Jardimet XR
Generic Name
Empagliflozin + Metformin Hydrochloride (Extended Release)
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
jardimet xr 10 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Jardimet XR 10 mg Tablet is an oral antidiabetic medication that combines two active ingredients, Empagliflozin and Metformin Hydrochloride (extended release). It is used to improve blood sugar control in adults with type 2 diabetes mellitus. Empagliflozin works by helping the kidneys remove more glucose from the bloodstream, while Metformin works by decreasing glucose production in the liver and improving insulin sensitivity.
Uses & Indications
Dosage
Adults
Typically, one Jardimet XR tablet (Empagliflozin 10 mg / Metformin 1000 mg) once daily in the morning with food. Dosage should be individualized based on effectiveness and tolerability, not exceeding recommended maximum doses for each component.
Elderly
Close monitoring of renal function is recommended. Dosage adjustments may be necessary based on renal function.
Renal_impairment
eGFR <30 mL/min/1.73 m2: contraindicated. eGFR 30-45 mL/min/1.73 m2: initiating Empagliflozin is not recommended; if already on it, reduce dose or discontinue. Metformin is also contraindicated for severe renal impairment.
How to Take
Take orally once daily with food, preferably in the morning. Swallow the tablet whole; do not crush, cut, or chew it.
Mechanism of Action
Empagliflozin is a selective SGLT2 inhibitor, preventing glucose reabsorption in the kidneys, leading to increased urinary glucose excretion. Metformin is a biguanide that reduces hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Onset
Glycemic effects typically begin within hours to days of initiation.
Excretion
Empagliflozin is primarily excreted via urine (approximately 54%) and feces (approximately 41%). Metformin is primarily excreted unchanged in the urine.
Half life
Empagliflozin: approximately 12.4 hours. Metformin: approximately 6.2 hours (plasma), 17.6 hours (blood).
Absorption
Empagliflozin is rapidly absorbed with peak plasma concentrations reached in 1.5 hours. Metformin XR absorption is prolonged, with peak plasma concentrations occurring at 7 hours after administration. Food increases AUC for Empagliflozin and slightly decreases Cmax for Metformin XR.
Metabolism
Empagliflozin is mainly metabolized by glucuronidation. Metformin is not metabolized and is excreted unchanged.
Side Effects
Contraindications
- Hypersensitivity to Empagliflozin or Metformin or any excipients.
- Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute conditions with potential to alter renal function (e.g., dehydration, severe infection, shock).
- Hepatic impairment (for Metformin component).
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with Metformin.
Iodinated contrast agents
Temporarily discontinue Metformin at the time of or prior to an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2.
Diuretics (e.g., Thiazide, Loop Diuretics)
May increase the risk of dehydration and hypotension with Empagliflozin.
Insulin or Insulin Secretagogues (e.g., Sulfonylureas)
Increased risk of hypoglycemia; a lower dose of insulin or secretagogue may be required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to severe hypoglycemia (if combined with insulin/sulfonylurea), lactic acidosis (due to Metformin), or dehydration. Management includes supportive care, correction of hypoglycemia, rehydration, and in severe cases of lactic acidosis, hemodialysis may be necessary.
Pregnancy & Lactation
Pregnancy: Use is not recommended during the second and third trimesters due to potential renal effects on the fetus. Lactation: Not recommended. Discontinue the drug or nursing, considering the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to Empagliflozin or Metformin or any excipients.
- Severe renal impairment (eGFR <30 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Acute conditions with potential to alter renal function (e.g., dehydration, severe infection, shock).
- Hepatic impairment (for Metformin component).
Drug Interactions
Alcohol
Increases the risk of lactic acidosis with Metformin.
Iodinated contrast agents
Temporarily discontinue Metformin at the time of or prior to an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2.
Diuretics (e.g., Thiazide, Loop Diuretics)
May increase the risk of dehydration and hypotension with Empagliflozin.
Insulin or Insulin Secretagogues (e.g., Sulfonylureas)
Increased risk of hypoglycemia; a lower dose of insulin or secretagogue may be required.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to severe hypoglycemia (if combined with insulin/sulfonylurea), lactic acidosis (due to Metformin), or dehydration. Management includes supportive care, correction of hypoglycemia, rehydration, and in severe cases of lactic acidosis, hemodialysis may be necessary.
Pregnancy & Lactation
Pregnancy: Use is not recommended during the second and third trimesters due to potential renal effects on the fetus. Lactation: Not recommended. Discontinue the drug or nursing, considering the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA for original, DGDA for local generics)
Patent Status
Generic available (original patent holder: Boehringer Ingelheim/Eli Lilly)
Clinical Trials
Extensive clinical trials (e.g., EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved for Empagliflozin, and various trials for Metformin) have demonstrated efficacy in glycemic control and cardiovascular/renal benefits.
Lab Monitoring
- Renal function (eGFR) periodically (at least annually, more frequently in elderly or renally impaired patients).
- Blood glucose levels (fasting, postprandial, HbA1c).
- Liver function tests (baseline and periodically for Metformin).
- Electrolytes (if dehydration suspected).
Doctor Notes
- Emphasize patient education on hydration and symptom recognition for UTIs/genital infections and DKA/lactic acidosis.
- Monitor renal function closely, especially before initiation and during therapy.
- Consider temporary discontinuation in conditions predisposing to dehydration or acute renal failure.
Patient Guidelines
- Take as directed by your doctor, usually once daily with food.
- Stay well-hydrated to reduce the risk of dehydration.
- Report any symptoms of yeast infection, UTIs, or severe abdominal pain immediately.
- Be aware of the symptoms of lactic acidosis (e.g., malaise, muscle pain, respiratory distress) and seek immediate medical attention if they occur.
- Do not stop taking the medicine without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine generally does not affect the ability to drive or operate machinery. However, if used in combination with insulin or sulfonylurea, it may increase the risk of hypoglycemia which can impair driving ability. Be aware of signs of hypoglycemia.
Lifestyle Advice
- Maintain a balanced diet and regular exercise routine.
- Limit alcohol intake.
- Monitor blood sugar regularly at home.
- Follow up with your doctor for regular check-ups.
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