Brand name:
RASTINON (Tolbutamide, Orinase)
Pronounced: OR-in-aze
Generic name: Tolbutamide
Why is RASTINON (Tolbutamide, Orinase) prescribed?

RASTINON (Tolbutamide, Orinase) is an oral antidiabetic medication used to treat type 2 (non-insulin-dependent) diabetes. Diabetes occurs when the body does not make enough insulin, or when the insulin that is produced no longer works properly. Insulin works by helping sugar get inside the body's cells, where it is then used for energy.

There are two forms of diabetes: type 1 (insulin-dependent) and type 2 (non-insulin-dependent). Type 1 diabetes usually requires taking insulin injections for life, while type 2 diabetes can usually be treated by dietary changes, exercise, and/or oral antidiabetic medications such as RASTINON (Tolbutamide, Orinase). RASTINON (Tolbutamide, Orinase) controls diabetes by stimulating the pancreas to secrete more insulin and by helping insulin work better.

Occasionally, type 2 diabetics must take insulin injections temporarily during stressful periods or times of illness. When diet, exercise, and an oral antidiabetic medication fail to reduce symptoms and/or blood sugar levels, a person with type 2 diabetes may require long-term insulin injections.
Most important fact about RASTINON (Tolbutamide, Orinase)

Always remember that RASTINON (Tolbutamide, Orinase) is an aid to, not a substitute for, good diet and exercise. Failure to follow a sound diet and exercise plan can lead to serious complications, such as dangerously high or low blood sugar levels. Remember, too, that RASTINON (Tolbutamide, Orinase) is not an oral form of insulin, and cannot be used in place of insulin.
How should you take RASTINON (Tolbutamide, Orinase)?

In general, RASTINON (Tolbutamide, Orinase) should be taken 30 minutes before a meal to achieve the best control over blood sugar levels. However, the exact dosing schedule, as well as the dosage amount, must be determined by your physician. Ask your doctor when it is best for you to take this medication.

To help prevent low blood sugar levels (hypoglycemia) you should:

Understand the symptoms of hypoglycemia.
Know how exercise affects your blood sugar levels.
Maintain an adequate diet.
Keep a product containing quick-acting sugar with you at all times.
Limit alcohol intake. If you drink alcohol, it may cause breathlessness and facial flushing.

If you miss a dose...

Take it as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.

Storage instructions...

Store at room temperature.
RASTINON (Tolbutamide, Orinase) side effects

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking RASTINON (Tolbutamide, Orinase).

Side effects from RASTINON (Tolbutamide, Orinase) are rare and seldom require discontinuation of RASTINON (Tolbutamide, Orinase).

* Side effects may include:
Bloating, heartburn, nausea

RASTINON (Tolbutamide, Orinase), like all oral antidiabetics, may cause hypoglycemia (low blood sugar). The risk of hypoglycemia can be increased by missed meals, alcohol, other medications, fever, trauma, infection, surgery, or excessive exercise. To avoid hypoglycemia, you should closely follow the dietary and exercise plan suggested by your physician.

* Symptoms of mild hypoglycemia may include:
Cold sweat, drowsiness, fast heartbeat, headache, nausea, nervousness.

* Symptoms of more severe hypoglycemia may include:
Coma, pale skin, seizures, shallow breathing.

Contact your doctor immediately if these symptoms of severe low blood sugar occur.

Ask your doctor what you should do if you experience mild hypoglycemia. Severe hypoglycemia should be considered a medical emergency, and prompt medical attention is essential.
Why should RASTINON (Tolbutamide, Orinase) not be prescribed?

You should not take RASTINON (Tolbutamide, Orinase) if you have had an allergic reaction to it.

RASTINON (Tolbutamide, Orinase) should not be taken if you are suffering from diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity breath).

In addition, RASTINON (Tolbutamide, Orinase) should not be used as the sole therapy in treating type 1 (insulin-dependent) diabetes.
Special warnings about RASTINON (Tolbutamide, Orinase)

It's possible that drugs such as RASTINON (Tolbutamide, Orinase) may lead to more heart problems than diet treatment alone, or diet plus insulin. If you have a heart condition, you may want to discuss this with your doctor.

If you are taking RASTINON (Tolbutamide, Orinase), you should check your blood or urine periodically for abnormal sugar (glucose) levels.

It is important that you closely follow the diet and exercise plan recommended by your doctor.

Even people with well-controlled diabetes may find that stress, illness, surgery, or fever results in a loss of control over their diabetes. In these cases, your physician may recommend that you temporarily stop taking RASTINON (Tolbutamide, Orinase) and use injected insulin instead.

In addition, the effectiveness of any oral antidiabetic, including RASTINON (Tolbutamide, Orinase), may decrease with time. This may occur because of either a diminished responsiveness to RASTINON (Tolbutamide, Orinase) or a worsening of the diabetes.

Like other antidiabetic drugs, RASTINON (Tolbutamide, Orinase) may produce severe low blood sugar if the dosage is wrong. While taking RASTINON (Tolbutamide, Orinase), you are particularly susceptible to episodes of low blood sugar if:

You suffer from a kidney or liver problem;

You have a lack of adrenal or pituitary hormone;

You are elderly, run-down, malnourished, hungry, exercising heavily, drinking alcohol, or using more than one glucose-lowering drug.
Possible food and drug interactions when taking RASTINON (Tolbutamide, Orinase)

If RASTINON (Tolbutamide, Orinase) is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining RASTINON (Tolbutamide, Orinase) with the following:

Adrenal corticosteroids such as prednisone (Deltasone) and cortisone (Cortone)
Airway-opening drugs such as Proventil and Ventolin
Anabolic steroids such as testosterone
Barbiturates such as Amytal, Seconal, and phenobarbital
Beta blockers such as Inderal and Tenormin
Blood-thinning drugs such as Coumadin
Calcium channel blockers such as Cardizem and Procardia
Chloramphenicol (Chloromycetin)
Cimetidine (Tagamet)
Clofibrate (Atromid-S)
Colestipol (Colestid)
Epinephrine (EpiPen)
Estrogens (Premarin)
Fluconazole (Diflucan)
Furosemide (Lasix)
Isoniazid (Nydrazid)
Itraconazole (Sporanox)
Major tranquilizers such as Stelazine and Mellaril
MAO inhibitors such as Nardil and Parnate
Methyldopa (Aldomet)
Miconazole (Monistat)
Niacin (Nicobid, Nicolar)
Nonsteroidal anti-inflammatory agents such as Advil, aspirin, Motrin, Naprosyn, and Voltaren
Oral contraceptives
Phenytoin (Dilantin)
Probenecid (Benemid)
Rifampin (Rifadin)
Sulfa drugs such as Bactrim and Septra
Thiazide and other diuretics such as Diuril and HydroDIURIL
Thyroid medications such as Synthroid

Be cautious about drinking alcohol, since excessive alcohol can cause low blood sugar.
Special information if you are pregnant or breastfeeding

The effects of RASTINON (Tolbutamide, Orinase) during pregnancy have not been adequately established in humans. Since RASTINON (Tolbutamide, Orinase) has caused birth defects in rats, it is not recommended for use by pregnant women. Therefore, if you are pregnant or planning to become pregnant, you should take RASTINON (Tolbutamide, Orinase) only on the advice of your physician. Since studies suggest the importance of maintaining normal blood sugar (glucose) levels during pregnancy, your physician may prescribe injected insulin during your pregnancy. While it is not known if RASTINON (Tolbutamide, Orinase) enters breast milk, other similar medications do. Therefore, you should discuss with your doctor whether to discontinue RASTINON (Tolbutamide, Orinase) or to stop breastfeeding. If RASTINON (Tolbutamide, Orinase) is discontinued, and if diet alone does not control glucose levels, your doctor will consider giving you insulin injections.
Recommended dosage for RASTINON (Tolbutamide, Orinase)

Dosage levels are based on individual needs.

ADULTS
Overdosage

Any medication taken in excess can have serious consequences. An overdose of RASTINON (Tolbutamide, Orinase) can cause low blood sugar (see "Special warnings about RASTINON (Tolbutamide, Orinase)"). Eating sugar or a sugar-based product will often correct mild hypoglycemia. If you suspect an overdose, seek medical attention immediately.