GLUCARE 500/MG TAB 50/TAB

Indications

Approved Uses

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

Off-Label Uses

PCOS; prevention/delay of type 2 diabetes in high‑risk/prediabetes; antipsychotic‑associated weight gain (selected patients).

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults, immediate‑release): Initial 500 mg twice daily with meals (or 500 mg once daily if tolerability is a concern); 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 in divided doses.

Initial Dose

500mg twice daily or 850mg once daily.

Maintenance Dose

1500-2550mg per day in divided doses.

Maximum Dose

2550mg per day.

Children's Dosage

For children 10-16 years: Initial dose is 500mg twice daily. The dose can be increased weekly by 500mg up to a maximum of 2000mg per day in divided doses.

Dose Adjustment Notes

Titrate gradually (e.g., increase by 500 mg weekly or every 1-2 weeks) to minimize GI effects; assess renal function before start and periodically-do not initiate if eGFR 30-45 mL/min/1.73 m², contraindicated if eGFR <30; if eGFR falls <45, reassess benefit/risk and consider dose reduction with close monitoring.

How to Take

Take orally with meals (during or immediately after food) with a glass of water; swallow tablets whole (do not crush/chew).

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): nausea, vomiting, diarrhea, abdominal pain. Common (1-10%): flatulence, loss of appetite, metallic taste, vitamin B12 deficiency with long-term use. Uncommon (<1%): lactic acidosis, skin reactions (erythema, pruritus, urticaria)

Safety & Warnings

Contraindications

Contraindications: severe renal impairment (eGFR <30 mL/min/1.73m²), acute or chronic metabolic acidosis (including DKA), and hypersensitivity to metformin; do not use around iodinated contrast in at-risk patients per labeling (temporary discontinuation rather than absolute contraindication).

Warnings & Precautions

Warnings/precautions: lactic acidosis risk-assess renal function before start and periodically; hold in acute illness causing hypoxia or dehydration and around major surgery; manage iodinated contrast procedures with temporary discontinuation in at-risk patients; avoid excessive alcohol; consider avoiding in significant hepatic disease; monitor for vitamin B12 deficiency with long-term therapy; not for type 1 diabetes or DKA.

Age Restriction

Not approved for children under 10 years.

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporary hold in at-risk patients due to lactic acidosis risk), alcohol (increases lactic acidosis risk), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide-metabolic acidosis risk), cationic drugs that reduce renal tubular secretion/clearance of metformin (e.g., cimetidine, ranolazine, dolutegravir-↑ metformin exposure), and hyperglycemia-inducing drugs (e.g., corticosteroids, thiazide/loop diuretics) that may reduce glycemic control; insulin/secretagogues increase hypoglycemia risk when combined.

Interaction Severity

MAJOR: Iodinated contrast media (risk of AKI/metformin accumulation-temporarily withhold in at‑risk patients and reassess renal function before restarting). 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 (increases metformin levels), diuretics (dehydration/renal function impact), corticosteroids (hyperglycemia/antagonize effect).

Food Interaction

Take with food.

Alcohol Interaction

Moderate (increases lactic acidosis risk)

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

For children 10-16 years: Initial dose is 500mg twice daily. The dose can be increased weekly by 500mg up to a maximum of 2000mg per day in divided doses.

Elderly

Start at lower dose, titrate slowly, monitor renal function regularly; contraindicated if eGFR <30 mL/min/1.73m²; use with caution in patients ≥65 years

Kidney Impairment

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

Liver Impairment

Avoid use in patients with clinical or laboratory evidence of significant hepatic disease/impairment (no dose-adjustment strategy recommended).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly without consulting the prescriber; if discontinuation is needed, ensure an alternative glycemic management plan to avoid hyperglycemia.

Overdose

Overdose can cause lactic acidosis (e.g., nausea/vomiting, abdominal pain, malaise, myalgias, respiratory distress/hyperventilation, hypothermia, hypotension, bradyarrhythmias, altered mental status); management: stop metformin, urgent hospital evaluation, supportive care, and hemodialysis to remove metformin and correct acidosis when severe.

Patient Counseling

Take with meals to reduce GI upset; take consistently as prescribed alongside diet/exercise; avoid excessive alcohol; inform providers before surgery or iodinated-contrast imaging; maintain hydration and seek advice if vomiting/diarrhea/dehydration occurs; report symptoms suggestive of lactic acidosis (e.g., severe weakness, muscle pain, trouble breathing, abdominal pain, unusual sleepiness); long-term use may lower vitamin B12-report neuropathy/fatigue and attend periodic labs; hypoglycemia is uncommon alone but can occur with insulin/sulfonylureas.

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); consider periodic vitamin B12 (especially with long‑term use or anemia/neuropathy) and CBC if clinically indicated.

Pharmacology

Mechanism of Action

Decreases hepatic glucose production (gluconeogenesis), decreases intestinal glucose absorption, and improves insulin sensitivity/increases peripheral glucose uptake; mechanistically associated with AMPK activation.

Onset of Action

Within hours after a dose (peak plasma levels ~2-3 hours for immediate‑release); clinically meaningful glucose‑lowering is typically seen within 24-48 hours, with full effect developing over ~1-2 weeks.

Duration of Effect

Approximately 24 hours with regular dosing (glycemic effect is sustained with continued therapy; immediate‑release is commonly dosed 2-3 times daily).

Half-Life

Plasma elimination half‑life ~6 hours (commonly cited ~6.2 h); longer apparent half‑life in whole blood due to erythrocyte distribution.

Bioavailability

Approximately 50-60% (fasting); food reduces and delays absorption.

Metabolism

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

Excretion

Eliminated primarily by the kidneys as unchanged drug (via tubular secretion and filtration).

Protein Binding

Negligible.

Product Information

Available Dosage Forms

Immediate-release film-coated tablet

Composition per Dose

Each film-coated tablet: 500mg metformin hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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