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Does Tolinase (tolazamide) cause side effects?
Tolinase (tolazamide) is a prescription diabetes medication used with diet and exercise to reduce blood glucose levels in adult patients with type 2 diabetes mellitus. Other diabetes drugs are sometimes used in combination with Tolinase. Tolinase’s initial effect is to increase beta-cell insulin secretion.
Tolinase causes the pancreas to produce insulin and increases the body's response to it. Tolinase also may decrease the rate of hepatic glucose production, increase insulin receptor sensitivity, and increase the number of insulin receptors. The brand name Tolinase is discontinued.
Common side effects of Tolinase include:
- feeling unwell (malaise),
- spinning sensation (vertigo),
- increased sensitivity to the sunlight (photophobia),
- loss of appetite,
- feeling of stomach fullness,
- muscle weakness, and
- water loss from the body (diuresis).
Serious side effects of Tolinase include:
- disulfiram (Antabuse)-like reactions [for example, severe flushing accompanied by low blood pressure (hypotension) and fast heart rate],
- low blood glucose,
- low blood sodium,
- syndrome of inappropriate antidiuretic hormone secretion (SIADH),
- blood disorders, and
- liver dysfunction.
Drug interactions of Tolinase include quinolone antibiotics, which may result in abnormal changes in blood glucose.
Tolinase may increase blood levels of methotrexate by interfering with the binding of methotrexate to blood proteins.
What are the imporant side effects of Tolinase (tolazamide)?
Side effects associated with tolazamide therapy include:
- Increase sensitivity to the sunlight (photophobia),
- Sensations of stomach fullness
- Muscle weakness
- Water loss from the body (diuresis)
Possible serious side effects of tolazamide include:
Tolinase (tolazamide) side effects list for healthcare professionals
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 prescribing information.
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.
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.
What drugs interact with Tolinase (tolazamide)?
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.
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 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.
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.
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.
Safety and effectiveness in children have not been established.
Elderly patients are particularly susceptible to the hypoglycemic action of glucose lowering drugs. Hypoglycemia may be difficult to recognize in the elderly. The initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.
Elderly patients are prone to develop renal insufficiency, which may put them at risk of hypoglycemia. Dose selection should include assessment of renal function.
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Normal Blood Sugar Levels (Ranges) In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Type 2 Diabetes Diet Plan
A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Diabetes Symptoms in Men
Diabetes mellitus is a disease in which a person's blood sugar (blood glucose) is either too high (hyperglycemia) or too low (hypoglycemia) due to problems with insulin regulation in the body. There are two main types of diabetes mellitus, type 1 and type 2. Type 1 diabetes usually occurs during childhood, while type 2 diabetes usually occurs during adulthood, however, rates of both types of diabetes in children, adolescents, and teens is increasing. More men than women have diabetes in the US, and the disease can affect men differently than women.Warning symptoms of diabetes that men have and women do not include low testosterone (low-t), sexual problems, impotence (erectile dysfunction), decreased interest in sex, and retrograde ejaculation. Type 1 and type 2 diabetes symptoms and signs that are the same in men and women include skin infections, numbness or tingling in the feet or hands, nausea, excessive thirst or hunger, fatigue, irritability, blurred vision, weight gain, weight loss, urinary tract infections (URIs), and kidney problems. Treatment for type 1 diabetes is insulin, and treatment for type 2 diabetes are lifestyle changes like eating a healthy diet, getting exercise daily, and if necessary, diabetes medications.
Diabetes Symptoms in Women
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Type 1 vs. Type 2 Diabetes: Differences
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Diabetes Treatment: Medication, Diet, and Insulin
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Type 2 Diabetes
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Pregnancy and Gestational Diabetes
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Sex, Urinary, and Bladder Problems of Diabetes
Having diabetes can mean early onset and increased severity of bladder symptoms (urinary incontinence and urinary tract infections) and changes in sexual function. Men may have erectile dysfunction; and women may have problems with sexual response and vaginal lubrication. Keep your diabetes under control, and you can lower your risk of sexual and urologic problems.
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Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
Diabetes and Kidney Disease
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Tips for Managing Type 1 and 2 Diabetes at Home
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.