Description:

Xigduo XR tablets  is a once-daily combination oral antidiabetic medication used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin (an SGLT2 inhibitor) and metformin is appropriate. It may also reduce the risk of hospitalization for heart failure in patients with established cardiovascular disease or risk factors. Dapagliflozin promotes urinary glucose excretion by inhibiting renal SGLT2, while metformin reduces hepatic glucose production and intestinal absorption, providing complementary effects for better blood sugar management.

Prescription: Prescription-only (Rx). Requires a doctor’s prescription (typically from an endocrinologist or diabetologist) with monitoring of renal function, blood glucose, and cardiovascular status.

Therapeutic Category:

Antidiabetic combination / SGLT2 inhibitor + biguanide (for type 2 diabetes mellitus management).

Active Ingredients/Composition:

• Dapagliflozin (as dapagliflozin propanediol monohydrate)
• Metformin hydrochloride extended-release Specific strengths queried:
• 5 mg dapagliflozin / 1000 mg metformin HCl extended-release
• 10 mg dapagliflozin / 1000 mg metformin HCl extended-release Excipients include standard tablet components (e.g., hypromellose, carmellose sodium, magnesium stearate, lactose in some formulations; refer to label for full list).

Vitamins: None.

Minerals: None.

Variant: Extended-release (XR) film-coated tablets in queried strengths:

• 5 mg/1000 mg (often in 60-tablet packs)
• 10 mg/1000 mg (often in 30-tablet packs) Other strengths exist (e.g., 5/500 mg, 10/500 mg), but these are the high-metformin variants for patients needing higher metformin doses.

Consume Type:

Oral (extended-release tablet; swallow whole—do not crush, chew, or split to preserve extended-release mechanism).

Directions/Usage: Adults: One tablet once daily in the morning with food (to reduce GI side effects from metformin).

• Starting dose individualized based on current regimen (e.g., start at 5 mg/1000 mg if on lower dapagliflozin/metformin doses).
• May increase to 10 mg dapagliflozin component if needed/tolerated (max daily: 10 mg dapagliflozin / 2000 mg metformin).
• Gradual escalation of metformin component recommended to minimize GI upset. Take consistently; do not stop abruptly without medical advice. Regular monitoring of renal function (eGFR), blood glucose/HbA1c, and hydration essential. Not for type 1 diabetes or diabetic ketoacidosis.

Common Side Effects:

• Genital mycotic infections (e.g., yeast infections in females/males)
• Urinary tract infections
• Nasopharyngitis (cold-like symptoms)
• Diarrhoea, nausea, abdominal pain, dyspepsia
• Headache, back pain
• Volume depletion symptoms (e.g., hypotension, dizziness)
• Weight loss (beneficial in many) Serious rare: Ketoacidosis (euglycemic), lactic acidosis (from metformin), acute kidney injury, Fournier’s gangrene, bone fractures, amputations (SGLT2 class risks). Seek immediate help for dehydration, severe fatigue, fruity breath, or genital pain/swelling.

Package Type:

Blister packs or bottles (e.g., 60 tablets for 5 mg/1000 mg; 30 tablets for 10 mg/1000 mg; often in cartons with patient information).

Storage Advice: Store at room temperature (below 25-30°C), in the original package to protect from moisture and light. Keep tightly closed and out of reach of children.

Safety Advice:

• Assess renal function (eGFR) before starting and periodically (contraindicated if eGFR <30-45 mL/min/1.73 m² depending on indication; dose adjustment or discontinuation needed).
• Risk of lactic acidosis (metformin)—stop temporarily before iodinated contrast, surgery, or acute illness with dehydration.
• Risk of ketoacidosis (dapagliflozin)—monitor for symptoms even with normal glucose; higher risk in low-carb diets, illness, or reduced insulin.
• Volume depletion/dehydration—caution in elderly, diuretics, or low blood pressure; ensure adequate hydration.
• Genital/UTI/fungal infection risk—maintain hygiene; treat promptly.
• Contraindicated in severe renal/hepatic impairment, metabolic acidosis history, or hypersensitivity.
• Pregnancy/breastfeeding: Not recommended (discontinue if pregnancy occurs).
• Avoid alcohol excess; inform doctor of all medications (e.g., diuretics increase dehydration risk).
• Regular monitoring for heart/kidney benefits and adverse effects.

Product Substitutes: Other dapagliflozin + metformin XR combinations: Generic versions (e.g., from Sun Pharma, Cipla, or local importers in Ghana). Alternatives: Separate dapagliflozin (Forxiga) + metformin XR, or other SGLT2 + metformin combos (e.g., Jardiance Duo empagliflozin/metformin, Synjardy). For type 2 diabetes: Sitagliptin/metformin (Janumet), pioglitazone combos, or newer agents like GLP-1 agonists—consult endocrinologist per guidelines (e.g., ADA or Ghana diabetes protocols).

Manufacturer/Marketer:

AstraZeneca

Country of Origin:

United States