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Tolinase

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Overview

What is Tolinase?

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 solubility of tolazamide at pH 6.0 (mean urinary pH) is 27.8 mg per 100 mL.

The chemical names for tolazamide are (1) Benzenesulfonamide, -[[(hexahydro-1-azepin-1-yl) amino] carbonyl]-4-methyl-; (2) 1-(Hexahydro-1-azepin-1-yl)-3-(-tolylsulfonyl)urea and its molecular weight is 311.40. The structural formula is represented below:

TOLINASE 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 does Tolinase look like?



What are the available doses of Tolinase?

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What should I talk to my health care provider before I take Tolinase?

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How should I use Tolinase?

TOLINASE Tablets are indicated as an adjunct to diet to lower the blood glucose in patients with noninsulin 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 sulfonylurea or insulin should be considered. Use of TOLINASE 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.

During maintenance programs, TOLINASE 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 in asymptomatic 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.

There is no fixed dosage regimen for the management of diabetes mellitus with TOLINASE Tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient'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 patient's response to therapy.

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


What interacts with Tolinase?

TOLINASE Tablets are contraindicated in patients with: 1) known hypersensitivity or allergy to TOLINASE; 2) diabetic ketoacidosis, with or without coma. This condition should be treated with insulin; 3) Type I diabetes, as sole therapy.



What are the warnings of Tolinase?

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What are the precautions of Tolinase?

General

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.

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 Tablets and administer insulin.

The effectiveness of any hypoglycemic drug, including TOLINASE, 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.

Information for Patients

Patients should be informed of the potential risks and advantages of TOLINASE 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.

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, the patient should be closely observed for hypoglycemia. When such drugs are withdrawn from a patient receiving TOLINASE, 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, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving TOLINASE, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving TOLINASE, 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 carcinogenicity was found.

Pregnancy

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 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 ). The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see ).

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


What are the side effects of Tolinase?

TOLINASE 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 and sections.

Gastrointestinal Reactions

Cholestatic jaundice may occur rarely; TOLINASE 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; if skin reactions persist, the drug should be discontinued.

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

Hematologic Reactions

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic Reactions

Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas; however, disulfiram-like reactions with TOLINASE 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 sulfonylureas, and it has been suggested that these sulfonylureas 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 is difficult to assess.


What should I look out for while using Tolinase?

TOLINASE Tablets are contraindicated in patients with: 1) known hypersensitivity or allergy to TOLINASE; 2) diabetic ketoacidosis, with or without coma. This condition should be treated with insulin; 3) Type I diabetes, as sole therapy.

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 tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ 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 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.


What might happen if I take too much Tolinase?

Overdosage of sulfonylureas, including TOLINASE 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.


How should I store and handle Tolinase?

TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].TOLINASE Tablets are available in the following strengths and package sizes:100 mg  Unit-of-Use Bottles of 100    NDC 0009-0070-02250 mg  Bottles of 200                       NDC 0009-0114-04  Bottles of 1000                     NDC 0009-0114-02  Unit-of-Use Bottles of 100    NDC 0009-0114-05500 mg  Unit-of-Use Bottles of 100    NDC 0009-0477-06Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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 Tablets, may become unresponsive or poorly responsive over time. Alternatively, TOLINASE 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.

Non-Clinical Toxicology
TOLINASE Tablets are contraindicated in patients with: 1) known hypersensitivity or allergy to TOLINASE; 2) diabetic ketoacidosis, with or without coma. This condition should be treated with insulin; 3) Type I diabetes, as sole therapy.

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 tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ 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 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.

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, the patient should be closely observed for hypoglycemia. When such drugs are withdrawn from a patient receiving TOLINASE, 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, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving TOLINASE, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving TOLINASE, 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.

TOLINASE 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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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