Novonorm (other name Prandin)

INDICATIONS

Prandin (repaglinide) is an oral diabetes medicine that helps control blood sugar levels. This medication lowers blood sugar by causing the pancreas to produce insulin.

Prandin is used together with diet and exercise to treat type 2 diabetes. Other diabetes medicines are sometimes used in combination with repaglinide if needed.

Prandin may aso be used for purposes not listed in this medication guide.

INSTRUCTIONS  

Take Prandin exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Prandin is usually taken 2 to 4 times daily, within 30 minutes before eating a meal. Follow your doctor's instructions. If you skip a meal, do not take your dose of Prandin. Wait until your next meal.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. 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.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking Prandin for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your Prandin dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Prandin is only part of a complete program of treatment that also includes 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.

Use Prandin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

MORE INFO

Active ingredient: Repaglinide

Repaglinide is a white to off-white powder with molecular formula C27 H36 N2 O4 and a molecular weight of 452.6. PRANDIN tablets contain 0.5 mg, 1 mg, or 2 mg of repaglinide. In addition each tablet contains the following inactive ingredients: calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, maize starch, polacrilin potassium, povidone, glycerol (85%), magnesium stearate, meglumine, and poloxamer. The 1 mg and 2 mg tablets contain iron oxides (yellow and red, respectively) as coloring agents.

SAFETY INFORMATION

Do not use Prandin if you are allergic to repaglinide, if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). You should not use Prandin together with gemfibrozil (Lopid) or NPH insulin (such as isophane insulin).

Before taking repaglinide, tell your doctor or pharmacist if you are allergic to it; 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. 

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.

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 low blood sugar.

During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.

During pregnancy this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy. Discuss the risks and benefits of different treatments (such as diet, exercise, and medications including insulin).

FDA pregnancy category C. It is not known whether Prandin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Prandin. It is not known whether repaglinide passes into breast milk or if it could be harmful to a nursing baby. You should not breast-feed while you are taking Prandin.

SIDE EFFECTS

Weight gain, diarrhea, and joint pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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.

Repaglinide can cause low blood sugar (hypoglycemia) especially if you are taking other medicines for diabetes. Consuming large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include chills, cold sweat, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands or feet, or 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, raise your blood sugar quickly by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. 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 doctor may need to adjust your diabetes medication(s).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

More info:

Tell your doctor about all other medications you use, especially:

cyclosporine (Gengraf, Neoral, Sandimmune);

St. John's wort;

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);

a barbiturate such as phenobarbital (Solfoton);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

HIV/AIDS medicine such as delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir), and others;

rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin); or

seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), primidone (Mysoline), and others.

You may be more likely to have hyperglycemia (high blood sugar) if you are taking Prandin with other drugs that raise blood sugar, such as:

isoniazid;

diuretics (water pills);

steroids (prednisone and others);

phenothiazines (Compazine and others);

thyroid medicine (Synthroid and others);

birth control pills and other hormones;

seizure medicines (Dilantin and others); and

diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking other drugs that lower blood sugar, such as:

probenecid (Benemid);

a blood thinner (warfarin, Coumadin);

some nonsteroidal anti-inflammatory drugs (NSAIDs);

aspirin or other salicylates (including Pepto-Bismol);

a blood thinner (warfarin, Coumadin, Jantoven, and others);

sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);

a monoamine oxidase inhibitor (MAOI); or

other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos, Duetact, Actoplus Met), or rosiglitazone (Avandia, Avandaryl, Avandamet).

These lists are not complete and there are many other medicines that can increase or decrease the effects of Prandin on lowering your blood sugar. Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.