Daplyza - M (dapagliflozin + metformin hci): Uses, Dosage & Side Effects

What it's for (Indications)

Dapagliflozin + Metformin HCl is indicated to improve glycemic control in patients with type 2 diabetes mellitus by lowering both basal and postprandial plasma glucose.
Additionally, dapagliflozin, a component of this combination, is indicated in adults for chronic heart failure and chronic kidney disease.

Dosage Information

Type	Guideline
Standard	Assess renal function and volume status before initiating treatment; correct any volume depletion. Administer orally once daily in the morning with food. Dosage should be individualized based on the patient’s current treatment. For glycemic control in patients aged 10 years and older not already on dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. For adults requiring dapagliflozin for heart failure or chronic kidney disease indications, the recommended dosage is 10 mg once daily. The daily dosage should not exceed 10 mg dapagliflozin / 2,000 mg metformin HCl extended-release. Specific dosage adjustments for renal impairment can be found in the full prescribing information. The medication may need to be discontinued at the time of, or prior to, iodinated contrast administration.

Type

Guideline

Standard

Assess renal function and volume status before initiating treatment; correct any volume depletion. Administer orally once daily in the morning with food. Dosage should be individualized based on the patient’s current treatment. For glycemic control in patients aged 10 years and older not already on dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. For adults requiring dapagliflozin for heart failure or chronic kidney disease indications, the recommended dosage is 10 mg once daily. The daily dosage should not exceed 10 mg dapagliflozin / 2,000 mg metformin HCl extended-release. Specific dosage adjustments for renal impairment can be found in the full prescribing information. The medication may need to be discontinued at the time of, or prior to, iodinated contrast administration.

Safety & Warnings

Common Side Effects

Common side effects include excessive urination, increased thirst, urinary tract infection (UTI), nasopharyngitis, diarrhea, dizziness, back ache, and genital mycotic infections (e.
g.
, female genital mycotic infection).
Low blood glucose levels (hypoglycemia) can occur, especially with concomitant insulin or insulin secretagogues.
More serious adverse reactions include lactic acidosis, diabetic ketoacidosis, volume depletion (dehydration), urosepsis and pyelonephritis (severe UTIs), and necrotizing fasciitis of the perineum (Fournier’s Gangrene).
Metformin may also lead to decreased Vitamin B12 concentrations.

Serious Warnings

Black Box Warning: WARNING: LACTIC ACIDOSIS. Postmarketing cases of metformin-associated lactic acidosis, sometimes fatal, have been reported. Symptoms include malaise, myalgias, respiratory distress, somnolence, and abdominal pain. This condition is characterized by elevated blood lactate levels (>5 mmol/L) and anion gap acidosis.
Pregnancy & Lactation: Dapagliflozin should not be used during pregnancy due to potential fetal harm; consult a doctor.
During lactation, use only if absolutely necessary, consulting a doctor who may advise stopping breastfeeding or the medication.
Renal & Hepatic Impairment: Assess renal function prior to initiation and as clinically indicated.
Use with caution in patients with kidney disease due to increased risk of severe side effects; close monitoring of kidney function and potential dose modifications/substitutions are necessary.
Patients with liver diseases should consult their doctor for possible dose adjustments or alternative treatments.
Alcohol: Alcohol consumption is contraindicated due to an increased risk of both high and low blood sugar levels.
Driving & Dizziness: This medication may cause dizziness and sleepiness; avoid driving or operating machinery until you know how it affects you.
Dehydration & Volume Depletion: Assess and correct volume status before initiating treatment.
Older persons are at increased risk of dehydration, kidney issues, and lightheadedness.
Hypoglycemia: Increased risk of low blood glucose levels (hypoglycemia) when used concomitantly with insulin or insulin secretagogues.
Ketoacidosis: Diabetic ketoacidosis, including in patients with Type 1 Diabetes Mellitus, has been reported.
Monitor for symptoms of ketoacidosis.
Increased ketone levels may occur during stress (e.
g.
, infection, injury, fever, surgery) or if not eating adequately.
Consult doctor for regimen adjustments.
Infections: Risk of severe urinary tract infections (urosepsis and pyelonephritis), genital mycotic infections, and necrotizing fasciitis of the perineum (Fournier’s Gangrene).
Monitor for symptoms of these infections.
Vitamin B12 Levels: Metformin may decrease Vitamin B12 concentrations; periodic monitoring may be advisable.
Hypersensitivity & Allergies: Inform your doctor about any hypersensitivity to dapagliflozin, metformin HCl, or excipients, or other allergies.
Inactive components can cause reactions.
Medical History: Inform your doctor about your complete medical history, including kidney problems (e.
g.
, dialysis), liver disorders, alcohol use/abuse, dehydration, low blood pressure, high blood cholesterol, or a history of vaginal or penile yeast infections.
Pre-Surgery: Inform your doctor or dentist about all medications (prescription, non-prescription, herbal) you are taking before any surgery.
The medication may need to be discontinued at the time of, or prior to, iodinated contrast administration.

How it Works (Mechanism of Action)

Dapagliflozin inhibits Sodium-glucose cotransporter 2 (SGLT2), reducing glucose reabsorption in the renal tubules and promoting urinary glucose excretion. This action also decreases sodium reabsorption, affecting cardiac pre- and afterload, sympathetic activity, and intraglomerular pressure. Metformin HCl is an antihyperglycemic agent that primarily lowers basal and postprandial plasma glucose by decreasing hepatic glucose production and improving insulin sensitivity.