Tolinase (Tolazamide)
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Tolinase (Tolazamide)

Tolinase®
(tolazamide) Tablets, USP

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 include headache, hunger, weakness, sweating, tremor, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Call your doctor at once if you have a serious side effect such...

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 »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

TOLINASE (tolazamide) Tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone.

In initiating treatment for noninsulin-dependent diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed and cardiovascular risk factors should be identified and corrective measures taken where possible.

If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sul-fonylurea or insulin should be considered. Use of TOLINASE (tolazamide) must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient thus requiring only short-term administration of TOLINASE (tolazamide) .

During maintenance programs, TOLINASE (tolazamide) should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgments should be based on regular clinical and laboratory evaluations.

In considering the use of TOLINASE (tolazamide) in asymp-tomatic patients, it should be recognized that controlling the blood glucose in noninsulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of diabetes mellitus with TOLINASE (tolazamide) Tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patientγ¢††s blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, ie, inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, ie, loss of adequate blood glucose response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patientγ¢††s response to therapy.

Short-term administration of TOLINASE (tolazamide) may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

Usual Starting Dose

The usual starting dose of TOLINASE (tolazamide) Tablets for the mild to moderately severe Type II diabetic patient is 100-250 mg daily administered with breakfast or the first main meal. Generally, if the fasting blood glucose is less than 200 mg/dl, the starting dose is 100 mg/day as a single daily dose. If the fasting blood glucose value is greater than 200 mg/dl, the starting dose is 250 mg/day as a single dose. If the patient is malnourished, underweight, elderly, or not eating properly, the initial therapy should be 100 mg once a day. Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary regimen are more prone to exhibit unsatisfactory response to drug therapy.

Transfer From Other Hypoglycemic Therapy Patients Receiving Other Oral Antidiabetic Therapyγ¢††Transfer of patients from other oral antidiabetes regimens to TOLINASE (tolazamide) should be done conservatively. When transferring patients from oral hypoglycemic agents other than chlor-propamide to TOLINASE (tolazamide) , no transition period or initial or priming dose is necessary. When transferring from chlorpropamide, particular care should be exercised to avoid hypoglycemia.

Tolbutamide: If receiving less than 1 gm/day, begin at 100 mg of tolazamide per day. If receiving 1 gm or more per day, initiate at 250 mg of tolaza-mide per day as a single dose.

Chlorpropamide: 250 mg of chlorpropamide may be considered to provide approximately the same degree of blood glucose control as 250 mg of tolazamide. The patient should be observed carefully for hypoglycemia during the transition period from chlorpropamide to TOLINASE (tolazamide) (one to two weeks) due to the prolonged retention of chlor-propamide in the body and the possibility of a subsequent overlapping drug effect.

Acetohexamide: 100 mg of tolazamide may be considered to provide approximately the same degree of blood glucose control as 250 mg of ace-tohexamide.

Patients Receiving Insulinγ¢††Some Type II diabetic patients who have been treated only with insulin may respond satisfactorily to therapy with TOLINASE (tolazamide) . If the patientγ¢††s previous insulin dosage has been less than 20 units, substitution of 100 mg of tolazamide per day as a single daily dose may be tried. If the previous insulin dosage was less than 40 units, but more than 20 units, the patient should be placed directly on 250 mg of tolazamide per day as a single dose. If the previous insulin dosage was greater than 40 units, the insulin dosage should be decreased by 50% and 250 mg of tolazamide per day started. The dosage of TOLINASE (tolazamide) should be adjusted weekly (or more often in the group previously requiring more than 40 units of insulin).

During this conversion period when both insulin and TOLINASE (tolazamide) are being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.

Maximum Dose

Daily doses of greater than 1000 mg are not recommended. Patients will generally have no further response to doses larger than this.

Usual Maintenance Dose

The usual maintenance dose is in the range of 100-1000 mg/day with the average maintenance dose being 250-500 mg/day. Following initiation of therapy, dosage adjustment is made in increments of 100 mg to 250 mg at weekly intervals based on the patientγ¢††s blood glucose response.

Dosage Interval

Once a day therapy is usually satisfactory. Doses up to 500 mg/day should be given as a single dose in the morning. 500 mg once daily is as effective as 250 mg twice daily. When a dose of more than 500 mg/day is required, the dose may be divided and given twice daily.

In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hep-atic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section).

HOW SUPPLIED

TOLINASE (tolazamide) Tablets are available in the following strengths and package sizes:

100 mg (white, round, scored, imprinted TOLINASE (tolazamide) 100)

Unit-of-Use Bottles of 100

NDC 0009-0070-02

250 mg (white, round, scored, imprinted TOLINASE (tolazamide) 250)

Bottles of 200

NDC 0009-0114-04

Bottles of 1000

NDC 0009-0114-02

Unit-of-Use Bottles of 100

NDC 0009-0114-05

500 mg (white, round, scored, imprinted TOLINASE (tolazamide) 500)

Unit-of-Use Bottles of 100

NDC 0009-0477-06

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Pharmacia & Upjohn Company, Kalamazoo, Michigan 49001, USA, Revised January 2000

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

TOLINASE (tolazamide) Tablets have generally been well tolerated. In clinical studies in which more than 1,784 diabetic patients were specifically evaluated for incidence of side effects, only 2.1% were discontinued from therapy because of side effects.

Hypoglycemia: See PRECAUTIONS and OVERDOSAGE sections.

Gastrointestinal Reactions: Cholestatic jaundice may occur rarely; TOLINASE (tolazamide) Tablets should be discontinued if this occurs. Gastrointestinal disturbances, eg, nausea, epigastric fullness, and heartburn, are the most common reactions and occurred in 1% of patients treated during clinical trials. They tend to be dose-related and may disappear when dosage is reduced.

Dermatologic Reactions: Allergic skin reactions, eg, pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in 0.4% of patients treated during clinical trials. These may be transient and may disappear despite continued use of TOLINASE (tolazamide) ; if skin reactions persist, the drug should be discontinued.

Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.

Hematologic Reactions: Leukopenia, agranulocy-tosis, thrombocytopenia, hemolytic anemia, aplas-tic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic Reactions: Hepatic porphyria and disul-firam-like reactions have been reported with sul-fonylureas; however, disulfiram-like reactions with TOLINASE (tolazamide) have been reported very rarely.

Cases of hyponatremia have been reported with tolazamide and all other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain other sul-fonylureas, and it has been suggested that these sul-fonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.

Miscellaneous: Weakness, fatigue, dizziness, vertigo, malaise and headache were reported infrequently in patients treated during clinical trials. The relationship to therapy with TOLINASE (tolazamide) is difficult to assess.

Read the Tolinase (tolazamide) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents. When such drugs are administered to a patient receiving TOLINASE (tolazamide) , the patient should be closely observed for hypoglycemia. When such drugs are withdrawn from a patient receiving TOLINASE (tolazamide) , the patient should be observed closely for loss of control.

Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympa-thomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving TOLINASE (tolazamide) , the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving TOLINASE (tolazamide) , the patient should be observed closely for hypoglycemia.

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical or vaginal preparations of miconazole is not known.

Carcinogenicity

In a bioassay for carcinogenicity, rats and mice of both sexes were treated with tolazamide for 103 weeks at low and high doses. No evidence of car-cinogenicity was found.

Pregnancy

Teratogenic Effects:

Pregnancy Category C. TOLINASE (tolazamide) , administered to pregnant rats at ten times the human dose, decreased litter size but did not produce terato-genic effects in the offspring. In rats treated at a daily dose of 14 mg/kg no reproductive aberrations or drug related fetal anomalies were noted. At an elevated dose of 100 mg/kg per day there was a reduction in the number of pups born and an increased perinatal mortality. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, TOLINASE (tolazamide) is not recommended for the treatment of the pregnant diabetic patient. Serious consideration should also be given to the possible hazards of the use of TOLINASE (tolazamide) in women of child bearing age and in those who might become pregnant while using the drug.

Because recent information suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.

Nonteratogenic Effects:

Prolonged severe hypoglycemia (four to ten days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. If TOLINASE (tolazamide) is used during pregnancy, it should be discontinued at least two weeks before the expected delivery date.

Nursing Mothers

Although it is not known whether tolazamide is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If the drug is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Elderly patients are particularly susceptible to the hypoglycemic action of glucose lowering drugs. Hypoglycemia may be difficult to recognize in the elderly (see PRECAUTIONS). The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see DOSAGE AND ADMINISTRATION).

Elderly patients are prone to develop renal insufficiency, which may put them at risk of hypoglycemia. Dose selection should include assessment of renal function.

 

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

SPECIAL

WARNINGS

ON INCREASED RISK OF CARDIOVASCULAR MORTALITY

The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with noninsulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (DIABETES, 19 (supp. 2):747-830, 1970.) UGDP reported that patients treated for five to eight years with diet plus a fixed dose of tolbu-tamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 21/2 times that of patients with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of TOLINASE (tolazamide) and of alternative modes of therapy.

Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

PRECAUTIONS

General

Hypoglycemia--All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection and dosage and instructions are important to avoid hypoglycemic episodes. Renal or hepatic insufficiency may cause elevated blood levels of tolazamide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions. Elderly, debilitated, or malnourished patients and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycemic action of glucose lowering drugs. Hypoglycemia may be difficult to recognize in the elderly and in people who are taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.

Loss of Control of Blood Glucoseγ¢††When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, loss of control of blood glucose may occur. At such times it may be necessary to discontinue TOLINASE (tolazamide) Tablets and administer insulin.

The effectiveness of any hypoglycemic drug, including TOLINASE (tolazamide) , in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage of sulfonylureas, including TOLINASE (tolazamide) Tablets, can produce hypoglycemia.

Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustment in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is suspected or diagnosed, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate which will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery.

CONTRAINDICATIONS

TOLINASE (tolazamide) Tablets are contraindicated in patients with:

1) known hypersensitivity or allergy to TOLINASE (tolazamide) ;

2) diabetic ketoacidosis, with or without coma. This condition should be treated with insulin;

3) Type I diabetes, as sole therapy.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Actions

Tolazamide appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by which tolazamide lowers blood glucose during long-term administration has not been clearly established. With chronic administration in Type II diabetic patients, the blood glucose lowering effect persists despite a gradual decline in the insulin secretory response to the drug. Extrapancreatic effects may be involved in the mechanism of action of oral sulfonylurea hypoglycemic drugs.

Some patients who are initially responsive to oral hypoglycemic drugs, including TOLINASE (tolazamide) Tablets, may become unresponsive or poorly responsive over time. Alternatively, TOLINASE (tolazamide) Tablets may be effective in some patients who have become unresponsive to one or more other sulfonylurea drugs.

In addition to its blood glucose lowering actions, tolazamide produces a mild diuresis by enhancement of renal free water clearance.

Pharmacokinetics

Tolazamide is rapidly and well absorbed from the gastrointestinal tract. Peak serum concentrations occur at three to four hours following a single oral dose of the drug. The average biological half-life of the drug is seven hours. The drug does not continue to accumulate in the blood after the first four to six doses are administered. A steady or equilibrium state is reached during which the peak and nadir values do not change from day to day after the fourth to sixth doses.

Tolazamide is metabolized to five major metab-olites ranging in hypoglycemic activity from 0-70%. They are excreted principally in the urine. Following a single oral dose of tritiated tolazamide, 85% of the dose was excreted in the urine and 7% in the feces over a five-day period. Most of the urinary excretion of the drug occurred within the first 24 hours post administration.

When normal fasting nondiabetic subjects are given a single 500 mg dose of tolazamide orally, a hypoglycemic effect can be noted within 20 minutes after ingestion with a peak hypoglycemic effect occurring in two to four hours. Following a single oral dose of 500 mg tolazamide, a statistically significant hypoglycemic effect was demonstrated in fasted nondiabetic subjects 20 hours after administration. With fasting diabetic patients, the peak hypoglycemic effect occurs at four to six hours. The duration of maximal hypoglycemic effect in fed diabetic patients is about ten hours, with the onset occurring at four to six hours and with the blood glucose levels beginning to rise at 14 to 16 hours. Single dose potency of tolazamide in normal subjects has been shown to be 6.7 times that of tolbu-tamide on a milligram basis. Clinical experience in diabetic patients has demonstrated tolazamide to be approximately five times more potent than tolbu-tamide on a milligram basis, and approximately equivalent in milligram potency to chlorpropamide.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be informed of the potential risks and advantages of TOLINASE (tolazamide) and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose.

The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained.

Laboratory Tests

Blood and urine glucose should be monitored periodically. Measurement of glycosylated hemoglobin may be useful in some patients.

Please also refer to the WARNINGS and PREACAUTIONS sections.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be informed of the potential risks and advantages of TOLINASE (tolazamide) and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose.

The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained.

Laboratory Tests

Blood and urine glucose should be monitored periodically. Measurement of glycosylated hemoglobin may be useful in some patients.

Please also refer to the WARNINGS and PREACAUTIONS sections.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Tolinase Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TOLAZAMIDE - ORAL

(tol-AZ-a-mide)

COMMON BRAND NAME(S): Tolinase

USES: Tolazamide is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes (non-insulin-dependent diabetes). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Tolazamide belongs to the class of drugs known as sulfonylureas. It works by stimulating the release of your body's natural insulin, thereby lowering your blood sugar.

HOW TO USE: Take this medication by mouth, usually once daily with breakfast or the first main meal, or as directed by your doctor. Some patients, especially those taking higher doses, may be directed to take this drug twice a day with the morning and evening meals. The dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Disclaimer

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.

Read the Tolinase (tolazamide) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Tolinase Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

Beta-blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on nonprescription/herbal products carefully. Some products contain sugar/alcohol and may affect your blood sugar levels. Ask your doctor or pharmacist about using these products safely.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: shakiness, rapid heartbeat, unexplained sweating, loss of consciousness, seizures.

NOTES: Do not share this medication with others.

It is recommended that you attend a diabetes education program to understand diabetes and all the important aspects of its treatment including meals/diet, exercise, personal hygiene, medications, and getting regular eye, foot and medical exams.

Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor for side effects and response to therapy. Regularly check your blood sugar levels if so directed by your doctor or pharmacist.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Tolinase Patient Information Including Side Effects

Brand Names: Tolinase

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

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 not listed in this medication guide.

Tolazamide 250 mg-MYL

white, imprinted with 250, MYLAN 217

Tolazamide 250 mg-ZEN

round, white, imprinted with Z 2979

Tolazamide 500 mg-MYL

round, white, imprinted with MYLAN 551

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 include headache, hunger, weakness, sweating, tremor, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal). Carry hard candy or glucose tablets with you in case you have low blood sugar.

Call your doctor at once if you have a serious side effect such as:

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

Read the Tolinase (tolazamide) Side Effects Center for a complete guide to possible side effects »

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 not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. 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, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your tolazamide dose.

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.

Side Effects Centers

Tolinase Patient Information including How Should I Take

What should I discuss with my doctor before taking tolazamide (Tolinase)?

You should 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).

To make sure you can safely take tolazamide, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease; or
  • a history of heart disease.

FDA pregnancy category C. It is not known whether tolazamide will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether tolazamide passes into breast milk or if it could be harmful to a nursing baby. Do not take tolazamide without telling your doctor if you are breast-feeding a baby.

How should I take tolazamide (Tolinase)?

Take 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.

Tolazamide is usually taken once a day, with breakfast or the first main meal of the day. Follow your doctor's instructions.

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 tolazamide 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 tolazamide dose if needed. Do not change your medication dose or schedule without your doctor's advice.

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.

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

Store at room temperature away from moisture and heat.

Side Effects Centers

Tolinase Patient Information including If I Miss a Dose

What happens if I miss a dose (Tolinase)?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Tolinase)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.A tolazamide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking tolazamide (Tolinase)?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

What other drugs will affect tolazamide (Tolinase)?

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

  • isoniazid;
  • diuretics (water pills);
  • steroids (prednisone and others);
  • heart or blood pressure medication (Cartia, Cardizem, Covera, Isoptin, Verelan, and others);
  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • seizure medicines (Dilantin and others);
  • diet pills or medicines to treat asthma, colds or allergies; and
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

You may be more likely to have hypoglycemia (low blood sugar) if you take tolazamide with other drugs that can lower blood sugar, such as:

  • exenatide (Byetta);
  • probenecid (Benemid);
  • some nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • a blood thinner (warfarin, Coumadin and others);
  • heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);
  • sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others);
  • a monoamine oxidase inhibitor (MAOI); or
  • other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

These lists are not complete and there are many other medicines that can increase or decrease the effects of tolazamide on lowering your 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.

Where can I get more information?

Your pharmacist can provide more information about tolazamide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.09. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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