Repaglinide and metformin (Oral)

Repaglinide and metformin combination is used to treat high blood sugar levels caused by type 2 diabetes mellitus (sugar diabetes). It is used along with a proper diet and exercise to help control blood sugar levels in patients who are already being treated with a meglitinide and metformin combination or in patients who have been taking either meglitinide or metformin but did not work well.

Repaglinide makes your pancreas release more insulin into the bloodstream. Metformin decreases the absorption of sugar from the stomach, lowers the release of stored sugar from the liver, and helps your body use sugar more effectively.

This medicine is available only with your doctor's prescription.

Your doctor will want to check how you're doing at regular visits, especially during the first few weeks you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

Make sure to tell your doctor if you are using gemfibrozil (Lopid®) before you start taking this medicine. Taking both together with this medicine may increase your risk of serious side effects. Also inform your doctor if you are using insulin to manage your diabetes.

It is very important to carefully follow any instructions from your health care team about:

• Alcohol—Drinking alcohol may lead to severe low blood sugar. Discuss this with your health care team.
• Counseling—Other family members should learn how to prevent side effects or assist with side effects if they happen. Additionally, patients with diabetes may need special counseling about changes in medicine dosing related to lifestyle changes, like exercise and diet. Counseling about contraception and pregnancy may also be necessary due to issues that can arise for patients with diabetes during pregnancy.
• Travel—Keep your recent prescription and medical history with you. Be prepared for emergencies as you normally would. Adjust for changing time zones and aim to keep your meal times as close to your usual schedule as possible.
• In case of emergency—You may need emergency help for a problem caused by your diabetes at some point. Be prepared for these emergencies. It is advisable to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that states you have diabetes and lists all your medicines.

In certain situations, too much metformin and repaglinide can lead to lactic acidosis. Symptoms of lactic acidosis are severe and can appear quickly, usually when other serious health conditions unrelated to the medicine are present, such as a heart attack or kidney failure. Contact your doctor immediately if you experience abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, general discomfort, muscle pain or cramping, nausea, or unusual sleepiness, tiredness, or weakness.

Inform your doctor or dentist that you are taking this medicine. Your doctor may recommend stopping this medicine before major surgery or diagnostic tests (e.g., x-rays, CT scans, and MRIs), especially those that use contrast dye.

This medicine may cause hypoglycemia (low blood sugar). This is more likely if you take this medicine with certain other medications. Low blood sugar needs to be treated before it leads to unconsciousness. People experience different symptoms of low blood sugar. It is important for you to identify your usual symptoms so you can treat it quickly. Discuss with your doctor the best way to manage low blood sugar.

Hyperglycemia (high blood sugar) can happen if you do not take enough or miss a dose of your medicine, overeat or do not stick to your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and needs to be treated promptly. It is important to learn your symptoms so you can address it quickly. Talk to your doctor about the best way to treat high blood sugar.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine compared to the benefits it may provide. Here are important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medications. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of repaglinide and metformin combination in children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not found any specific problems for elderly patients that would limit the use of the repaglinide and metformin combination. However, older adults are more likely to have kidney problems related to aging, which may require a dose adjustment for those taking repaglinide and metformin combination.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together but could lead to interactions. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The following interactions are chosen for their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acetrizoic Acid
• Diatrizoate
• Ethiodized Oil
• Gemfibrozil
• Iobenzamic Acid
• Iobitridol
• Iocarmic Acid
• Iocetamic Acid
• Iodamide
• Iodipamide
• Iodixanol
• Iodohippuric Acid
• Iodopyracet
• Iodoxamic Acid
• Ioglicic Acid
• Ioglycamic Acid
• Iohexol
• Iomeprol
• Iopamidol
• Iopanoic Acid
• Iopentol
• Iophendylate
• Iopronic Acid
• Ioseric Acid
• Iosimide
• Iotasul
• Iothalamate
• Iotrolan
• Iotroxic Acid
• Ioxaglate
• Ioxitalamic Acid
• Ipodate
• Metrizamide
• Metrizoic Acid
• Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Abametapir
• Abiraterone Acetate
• Acetazolamide
• Alogliptin
• Aspirin
• Atazanavir
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Clopidogrel
• Dabrafenib
• Darolutamide
• Dasabuvir
• Delafloxacin
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Elexacaftor
• Enasidenib
• Encorafenib
• Enoxacin
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iopromide
• Ioversol
• Isavuconazole
• Itraconazole
• Lanreotide
• Leflunomide
• Leniolisib
• Letermovir
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lomefloxacin
• Mavacamten
• Metformin
• Methazolamide
• Metolazone
• Metreleptin
• Midostaurin
• Moxifloxacin
• Nateglinide
• Netupitant
• Norfloxacin
• Octreotide
• Ofloxacin
• Omaveloxolone
• Ombitasvir
• Paritaprevir
• Pasireotide
• Phenobarbital
• Pioglitazone
• Pirtobrutinib
• Pixantrone
• Polythiazide
• Pramlintide
• Primidone
• Ranolazine
• Repaglinide
• Semaglutide
• Simeprevir
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Tafenoquine
• Tecovirimat
• Teriflunomide
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Topiramate
• Triamterene
• Trofinetide
• Trovafloxacin
• Vandetanib
• Zonisamide

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Abiraterone Acetate
• Acebutolol
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Clarithromycin
• Colesevelam
• Cyclosporine
• Deferasirox
• Eltrombopag
• Esmolol
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Ketoconazole
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Patiromer
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Rifapentine
• Safinamide
• Selegiline
• Sotalol
• Telithromycin
• Timolol
• Tirzepatide
• Tranylcypromine
• Trimethoprim
• Verapamil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating certain foods or drinking alcohol or using tobacco, as interactions may occur. The following interactions are chosen for their potential importance and may not include all possible interactions.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Underactive adrenal glands or
• Alcohol abuse or
• Dehydration (not enough water in your body) or
• Heart attack or
• Heart failure or
• Liver disease, or a history of or
• Underactive pituitary gland or
• Poor nutritional status or
• Sepsis (severe infection) or
• Weakened physical condition—Use with caution. May worsen side effects.

• Diabetic ketoacidosis (ketones in the blood) or
• Severe kidney disease or
• Metabolic acidosis (acid in the blood) or
• Type I diabetes—Should not be used in patients with these conditions.

• Fever or
• Infection or
• Surgery or
• Trauma—Use with caution. These conditions may affect blood sugar control.

• Vitamin B12 deficiency—Use with caution. May worsen this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety
• blurred vision
• body aches or pain
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• cough
• depression
• difficulty with breathing
• dizziness
• ear congestion
• fast heartbeat
• fever
• headache
• increased hunger
• loss of voice
• nasal congestion
• nausea
• nervousness
• nightmares
• runny nose
• seizures
• shakiness
• slurred speech
• sneezing
• sore throat
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• PrandiMet

Chemical Class: Meglitinide

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes and will help the medicine work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

This medicine is usually taken within 15 minutes before a meal but may be taken up to 30 minutes before a meal. If you skip a meal, you should skip your dose for that meal.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For Type 2 diabetes: For patients on meglitinide therapy: Adults—At first, 500 milligrams (mg) metformin 2 times a day. Your doctor may gradually increase your dose until your blood sugar is controlled. Children—Use and dose must be determined by your doctor. For patients on metformin therapy: Adults—At first, 1 milligram (mg) repaglinide and 500 mg metformin combination 2 times a day. Your doctor may gradually increase your dose until your blood sugar is controlled. Children—Use and dose must be determined by your doctor. For patients not on repaglinide and metformin therapy: Adults—The dose should be individualized starting at 1 milligram (mg) repaglinide and 500 mg metformin combination 2 times a day. Your doctor may increase your dose as needed to control your blood sugar up to a maximum of 10 mg repaglinide and 2500 mg metformin combination per day, divided into 2 or 3 doses. Children—Use and dose must be determined by your doctor. For patients previously treated separately with repaglinide and metformin: Adults—The dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.