JALRA M 50/850/MG FC TAB 60/FC TAB

Indications

Approved Uses

Type 2 diabetes mellitus in adults as an adjunct to diet and exercise when glycaemic control is inadequate on metformin alone, or in patients already treated with vildagliptin and metformin as separate tablets (substitution).

Dosage & Administration

Dosing by Condition

Type 2 diabetes (adults): typically 1 tablet (50/850 mg) twice daily with meals; maximum vildagliptin 100 mg/day (50 mg twice daily) and metformin up to the patient-appropriate daily dose (commonly up to 2000 mg/day depending on labeling/tolerability).

Maximum Dose

Vildagliptin 100mg/day (50mg twice daily) + Metformin 2000mg/day (based on metformin component); maximum metformin 3000mg/day in some guidelines but limited by vildagliptin 100mg/day cap

Children's Dosage

Not approved for children under 18 years.

Dose Adjustment Notes

Individualize based on prior therapy and tolerability; take with meals and titrate metformin to reduce GI effects; assess renal function before initiation and periodically-do not use the fixed-dose combination in moderate/severe renal impairment where vildagliptin would require dose reduction and metformin may be contraindicated (e.g., eGFR <30 mL/min/1.73 m²).

How to Take

Swallow the film-coated tablet whole with water, taken with or immediately after meals; do not crush or chew.

Side Effects

Common Side Effects

Common: gastrointestinal upset (nausea, diarrhea, abdominal pain, decreased appetite), headache, dizziness; nasopharyngitis/upper respiratory symptoms; hypoglycaemia mainly when used with insulin or a sulfonylurea.

Side Effect Frequency

Most common: gastrointestinal adverse effects from metformin (e.g., diarrhea, nausea, abdominal discomfort; typically common and may be very common in practice, especially at initiation). Common: headache, dizziness, nasopharyngitis/URTI. Hypoglycemia: uncommon unless used with insulin or a sulfonylurea. Rare/very rare but serious: lactic acidosis (metformin; very rare), hepatitis/hepatic enzyme elevations (rare), pancreatitis (rare), angioedema/bullous pemphigoid (rare).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to metformin or vildagliptin; severe renal impairment (eGFR <30 mL/min/1.73 m²); acute or chronic metabolic acidosis including diabetic ketoacidosis (with or without coma); hepatic impairment/active liver disease (including significant transaminase elevations); acute conditions that can cause tissue hypoxia or worsen renal function (e.g., shock, severe dehydration, severe infection).

Age Restriction

Not approved under 18 years

Driving Warning

No specific driving warning; does not cause drowsiness

Drug Interactions

Drug Interactions

Key interactions: iodinated contrast media (temporarily stop metformin around contrast in at-risk patients due to lactic acidosis risk); alcohol (increases lactic acidosis risk); carbonic anhydrase inhibitors (e.g., topiramate/acetazolamide) (increase metabolic acidosis/lactic acidosis risk); cationic drugs competing for renal tubular secretion (e.g., cimetidine) (increase metformin exposure); insulin/sulfonylureas (additive hypoglycemia); drugs that raise glucose (corticosteroids, thiazide/loop diuretics, sympathomimetics) (reduced glycemic control).

Food Interaction

Take with food (with or immediately after meals).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Contraindicated

Children

Not approved for children under 18 years.

Elderly

Use with caution; monitor renal function regularly as eGFR declines with age; dose adjustment based on renal function; avoid in patients with eGFR <45 mL/min/1.73m²

Storage & Patient Advice

Stopping the Medicine

Do not stop JALRA M without medical advice; stopping can worsen glycemic control-contact the prescriber before discontinuation or dose changes.

Overdose

Overdose may cause muscle pain, mild and transient paresthesia, fever, edema, transient increase in lipase (400 mg); edema of feet/hands, increases in CPK, AST, CRP, myoglobin (600 mg); treat as medical emergency with supportive care.

Patient Counseling

Take with or after meals; avoid excessive alcohol; know and seek urgent care for lactic acidosis symptoms (e.g., rapid breathing, severe weakness, abdominal pain, hypothermia) and stop/seek advice during severe vomiting/diarrhea/dehydration; inform providers before surgery or iodinated-contrast imaging; monitor glucose as directed and expect higher hypoglycaemia risk if combined with insulin/sulfonylurea; report signs of liver injury (jaundice/dark urine) and pancreatitis (severe persistent abdominal pain).

Pharmacology

Mechanism of Action

Vildagliptin inhibits DPP-4, increasing endogenous incretins (GLP-1/GIP) to enhance glucose-dependent insulin secretion and suppress glucagon; metformin decreases hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity.

Onset of Action

DPP-4 inhibition occurs within hours after dosing; glucose-lowering effect begins within 24-48 hours, with fuller HbA1c effect over ~1-2 weeks (and continues to improve over subsequent weeks).

Duration of Effect

Approximately 24 hours per dose for DPP-4 inhibition and glycaemic effect; intended to maintain control across the dosing interval with twice-daily administration.

Half-Life

Vildagliptin: approximately 3 hours; Metformin: approximately 6.5 hours (plasma), 17.6 hours (blood)

Bioavailability

Vildagliptin oral bioavailability ~85%; metformin oral bioavailability ~50-60% (fasting; food may reduce/delay absorption).

Metabolism

Vildagliptin: primarily metabolized by non-CYP hydrolysis to an inactive major metabolite (e.g., LAY151), with minimal CYP involvement. Metformin: not metabolized (excreted unchanged).

Excretion

Vildagliptin: total plasma and renal clearance 41 and 13 L/h; major metabolite LAY 151 (M20.7) 57% of dose; other metabolites N-glucuronide, N-amide hydrolysis, oxidation products. Metformin: eliminated unchanged by the kidneys (renal excretion via filtration and active tubular secretion; ~90% recovered in urine within 24 hours).

Protein Binding

Vildagliptin: low plasma protein binding (~9.3%). Metformin: negligible protein binding.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: Vildagliptin 50mg + Metformin hydrochloride 850mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 16-06-2026