Synjardy

Generic name: Empagliflozin and Metformin Hydrochloride

Drug class: SGLT2 Inhibitor and Biguanide

Dosage form: Tablets

Route of administration: Oral

Dose: Typically, one tablet twice daily with meals. The initial dose is usually the metformin dose the patient is already taking, combined with the lowest dose of empagliflozin. Doses are adjusted based on the patient’s blood sugar levels. If used with insulin or a sulfonylurea, their doses may need to be lowered to avoid hypoglycemia.

Mechanism of action: Empagliflozin inhibits the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing glucose excretion in urine. Metformin decreases hepatic glucose production and enhances insulin sensitivity, leading to improved glucose uptake by tissues.

Drug usage cases:

• Adjunct to diet and exercise to improve glycemic control in adults and children aged 10 years and older with type 2 diabetes.
• In patients whose diabetes is not sufficiently controlled by metformin alone.
• In combination with other diabetes medicines in patients whose diabetes is not sufficiently controlled on these medicines plus metformin.
• In patients who are already taking metformin and empagliflozin as separate tablets.

Drug contraindications:

• Severe kidney problems or on dialysis.
• Metabolic acidosis or diabetic ketoacidosis.
• Allergy to empagliflozin, metformin, or any of the ingredients in Synjardy.
• Type 1 diabetes.

Side effects:

• Dehydration: dizziness, fainting, light-headedness, or weakness, especially when standing up.
• Ketoacidosis: nausea, vomiting, abdominal pain, tiredness, or trouble breathing.
• Kidney problems: sudden kidney injury, especially in those with existing kidney issues or over 75 years old.
• Serious urinary tract infections: burning sensation when urinating, frequent or urgent need to urinate, pain in the lower abdomen or pelvis, or blood in the urine.
• Low blood sugar (hypoglycemia): headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking, or sweating, particularly when used with insulin or sulfonylureas.
• Vaginal yeast infections in women: itching, odor, discharge, or pain in the genital area.
• Yeast infections of the penis in men: redness, itching, swelling, rash, or pain in the genital area.
• Low vitamin B12 levels: long-term use may decrease vitamin B12 levels in the blood.
• Increased fats in the blood (cholesterol): may occur during treatment.

Warnings:

• Risk of lactic acidosis: a rare but serious condition that can be fatal. Symptoms include unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.
• Risk of ketoacidosis: even with blood sugar less than 250 mg/dL. Symptoms include nausea, vomiting, abdominal pain, tiredness, or trouble breathing.
• Risk of dehydration: especially in those with low blood pressure, kidney problems, over 65 years old, on a low-salt diet, or taking medicines to lower blood pressure.
• Risk of serious urinary tract infections: may lead to hospitalization. Symptoms include burning sensation when urinating, frequent or urgent need to urinate, pain in the lower abdomen or pelvis, or blood in the urine.
• Risk of low blood sugar (hypoglycemia): especially when used with insulin or sulfonylureas. Symptoms include headache, drowsiness, weakness, irritability, hunger, fast heartbeat, confusion, shaking, or sweating.
• Risk of genital yeast infections: in both men and women. Symptoms include itching, odor, discharge, or pain in the genital area.
• Risk of low vitamin B12 levels: long-term use may decrease vitamin B12 levels in the blood.
• Risk of increased fats in the blood (cholesterol): may occur during treatment.

Use during pregnancy or breastfeeding: The safety of Synjardy during pregnancy and breastfeeding is not well established. It is not known if Synjardy passes into breast milk. If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using Synjardy.