PrandiMet

Generic Name: repaglinide and metformin (Oral route)

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

Oral route(Tablet)

Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure. Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate. If acidosis is suspected, discontinue metformin hydrochloride/repaglinide and hospitalize the patient immediately .

Commonly used brand name(s)

In the U.S.

  • PrandiMet

Available Dosage Forms:

  • Tablet

Therapeutic Class: Hypoglycemic

Chemical Class: Meglitinide

Uses For PrandiMet

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. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future .

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Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Repaglinide causes your pancreas to release more insulin into the blood stream. Metformin reduces the absorption of sugar, reduces the release of stored sugar from the liver, and helps your body's cells use sugar better .

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

Before Using PrandiMet

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.

Pediatric

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 .

Geriatric

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 dosage in patients receiving repaglinide and metformin combination .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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.

  • 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
  • Iopromide
  • Iopronic Acid
  • Ioseric Acid
  • Iosimide
  • Iotasul
  • Iothalamate
  • Iotrolan
  • Iotroxic Acid
  • Ioversol
  • 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 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.

  • Abiraterone Acetate
  • Acetazolamide
  • Alatrofloxacin
  • Balofloxacin
  • Cimetidine
  • Ciprofloxacin
  • Clinafloxacin
  • Dichlorphenamide
  • Dofetilide
  • Dolutegravir
  • Enoxacin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Itraconazole
  • Levofloxacin
  • Lomefloxacin
  • Metreleptin
  • Moxifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pefloxacin
  • Pixantrone
  • Prulifloxacin
  • Rufloxacin
  • Sparfloxacin
  • Temafloxacin
  • Tosufloxacin
  • Trovafloxacin Mesylate
  • 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.

  • Acebutolol
  • Alprenolol
  • Atenolol
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bitter Melon
  • Bucindolol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cephalexin
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Deferasirox
  • Dilevalol
  • Eltrombopag
  • Enalaprilat
  • Enalapril Maleate
  • Esmolol
  • Fenugreek
  • Glucomannan
  • Guar Gum
  • Iproniazid
  • Isocarboxazid
  • Ketoconazole
  • Labetalol
  • Levobunolol
  • Linezolid
  • Mepindolol
  • Methylene Blue
  • Metipranolol
  • Metoprolol
  • Moclobemide
  • Nadolol
  • Nebivolol
  • Nialamide
  • Oxprenolol
  • Penbutolol
  • Phenelzine
  • Pindolol
  • Procarbazine
  • Propranolol
  • Psyllium
  • Ranolazine
  • Rasagiline
  • Rifampin
  • Rifapentine
  • Selegiline
  • Sotalol
  • Talinolol
  • Telithromycin
  • Teriflunomide
  • Tertatolol
  • Timolol
  • Tranylcypromine
  • Trimethoprim
  • Trospium

Interactions with Food/Tobacco/Alcohol

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:

  • Alcohol intoxication or
  • Underactive adrenal glands, not properly controlled or
  • Underactive pituitary gland, not properly controlled or
  • Undernourished condition or
  • Weakened physical condition or
  • Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking repaglinide and metformin combination .
  • Congestive heart failure or
  • Dehydration (not enough water in your body) or
  • Heart attack or
  • Hypoxemia (low oxygen in the blood) or
  • Sepsis (serious illness due to a bacterial infection) or
  • Shock—Lactic acidosis can occur in these conditions, and chances of it occurring are even greater with use of this medicine. If these conditions occur, you should stop taking this medicine as soon as possible .
  • Diabetic ketoacidosis (ketones in the blood) or
  • Kidney disorder or
  • Metabolic acidosis (extra acids in the blood) or
  • Type I diabetes—Should not be used in patients with these conditions .
  • Fever or
  • Infection or
  • Surgery or
  • Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin .
  • Liver disorder—Higher blood levels of this medicine may occur, which may cause serious problems. Patients with impaired liver function generally should not use this medicine .

Proper Use of PrandiMet

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to 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 repaglinide therapy:
        • Adults—At first, 500 milligrams (mg) metformin two 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 milligrams (mg) metformin combination two 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—At first, either the 1 milligram (mg) repaglinide and 500 milligrams (mg) metformin combination two or three times a day or 2 mg repaglinide and 500 mg metformin combination two or three times a day, as directed by your doctor. 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 two or three 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 PrandiMet

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine .

Make sure your doctor knows if you are using gemfibrozil (Lopid®) and itraconazole (Sporanox®) 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 .

Radiologic procedures (e.g., x-rays, CT scans, and MRIs) that use intravenous contrast media can cause kidney problems and lactic acidosis in people who take metformin. Use of this medicine should be discontinued before you have one of these procedures. The medicine should not be started again during the 48 hours after the procedure. You may begin taking your medicine again after the doctor checks your kidneys for normal function

Use of this medicine should be stopped during surgical procedures (except for minor surgical procedures). You can take your medicine again after your doctor makes sure your kidneys are normal

Repaglinide and metformin combination can cause low blood sugar. However, this can also occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take repaglinide and metformin combination with another type of diabetes medicine. The symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so you can treat it quickly .

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness .

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it .

PrandiMet Side Effects

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 in 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.

See also: Side effects (in more detail)

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