MELIGAMET 50/1000 MG 60 TAB

Indications

Approved Uses

To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.

Off-Label Uses

Metformin-related off-label uses include polycystic ovary syndrome (PCOS) and diabetes prevention in high-risk/prediabetes populations; the sitagliptin/metformin fixed-dose combination itself is not typically used off-label.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: 1 tablet (50/1000 mg) twice daily with meals when appropriate based on prior metformin dose/tolerance; maximum sitagliptin 100 mg/day and metformin 2000 mg/day.

Initial Dose

For patients not currently on metformin: 50mg sitagliptin/500mg metformin twice daily. For patients already on metformin: 50mg sitagliptin twice daily plus the patient's current metformin dose.

Maintenance Dose

Sitagliptin 50mg + Metformin 1000mg twice daily with meals

Maximum Dose

100mg sitagliptin and 2000mg metformin per day.

Children's Dosage

Not approved for children. Safety and efficacy have not been established in the pediatric population.

Dose Adjustment Notes

Individualize dose based on prior therapy and glycemic response; titrate metformin to improve GI tolerability. Renal: contraindicated if eGFR <30 mL/min/1.73 m²; do not initiate if eGFR 30-45 and reassess risk/benefit if it falls <45; limit sitagliptin total daily dose to 50 mg/day when eGFR 30-45 and 25 mg/day when eGFR <30 or on dialysis (use separate components if needed).

How to Take

Take orally with meals (typically twice daily). Swallow the tablet whole with water; do not crush, chew, or split.

Side Effects

Common Side Effects

Diarrhea, nausea/vomiting, abdominal pain/dyspepsia, flatulence, decreased appetite; headache; nasopharyngitis/upper respiratory tract infection.

Side Effect Frequency

Very common/common: GI effects from metformin (diarrhea, nausea, abdominal discomfort; vomiting can occur) and infections such as nasopharyngitis/URTI and headache (more associated with sitagliptin). Hypoglycemia: mainly when used with insulin or a sulfonylurea. Rare/serious: lactic acidosis (metformin), pancreatitis (sitagliptin), hypersensitivity reactions, severe arthralgia, bullous pemphigoid; long-term metformin may reduce vitamin B12.

Safety & Warnings

Contraindications

Contraindicated in: eGFR <30 mL/min/1.73m²; acute or chronic metabolic acidosis (including DKA); hypersensitivity to metformin or sitagliptin. Not recommended/avoid in severe hepatic impairment and in acute conditions predisposing to hypoxia or renal function deterioration; temporarily discontinue around iodinated contrast in at-risk patients per metformin guidance.

Warnings & Precautions

Lactic acidosis risk-assess eGFR before start and periodically; hold for iodinated contrast in at-risk patients and during acute illness/hypoxia/surgery as appropriate; avoid excessive alcohol; pancreatitis-stop if suspected; hypoglycemia with insulin/secretagogues-consider dose reduction; vitamin B12 deficiency with long-term metformin-monitor; severe arthralgia and bullous pemphigoid-discontinue if occurs; hypersensitivity reactions-stop; not for type 1 diabetes or DKA; use caution in elderly and in heart failure/volume depletion due to renal risk.

Age Restriction

Not approved under 18 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast (hold metformin in at-risk patients); alcohol (↑ lactic acidosis risk); carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide-↑ metabolic acidosis risk); drugs that reduce renal function (e.g., NSAIDs, ACEi/ARBs, diuretics) or compete for renal tubular secretion (e.g., cimetidine) may ↑ metformin exposure; insulin/sulfonylureas (↑ hypoglycemia-may need dose reduction); digoxin (sitagliptin may slightly ↑ digoxin levels).

Interaction Severity

MAJOR: Iodinated contrast media (temporarily withhold metformin in at-risk patients and reassess renal function after exposure), excessive alcohol (↑ lactic acidosis risk). MODERATE: Carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) (↑ metabolic/lactic acidosis risk), insulin/sulfonylureas (↑ hypoglycemia risk), diuretics/corticosteroids (may worsen glycemic control), cimetidine (↑ metformin exposure). MINOR: Digoxin (small ↑ exposure with sitagliptin).

Food Interaction

Take with food (meals).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children. Safety and efficacy have not been established in the pediatric population.

Elderly

Use with caution in patients ≥65 years due to increased risk of renal impairment and lactic acidosis. Monitor renal function regularly. Do not use in patients ≥80 years unless renal function is confirmed to be normal.

Kidney Impairment

eGFR ≥45: usual dosing per product strength; eGFR 30-44: do not initiate-if continuing, limit to sitagliptin 50 mg/day with metformin 1000 mg/day (i.e., max 50/1000 once daily) and monitor closely; eGFR <30: contraindicated.

Liver Impairment

No specific dose adjustment for mild-moderate hepatic impairment, but use with caution; avoid/contraindicated in severe hepatic impairment due to increased lactic acidosis risk (metformin).

Storage & Patient Advice

Storage Conditions

Store below 30°C. Keep in original packaging. Keep out of reach of children.

Missed Dose

Take the missed dose as soon as remembered with food unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule. Do not double doses.

Stopping the Medicine

Do not stop without medical advice; stop immediately and seek urgent care if lactic acidosis or pancreatitis is suspected (and hold around iodinated contrast/surgery as directed).

Overdose

Metformin overdose can cause lactic acidosis (GI symptoms, malaise, myalgias, respiratory distress/hyperventilation, hypothermia, hypotension, bradyarrhythmias, altered mental status/coma); sitagliptin overdose data are limited-supportive care; consider activated charcoal if early, and hemodialysis can remove metformin-seek emergency care.

Patient Counseling

Take Meligamet (sitagliptin 50 mg/metformin 1000 mg) with meals to reduce GI upset and take it exactly as prescribed. Monitor blood glucose as directed; hypoglycemia is uncommon with this product alone but risk increases if combined with insulin or a sulfonylurea. Avoid excessive alcohol and maintain hydration. Seek urgent care for symptoms of lactic acidosis (e.g., unusual muscle pain, severe weakness, abdominal pain, rapid/deep breathing, marked drowsiness, feeling cold), and for severe/persistent abdominal pain (possible pancreatitis). Tell healthcare providers you take metformin before surgery or iodinated contrast imaging-metformin may need temporary interruption and renal function reassessment. Report severe allergic reactions (rash, facial swelling, trouble breathing), severe joint pain, or blistering skin lesions (bullous pemphigoid). Attend regular follow-up for HbA1c and kidney function; consider periodic vitamin B12 assessment with long-term metformin use.

Monitoring Requirements

HbA1c about every 3 months until controlled then every 6 months; self-monitoring/fasting glucose as clinically indicated; renal function (eGFR) at baseline and at least annually (more often if elderly/CKD); vitamin B12 periodically with long-term metformin; monitor for pancreatitis symptoms and for hypoglycemia if used with insulin/sulfonylurea.

Pharmacology

Mechanism of Action

Metformin decreases hepatic glucose production, decreases intestinal glucose absorption, and improves 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: DPP-4 inhibition within hours (peak ~1-4 hours). Metformin: glucose-lowering begins within days, with most effect over ~1-2 weeks (HbA1c impact assessed over ~8-12 weeks).

Duration of Effect

Sitagliptin: ~24 hours. Metformin (immediate-release): glucose-lowering effect is maintained with BID dosing; plasma half-life ~6 hours (not >24 hours).

Half-Life

Metformin: plasma t1/2 ~6.2 hours (effective t1/2 longer in erythrocytes). Sitagliptin: terminal t1/2 ~12.4 hours.

Bioavailability

Metformin: ~50-60% (fasting; decreases with food). Sitagliptin: ~87%.

Metabolism

Metformin: not metabolized; excreted unchanged. Sitagliptin: minimal metabolism; minor CYP3A4 and CYP2C8 involvement.

Excretion

Metformin: eliminated renally, largely unchanged (majority of absorbed drug; negligible metabolism). Sitagliptin: primarily renal; ~79% excreted unchanged in urine, with a smaller fecal component (~13%).

Protein Binding

Metformin: negligible (<1%); Sitagliptin: approximately 38%

Product Information

Available Dosage Forms

Tablet (immediate-release) for this product.

Composition per Dose

Each tablet: Sitagliptin 50mg (as sitagliptin hydrochloride) + Metformin 1000mg (as metformin hydrochloride)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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