Prandimet

(Repaglinide/Metformin Hydrochloride)

The active ingredients in PrandiMet are repaglinide and metformin. Repaglinide is a meglitinide that works by stimulating the pancreas to release insulin in response to meals, helping control post-meal blood glucose spikes. Metformin belongs to the drug class called biguanides. It reduces hepatic glucose production, decreases intestinal glucose absorption, and improves insulin sensitivity in peripheral tissues. Together, they lower blood glucose levels by addressing both insulin secretion and insulin resistance.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using PrandiMet. However, the following is a synopsis of the general guidelines for the use of PrandiMet:

• PrandiMet is taken by mouth with meals.
• It should be taken before each main meal to reduce the risk of hypoglycemia.
• If a meal is skipped, the dose should be skipped.
• Tablets should be swallowed whole and not crushed or chewed.
• Blood glucose levels should be monitored regularly.
• Dosage may be adjusted gradually to improve glycemic control.
• Drinking alcohol should be limited due to the increased risk of lactic acidosis and low blood sugar.

Some mild or common side effects of PrandiMet include:

• Hyperglycemia or low blood sugar.
• Headache.
• Nausea or vomiting.
• Diarrhea.
• Abdominal pain.
• Upper respiratory symptoms.
• Weight gain.

Some individuals may experience serious side effects while using PrandiMet. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Symptoms of lactic acidosis such as unusual muscle pain, trouble breathing, stomach discomfort, dizziness, or feeling cold.
• Severe hypoglycemia with confusion, seizures, or loss of consciousness.
• Signs of heart failure such as shortness of breath or swelling of the legs.
• Allergic reactions, including rash, itching, or swelling.
• Symptoms of diabetic ketoacidosis such as nausea, vomiting, and abdominal pain.

These are not all of the possible side effects of PrandiMet. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting PrandiMet, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney disease or renal impairment.
• Liver disease.
• Heart failure or other cardiovascular conditions.
• A history of lactic acidosis.
• Type 1 diabetes mellitus.
• Diabetic ketoacidosis.
• Sepsis or severe infection.
• Vitamin B12 deficiency.
• Conditions causing hypoxia or dehydration.

Boxed Warning

PrandiMet contains metformin, which carries a risk of lactic acidosis.

Lactic acidosis is a rare but serious metabolic acidosis that can be life-threatening. Risk factors include renal impairment, heart failure, excessive alcohol intake, sepsis, dehydration, and use of contrast dye. Prompt discontinuation and medical evaluation are required if lactic acidosis is suspected.

PrandiMet should not be used in individuals who:

• Have severe renal impairment.
• Have metabolic acidosis, including diabetic ketoacidosis.
• Have a known hypersensitivity to repaglinide or metformin.
• They are experiencing conditions associated with hypoxia or dehydration.

PrandiMet begins lowering blood glucose levels shortly after dosing, particularly around meals. Full improvement in glycemic control may take several weeks as the dose is adjusted and insulin sensitivity improves.

When PrandiMet is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Gemfibrozil can increase repaglinide levels and raise the risk of hypoglycemia.
• Clarithromycin may increase repaglinide exposure.
• Rifampin may reduce repaglinide effectiveness.
• Ketoconazole or itraconazole, which affect CYP3A4 metabolism.
• Trimethoprim or furosemide may increase metformin levels.
• Alcohol increases the risk of lactic acidosis.
• Other active ingredients such as meglitinide, carbamazepine, chlorothiazide, and conivaptan.

PrandiMet tablets are available in several dosage strengths combining repaglinide and metformin. Your healthcare provider will determine the appropriate dose and titration schedule based on blood glucose levels and treatment response.

It should be stored at room temperature, away from the reach of children or pets.

PrandiMet is manufactured by Novo Nordisk.

No. PrandiMet is available only as a brand-name medication.

Do not stop taking PrandiMet without medical advice. Sudden discontinuation may result in uncontrolled blood sugar levels. Your healthcare provider will guide any treatment changes.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.