Empaglif-M 12.5 mg+1000 mg (Tablet)
Unit Price: ৳ 28.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Empagliflozin metformin hydrochloride |
| Company | Aristopharma ltd |
| Also available as |
Indications
- Treatment of adults with type 2 diabetes mellitus
- Adjunct to diet and exercise
- In patients insufficiently controlled on Metformin
- In combination with other medicinal products for diabetes
- In patients treated with Empagliflozin and Metformin separately
Pharmacology
- Empagliflozin inhibits Sodium-Glucose Co-Transporter 2 (SGLT2)
- Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug
- Reduces renal reabsorption of filtered glucose
- Lowers renal threshold for glucose
- Decreases hepatic glucose production
- Increases insulin sensitivity
Dosage & Administration
- Individualized based on effectiveness and tolerability
- Take combination twice daily with meals
- Gradual dose escalation to reduce gastrointestinal side effects
- Maximum recommended daily doses for Metformin Hydrochloride and Empagliflozin
- Extended-release formulations available
- Assess renal function before initiating
- Not recommended for pediatric patients under 18 years of age
Interaction
- Increased urine volume and frequency of voids with diuretics
- Increased risk for hypoglycemia with insulin or insulin secretagogues
- Monitoring glycemic control with urine glucose tests not recommended
- Drugs that reduce Metformin clearance may increase accumulation
- Carbonic anhydrase inhibitors may increase risk of lactic acidosis
- Alcohol can potentiate the effect of Metformin on lactate metabolism
Contraindications
- Hypersensitivity to Empagliflozin and Metformin
- Acute metabolic acidosis
- Diabetic pre-coma
- Severe renal failure
- Acute conditions altering renal function
- Conditions causing tissue hypoxia
- Hepatic impairment
- Acute alcohol intoxication
- Alcoholism
Side Effects
- Urinary tract infection and female genital mycotic infections
- Diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache
- Hypoglycemia, gastrointestinal symptoms, vaginal moniliasis, vulvovaginitis, balanitis, urinary tract infection
- Volume depletion, urticaria, dysuria, blood creatinine increased, haematocrit increased
- Diabetic ketoacidosis
Pregnancy & Lactation
- Potential risk to fetus during second and third trimesters
- Not recommended during breastfeeding
Precautions & Warnings
- Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis
- Assessment and correction of volume status before initiating
- Assessment for ketoacidosis in patients presenting with signs and symptoms of metabolic acidosis
- Consideration of temporarily discontinuing in settings of reduced oral intake or fluid losses
- Increased risk for urinary tract infections
- Consideration of lowering insulin dose to reduce risk of hypoglycemia
- Monitoring of vitamin B12 levels
- Monitoring and treatment of increased LDL-C
Overdose Effects
- No toxicity seen with single doses up to 800 mg Empagliflozin
- No hypoglycemia seen with Metformin doses up to 85 g
- Lactic acidosis is a medical emergency and must be treated in hospital
- Treatment initiation appropriate to patient's clinical status
- Most effective method to remove lactate and Metformin is haemodialysis
Therapeutic Class
- Combination Oral hypoglycemic preparations
Storage Conditions
- Keep below 30°C temperature
- Protected from light and moisture
- Keep out of the reach of children