What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Synjardy XR (Empagliflozin / Metformin HCI)
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Product Details
Description
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) is used with diet and exercise to treat adults with type 2 diabetes.
Synjardy XR is available in oral tablets of the following strengths:
- 5 mg empagliflozin/1,000 mg metformin HCl extended-release
- 10 mg empagliflozin/1,000 mg metformin HCl extended-release
- 12.5 mg empagliflozin/1,000 mg metformin HCl extended-release
- 25 mg empagliflozin/1,000 mg metformin HCl extended-release
Fact Table
Formula
Empagliflozin: C23H27ClO7 Metformin HCl: C4H11N5 · HCl
License
Approved by the FDA and other regulatory bodies for the treatment of type 2 diabetes
Bioavailability
Empagliflozin: ~78% Metformin HCl: 50–60% under fasting conditions
Legal status
Rx-Only
Chemical Name
Empagliflozin / Metformin HCI
Elimination half-life
Empagliflozin: ~12.4 hours Metformin HCl: ~6.2 hours
Dosage (Strength)
5 mg empagliflozin/1,000 mg metformin HCl extended-release 10 mg empagliflozin/1,000 mg metformin HCl extended-release 12.5 mg empagliflozin/1,000 mg metformin HCl extended-release 25 mg empagliflozin/1,000 mg metformin HCl extended-release
Pregnancy
Consult doctor
Brands
Synjardy XR
Protein binding
Empagliflozin: ~86% Metformin HCl: Not significant
PubChem CID
Empagliflozin: 11949646 Metformin HCl: 14219
MedlinePlus
Empagliflozin and Metformin (Extended-Release): a616004
ChEBI
Empagliflozin: 82720 Metformin HCl: Not specifically listed in ChEBI.
ATC code
Empagliflozin and Metformin: A10BD20
DrugBank
Empagliflozin: DB09038 Metformin HCl: DB00331
KEGG
Empagliflozin: D10459 Metformin: D00944 (Note: KEGG lists Metformin, not specifically the HCl form)
Routes of administration
By mouth
Directions
Take Synjardy XR as your doctor has prescribed. If you have any questions or concerns, talk to your doctor or pharmacist.
Synjardy XR dosing is individualized based on kidney function and current treatment regimen.
Typically, the dose is to take one tablet by mouth once daily with breakfast. The maximum recommended dose is 25 mg empagliflozin/2,000 mg metformin HCl daily. The tablet should be swallowed whole; do not split, crush, or chew it.
You may need to stop taking Synjardy XR at the time of, or before, receiving iodinated contrast imaging.
Ingredients
Each Synjardy XR tablet contains empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride, a biguanide.
Inactive ingredients include polyethylene oxide, hypromellose, and magnesium stearate. The tablet film coating and ink include hypromellose, titanium dioxide, polydextrose, polyethylene glycol, talc, carnauba wax, purified water, ferrosoferric oxide, propylene glycol, isopropyl alcohol, ferric oxide yellow (5 mg/1,000 mg; 10 mg/1,000 mg; 25 mg/1,000 mg), ferric oxide red (10 mg/1,000 mg), and FD and C blue#2/indigo carmine aluminum lake (12.5 mg/1,000 mg; 25 mg/1,000 mg).
Contraindications
Patients with severe kidney problems, metabolic acidosis, or an allergy to empagliflozin, metformin, or any of the other ingredients should not take Synjardy XR.
Cautions
Synjardy XR has FDA Boxed Warnings regarding cases of lactic acidosis associated with metformin that led to death, hypothermia, low blood pressure, and resistant, slow heart arrhythmias. Patients who have kidney problems, are using certain medications, are 65 years old or older, have radiological studies with contrast, have surgery or other procedures, have low oxygen levels, consume excessive amounts of alcohol, or have liver problems may be at increased risk.
- Before you start treatment with Synjardy XR, tell your doctor about the following:
- All the medications you take, including prescription and over-the-counter medications
- Your allergies
- Your medical history and health problems
- If you are pregnant or breastfeeding
- Ketoacidosis, a life threatening problem, can occur during treatment with Synjardy XR.
- Volume loss, especially in patients with kidney problems, older patients, and in patients taking fluid pills, can occur with the use of Synjardy XR.
- Serious urinary tract infections can occur with the use of Synjardy XR. Contact your doctor right away if you develop signs and symptoms of a urinary tract infection.
- Low blood sugar can occur with the use of Synjardy XR, especially if patients are also taking insulin or other blood sugar-lowering medications. Patients are recommended to treat their low blood sugar as their doctor has instructed.
- A rare but serious, potentially fatal condition called gangrene can occur with the use of Synjardy XR. Seek medical care right away if you have fever, fatigue, or pain, tenderness, redness, or swelling in the genital or perineal area.
- Fungal infections in the genital areas can occur with the use of Synjardy XR.
- Serious allergic reactions, including angioedema (swelling underneath the skin), can occur with the use of Synjardy XR.
- Vitamin B12 levels may become lower with the use of Synjardy XR.
Side Effects
Common Synjardy XR side effects include urinary tract infection, fungal infection in the genital areas, diarrhea, nausea, vomiting, gas, stomach discomfort, indigestion, headache, and weakness. However, these are not all the side effects that can occur.
Contact your doctor right away if you develop side effects that bother you or won't go away.
Reference:
- Synjardy XR (empagliflozin and metformin hydrochloride extended-release tablets), for oral use. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2022.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13765
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