Prandimet

DRUG DESCRIPTION

PrandiMet (repaglinide and metformin HCl) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: repaglinide and metformin HCl. The concomitant use of repaglinide and metformin HCl has been previously approved based on clinical trials in patients with type 2 diabetes inadequately controlled on exercise, diet, and metformin HCl alone.

Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid, is chemically unrelated to the oral sulfonylurea insulin secretagogues. Repaglinide is a white to off-white powder with molecular formula C27H36N2O4 and a molecular weight of 452.6 with the structural formula as shown below. Repaglinide is freely soluble in methanol and ethanol. The pKa of repaglinide in acid is 3.9, and the pKa in amine is 6.0.

Structural formula of Repaglinide

Repaglinide Structural Formula Illustration

Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin HCl is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula of metformin HCl is:

Structural formula of Metformin HCl

PrandiMet (repaglinide and metformin hcl tablets) is available as a tablet for oral administration containing 1 mg repaglinide with 500 mg metformin HCl (1 mg/500 mg) or 2 mg repaglinide with 500 mg metformin HCl (2 mg/500 mg) formulated with the following inactive ingredients: poloxamer 188, microcrystalline cellulose, polacrillin potassium, magnesium stearate, hypromellose 3cp or 6cp, povidone, meglumine, sorbitol, talc, titanium dioxide, red or yellow iron oxide, and polyethylene glycol. Propylene glycol is present in the 2 mg/500 mg PrandiMet (repaglinide and metformin hcl tablets) tablets.

What are the possible side effects of metformin and repaglinide (PrandiMet)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • sudden numbness or weakness, especially on one side of the body; or
  • stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

    ...

Read All Potential Side Effects and See Pictures of Prandimet »

What are the precautions when taking repaglinide and metformin hcl tablets (Prandimet)?

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to repaglinide or metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as obstructive lung disease, severe asthma), blood problems (such as anemia, vitamin B12 deficiency), heart problems (such as heart failure, recent heart attack),...

Read All Potential Precautions of Prandimet »


Prandimet Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, diarrhea, and upset stomach may occur as your body adjusts to the metformin. Weight gain and joint pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after you are on the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause low blood sugar (hypoglycemia), especially if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to repaglinide or metformin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (such as obstructive lung disease, severe asthma), blood problems (such as anemia, vitamin B12 deficiency), heart problems (such as heart failure, recent heart attack), liver disease, recent stroke.

Before having surgery or any X-ray/scanning procedure using injectable iodinated contrast material, tell your doctor that you are taking this medication. You will need to temporarily stop this medication before the time of your surgery/procedure. Consult your doctor for further instructions.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing hypoglycemia and lactic acidosis. Consult your doctor or pharmacist about using alcohol safely.

It may be harder to control your blood sugar when your body is stressed (such as fever, infection, injury, or surgery). Tell your doctor if you get a serious infection or injury. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication can cause changes in the menstrual cycle and make it easier to become pregnant. If you do not want to become pregnant, consult your doctor or pharmacist about using reliable birth control.

During pregnancy, this medication should be used only when clearly needed. Insulin treatment may be preferred during pregnancy. Discuss the risks and benefits with your doctor. Follow your doctor's instructions carefully.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Prandimet Patient Information Including Side Effects

Brand Names: PrandiMet

Generic Name: metformin and repaglinide (Pronunciation: met FOR min and re PAG li nide)

  • What is metformin and repaglinide (Prandimet)?
  • What are the possible side effects of metformin and repaglinide (Prandimet)?
  • What is the most important information I should know about metformin and repaglinide (Prandimet)?
  • What should I discuss with my doctor before taking metformin and repaglinide (Prandimet)?
  • How should I take metformin and repaglinide (Prandimet)?
  • What happens if I miss a dose (Prandimet)?
  • What happens if I overdose (Prandimet)?
  • What should I avoid while taking metformin and repaglinide (Prandimet)?
  • What other drugs will affect metformin and repaglinide (Prandimet)?
  • Where can I get more information?

What is metformin and repaglinide (Prandimet)?

Metformin and repaglinide are oral diabetes medications that help control blood sugar levels. Repaglinide works by causing the pancreas to produce insulin. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines.

The combination of metformin and repaglinide is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes.

Metformin and repaglinide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of metformin and repaglinide (Prandimet)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • sudden numbness or weakness, especially on one side of the body; or
  • stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • mild nausea or stomach upset; or
  • runny or stuffy nose, sneezing, cough, or cold symptoms.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them:

  • hunger, weakness, nausea, irritability, tremors;
  • drowsiness, dizziness, headache, blurred vision;
  • confusion, irritability, trouble concentrating;
  • sweating, fast heartbeat;
  • seizure (convulsions); or
  • fainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, hard candy, milk, or glucose tablets. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about metformin and repaglinide (Prandimet)?

Some people have developed a life-threatening condition called lactic acidosis while taking metformin. Get emergency medical help if you have any of these symptoms of lactic acidosis: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

You should not use this medication if you are allergic to metformin or repaglinide, or if you have type 1 diabetes, kidney disease, if you also take gemfibrozil (Lopid) and itraconazole (Sporanox), or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Do not use metformin and repaglinide together with NPH insulin (such as isophane insulin).

Before taking metformin and repaglinide, tell your doctor if you are allergic to any medications, or if you have liver disease.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, nausea, blurred vision, fast heartbeat, sweating, tremor, irritability, or trouble concentrating. Carry a piece of hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Metformin and repaglinide is only part of a complete program of treatment that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

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