Evaglip10 mg+5 mg

Evaglip 10 mg+5 mg is a fixed-dose combination of an SGLT2 inhibitor (empagliflozin) and a DPP-4 inhibitor (linagliptin), indicated as follows:

Established / FDA-approved use

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, when treatment with both empagliflozin and linagliptin is appropriate.

Not appropriate uses

• Not indicated for type 1 diabetes mellitus (may increase risk of diabetic ketoacidosis in this population).
• Not indicated for treatment of diabetic ketoacidosis.
• Not recommended in patients with a history of pancreatitis or severe renal impairment.

Evaglip 10 mg+5 mg is not a substitute for insulin in insulin-requiring patients and is used only under medical supervision as part of an overall diabetes management plan.

Each film-coated tablet of Evaglip 10 mg+5 mg contains empagliflozin and linagliptin in one of the following fixed-dose strength combinations:

• Empagliflozin 10 mg + Linagliptin 5 mg
• Empagliflozin 25 mg + Linagliptin 5 mg

Excipients vary by manufacturer; consult the specific product package insert for the complete excipient list.

Evaglip 10 mg+5 mg combines two complementary oral anti-diabetic agents in a single tablet:

• Empagliflozin — a sodium-glucose co-transporter 2 (SGLT2) inhibitor that lowers blood glucose by increasing urinary glucose excretion.
• Linagliptin — a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases incretin hormone levels, enhancing glucose-dependent insulin secretion and reducing glucagon secretion.

Combining both mechanisms in Evaglip 10 mg+5 mg provides complementary glycemic control for adults with type 2 diabetes who require more than a single oral agent.

Evaglip 10 mg+5 mg belongs to the combination class of oral anti-diabetic agents: SGLT2 inhibitor + DPP-4 inhibitor, used for management of type 2 diabetes mellitus.

Evaglip 10 mg+5 mg works through two distinct, complementary mechanisms:

Empagliflozin (SGLT2 inhibitor)

Inhibits sodium-glucose co-transporter 2 in the renal proximal tubule, reducing glucose reabsorption and increasing urinary glucose excretion, thereby lowering plasma glucose in an insulin-independent manner. Empagliflozin has also been shown to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

Linagliptin (DPP-4 inhibitor)

Inhibits the DPP-4 enzyme, slowing degradation of incretin hormones (GLP-1 and GIP). This increases glucose-dependent insulin release from pancreatic beta cells and decreases glucagon secretion, lowering blood glucose in a glucose-dependent manner (low intrinsic hypoglycemia risk when used alone).

Together, the two components of Evaglip 10 mg+5 mg act on different physiological pathways to provide additive glycemic control.

Evaglip 10 mg+5 mg tablets should be swallowed whole with water, once daily in the morning, with or without food. Do not split, crush, or chew the tablets unless specifically advised. Take at approximately the same time each day to maintain consistent blood levels. Missed doses should not be doubled up.

Evaglip 10 mg+5 mg has the following clinically significant drug interactions:

• Insulin and insulin secretagogues (sulfonylureas): Concurrent use increases the risk of hypoglycemia; a lower dose of the insulin or secretagogue may be required.
• Diuretics: May potentiate the volume-depleting/diuretic effect of empagliflozin, increasing risk of hypotension and dehydration.
• Strong CYP3A4/P-glycoprotein inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May substantially reduce linagliptin exposure and effectiveness; consider an alternative anti-diabetic agent.
• Lithium: SGLT2 inhibitors may decrease serum lithium concentrations; monitor lithium levels during and after use.
• Urine glucose tests: Empagliflozin causes false-positive results on urine glucose tests; blood glucose monitoring is not affected, but choose alternative methods for urine-based screening if needed.

Adverse effects reported with Evaglip 10 mg+5 mg include:

Common

• Urinary tract infections
• Nasopharyngitis and upper respiratory tract infection
• Genital mycotic (yeast) infections, more common in females
• Increased urination

Serious (see Precautions and Warnings for detail)

• Diabetic ketoacidosis (can occur even with near-normal blood glucose)
• Fournier's gangrene (necrotizing infection of the genital/perineal area)
• Acute pancreatitis
• Volume depletion, hypotension, and acute kidney injury
• Hypoglycemia (mainly when combined with insulin or a sulfonylurea)
• Severe and disabling joint pain (arthralgia)
• Bullous pemphigoid (blistering skin reaction)
• Hypersensitivity reactions, including angioedema and anaphylaxis

Pregnancy: Evaglip 10 mg+5 mg is not recommended during the second and third trimesters of pregnancy, based on animal data showing adverse renal effects during a period corresponding to human late second and third trimester kidney development. Data on use in the first trimester are limited. If pregnancy is confirmed, Evaglip 10 mg+5 mg should generally be discontinued and an alternative anti-diabetic regimen used; use only if clearly needed and after consulting a physician, who will weigh potential benefit against potential risk to the fetus.

Lactation: Use of Evaglip 10 mg+5 mg is not recommended while breastfeeding, because of the potential for effects on renal maturation in a breastfed infant, based on findings in juvenile animal studies. Discuss alternative treatment options with a physician if breastfeeding is planned.

Before and during treatment with Evaglip 10 mg+5 mg, the following precautions apply:

Diabetic ketoacidosis (DKA)

Cases of ketoacidosis, including life-threatening and fatal cases, have been reported, sometimes with only mildly elevated glucose (euglycemic DKA). Assess for ketoacidosis in patients with symptoms such as nausea, vomiting, abdominal pain, malaise, or shortness of breath regardless of glucose level; discontinue Evaglip 10 mg+5 mg immediately if suspected. Withhold before major surgery or periods of prolonged fasting/acute serious illness.

Fournier's gangrene

Rare but serious and life-threatening necrotizing infection of the genital/perineal area has been reported with SGLT2 inhibitors. Seek urgent medical attention for genital or perineal pain, tenderness, erythema, swelling, fever, or malaise; discontinue Evaglip 10 mg+5 mg immediately if suspected and initiate treatment.

Genital mycotic infections and urinary tract infections

Increased risk, particularly in females and uncircumcised males; monitor and treat as needed.

Volume depletion

May cause symptomatic hypotension, especially in the elderly, patients with renal impairment, low systolic blood pressure, or those on diuretics/antihypertensives. Assess and correct volume status before initiating.

Lower limb amputation

An increased risk of lower-limb amputation (mostly toe) has been observed with SGLT2 inhibitors as a class. Monitor for new pain, tenderness, ulcers, or infection of the lower limb; counsel on routine preventive foot care.

Acute pancreatitis

Has been reported with DPP-4 inhibitors, including fatal cases. Discontinue promptly and do not restart if pancreatitis is suspected.

Hypoglycemia

Risk increases when combined with insulin or sulfonylureas; a reduced dose of these agents may be needed.

Heart failure

An increased risk of heart failure has been observed with other DPP-4 inhibitors; consider risks and benefits in patients with existing risk factors for heart failure.

Impaired hepatic function

Use with caution; limited data in severe hepatic impairment.

Bullous pemphigoid and severe arthralgia

Advise patients to report new blistering or erosions of the skin, or severe and persistent joint pain; discontinue if these occur.

There is limited clinical experience with overdose of Evaglip 10 mg+5 mg. In case of suspected overdose, seek immediate medical attention or contact a poison control center/emergency services. Management should include supportive measures based on the patient's clinical status, monitoring of blood glucose, electrolytes, renal function, and volume status, and treatment as clinically indicated. Hemodialysis is not expected to significantly remove either empagliflozin or linagliptin from the circulation.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly

Elderly patients taking Evaglip 10 mg+5 mg are at greater risk of volume depletion and should be monitored closely for hypotension and dehydration, particularly if also on diuretics.

Renal impairment

Not recommended to initiate below eGFR 45 mL/min/1.73m²; contraindicated in severe renal impairment, end-stage renal disease, or dialysis. See Dosage and Administration.

Hepatic impairment

No dose adjustment for mild-to-moderate impairment; caution advised in severe impairment due to limited data.

Pediatric patients

Safety and efficacy have not been established in patients under 18 years; not recommended for pediatric use.

Pregnancy and lactation

See Pregnancy and Lactation section.

Evaglip 10 mg+5 mg is generally used long-term as part of ongoing management of type 2 diabetes mellitus. Duration of therapy should be determined by the treating physician based on glycemic response, tolerability, renal function, and overall treatment goals, with periodic reassessment (e.g., HbA1c monitoring) to confirm continued benefit.

Evaglip 10 mg+5 mg: SGLT2 inhibitor (empagliflozin) + DPP-4 inhibitor (linagliptin); combination oral anti-diabetic agent.

Evaglip 10 mg+5 mg lowers blood glucose through two complementary mechanisms: empagliflozin inhibits SGLT2 in the kidney to increase urinary glucose excretion independent of insulin, while linagliptin inhibits DPP-4 to raise active incretin hormone levels, enhancing glucose-dependent insulin secretion and suppressing glucagon release.

The safety and efficacy of Evaglip 10 mg+5 mg in pediatric patients (under 18 years of age) have not been established. It is therefore not recommended for use in children or adolescents. Type 2 diabetes in pediatric patients should be managed according to age-appropriate, evidence-based treatment protocols under specialist supervision.