DIVINUS 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

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

Off-Label Uses

Type 1 diabetes mellitus (adjunct to insulin) is an off-label use in some settings but is generally not recommended due to increased DKA risk; NAFLD is investigational and not an established off-label indication.

Dosage & Administration

Dosing by Condition

Type 2 diabetes: 5 mg PO once daily, may increase to 10 mg once daily if additional glycemic control needed and tolerated; Heart failure: 10 mg PO once daily; Chronic kidney disease: 10 mg PO once daily.

Initial Dose

5mg once daily for type 2 diabetes; 10mg once daily for heart failure and chronic kidney disease.

Maintenance Dose

5-10 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 10mg once daily.

How to Take

Swallow tablet whole with water; take once daily, with or without food, at the same time each day (morning is commonly preferred).

Side Effects

Common Side Effects

Genital mycotic infections, urinary tract infections, increased urination (polyuria/pollakiuria), and nasopharyngitis; hypoglycemia can occur when used with insulin or sulfonylureas.

Safety & Warnings

Contraindications

Contraindicated in patients with serious hypersensitivity to dapagliflozin and in patients on dialysis (ESRD on dialysis).

Age Restriction

Adults; pediatric use for type 2 diabetes is approved in children ≥10 years (where locally authorized).

Drug Interactions

Drug Interactions

Key interactions: insulin/insulin secretagogues (↑ hypoglycemia risk), diuretics/other antihypertensives (↑ volume depletion/hypotension), and lithium (may ↓ lithium concentrations).

Food Interaction

No restriction.

Special Populations

Children

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

Elderly

No dose adjustment based on age alone; increased risk of volume depletion and renal impairment in elderly - assess renal function and volume status before initiating; monitor closely

Kidney Impairment

T2DM glycemic control: do not initiate if eGFR <45 mL/min/1.73m²; HF/CKD: may be used down to eGFR ≥25 mL/min/1.73m²; if eGFR falls below 25, continuation may be considered but initiation is generally not recommended; contraindicated in dialysis.

Liver Impairment

Mild-moderate hepatic impairment: no adjustment; severe hepatic impairment: start 5 mg once daily and use caution (10 mg may be used if tolerated/needed per clinician judgment).

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered on the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Monitoring Requirements

Check renal function (eGFR/serum creatinine) before initiation and periodically; monitor blood pressure/volume status, glycemic control (glucose/HbA1c in diabetes), and watch for genital/urinary infections; assess for ketoacidosis if symptomatic and consider ketone testing during acute illness or reduced intake.

Pharmacology

Mechanism of Action

Selective SGLT2 inhibition in the proximal renal tubule reduces glucose reabsorption and increases urinary glucose excretion, lowering plasma glucose independently of insulin.

Onset of Action

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

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Half-Life

Approximately 12.9 hours

Bioavailability

Approximately 78%

Metabolism

Primarily metabolized by UGT1A9-mediated glucuronidation to inactive metabolites (e.g., dapagliflozin 3‑O‑glucuronide), with minimal CYP involvement.

Excretion

Eliminated mainly as metabolites: ~75% recovered in urine (≈2% as unchanged drug) and ~21% in feces.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

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

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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