FORXIGA 10/MG FC TAB 28/TAB

Indications

Approved Uses

Adults with type 2 diabetes mellitus: adjunct to diet and exercise to improve glycemic control; Adults with heart failure (to reduce risk of cardiovascular death and hospitalization for heart failure); Adults with chronic kidney disease (to reduce risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure).

Off-Label Uses

Type 1 diabetes mellitus (adjunct to insulin) is off-label in many jurisdictions and generally not recommended due to increased DKA risk; HFpEF is not off-label in many current labels/guidelines (often an approved/endorsed HF indication depending on jurisdiction).

Dosage & Administration

Dosing by Condition

Type 2 Diabetes: Initial 5 mg once daily, may be increased to 10 mg once daily for additional glycemic control. Heart Failure: 10 mg once daily. Chronic Kidney Disease: 10 mg once daily.

Initial Dose

10 mg once daily.

Maintenance Dose

10 mg once daily.

Maximum Dose

10 mg once daily

Children's Dosage

Approved for children aged 10 years and older for type 2 diabetes; the recommended dose is 10 mg once daily.

Dose Adjustment Notes

Usual dose is 10 mg once daily; for glycemic control, initiation/continuation depends on renal function (reduced efficacy at low eGFR and not recommended below certain eGFR thresholds per label), while for HF/CKD benefits it may be used down to lower eGFR thresholds per current labeling; no routine dose adjustment for mild/moderate hepatic impairment, and consider 5 mg starting dose in severe hepatic impairment if using a 5 mg strength.

Side Effects

Common Side Effects

Genital mycotic infections (vulvovaginitis, balanitis), urinary tract infection, increased urination (polyuria), and upper respiratory symptoms (e.g., nasopharyngitis).

Side Effect Frequency

Very common/common: genital mycotic infections and urinary tract infections; increased urination and nasopharyngitis are common; hypoglycemia is common primarily when combined with insulin or sulfonylureas; serious but rare/uncommon: ketoacidosis, volume depletion/hypotension, acute kidney injury, Fournier’s gangrene.

Safety & Warnings

Contraindications

Hypersensitivity to dapagliflozin or any excipient; patients on dialysis.

Warnings & Precautions

Warnings/precautions: ketoacidosis risk (can be euglycemic; withhold for major surgery/prolonged fasting/acute illness), volume depletion/hypotension (higher risk with diuretics/elderly/renal impairment), genital mycotic infections, serious UTIs (urosepsis/pyelonephritis), Fournier’s gangrene, monitor renal function, hypoglycemia risk when used with insulin/secretagogues, avoid use in type 1 diabetes, consider temporary interruption during acute illness to reduce dehydration/DKA risk.

Age Restriction

Not approved under 10 years of age.

Driving Warning

Safe

Drug Interactions

Interaction Severity

Clinically significant: insulin/insulin secretagogues (hypoglycemia risk-may need dose reduction) and diuretics (additive volume depletion/hypotension/AKI risk); other interactions (e.g., UGT inducers) are generally of lesser clinical impact but may reduce exposure/efficacy.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Approved for children aged 10 years and older for type 2 diabetes; the recommended dose is 10 mg once daily.

Kidney Impairment

T2DM (glycemic control): do not initiate if eGFR <45 mL/min/1.73m²; HF/CKD: may initiate and continue 10 mg daily if eGFR ≥25; if eGFR falls <25 while on therapy, continuation of 10 mg may be considered; contraindicated in dialysis.

Storage & Patient Advice

Stopping the Medicine

Do not stop without consulting the prescriber; if stopped, ensure alternative management for diabetes/HF/CKD as appropriate.

Overdose

Likely effects: increased diuresis/volume depletion and hypotension; hypoglycemia is uncommon unless used with insulin/secretagogues; management is supportive (fluids, monitor vitals/electrolytes/renal function) and seek urgent medical care; not expected to be effectively removed by hemodialysis.

Patient Counseling

Take 10 mg once daily with or without food; maintain hydration and expect possible increased urination; counsel on genital hygiene and to report symptoms of genital/urinary infection; educate on sick-day rules and to seek urgent care for ketoacidosis symptoms (nausea/vomiting/abdominal pain, rapid breathing) or severe perineal pain/swelling; consider temporary interruption before major surgery/prolonged fasting; warn about hypoglycemia only if used with insulin/sulfonylurea.

Pharmacology

Mechanism of Action

Selective, reversible SGLT2 inhibitor that reduces renal glucose reabsorption in the proximal tubule, increasing urinary glucose excretion and lowering plasma glucose (insulin-independent).

Duration of Effect

24 hours.

Half-Life

Approximately 12.9 hours.

Protein Binding

Approximately 91%.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 10 mg dapagliflozin (as dapagliflozin propanediol monohydrate)

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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