METFOR 850/MG FC TAB 60/TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (immediate-release): Initial: 850 mg once daily with a meal OR 500 mg twice daily with meals; titration: increase by 500 mg weekly or 850 mg every 1-2 weeks as tolerated; maintenance: commonly 1500-2000 mg/day in 2-3 divided doses; maximum: 2550 mg/day (immediate‑release).

Initial Dose

850 mg once daily with the main meal (or 500 mg twice daily)

Maintenance Dose

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

Maximum Dose

2550 mg per day in divided doses.

Children's Dosage

Initial: 500 mg twice daily with meals; increase by 500 mg weekly up to maximum 2000 mg/day in divided doses.

Dose Adjustment Notes

Titrate gradually to minimize GI effects (e.g., increase by 500 mg weekly or by 850 mg every 1-2 weeks as tolerated); assess renal function before start and periodically-contraindicated if eGFR <30 mL/min/1.73 m², and initiation is generally not recommended if eGFR 30-45 mL/min/1.73 m² (if already on therapy, consider dose reduction and close monitoring).

How to Take

Swallow the film‑coated tablet whole with water, taken with meals (during or immediately after food), typically in divided doses with breakfast and/or dinner as prescribed.

Side Effects

Common Side Effects

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

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.

Warnings & Precautions

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

Age Restriction

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

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporarily withhold in at-risk patients), alcohol (↑ lactic acidosis risk), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide; ↑ acidosis risk), and drugs that reduce renal clearance/compete for tubular secretion (e.g., cimetidine; also ranolazine, dolutegravir, trimethoprim) which can ↑ metformin exposure; monitor with diuretics/NSAIDs/ACEi if renal function may worsen.

Interaction Severity

"MAJOR: Iodinated contrast media (risk of acute kidney injury and lactic acidosis-temporarily withhold metformin at/around the procedure in at‑risk patients and restart after renal function is stable); excessive alcohol intake (increases lactic acidosis risk).
MODERATE: Carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide) (increased metabolic acidosis/lactic acidosis risk); drugs that can worsen glycemia or renal function (e.g., systemic corticosteroids; diuretics) may reduce efficacy or increase risk; cationic drugs competing for renal tubular secretion (e.g., cimetidine, trimethoprim) can increase metformin exposure.
MINOR: ACE inhibitors/ARBs (may enhance glucose-lowering in some patients-monitor)."

Food Interaction

Take with food

Alcohol Interaction

Use with caution; excessive alcohol increases lactic acidosis risk.

Special Populations

Pregnancy

Category B (old system); Risk Summary: Disease-associated risks vs. limited data; discuss with healthcare provider.

Breastfeeding

Caution; low levels in milk, monitor infant for GI effects/hypoglycemia; consider benefits/risks.

Children

Initial: 500 mg twice daily with meals; increase by 500 mg weekly up to maximum 2000 mg/day in divided doses.

Elderly

Start at lower dose, titrate slowly, monitor renal function closely at least every 3-6 months; avoid use if eGFR <30 mL/min/1.73m²; maximum benefit-risk assessment required in patients ≥80 years

Kidney Impairment

eGFR ≥60: no adjustment; eGFR 45-59: continue/monitor; eGFR 30-44: do not initiate-if continuing, use lower dose and monitor closely; eGFR <30: contraindicated.

Liver Impairment

Avoid/not recommended in patients with hepatic impairment (no dose-adjustment strategy; generally do not use).

Storage & Patient Advice

Stopping the Medicine

Do not stop without medical advice; abrupt discontinuation can worsen glycemic control-seek prescriber guidance for a plan/alternative therapy.

Overdose

Overdose can cause lactic acidosis (e.g., malaise, myalgias, respiratory distress, abdominal symptoms, hypothermia/hypotension/bradyarrhythmias, altered mental status); stop metformin, seek emergency care, provide supportive management, and consider hemodialysis to remove metformin and correct acidosis.

Patient Counseling

Take with meals (during or immediately after) to reduce stomach upset; avoid excessive alcohol; inform providers before surgery or iodinated-contrast imaging; seek urgent care for symptoms suggestive of lactic acidosis (e.g., severe weakness, myalgias, dyspnea, abdominal pain, persistent vomiting, hypothermia); maintain hydration and contact a clinician during significant vomiting/diarrhea or dehydration (temporary interruption may be needed); monitor blood glucose as directed and have kidney function checked regularly; long-term use may lower vitamin B12-periodic testing may be needed; do not stop without medical advice.

Monitoring Requirements

Renal function (eGFR) at baseline and at least annually (more often if elderly or at risk of renal impairment); glycemic control (HbA1c about every 3 months until stable then every 3-6 months, plus SMBG as appropriate); vitamin B12 periodically (especially with long-term use or anemia/neuropathy); consider periodic hematologic parameters; hepatic function as clinically indicated.

Pharmacology

Mechanism of Action

Decreases hepatic glucose production (gluconeogenesis), decreases intestinal glucose absorption, and improves insulin sensitivity by increasing peripheral glucose uptake/utilization (mechanistically linked to AMPK activation).

Duration of Effect

Each immediate-release dose provides glucose-lowering effect for approximately 8-12 hours; with regular dosing (typically 2-3 times daily), overall glycemic control is maintained throughout the day.

Half-Life

Elimination half-life ~4-8.7 hours in plasma; longer apparent half-life in whole blood (~17.6 hours) due to erythrocyte distribution.

Bioavailability

50-60% (under fasting conditions)

Metabolism

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

Excretion

Eliminated primarily by the kidneys as unchanged drug (>90%) via active tubular secretion and glomerular filtration.

Protein Binding

Negligible.

Product Information

Available Dosage Forms

Film-coated tablet, extended-release tablet, oral solution (for immediate-release: 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

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.