GLIPTAMET 50/850/MG FC TAB 56/FC TAB

Indications

Approved Uses

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [15, 27]

Off-Label Uses

Not applicable for the fixed-dose sitagliptin/metformin product; metformin alone is used off-label for PCOS and sometimes prediabetes, but the combination product is generally not used/recommended for those indications.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: individualize based on prior therapy; commonly 1 tablet (50/850 mg) twice daily with meals when this strength is appropriate. Usual maximum sitagliptin is 100 mg/day; metformin maximum is typically 2000 mg/day (up to 2550 mg/day for some immediate‑release regimens if tolerated and appropriate).

Initial Dose

For patients not currently treated with metformin, the initial dose is 1 tablet (50 mg sitagliptin/850 mg metformin HCl) twice daily. For patients already on metformin, the starting dose should provide sitagliptin 50 mg twice daily and the dose of metformin already being taken.

Maintenance Dose

1 tablet (sitagliptin 50mg/metformin 850mg) twice daily; dose may be titrated based on efficacy and tolerability

Maximum Dose

Sitagliptin 100 mg/day + Metformin 2000 mg/day (maximum for this 50/850 mg strength: 2 tablets daily = 100/1700 mg/day; higher metformin doses require other strengths/individual components).

Children's Dosage

Not approved for children under 18 years of age. [6, 27]

Dose Adjustment Notes

Assess eGFR before initiation and at least annually (more often if at risk). Metformin component: avoid initiation if eGFR 30-45 mL/min/1.73m² and reassess risk/benefit if eGFR falls <45; contraindicated if eGFR <30. Sitagliptin requires renal dose reduction in moderate-severe impairment, so in such patients use individual components (or an appropriate strength) rather than this fixed 50/850 mg tablet.

How to Take

Swallow tablet(s) whole with water; do not crush, chew, or split. Take with meals (typically twice daily with morning and evening meals) to improve gastrointestinal tolerability.

Side Effects

Common Side Effects

Common: diarrhea, nausea, vomiting, abdominal discomfort/pain, flatulence; headache; nasopharyngitis/upper respiratory tract infection. Hypoglycemia is uncommon with this combination alone but can occur when used with insulin or a sulfonylurea.

Side Effect Frequency

Very common (≥10%): gastrointestinal adverse effects from metformin (e.g., diarrhea, nausea); Common (1-10%): upper respiratory tract infection/nasopharyngitis, headache, abdominal pain/flatulence/vomiting; Hypoglycemia: generally uncommon with sitagliptin+metformin alone but becomes common/very common when combined with insulin or a sulfonylurea; Uncommon/Rare: pancreatitis, hypersensitivity reactions, bullous pemphigoid (rare), lactic acidosis (very rare), vitamin B12 deficiency with long-term metformin.

Safety & Warnings

Contraindications

Contraindicated in: (1) severe renal impairment (eGFR <30 mL/min/1.73 m²), (2) acute or chronic metabolic acidosis including diabetic ketoacidosis (with or without coma), and (3) history of serious hypersensitivity reaction to sitagliptin or metformin.

Warnings & Precautions

Warnings/precautions: lactic acidosis risk-assess eGFR before start and periodically; withhold around iodinated contrast in at-risk patients and during acute illness/hypoxia/dehydration and restart only after renal function is stable; pancreatitis-discontinue if suspected; heart failure risk has been reported with DPP-4 inhibitors (monitor for symptoms); vitamin B12 deficiency can occur with long-term metformin (periodic assessment in at-risk patients); not for type 1 diabetes or DKA; monitor for hypersensitivity and severe skin reactions.

Age Restriction

Not approved under 18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporarily withhold metformin around procedures in at-risk patients and restart after renal function is stable), alcohol (increases lactic acidosis risk), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide-raise metabolic acidosis/lactic acidosis risk), drugs that reduce metformin clearance/raise exposure (e.g., cimetidine, ranolazine; other cationic renally-secreted drugs may increase metformin levels), insulin/insulin secretagogues (increase hypoglycemia risk), and drugs that worsen glycemic control (e.g., corticosteroids, thiazides/diuretics).

Interaction Severity

MAJOR/clinically significant: iodinated contrast media (temporarily withhold metformin in at‑risk patients and reassess renal function post‑procedure), excessive alcohol (increases lactic acidosis risk), carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) (increase metabolic acidosis/lactic acidosis risk). MODERATE: insulin or sulfonylureas (hypoglycemia risk-may need dose reduction), cimetidine/ranolazine (increase metformin exposure), diuretics/NSAIDs (renal function impact), corticosteroids (worsen glycemic control). MINOR: digoxin (small sitagliptin-related increase-monitor if clinically indicated).

Food Interaction

Take with food/meals to reduce metformin-related gastrointestinal adverse effects.

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children under 18 years of age. [6, 27]

Elderly

Use with caution in patients ≥65 years due to increased risk of renal impairment and lactic acidosis. Monitor renal function regularly. Start at lower metformin doses and titrate carefully. Avoid use if eGFR <45 mL/min/1.73m².

Kidney Impairment

Renal adjustment: contraindicated if eGFR <30 mL/min/1.73 m²; initiation not recommended if eGFR 30-45 mL/min/1.73 m²; if eGFR falls persistently below 45 during therapy, reassess and generally discontinue the fixed-dose combination (consider individual components with appropriate renal dosing if continued therapy is needed).

Liver Impairment

Hepatic impairment: avoid use (no dose adjustment recommended because metformin-containing products are generally not recommended in hepatic impairment due to increased lactic acidosis risk).

Storage & Patient Advice

Storage Conditions

Do not store above 30°C; keep in the original blister/original package to protect from moisture; shelf life: 24 months.

Missed Dose

Take the missed dose as soon as remembered with food; if it is near the time of the next dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop GLIPTAMET without prescriber advice due to risk of loss of glycemic control; discontinue immediately and seek urgent care if lactic acidosis is suspected, and stop promptly if pancreatitis is suspected.

Overdose

Overdose: metformin overdose can cause (sometimes fatal) lactic acidosis (e.g., malaise, myalgias, abdominal pain, respiratory distress/hyperventilation, hypothermia, hypotension, bradyarrhythmias, altered mental status/coma); sitagliptin overdose data are limited and usually less severe. Management: stop drug, urgent emergency evaluation/supportive care; hemodialysis is recommended for metformin-associated lactic acidosis (metformin is dialyzable; sitagliptin is modestly dialyzable).

Patient Counseling

Take with meals and swallow whole; expect possible GI upset early. Avoid excessive alcohol. Check blood glucose as directed; hypoglycemia is more likely if also on insulin/sulfonylurea. Seek urgent care for symptoms of lactic acidosis (e.g., severe weakness, muscle pain, trouble breathing, abdominal pain, vomiting, feeling cold) or pancreatitis (severe persistent abdominal pain ± radiating to back). Inform providers before surgery or iodinated-contrast imaging as metformin may need temporary interruption; keep follow-up for renal function and consider periodic vitamin B12 monitoring.

Monitoring Requirements

Monitor glycemic control (SMBG as appropriate; HbA1c about every 3 months until controlled then every 6 months). Renal function (eGFR/SCr) before start and at least annually (more often if elderly or at risk). Consider vitamin B12 periodically (e.g., every 1-2 years or if anemia/neuropathy). Monitor for pancreatitis symptoms and for hypoglycemia if used with insulin/sulfonylurea.

Pharmacology

Mechanism of Action

Metformin decreases hepatic gluconeogenesis, decreases intestinal glucose absorption, and improves peripheral insulin sensitivity; sitagliptin inhibits DPP‑4, increasing endogenous incretins (GLP‑1/GIP) to enhance glucose‑dependent insulin secretion and suppress glucagon.

Onset of Action

Sitagliptin: within hours. Metformin: within 24-48 hours for glucose lowering; full HbA1c effect typically seen over ~8-12 weeks.

Duration of Effect

Glucose-lowering effect is maintained for ~24 hours with regular once- or twice-daily dosing (sitagliptin DPP-4 inhibition persists ~24 hours; metformin effect is sustained with continued dosing rather than a single-dose duration).

Half-Life

Sitagliptin: ~12.4 hours (terminal t½); Metformin (IR): ~6.2 hours in plasma, with longer apparent half-life in whole blood (~17.6 hours) due to erythrocyte distribution; both are prolonged with renal impairment.

Bioavailability

Sitagliptin: ~87% (absolute oral bioavailability); Metformin (IR): ~50-60% (decreases with higher doses).

Metabolism

Sitagliptin: minimal metabolism; minor CYP3A4 and CYP2C8 involvement producing inactive metabolites; Metformin: not metabolized (excreted unchanged).

Excretion

Sitagliptin: primarily renal elimination, ~79% excreted unchanged in urine (via active tubular secretion) with total urinary recovery ~87%; Metformin: excreted unchanged in urine (renal), with the majority eliminated within 24 hours.

Protein Binding

Sitagliptin: low protein binding ~38%; Metformin: negligible protein binding.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: Sitagliptin 50mg (as sitagliptin phosphate monohydrate) + Metformin 850mg (as metformin hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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