GLUCOPHAGE 1000/MG TAB 30/TAB

Indications

Approved Uses

Type 2 diabetes mellitus as an adjunct to diet and exercise; may be used as monotherapy or in combination with other antidiabetic agents/insulin (including use in children ≥10 years where locally approved).

Dosage & Administration

Dosing by Condition

Type 2 diabetes (adults, immediate‑release): start 500 mg twice daily or 850 mg once daily with meals; increase by 500 mg weekly (or 850 mg every 2 weeks) as tolerated; usual effective dose ~2000 mg/day in divided doses; maximum 2550 mg/day. Pediatrics (≥10 years, IR): start 500 mg once daily, titrate weekly; maximum 2000 mg/day in divided doses. PCOS: not an approved indication (off‑label use varies).

Initial Dose

500 mg once or twice daily with meals (adults); increase gradually to minimize gastrointestinal side effects

Maintenance Dose

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

Maximum Dose

2550 mg per day (immediate-release); 2000 mg per day (extended-release).

Children's Dosage

Children 10 years and older: Initial 500 mg once daily with meals; increase by 500 mg weekly as tolerated; maximum 2000 mg/day in divided doses. Not approved for children under 10 years

How to Take

Oral: take with meals (or immediately after meals) with a glass of water; swallow the film‑coated tablet whole-do not crush or chew.

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): Gastrointestinal effects (nausea, vomiting, diarrhea, abdominal pain, loss of appetite). Common (1-10%): Taste disturbance (metallic taste). Very rare (<0.01%): Lactic acidosis. Not known/rare: Decreased vitamin B12 absorption/low B12 with long-term use; skin reactions (erythema, pruritus, urticaria); hepatic dysfunction/hepatitis.

Safety & Warnings

Contraindications

Contraindicated in: eGFR <30 mL/min/1.73 m²; acute or chronic metabolic acidosis (including DKA); hypersensitivity to metformin. (Hepatic impairment and contrast/surgery are key precautions/temporary holds rather than absolute contraindications in most guidance.)

Warnings & Precautions

Precautions: lactic acidosis risk-assess/monitor renal function; avoid/withhold during hypoxic states, severe illness/dehydration, and around surgery as clinically indicated; manage iodinated contrast by temporary discontinuation in at-risk patients and restart after renal function is stable (often ~48 hours); caution in elderly due to renal decline; monitor for vitamin B12 deficiency with long-term therapy; not for type 1 diabetes or DKA.

Age Restriction

Approved for adults and pediatric patients aged 10 years and older (not recommended/approved under 10 years).

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporarily withhold in at-risk patients); alcohol/excessive intake (↑ lactic acidosis risk); carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) (↑ metabolic acidosis risk); drugs that reduce renal clearance/compete for tubular secretion (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim) (↑ metformin exposure); hyperglycemia-inducing drugs (e.g., corticosteroids, some diuretics) may reduce glycemic control; insulin/sulfonylureas increase hypoglycemia risk.

Interaction Severity

MAJOR: iodinated contrast media in patients with AKI risk/eGFR 30-60, liver disease, alcoholism, or heart failure (withhold and reassess renal function); excessive alcohol (↑ lactic acidosis risk). MODERATE: cationic drugs competing for renal tubular secretion (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim) may ↑ metformin exposure; carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) may ↑ metabolic acidosis risk; drugs that worsen renal function (e.g., diuretics/NSAIDs) increase risk. MINOR/clinical: corticosteroids and some diuretics may worsen glycemia; insulin/sulfonylureas increase hypoglycemia risk when combined.

Food Interaction

Take with food

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Children

Children 10 years and older: Initial 500 mg once daily with meals; increase by 500 mg weekly as tolerated; maximum 2000 mg/day in divided doses. Not approved for children under 10 years

Elderly

Start at lower dose and titrate slowly. Monitor renal function closely as eGFR may decline with age. Dose should not exceed the maximum recommended dose. Contraindicated if eGFR <30 mL/min/1.73m²

Kidney Impairment

eGFR ≥60: no adjustment; eGFR 45-59: continue/monitor renal function every 3-6 months; eGFR 30-44: do not initiate-if continuing, reassess risk/benefit, 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 (no dose-adjustment strategy; generally not recommended).

Storage & Patient Advice

Overdose

Primary toxicity is lactic acidosis (hypoglycemia uncommon with metformin alone); manage with immediate discontinuation, urgent hospital care/supportive measures, and consider hemodialysis to remove metformin and correct acidosis.

Patient Counseling

Take with meals; swallow whole; GI upset is common early and improves with slow titration; avoid excessive alcohol; maintain hydration and seek urgent care for symptoms of lactic acidosis (e.g., rapid breathing, severe weakness, abdominal pain, persistent vomiting, hypothermia/confusion); inform providers before surgery or iodinated-contrast imaging; monitor kidneys and consider periodic vitamin B12; hypoglycemia is uncommon unless combined with insulin/sulfonylureas; store below 30°C.

Monitoring Requirements

Monitor renal function (eGFR) at baseline and at least annually (more often if elderly/at risk); monitor glycemic control (HbA1c about every 3 months until stable then every 3-6 months, plus SMBG as appropriate); check vitamin B12 periodically with long‑term use or anemia/neuropathy; monitor for GI intolerance and signs of lactic acidosis; hepatic tests are not routine unless clinically indicated.

Pharmacology

Mechanism of Action

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

Onset of Action

Initial glucose-lowering effect begins within hours after a dose; clinically meaningful improvement is usually seen within 24-48 hours, with maximal effect over ~1-2 weeks after initiation or dose change.

Duration of Effect

Glucose-lowering effect persists beyond a single dosing interval; with regular dosing, the therapeutic effect is maintained over 24 hours (steady-state), despite an individual dose having an apparent effect of ~10-12 hours for immediate-release formulations.

Half-Life

Plasma elimination half‑life ~6 hours (commonly cited range ~4-8.7 hours); longer apparent half‑life in whole blood due to erythrocyte distribution.

Metabolism

Not metabolized; excreted unchanged (no significant hepatic metabolism).

Excretion

Eliminated renally, largely unchanged, via glomerular filtration and active tubular secretion.

Protein Binding

Negligible (essentially not bound to plasma proteins).

Product Information

Available Dosage Forms

For this product: film‑coated tablet (immediate‑release) 1000 mg; metformin also exists in other products as extended‑release tablets and oral solution.

Composition per Dose

Each film-coated tablet: 1000 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.