Sinjard-M 5 mg+500 mg (Tablet)

Indications

• Treatment of adults with type 2 diabetes mellitus
• Adjunct to diet and exercise
• Inadequate control with maximally tolerated dose of Metformin alone
• In combination with other medicinal products for diabetes treatment
• Already being treated with Empagliflozin and Metformin as separate tablets

Pharmacology

• Inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2)
• Reduces renal reabsorption of filtered glucose
• Lowers renal threshold for glucose
• Increases urinary glucose excretion
• Biguanide type oral antihyperglycemic drug
• Lowers both basal and postprandial plasma glucose
• Does not produce hypoglycemia
• Decreases hepatic glucose production
• Decreases intestinal absorption of glucose
• Improves insulin sensitivity

Dosage & Administration

• Individualized dosage based on effectiveness and tolerability
• Take twice daily with meals
• Gradual dose escalation to reduce gastrointestinal side effects
• Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg
• Maximum recommended daily dose of Empagliflozin is 25 mg
• Extended-release formulations available
• Adjusted dosing for renal impaired patients
• Not recommended for pediatric patients under 18 years of age

Interaction

• Co-administration with diuretics
• Co-administration with insulin or insulin secretagogues
• Monitoring glycemic control with urine glucose tests not recommended
• Drugs that reduce Metformin clearance
• Carbonic Anhydrase Inhibitors interaction
• Interaction with drugs affecting glycemic control
• Alcohol interaction

Contraindications

• Hypersensitivity to Empagliflozin and Metformin
• Acute metabolic acidosis
• Diabetic pre-coma
• Severe renal failure (GFR <30 ml/min)
• Acute conditions altering renal function
• Disease causing tissue hypoxia
• Hepatic impairment
• Acute alcohol intoxication, alcoholism

Side Effects

• Urinary tract infection
• Female genital mycotic infections
• Diarrhea
• Nausea/vomiting
• Flatulence
• Abdominal discomfort
• Indigestion
• Asthenia
• Headache
• Hypoglycemia
• Vaginal moniliasis
• Urinary tract infection (including pyelonephritis and urosepsis)
• Thirst
• Taste disturbance
• Pruritus (generalised)
• Rash
• Increased urination
• Increased serum lipids
• Volume depletion
• Urticaria
• Dysuria
• Increased blood creatinine/Glomerular filtration rate decreased
• Increased haematocrit
• Diabetic ketoacidosis

Pregnancy & Lactation

• Potential risk to fetus
• Not recommended during breastfeeding

Precautions & Warnings

• Lactic Acidosis risk
• Hypotension risk
• Ketoacidosis risk
• Acute kidney injury and impairment in renal function
• Risk for urinary tract infections
• Hypoglycemia risk
• Vitamin B12 Deficiency risk
• Increased LDL-C risk
• No established evidence of macrovascular risk reduction

Overdose Effects

• No toxicity seen with high Empagliflozin doses
• Hypoglycemia not seen with high Metformin doses
• Lactic acidosis is a medical emergency
• Treatment should be initiated as appropriate

Therapeutic Class

• Combination Oral hypoglycemic preparations

Storage Conditions

• Keep below 30°C temperature
• Protected from light & moisture
• Keep out of the reach of children

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