Synjardy

Synjardy, a prescription medication approved by the FDA for adults with type 2 diabetes, combines empagliflozin and metformin. It is designed to improve blood sugar levels when paired with a healthy diet and exercise. Synjardy is available in both immediate and extended-release tablets, with various strengths. It is taken orally, typically with meals, and reduces glucose absorption, enhances insulin response, and promotes glucose elimination through urine. Side effects can range from mild gastrointestinal disturbances to severe conditions like lactic acidosis, making it crucial to follow medical guidance when using this medication.

Synjardy is a combination medication specifically formulated for adults with type 2 diabetes to enhance blood glucose control. This FDA-approved drug integrates two active ingredients, empagliflozin, and metformin, which belong to the drug classes of sodium-glucose cotransporter 2 (SGLT2) inhibitors and biguanides. Empagliflozin helps by expelling excess glucose through the urine, while metformin reduces glucose production in the liver, increases insulin sensitivity, and decreases glucose absorption from the gastrointestinal tract.

Available in both immediate-release (Synjardy) and extended-release (Synjardy XR) forms, it offers flexibility in dosing schedules to suit patient needs. The tablets are available in strengths ranging from 5 mg to 25 mg of empagliflozin combined with 500 mg or 1,000 mg of metformin, ensuring a tailored approach to diabetes management. Patients are advised to take Synjardy with meals to minimize gastrointestinal side effects such as nausea and diarrhea. The treatment with Synjardy is long-term, requiring regular monitoring by healthcare professionals to adjust dosages and manage any side effects.

Serious side effects include lactic acidosis, a rare but life-threatening condition, and ketoacidosis. Moreover, it’s contraindicated in patients with severe kidney impairment, acute metabolic acidosis, and those allergic to its components. When prescribed and monitored properly, Synjardy can be a vital part of diabetes management. However, patients must discuss their medical history with their doctor to avoid potential complications and ensure the drug is safe for their specific health conditions. This includes discussing other medications being taken to avoid adverse interactions, particularly with diuretics and insulin.

Synjardy is a prescription medication approved by the FDA specifically for adults diagnosed with type 2 diabetes. It is designed to:

• Help manage and lower blood sugar levels effectively.

Forms & Strengths of Synjardy?

Synjardy is a prescription medication formulated as oral tablets containing two active ingredients, metformin and empagliflozin.
Available Forms and Strengths

• Synjardy (Immediate-Release Tablets):
  • These tablets are taken twice daily.
  • Available in four strengths:
    • 5 mg / 1,000 mg (empagliflozin / metformin)
    • 5 mg / 1,000 mg (empagliflozin / metformin)
    • 12.5 mg / 1,000 mg (empagliflozin / metformin)
    • 12.5 mg / 1,000 mg (empagliflozin / metformin)
• Synjardy XR (Extended-Release Tablets):
  • These tablets are taken once daily.
  • Available in four strengths:
    • 5 mg / 1,000 mg (empagliflozin / metformin)
    • 10 mg / 1,000 mg (empagliflozin / metformin)
    • 12.5 mg / 1,000 mg (empagliflozin / metformin)
    • 25 mg / 1,000 mg (empagliflozin / metformin)

What Are the Recommended Dosage of Synjardy?

Dosage Guidelines for Type 2 Diabetes Using Synjardy

The appropriate starting dosage of Synjardy or Synjardy XR for managing type 2 diabetes can vary based on individual treatment history. The dosage is adjusted depending on whether a patient is already being treated with metformin, empagliflozin, or a combination of both. Dosage recommendations:

• Regular Synjardy Tablets: These should be taken twice daily with meals, as your healthcare provider prescribes.
• Synjardy XR Tablets: These extended-release tablets are taken once daily, preferably with your morning meal.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

• Determining Your Dosage: The dosage of Synjardy prescribed by your doctor will depend on various factors, including:
  • The type and severity of diabetes you are managing.
  • Your age.
  • Which form of Synjardy you are using.
  • Any other medical conditions you might have.
• Starting Dosage: Your treatment will typically begin with a lower dose, which will be adjusted over time to find the optimal amount that manages your condition effectively with minimal side effects.
• Duration of Treatment: Synjardy is generally intended for long-term use. If it is deemed safe and effective, you will likely continue taking it for an extended period.
• Instructions for Use:
  • Synjardy (Immediate-Release Tablets): Take these tablets twice daily with meals.
  • Synjardy XR (Extended-Release Tablets): Take these tablets once daily with your morning meal. It’s important to take Synjardy XR whole, without crushing, splitting, or chewing, to maintain the extended-release feature and prevent increased side effects.
  • Always take Synjardy with food to help reduce gastrointestinal side effects like an upset stomach or diarrhea.
  • Set reminders on your phone or use a medication timer to ensure you don’t miss a dose.
• Tablet Handling:
  • Synjardy XR: Do not crush, split, or chew these tablets as they damage the special coating designed for slow release, potentially leading to an increase in side effects.
  • Regular Synjardy Tablets: The manufacturer does not specify if these can be altered. If you need to modify how you take these tablets, consult your doctor or pharmacist for guidance.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Synjardy combines two active substances, metformin, and empagliflozin, each belonging to different drug classes that target diabetes management effectively. Metformin is part of a drug category known as biguanides, which is unique since metformin is the sole representative of this class. It enhances blood sugar control through several mechanisms:

• It reduces the amount of sugar absorbed from your food.
• It boosts the body’s responsiveness to insulin, helping use sugar more effectively.
• It decreases sugar production in the liver, preventing high blood sugar levels.

Empagliflozin falls under the sodium-glucose cotransporter 2 (SGLT2) inhibitors. This medication aids in reducing blood sugar by prompting the kidneys to remove excess glucose through urine. Besides managing blood sugar, empagliflozin is known to decrease the risk of cardiovascular issues in patients with both type 2 diabetes and existing heart disease. Though the exact process is not fully understood, it is believed that empagliflozin not only reduces blood sugar levels but also may reduce bodily fluid levels, thus lessening the strain on the heart and potentially lowering cardiovascular risk.

What Are the Synjardy Side Effects?

Many of the side effects associated with Synjardy are temporary and may resolve within a few days or weeks. However, if these side effects worsen or persist, it is important to consult your doctor or pharmacist. Common mild side effects of Synjardy include:

• diarrhea
• gas or bloating
• headache
• indigestion
• low vitamin B12 level
• nausea or vomiting
• upset stomach
• urinary tract infection (UTI)
• weakness
• lack of energy
• vaginal yeast infection
• upper respiratory infections, such as the common cold

Less common side effects of Synjardy can include:

• increased urination
• fungal genital infections in males
• joint pain

While serious side effects from Synjardy are rare, they can happen. If you experience any severe side effects, contact your doctor immediately. In cases where symptoms appear life-threatening or you believe you are having a medical emergency, call 911 right away. Serious side effects of Synjardy may include:

• Low level of fluid in the body. Signs may include:
  • Changes in levels of creatinine (a sign of kidney damage)
  • Hypotension that can cause symptoms such as lightheadedness, cold or clammy skin, or depression
• Low blood sugar level. Signs may include:
  • Feeling irritable or anxious
  • Sweating
  • Shakiness
  • Loss of consciousness
  • Confusion
  • Dizziness
• Allergic reaction
• Ketoacidosis
• Serious UTIs, including urosepsis & pyelonephritis
• Fournier’s gangrene
• Increased level of low-density lipoprotein (LDL) cholesterol
• Lactic acidosis

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

FDA Boxed Warning for Synjardy: Synjardy carries a boxed warning from the Food and Drug Administration (FDA), the agency’s most stringent caution, due to the risk of lactic acidosis. This rare but severe condition involves an accumulation of lactic acid in the bloodstream and requires immediate medical intervention at a hospital.

• Risk Factors for Lactic Acidosis: Individuals with certain health issues are at increased risk for developing lactic acidosis while using Synjardy, particularly those with liver or kidney problems, people aged 65 and older, individuals who consume large amounts of alcohol, and those taking specific medications like topiramate (Topamax).
• Symptoms of Lactic Acidosis:
  • Unusual muscle pain
  • Feeling unusually weak or tired
  • Stomach pain
  • Difficulty breathing
  • Dizziness
  • Feeling very sleepy
  • An irregular or slow heartbeat
  • Nausea or vomiting

If you experience lactic acidosis symptoms, stop taking Synjardy immediately and contact your doctor. If the symptoms appear life-threatening, dial 911 or seek emergency medical assistance without delay.

Before starting Synjardy, it’s crucial to discuss your complete health history with your doctor to ensure this medication is suitable for you. There are specific health conditions and factors that may affect whether Synjardy is an appropriate treatment option.

• Synjardy and Pregnancy: Synjardy is generally not recommended during the second and third trimesters of pregnancy. Research involving animals has shown that taking empagliflozin, one of the active ingredients in Synjardy, during these later stages of pregnancy can lead to kidney damage in the developing fetus. If you are pregnant or considering pregnancy, consult your doctor to discuss the safety of using Synjardy. Your doctor will help determine whether this medication is a viable option for managing your condition during pregnancy.
• Synjardy and Birth Control: It is advised that Synjardy should not be used during the second and third trimesters of pregnancy. If you are sexually active and there is a possibility of pregnancy for you or your partner, it is important to discuss your birth control options with your doctor while taking Synjardy. This conversation will help ensure that you are using effective contraception to prevent pregnancy during treatment, as the medication may pose risks during the later stages of pregnancy.
• Synjardy and Breastfeeding: It is generally recommended not to use Synjardy while breastfeeding. Studies in animals have shown that empagliflozin, one of the active ingredients in Synjardy, can pass into breast milk and may pose a risk of kidney problems in breastfed infants. If you are breastfeeding and considering starting Synjardy, it is crucial to discuss this with your doctor. 
• Allergies and Synjardy: If you have previously experienced an allergic reaction to Synjardy or any of its components, you should not take this medication. Allergic reactions can include symptoms like rash, itching, swelling, or difficulty breathing.
• Chronic Genital Yeast Infections: Empagliflozin, a key component of Synjardy, is known to increase the risk of genital yeast infections. Individuals with a history of chronic genital yeast infections are particularly at risk of experiencing this side effect. If you have had recurrent genital yeast infections, make sure to inform your doctor before beginning treatment with Synjardy.
• Liver Disease and Synjardy: Individuals with liver problems should be cautious when using Synjardy as they are at a heightened risk of developing lactic acidosis, a rare but potentially life-threatening condition characterized by an increased acid level in the blood. 
• Kidney Disease and Synjardy: Similarly, people with kidney disease are at increased risk for lactic acidosis if they use Synjardy. Before beginning treatment, ensure you discuss any history of kidney disease with your doctor.
• Imaging Tests Involving Iodine Contrast: If you are scheduled to undergo an imaging test that involves the use of iodine contrast (a type of dye injected into the veins to improve image clarity), you may need to stop taking Synjardy temporarily. Iodine contrast can interact with Synjardy, increasing the risk of lactic acidosis.
• Considerations for Older Adults Using Synjardy: If you are 65 years of age or older, you should be aware that you are at an increased risk of developing lactic acidosis, a serious and potentially life-threatening condition when using Synjardy. 
• Synjardy and Surgical Procedures: If you have any surgical procedures planned, you need to discuss with your doctor whether you should continue taking Synjardy. Surgical procedures often require fasting or following a restricted diet, which can affect how your body handles medications like Synjardy.

The Synjardy is contraindicated in people who have:

Had a serious hypersensitivity reaction (such as severe skin reaction or anaphylaxis).

Acute or chronic metabolic acidosis, including those with diabetic ketoacidosis.

Moderate to severe renal impairment, those with end-stage renal disease, or those undergoing dialysis.

• If you forget to take a dose of Synjardy, take it as soon as you remember.
• If it’s nearly time for your next scheduled dose, skip the one you missed. Continue with your regular dosing schedule.
• Do not take two doses simultaneously to make up for a missed one. This could lead to an increased risk of experiencing side effects.
• To ensure you don’t forget to take your medication, set a reminder on your phone or use a medication timer.

[Note: If you have missed a medication dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

It is crucial not to exceed the dosage of Synjardy prescribed by your doctor, as using more than recommended can cause serious side effects or lead to an overdose. If you believe you have taken too much Synjardy, contact your doctor immediately for guidance on the next steps to take. Prompt communication with your healthcare provider is essential to manage the situation effectively.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

• Store Synjardy tablets at room temperature, ideally at 77°F (25°C).
• Keep the tablets in a tightly sealed container to protect them from moisture and light.
• Do not store the medication in damp or wet areas, such as bathrooms, to prevent damage.
• Always keep Synjardy out of reach of children to avoid accidental ingestion.
• If you have unused Synjardy, dispose of it properly to prevent misuse and environmental damage. Consult your pharmacist or a local waste disposal company for safe disposal guidelines.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Synjardy may interact with various other medications, which can affect its effectiveness or increase the likelihood of side effects. It’s important to have a detailed discussion with your doctor and pharmacist before starting Synjardy. Make sure to inform them about all the medications you are currently taking, including prescription drugs or any over-the-counter drugs. This will help ensure that Synjardy is safe for you to use in conjunction with your other treatments. Please note that the list provided here does not cover all possible drug interactions with Synjardy.

Interaction of Synjardy with Other Diabetes Medications

People with diabetes often need multiple medications to control their blood sugar levels. However, using Synjardy in combination with other diabetes medications, especially those that increase insulin levels, can raise the risk of hypoglycemia (low blood sugar). It’s crucial to be aware of how these interactions might affect you. Examples of insulin medications that may lead to hypoglycemia when used with Synjardy include:

• Insulin Aspart
• Insulin lispro
• Insulin NPH
• Regular insulin
• Insulin detemir
• Insulin glargine

Other diabetes medications that can increase insulin levels and potentially cause hypoglycemia with Synjardy include:

• Glipizide
• Glyburide
• Glimepiride
• Nateglinide
• Repaglinide

If you are taking Synjardy along with other medications for diabetes, discuss with your doctor how to manage your risk of low blood sugar. Your doctor can provide strategies or adjust your medication regimen to help maintain stable blood sugar levels.

Interaction of Synjardy with Certain Blood Pressure Medications

When Synjardy is taken along with certain types of blood pressure medications, specifically diuretics (often referred to as water pills), there can be an increased risk of dehydration. Both Synjardy and diuretics enhance the production of urine, which can lead to a lower fluid level in the body. This effect might also result in reduced blood pressure and potential kidney damage. Common diuretics that may interact with Synjardy include:

• Bumetanide
• Chlorthalidone
• Furosemide
• Hydrochlorothiazide (often abbreviated as HCTZ)
• Torsemide

What Are the Other Synjardy Interactions?

Besides prescription medications, Synjardy can interact with various supplements and certain foods, which might influence how the drug works or affect its safety profile. These interactions can vary widely, leading to different effects. It is crucial to inform your doctor about any herbal products, supplements, or vitamins you are currently taking. Substances that may interact with Synjardy include:

Interaction of Synjardy with Alcohol

It is advisable to limit or avoid alcohol consumption while taking Synjardy. Alcohol can significantly impact blood sugar management by either raising or drastically lowering blood sugar levels. Moreover, alcohol increases the risk of several serious health conditions, including:

• Diabetic Ketoacidosis
• Hypoglycemia
• Pancreatitis
• Lactic Acidosis

Interaction of Synjardy with Herbs and Supplements

Currently, there are no specific herbs or supplements known to interact directly with Synjardy. However, because many supplements can affect blood sugar levels or kidney and liver function, it’s essential to discuss their use with your doctor or pharmacist. 

[Note: This isn’t a complete list, and there could be other drugs that interact with Synjardy. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

While Synjardy is effective for many individuals with type 2 diabetes, there are several other medications available that might be more suitable depending on your specific health needs and medical history. If you are considering alternatives to Synjardy, it’s important to discuss this with your doctor. Examples of other medications used to treat type 2 diabetes include:

• SGLT2 inhibitors, such as:
  • Jardiance (empagliflozin)
  • Farxiga (dapagliflozin)
  • Invokana (canagliflozin)
  • Steglatro (ertugliflozin)
• Biguanides, such as:
  • Glucophage (Metformin)
• Combination drugs that contain an SGLT2 inhibitor and a biguanide, such as:
  • Xigduo, Xigduo XR (dapagliflozin/metformin)
  • Invokamet, Invokamet XR (canagliflozin/metformin)
  • Segluromet (ertugliflozin/metformin)
• Thiazolidinediones, such as:
  • Actos (pioglitazone)
  • Avandia (rosiglitazone)
• Glucagon-like peptide-1 receptor agonists, such as:
  • Ozempic (semaglutide)
  • Rybelsus (semaglutide)
  • Trulicity (dulaglutide)
  • Victoza (liraglutide)
• Dipeptidyl peptidase-4 (DPP-4) inhibitors, such as:
  • Tradjenta (linagliptin)
  • Onglyza (saxagliptin)
  • Januvia (sitagliptin)
• Sulfonylureas, such as:
  • Glucotrol (glipizide)
  • Amaryl (glimepiride)
  • Glynase (glyburide)
  • Diabeta (glyburide)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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