Repaglinide and Metformin

Repaglinide/metformin is a prescription medication used to treat Type 2 Diabetes.

It is a single product containing 2 medications: repaglinide and metformin. Repaglinide belongs to a group of drugs called meglitinides, or simply glinides. It works by stimulating the pancreas to release more insulin which will help lower blood sugars. Metformin belongs to a group of drugs called biguanides. It works by reducing the amount of sugar that the liver produces. 

This medication comes in a tablet form and is usually given 2 to 3 times a day with meals. Common side effects of repaglinide/metformin include headaches, low blood sugars, nausea, and diarrhea.

Repaglinide/metformin is a prescription medication used to treat Type 2 Diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Repaglinide and Metformin may be found in some form under the following brand names:

• PrandiMet

Serious side effects have been reported with repaglinide/metformin. See the “Drug Precautions” section.

Common side effects of repaglinide/metformin include the following:

• Headaches
• Low blood sugars
• Nausea
• Vomiting
• Diarrhea
• Flatulence
• Urinary tract infection
• Joint pain

This is not a complete list of side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• HIV medications
• Gemfibrozil
• Alcohol
• Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• Diuretics such as
  • Furosemide (Lasix)
  • Torsemide (Demadex)
  • Bumetanide (Bumex)
  • Chlorothiazide (Diuril)
  • Chlorthalidone (Thalitone)
  • Hydrochlorothiazide (Microzide, HCTZ)
  • Metolazone (Zaroxolyn)
• Steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid, Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef)
• Medications that block a protein in the body (CYPA4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• Medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• Medications that increase the activity of the enzyme CYP2C8 such as rifampin
• Medications that block the enzyme CYP2C8 such as gemfibrozil (Lopid), fluvoxamine (Luvox), ketoconazole (Nizoral), trimethoprim (Bactrim, Septra, Primsol, Proloprim)

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with repaglinide/metformin including the following:

• Lactic Acidosis. Tell your healthcare provider right away if you have some or all of the following symptoms of lactic acidosis:
  • Extreme tiredness
  • Weakness, or discomfort
  • Nausea
  • Vomiting
  • Stomach pain
  • Decreased appetite
  • Deep and rapid breathing or shortness of breath
  • Dizziness
  • Lightheadedness
  • Fast or slow heartbeat
  • Flushing of the skin
  • Muscle pain
  • Feeling cold
• Hypoglycemia (low blood sugar).  Tell your healthcare provider right away if you have some or all of the following symptoms of low blood sugar:
  • Shakiness
  • Nervousness of anxiety
  • Sweating
  • Chills
  • Feeling Clammy
  • Confusion
  • Lightheadedness or dizziness
• Low Levels of Vitamin B12. Tell your healthcare provider right away if you have some or all of the following symptoms of having low levels of Vitamin B12
  • Wanting to eat ice or things that are not food
  • Diarrhea or constipation
  • Extreme tiredness or fatigue
  • Feeling lightheaded when standing up
  • Having difficulty concentrating
  • Having pale skin
  • Shortness of breath 
  • Swollen tongue
  • Gums that are bleeding
  • Confusion
  • Depression
  • Having tingling or numbness in the hands or feet

Do not take repaglinide/metformin if you:

• Are allergic to repaglinide, metformin, or to any of its ingredients
• Have kidney dysfunction or kidney damage
• Have acute or chronic metabolic acidosis
• Take gemfibrozil
• Are having radiologic exams where contrast dye is used

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of repaglinide/metformin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking repaglinide/metformin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Are allergic to repaglinide, metformin or to any of its ingredients
• Have heart failure
• Have liver problems
• Have kidney problems
• Use a certain type of insulin called NPH or Insulin N
• Drink alcohol
• Are planning on having surgery
• Are experiencing high levels of stress
• Are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Repaglinide/metformin falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Repaglinide/metformin should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Repaglinide/metformin has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from this drug, the use of repaglinide/metformin while breastfeeding is not recommended. 

Take repaglinide/metformin exactly as prescribed.

Repaglinide/metformin comes in a tablet form and is usually taken 2 to 3 times daily with food. 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of repaglinide/metformin at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• The condition being treated
• Other medical conditions you have
• Other medications you are taking
• How you respond to this medication
• Your weight
• Your height
• Your age
• Your gender

The starting dose for repaglinide/metformin is 1 mg/500 mg twice a day and slowly increased as necessary. The maximum dose per day is 10 mg of repaglinide and 2500 mg of metformin.

If you take too much repaglinide/metformin call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If repaglinide/metformin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store repaglinide/metformin at room temperature.
• Protect from moisture.
• Keep this and all medicines out of the reach of children.

Lactic acidosis is a rare but serious complication that 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.

The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as 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, repaglinide/metformin should be discontinued and the patient hospitalized immediately