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Indications - This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Metformin Hydrochloride is appropriate. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

Dosage & Administration - The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg. Recommended individualized starting dose: In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride. In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin. In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component. In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination. Renal impaired patient: Assess renal function before initiating this combination. In patients with an eGFR below 45 mL/min/1.73 m2 is contraindicated.

Side Effects - The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

Contraindications - Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

Others - Pregnancy & Lactation There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding. Precautions & Warnings Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m2. Overdose Effects In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.