Product Information:

TREVIAMET XR 50+500mg Tablets is a once-daily extended-release (XR) fixed-dose combination of two oral antidiabetic agents:

1. Sitagliptin Phosphate 50mg – a dipeptidyl peptidase-4 (DPP-4) inhibitor that enhances incretin hormones to stimulate insulin secretion and suppress glucagon in a glucose-dependent manner
2. Metformin Hydrochloride Extended-Release 500mg – a biguanide with prolonged action that reduces liver glucose production and improves insulin sensitivity

This lower-strength formulation is ideal for initiating dual therapy, elderly patients, or those requiring gentler titration due to gastrointestinal sensitivity or renal concerns.

Uses of (TREVIAMET XR 50+500MG TABLETS):

1. Initial combination therapy in adults with type 2 diabetes mellitus and HbA1c ≥7.5%
2. Patients inadequately controlled on metformin or sitagliptin monotherapy
3. Elderly or frail individuals needing reduced metformin exposure
4. To improve adherence with once-daily dosing and reduced GI side effects

Key Benefits of (TREVIAMET XR 50+500MG TABLETS):

1. Once-daily dosing improves long-term compliance
2. Extended-release metformin significantly reduces nausea, diarrhea, and abdominal discomfort
3. Dual mechanism targets both fasting and postprandial blood glucose
4. Low risk of hypoglycemia when used without insulin or sulfonylureas
5. Weight-neutral—unlike insulin or sulfonylureas

How To Use (TREVIAMET XR 50+500MG TABLETS):

1. Take once daily with the evening meal to further minimize gastrointestinal effects.
2. Swallow whole with water—do not crush, chew, or split (this would destroy the extended-release mechanism).
3. Continue diet, exercise, and regular blood glucose monitoring.
4. Dose may be escalated based on glycemic response and tolerability.

When Not to Use (TREVIAMET XR 50+500MG TABLETS):

Do not use if you have:

1. Type 1 diabetes or diabetic ketoacidosis
2. Severe renal impairment (eGFR <30 mL/min)
3. Acute or chronic metabolic acidosis (including lactic acidosis)
4. Hypersensitivity to sitagliptin, metformin, or any excipients
5. History of pancreatitis (use DPP-4 inhibitors cautiously)

⚠️ Temporary discontinuation required: Before iodinated contrast imaging or major surgery.

Side Effects of (TREVIAMET XR 50+500MG TABLETS):

Common:

1. Mild bloating, abdominal discomfort, or loose stools (less than immediate-release metformin)
2. Headache, upper respiratory infection
3. Metallic taste

Less common:

1. Vitamin B12 deficiency (with long-term metformin use)
2. Joint pain (rare; may indicate serious reaction to sitagliptin)

Serious (rare):

1. Lactic acidosis (symptoms: unusual muscle pain, drowsiness, slow heartbeat, trouble breathing)—seek emergency care
2. Acute pancreatitis (persistent severe abdominal pain radiating to back)—discontinue immediately
3. Hypoglycemia (mainly if combined with insulin or sulfonylureas)
4. Discontinue and seek help if severe symptoms occur.

Dosage: (TREVIAMET XR 50+500MG TABLETS):

1. Adults: One tablet once daily with evening meal
2. May be increased to two tablets daily (max: sitagliptin 100mg + metformin XR 1000mg/day) if needed
3. Renal function guidance:
4. eGFR ≥45 mL/min: Safe to use
5. eGFR 30–44 mL/min: Avoid initiation; use only if benefits outweigh risks
6. eGFR <30 mL/min: Contraindicated

Who It’s For (TREVIAMET XR 50+500MG TABLETS):

1. Adults newly diagnosed with type 2 diabetes starting dual therapy
2. Elderly or GI-sensitive patients
3. Those transitioning from immediate-release metformin with intolerance

Warnings & Precautions:

1. Monitor renal function before starting and periodically thereafter
2. Check vitamin B12 levels annually during long-term therapy
3. Discontinue 48 hours before procedures involving iodinated contrast
4. Avoid excessive alcohol intake (increases lactic acidosis risk)
5. Educate patients on symptoms of lactic acidosis and pancreatitis

Drug Interactions:

1. Iodinated contrast agents: Temporarily stop metformin to avoid lactic acidosis
2. Cimetidine, furosemide, nifedipine: May increase metformin levels
3. Insulin or sulfonylureas: May increase hypoglycemia risk
4. Always inform your doctor about all medications and supplements.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date. Available by prescription in Pakistan.