cimetidine and other OCT2/MATE inhibitors can increase metformin exposure; drugs that raise glucose (e.g., corticosteroids, thiazide/loop diuretics) may reduce glycemic control.

Food Interaction

Take with food

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Use with caution; limited data, consider benefits/risks; present in breast milk at low levels (0.11-1% of maternal dose)

Children

For children 10 years and older: Initial dose is 500 mg twice a day. The dose may be increased in 500 mg increments weekly up to a maximum of 2000 mg per day in divided doses.

Elderly

Start at lower dose and titrate cautiously; monitor renal function regularly as eGFR declines with age; dose should be adjusted based on renal function; maximum dose should be conservative

Kidney Impairment

eGFR ≥60: no adjustment, monitor at least annually; eGFR 45-59: continue, monitor every 3-6 months; eGFR 30-44: do not initiate-if already on, consider dose reduction (often max 1000 mg/day) and monitor every ~3 months; eGFR <30: contraindicated.

Liver Impairment

Avoid/not recommended in hepatic impairment (no dose-adjustment strategy; increased lactic acidosis risk).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered with food unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop without clinician advice; if discontinued, arrange alternative glycemic management and monitor glucose.

Overdose

Overdose may cause lactic acidosis; symptoms include malaise, myalgias, abdominal pain, nausea/vomiting, respiratory distress, hypothermia, hypotension, bradyarrhythmias, and altered mental status-seek emergency care; management is supportive with consideration of hemodialysis to remove metformin and correct acidosis.

Patient Counseling

Take with meals to reduce stomach upset; avoid excessive alcohol; inform providers before surgery or iodinated-contrast imaging; maintain diet/exercise; recognize and seek urgent care for symptoms of lactic acidosis (e.g., severe weakness, myalgias, dyspnea, abdominal pain, persistent nausea/vomiting, hypothermia, dizziness); stay hydrated and report persistent GI intolerance; long-term use may lower vitamin B12-periodic testing may be needed.

Monitoring Requirements

Monitor renal function (eGFR) at baseline and at least annually (more often if elderly or at risk of renal decline); monitor glycemic control (HbA1c about every 3 months until stable then every 3-6 months, plus SMBG as appropriate); check vitamin B12 periodically (e.g., every 2-3 years or sooner if anemia/neuropathy); consider hepatic function and clinical risk factors for lactic acidosis.

Pharmacology

Bioavailability

50-60% (under fasting conditions).

Metabolism

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

Protein Binding

Negligible.

Product Information

Available Dosage Forms

Film-coated tablet, extended-release tablet, oral solution

Composition per Dose

Each film-coated tablet: 500 mg metformin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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