Pronunciation:

re-PAG-li-nide, met-FOR-min hye-droe-KLOR-ide

Brand Names:

• PrandiMet

Warnings:

Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL. Risk factors include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment. If suspected, immediately discontinue repaglinide/metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended .

Classifications:

Chemical—

Meglitinide

Uses of This Medicine:

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

Repaglinide causes your pancreas to release more insulin into the blood stream. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of repaglinide and metformin combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of repaglinide and metformin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of in the dose for patients receiving repaglinide and metformin combination.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Gemfibrozil

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

• Abametapir
• Abiraterone Acetate
• Acetazolamide
• Alogliptin
• Asciminib
• Aspirin
• Atazanavir
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Carbamazepine
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Clopidogrel
• Dabrafenib
• Darolutamide
• Dasabuvir
• Delafloxacin
• Diatrizoate
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Elexacaftor
• Eltrombopag
• Encorafenib
• Enoxacin
• Ethiodized Oil
• 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
• Iodipamide
• Iodixanol
• Iohexol
• Iopamidol
• Iopanoic Acid
• Iopromide
• Iothalamate
• Iotrolan
• Ioversol
• Ioxaglate
• Ipodate
• Isavuconazole
• Itraconazole
• Lanreotide Acetate
• Leflunomide
• Leniolisib
• Letermovir
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lomefloxacin
• Mavacamten
• Metformin
• Methazolamide
• Metolazone
• Metreleptin
• Metrizamide
• Midostaurin
• Moxifloxacin
• Nateglinide
• Netupitant
• Norfloxacin
• Octreotide Acetate
• Ofloxacin
• Omaveloxolone
• Ombitasvir
• Paritaprevir
• Pasireotide Diaspartate
• 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 cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal glands (underactive) or
• Alcohol abuse or
• Dehydration (not enough water in your body) or
• Heart attack or
• Heart failure or
• Liver disease, or history of or
• Pituitary gland (underactive) or
• Poorly nourished condition or
• Sepsis (severe infection) or
• Weakened physical condition—Use with caution. May cause side effects to become worse.

• Diabetic ketoacidosis (ketones in the blood) or
• Kidney disease, severe 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 cause problems with blood sugar control.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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

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

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

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
• In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all of your medicines.

Under certain conditions, too much metformin and repaglinide can cause lactic acidosis. Symptoms of lactic acidosis are severe and quick to appear and usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Call your doctor right away if you have abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, general feeling of discomfort, muscle pain or cramping, nausea, or unusual sleepiness, tiredness, or weakness. .

Let your doctor or dentist know you are taking this medicine. Your doctor may advise you to stop taking this medicine before you have major surgery or diagnostic tests (eg, x-rays, CT scans, and MRIs), especially tests that use a contrast dye.

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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. Also, your health care professional may 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 or 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.