GLUCARE XR 750MG 30TAB

Indications

Approved Uses

Type 2 diabetes mellitus (as monotherapy or in combination with other antidiabetic agents or insulin)

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults, extended‑release): start 500 mg once daily with the evening meal (or 750 mg once daily if using a 750‑mg XR product); increase by 500 mg weekly (or 750 mg every 1-2 weeks) as tolerated; usual maintenance 1000-2000 mg once daily with the evening meal; maximum 2000 mg/day for most XR products.

Initial Dose

750 mg once daily with the evening meal

Maintenance Dose

1500-2000 mg once daily or in divided doses

Maximum Dose

2000 mg per day (extended-release); 3000 mg per day (immediate-release)

Children's Dosage

Not approved for children under 10 years. In children 10-17 years (immediate-release only): 500 mg twice daily, maximum 2000 mg/day. Extended-release formulation not established in pediatric patients

Dose Adjustment Notes

Titrate gradually to minimize GI effects; assess renal function (eGFR) before start and periodically-do not use if eGFR <30 mL/min/1.73 m², and avoid initiating if eGFR 30-45 (if already on therapy, reassess risk/benefit and consider dose reduction); temporarily withhold around iodinated contrast in at‑risk patients and restart after renal function is stable (typically ≥48 hours).

How to Take

Take orally with food (preferably with the evening meal); swallow the extended‑release tablet whole with water-do not crush, chew, or split.

Side Effects

Common Side Effects

Diarrhea, nausea, vomiting, abdominal discomfort/pain, flatulence, indigestion, taste disturbance (metallic taste), decreased appetite; long‑term use may reduce vitamin B12 levels.

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; temporarily discontinue around iodinated contrast in at-risk patients (not an absolute contraindication).

Warnings & Precautions

Lactic acidosis risk-higher with renal impairment, age ≥65, hypoxic states (e.g., heart failure/sepsis), dehydration/acute illness, excessive alcohol, and hepatic impairment; assess eGFR before start and periodically; temporarily withhold for iodinated contrast in at-risk patients and around major surgery/acute hypoxic illness; monitor for vitamin B12 deficiency with long-term therapy; not for type 1 diabetes or DKA.

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (withhold per renal function/risk), alcohol (↑ lactic acidosis risk), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide; ↑ acidosis risk), cationic drugs that reduce renal tubular secretion/clearance (e.g., cimetidine, ranolazine, dolutegravir, trimethoprim), and drugs that raise glucose (e.g., corticosteroids, some diuretics).

Interaction Severity

MAJOR: Iodinated contrast media in patients with risk factors for AKI (hold metformin and restart when renal function stable); excessive alcohol intake (increases lactic acidosis risk). MODERATE: Carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) (additive acidosis risk); cimetidine (may increase metformin exposure); drugs that can impair renal function (e.g., NSAIDs/diuretics) (increase accumulation risk); hyperglycemia-inducing drugs (e.g., corticosteroids) (reduced glycemic control).

Food Interaction

Take with food.

Alcohol Interaction

Dangerous

Special Populations

Children

Not approved for children under 10 years. In children 10-17 years (immediate-release only): 500 mg twice daily, maximum 2000 mg/day. Extended-release formulation not established in pediatric patients

Elderly

Start at lower dose and titrate cautiously. Monitor renal function more frequently (every 3-6 months) as eGFR may decline with age. Contraindicated if eGFR <30 mL/min/1.73m². Avoid in patients ≥80 years unless renal function is confirmed to be normal

Kidney Impairment

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

Liver Impairment

Avoid in severe hepatic impairment/clinical hepatic disease; if mild-moderate impairment, use only with caution due to lactic acidosis risk (no specific dose adjustment established).

Storage & Patient Advice

Stopping the Medicine

Do not stop without prescriber advice; stopping can worsen glycemic control (no taper required).

Overdose

Overdose can cause metformin-associated lactic acidosis (GI symptoms, malaise/myalgia, respiratory distress/hyperventilation, hypothermia, hypotension, bradyarrhythmias, altered mental status); management is immediate discontinuation, urgent hospital care/supportive treatment, and hemodialysis to remove metformin and correct acidosis.

Patient Counseling

Take with food (preferably the evening meal) and swallow XR tablet whole (do not crush/chew/split); GI upset is common early and improves with gradual titration; avoid excessive alcohol; know urgent signs of lactic acidosis (e.g., severe weakness, muscle pain, trouble breathing, abdominal pain, marked nausea/vomiting, feeling cold) and seek emergency care; tell providers before iodinated-contrast imaging/surgery; monitor glucose as directed; long-term use may lower vitamin B12-report neuropathy/anemia symptoms and check levels periodically; an “empty tablet shell” may be seen in stool with some XR products.

Monitoring Requirements

Renal function (eGFR) at baseline and at least annually (more often if eGFR <60 or risk of decline); glycemic control (HbA1c about every 3 months until stable then every 3-6 months, plus SMBG as directed); vitamin B12 periodically (e.g., every 2-3 years or sooner if anemia/neuropathy); assess for GI intolerance and symptoms of lactic acidosis; 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 (partly via AMPK activation).

Onset of Action

Initial glucose-lowering effect typically seen within 24-48 hours; maximal effect may take 1-2 weeks after initiation or dose titration.

Duration of Effect

Approximately 24 hours per dose (extended‑release formulation).

Half-Life

Elimination half-life ~6 hours in plasma; longer apparent half-life in whole blood (~17 hours) due to erythrocyte distribution.

Bioavailability

Metformin absolute oral bioavailability is approximately 50-60% (immediate-release); extended‑release has similar overall exposure but slower absorption (lower Cmax, delayed Tmax) and may have slightly lower bioavailability depending on formulation/food.

Metabolism

Not metabolized; excreted unchanged.

Excretion

Primarily renal excretion; eliminated unchanged in urine via glomerular filtration and active tubular secretion (most of the absorbed dose recovered in urine).

Protein Binding

Negligible (essentially not bound to plasma proteins).

Product Information

Available Dosage Forms

For this product: extended‑release oral tablet only.

Composition per Dose

Each extended-release tablet: 750 mg metformin hydrochloride

Generic Availability

Yes

Diabetes Type

Type 2

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