DAPXIGA 10/MG TAB 30/TAB

Indications

Approved Uses

Adults with type 2 diabetes mellitus (as an adjunct to diet and exercise to improve glycemic control); adults with heart failure (to reduce the risk of cardiovascular death and hospitalization for heart failure); adults with chronic kidney disease at risk of progression (to reduce the 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; other proposed uses (e.g., NAFLD) remain investigational and are not established indications.

Dosage & Administration

Dosing by Condition

Type 2 Diabetes Mellitus (for glycemic control): Initial 5mg once daily, may increase to 10mg once daily. Heart Failure: 10mg once daily. Chronic Kidney Disease: 10mg once daily.

Maintenance Dose

10mg once daily.

Maximum Dose

10mg once daily.

Children's Dosage

Approved ≥10 years for T2DM; not recommended <10 years.

Dose Adjustment Notes

Dose: 10 mg orally once daily (no titration above 10 mg). Renal function: for glycemic control in T2DM, initiation is generally not recommended at eGFR <45 mL/min/1.73 m² due to reduced glucose-lowering efficacy; for HF/CKD indications, may be initiated/continued down to eGFR ≥25 mL/min/1.73 m² per contemporary labeling/guidelines. Concomitant insulin or insulin secretagogues: consider dose reduction to reduce hypoglycemia risk.

How to Take

Swallow tablet whole with water; can be taken with or without food; take at the same time each day, preferably in the morning

Side Effects

Common Side Effects

Genital mycotic infections (e.g., vulvovaginitis, balanitis), urinary tract infection, increased urination (polyuria/pollakiuria), and nasopharyngitis; volume depletion-related symptoms (e.g., dizziness) can occur especially with diuretics/elderly.

Safety & Warnings

Warnings & Precautions

Warnings/precautions: assess/correct volume depletion before start and monitor BP/renal function; risk of DKA (withhold during acute illness, prolonged fasting, and before major surgery); genital mycotic infections and UTIs (including urosepsis/pyelonephritis); Fournier’s gangrene; hypoglycemia risk with insulin/secretagogues; monitor renal function and consider temporary interruption during dehydration/acute serious illness.

Age Restriction

Approved for patients ≥10 years with type 2 diabetes; not recommended <10 years.

Driving Warning

May cause dizziness or lightheadedness (rise slowly from sitting/lying).

Drug Interactions

Interaction Severity

MODERATE: insulin and insulin secretagogues (additive hypoglycemia risk-consider dose reduction); MODERATE: diuretics (additive volume depletion/hypotension risk). Additional clinically relevant: UGT1A9 inducers (e.g., rifampin) may reduce exposure/efficacy-monitor response.

Food Interaction

No clinically meaningful food restriction; may be taken with or without food.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Not assigned (Risk Summary: Insufficient data in pregnant women to inform drug-associated risk; animal data suggest potential risk).

Breastfeeding

Use with caution (present in human milk; consider benefits/risks).

Children

Approved ≥10 years for T2DM; not recommended <10 years.

Kidney Impairment

eGFR ≥25 mL/min/1.73m²: 10 mg once daily (no adjustment) for HF/CKD benefit; for glycemic control, efficacy is reduced at lower eGFR and initiation for glucose lowering is generally not recommended below 45. eGFR <25: do not initiate; if already on 10 mg for HF/CKD, may continue per clinician judgment. Dialysis: contraindicated/not recommended.

Liver Impairment

Mild-moderate hepatic impairment: no dose adjustment; severe hepatic impairment: start with 5 mg once daily (use caution; may increase to 10 mg if tolerated/needed).

Storage & Patient Advice

Stopping the Medicine

Do not stop without consulting the prescriber; therapy is typically long-term and stopping may worsen glycemic control and/or HF/CKD outcomes.

Overdose

Overdose: provide supportive care (monitor volume status, BP, renal function/electrolytes); hypoglycemia is uncommon unless used with insulin/secretagogues; dapagliflozin is not effectively removed by hemodialysis-seek urgent medical/poison center advice.

Patient Counseling

Take 10 mg once daily (with or without food; often in the morning). Expect increased urination and maintain hydration; rise slowly if dizzy. Report genital itching/discharge or UTI symptoms promptly. Seek urgent care for symptoms of ketoacidosis (nausea/vomiting, abdominal pain, rapid breathing, unusual fatigue) even if glucose is not very high. Temporarily withhold during prolonged fasting/acute illness and before major surgery per local guidance; discuss sick-day rules. If used with insulin/sulfonylurea, watch for hypoglycemia. Seek urgent care for severe perineal pain/swelling/redness (rare Fournier’s gangrene).

Monitoring Requirements

Before initiation and periodically: renal function (eGFR/serum creatinine) and volume status/blood pressure; in diabetes: glucose/HbA1c as appropriate. Ongoing: monitor for genital mycotic infections/UTIs, symptoms of ketoacidosis (especially during acute illness/fasting), and signs of volume depletion; consider foot/skin monitoring in high-risk patients.

Pharmacology

Mechanism of Action

Selective SGLT2 inhibition in the proximal renal tubule, reducing renal glucose reabsorption and increasing urinary glucose excretion (insulin-independent glucose lowering) with downstream natriuretic/diuretic and cardio-renal effects.

Onset of Action

Within hours after the first dose (increased urinary glucose excretion begins rapidly).

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Approximately 12.9 hours

Bioavailability

Approximately 78%

Metabolism

Primarily metabolized via UGT1A9-mediated glucuronidation to inactive dapagliflozin 3‑O‑glucuronide; minimal CYP involvement.

Excretion

Elimination is mainly as metabolites in urine, with additional fecal excretion; only a small fraction is excreted unchanged in urine.

Protein Binding

Approximately 91%

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

Insulin Type

Not an insulin

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