Tolinase

DRUG DESCRIPTION

TOLINASE Tablets contain tolazamide, an oral blood glucose lowering drug of the sulfonylurea class. Tolazamide is a white or creamy-white powder with a melting point of 165 to 173 C. The sol-ubility of tolazamide at pH 6.0 (mean urinary pH) is 27.8 mg per 100 mL.

The chemical names for tolazamide are (1) Ben-zenesulfonamide, N-[[(hexahydro-1H-azepin-1-yl) amino] carbonyl]-4-methyl-; (2) 1-(Hexahydro-1H-azepin-1-yl)-3-(p-tolylsulfonyl)urea and its molecular weight is 311.40.

TOLINASE (tolazamide) Tablets for oral administration are available as scored, white tablets containing 100 mg, 250 mg or 500 mg tolazamide. Inactive ingredients: calcium sulfate, docusate sodium, magnesium stearate, methylcellulose, sodium alginate.

What are the possible side effects of tolazamide (Tolinase)?

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.

Hypoglycemia, or low blood sugar, is the most common side effect of tolazamide. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy...

Read All Potential Side Effects and See Pictures of Tolinase

What are the precautions when taking tolazamide (Tolinase)?

Before taking tolazamide, tell your doctor or pharmacist if you are allergic to it; or to other sulfonylurea drugs (e.g., glyburide, tolbutamide); 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: a certain metabolic condition (diabetic ketoacidosis), severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, thyroid problems, poor diet, irregular eating patterns, certain hormonal conditions...

Read All Potential Precautions of Tolinase


Tolinase Consumer (continued)

SIDE EFFECTS: Stomach cramps, bloating, heartburn, loss of appetite, constipation, diarrhea, nausea, vomiting, or weight gain 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: sun sensitivity, skin changes (e.g., darkening, thickening), unusual fatigue, fast/pounding heartbeat, easy bruising/bleeding, mental/mood changes, sudden weight gain, swelling of the hands/feet, muscle weakness/spasm.

Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes or skin, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, signs of infection (e.g., fever, persistent sore throat), seizures.

This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, 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 are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. Closely monitor your blood sugar levels for at least 1-2 days after an episode of hypoglycemia.

Check with your doctor or pharmacist about what you should do if you miss a meal.

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

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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: Before taking tolazamide, tell your doctor or pharmacist if you are allergic to it; or to other sulfonylurea drugs (e.g., glyburide, tolbutamide); 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: a certain metabolic condition (diabetic ketoacidosis), severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, thyroid problems, poor diet, irregular eating patterns, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), mineral imbalance (low sodium blood level).

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. Rarely, alcohol can interact with tolazamide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about the safe use of alcohol.

During times of stress, such as fever, infection, injury, or surgery, it may be more difficult to control your blood sugar. Consult your doctor as a change in your medication or how often you test your blood sugar may be required.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially low blood sugar.

This medication should be used only when clearly needed during pregnancy. It is not recommended for use for at least 2 weeks before delivery because it may cause low blood sugar in the newborn. Your doctor may substitute insulin for this drug during your pregnancy. Follow all instructions carefully. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.


Tolinase Patient Information Including Side Effects

Brand Names: Tolinase

Generic Name: tolazamide (Pronunciation: tole AZ a mide)

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

What is tolazamide (Tolinase)?

Tolazamide is an oral diabetes medicine that helps control blood sugar levels. This medication helps your body respond better to insulin produced by your pancreas.

Tolazamide is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. Other diabetes medicines are sometimes used in combination with tolazamide if needed.

Tolazamide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of tolazamide (Tolinase)?

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.

Hypoglycemia, or low blood sugar, is the most common side effect of tolazamide. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

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

  • chest pain, shortness of breath, feeling like you might pass out;
  • easy bruising or bleeding, unusual weakness; or
  • extreme thirst with headache, nausea, vomiting, and weakness.

Less serious side effects may include:

  • dizziness or weakness;
  • headache, tired feeling;
  • mild nausea, heartburn, full feeling;
  • skin rash, redness, or itching; or
  • increased skin sensitivity to sunlight.

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 tolazamide (Tolinase)?

Do not use this medication if you are allergic to tolazamide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

Before taking tolazamide, tell your doctor if you have kidney or liver disease, or a history of heart 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, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic 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.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your medication doses if needed.

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

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