Diabinese (Chlorpropamide)
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Diabinese (Chlorpropamide)

DIABINESE®
(chlorpropamide) Tablets, USP
For Oral Use

DRUG DESCRIPTION

DIABINESE® (chlorpropamide), is an oral blood-glucose-lowering drug of the sulfonylurea class. Chlorpropamide is l-[(p-Chlorophenyl)sulfonyl]-3-propylurea, C10H13ClN2O3S, and has the structural formula:

DIABINESE® 
  (chlorpropamide) Structural Formula Illustration

Chlorpropamide is a white crystalline powder, that has a slight odor. It is practically insoluble in water at pH 7.3 (solubility at pH 6 is 2.2 mg/mL). It is soluble in alcohol and moderately soluble in chloroform. The molecular weight of chlorpropamide is 276.74. DIABINESE (chlorpropamide) is available as 100 mg and 250 mg tablets.

Inert ingredients are: alginic acid; Blue 1 Lake; hydroxypropyl cellulose; magnesium stearate; precipitated calcium carbonate; sodiukm lauryl sulfate; starch.

What are the possible side effects of chlorpropamide (Diabinese)?

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 chlorpropamide. Symptoms include headache, hunger, weakness, sweating, tremors, 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.

Stop taking chlorpropamide and call your doctor at...

Read All Potential Side Effects and See Pictures of Diabinese »

What are the precautions when taking chlorpropamide (Diabinese)?

Before taking chlorpropamide, tell your doctor or pharmacist if you are allergic to it; or to other sulfonylurea drugs (e.g., 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).

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,...

Read All Potential Precautions of Diabinese »

Last reviewed on RxList: 3/25/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DIABINESE (chlorpropamide) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

DOSAGE AND ADMINISTRATION

There is no fixed dosage regimen for the management of type 2 diabetes with DIABINESE (chlorpropamide) or any other hypoglycemic agent. The patient's blood glucose must be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood glucose lowering 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 DIABINESE (chlorpropamide) may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

The total daily dosage is generally taken at a single time each morning with breakfast. Occasionally cases of gastrointestinal intolerance may be relieved by dividing the daily dosage. A LOADING OR PRIMING DOSE IS NOT NECESSARY AND SHOULD NOT BE USED.

Initial Therapy

  1. The mild to moderately severe, middle-aged, stable type 2 diabetes patient should be started on 250 mg daily. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section). Older patients should be started on smaller amounts of DIABINESE (chlorpropamide) , in the range of 100 to 125 mg daily.
  2. No transition period is necessary when transferring patients from other oral hypoglycemic agents to DIABINESE (chlorpropamide) . The other agent may be discontinued abruptly and chlorpropamide started at once. In prescribing chlorpropamide, due consideration must be given to its greater potency.

Many mild to moderately severe, middle-aged, stable type 2 diabetes patients receiving insulin can be placed directly on the oral drug and their insulin abruptly discontinued. For patients requiring more than 40 units of insulin daily, therapy with DIABINESE (chlorpropamide) may be initiated with a 50 per cent reduction in insulin for the first few days, with subsequent further reductions dependent upon the response.

During the initial period of therapy with chlorpropamide, hypoglycemic reactions may occasionally occur, particularly during the transition from insulin to the oral drug. Hypoglycemia within 24 hours after withdrawal of the intermediate or long-acting types of insulin will usually prove to be the result of insulin carry-over and not primarily due to the effect of chlorpropamide.

During the insulin withdrawal period, the patient should self-monitor glucose levels at least three times daily. If they are abnormal, the physician should be notified immediately. In some cases, it may be advisable to consider hospitalization during the transition period.

Five to seven days after the initial therapy, the blood level of chlorpropamide reaches a plateau. Dosage may subsequently be adjusted upward or downward by increments of not more than 50 to 125 mg at intervals of three to five days to obtain optimal control. More frequent adjustments are usually undesirable.

Maintenance Therapy

Most moderately severe, middle-aged, stable type 2 diabetes patients are controlled by approximately 250 mg daily. Many investigators have found that some milder diabetics do well on daily doses of 100 mg or less. Many of the more severe diabetics may require 500 mg daily for adequate control. PATIENTS WHO DO NOT RESPOND COMPLETELY TO 500 MG DAILY WILL USUALLY NOT RESPOND TO HIGHER DOSES. MAINTENANCE DOSES ABOVE 750 mg DAILY SHOULD BE AVOIDED.

HOW SUPPLIED

Strength Tablet Description Tablet Code NDC Package Size
DIABINESE (chlorpropamide) 100 mg Blue, D- shaped, scored 393 0069-3930-66 100's
DIABINESE (chlorpropamide) 250 mg Blue, D- shaped, scored 394 0069-3940-66
0069-3940-82
100's
1000's

RECOMMENDED STORAGE: Store below 86°F (30°C).

Distributed by: Pfizer Labs, Division of Pfizer Inc, NY, NY, 10017

Last reviewed on RxList: 3/25/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Body as a Whole: Disulfiram-like reactions have rarely been reported with DIABINESE (chlorpropamide) (see DRUG INTERACTIONS).

Central and Peripheral Nervous System: Dizziness and headache.

Hypoglycemia: See PRECAUTIONS and OVERDOSAGE sections.

Gastrointestinal: Gastrointestinal disturbances are the most common reactions; nausea has been reported in less than 5% of patients, and diarrhea, vomiting, anorexia, and hunger in less than 2%. Other gastrointestinal disturbances have occurred in less than 1% of patients including proctocolitis. They tend to be dose-related and may disappear when dosage is reduced.

Liver/Biliary: Cholestatic jaundice and hepatitis may occur rarely, which may progress to liver failure; DIABINESE (chlorpropamide) should be discontinued if this occurs. Hepatic porphyria and disulfiram-like reactions have been reported with DIABINESE (chlorpropamide) .

Skin/Appendages: Pruritus has been reported in less than 3% of patients. Other allergic skin reactions, e.g., urticaria and maculopapular eruptions have been reported in approximately 1% or less of patients. These may be transient and may disappear despite continued use of DIABINESE (chlorpropamide) ; if skin reactions persist the drug should be discontinued.

As with other sulfonylureas, porphyria cutanea tarda and photosensitivity reactions have been reported.

Skin eruptions rarely progressing to erythema multiforme and exfoliative dermatitis have also been reported.

Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia (see PRECAUTIONS), aplastic anemia, pancytopenia, and eosinophilia have been reported with sulfonylureas.

Metabolic/Nutritional Reactions: Hypoglycemia (see PRECAUTIONS and OVERDOSAGE sections). Hepatic porphyria and disulfiram-like reactions have been reported with DIABINESE (chlorpropamide) . See DRUG INTERACTIONS section.

Endocrine Reactions: On rare occasions, chlorpropamide has caused a reaction identical to the syndrome of inappropriate antidiuretic hormone (ADH) secretion. The features of this syndrome result from excessive water retention and include hyponatremia, low serum osmolality, and high urine osmolality. This reaction has also been reported for other sulfonylureas.

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

DRUG INTERACTIONS

The following products can lead to hypoglycemia:

The hypoglycemic action of sulfonylurea 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 DIABINESE (chlorpropamide) , the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving DIABINESE (chlorpropamide) , the patient should be observed closely for loss of control.

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

Alcohol: In some patients, a disulfiram-like reaction may be produced by the ingestion of alcohol. Moderate to large amounts of alcohol may increase the risk of hypoglycemia (ref.l), (ref. 2).

The following products can lead to hyperglycemia:

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 DIABINESE (chlorpropamide) , the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving DIABINESE (chlorpropamide) , the patient should be observed closely for hypoglycemia.

Since animal studies suggest that the action of barbiturates may be prolonged by therapy with chlorpropamide, barbiturates should be employed with caution.

Last reviewed on RxList: 3/25/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Special Warning 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 non-insulin-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 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2V2 times that of patients treated 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 over-all 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 DIABINESE (chlorpropamide) 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

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with DIABINESE (chlorpropamide) or any other anti-diabetic drug.

Hypoglycemia: All sulfonylurea drugs including chlorpropamide are capable of producing severe hypoglycemia, which may result in coma, and may require hospitalization. Patients experiencing hypoglycemia should be managed with appropriate glucose therapy and be monitored for a minimum of 24 to 48 hours (see OVERDOSAGE section). Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Regular, timely carbohydrate intake is important to avoid hypoglycemic events occurring when a meal is delayed or insufficient food is eaten or carbohydrate intake is unbalanced. Renal or hepatic insufficiency may affect the disposition of DIABINESE (chlorpropamide) and 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.

Because of the long half-life of chlorpropamide, patients who become hypoglycemic during therapy require careful supervision of the dose and frequent feedings for at least 3 to 5 days. Hospitalization and intravenous glucose may be necessary.

Loss of control of blood glucose: When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue DIABINESE (chlorpropamide) and administer insulin.

The effectiveness of any oral hypoglycemic drug, including DIABINESE (chlorpropamide) , 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.

Hemolytic Anemia: Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because DIABINESE (chlorpropamide) belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In post marketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.

Geriatric Use

The safety and effectiveness of DIABINESE (chlorpropamide) in patients aged 65 and over has not been properly evaluated in clinical studies. Adverse event reporting suggests that elderly patients may be more prone to developing hypoglycemia and/or hyponatremia when using DIABINESE (chlorpropamide) . Although the underlying mechanisms are unknown, abnormal renal function, drug interaction and poor nutrition appear to contribute to these events.

Laboratory Tests

Blood glucose should be monitored periodically. Measurement of glycosylated hemoglobin should be performed and goals assessed by the current standard of care.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with DIABINESE (chlorpropamide) have not been conducted to evaluate carcinogenic or mutagenic potential.

Rats treated with continuous DIABINESE (chlorpropamide) therapy for 6 to 12 months showed varying degrees of suppression of spermatogenesis at a dose level of 250 mg/kg (five times the human dose based on body surface area). The extent of suppression seemed to follow that of growth retardation associated with chronic administration of high-dose DIABINESE in rats. The human dose of chlorpropamide is 500 mg/day (300 mg/M2). Six- and 12-month toxicity work in the dog and rat, respectively, indicates the 150 mg/kg is well tolerated. Therefore, the safety margins based upon body-surf ace-area comparisons are three times human exposure in the rat and 10 times human exposure in the dog.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Animal reproductive studies have not been conducted with DIABINESE (chlorpropamide) . It is also not known whether DIABINESE (chlorpropamide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DIABINESE (chlorpropamide) should be given to a pregnant woman only if the potential benefits justify the potential risk to the patient and fetus.

Because data suggest 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 (4 to 10 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 DIABINESE (chlorpropamide) is used during pregnancy, it should be discontinued at least one month before the expected delivery date and other therapies instituted to maintain blood glucose levels as close to normal as possible.

Nursing Mothers

An analysis of a composite of two samples of human breast milk, each taken five hours after ingestion of 500 mg of chlorpropamide by a patient, revealed a concentration of 5 mcg/mL. For reference, the normal peak blood level of chlorpropamide after a single 250 mg dose is 30 mcg/mL. Therefore, it is not recommended that a woman breast feed while taking this medication.

Use in Children

Safety and effectiveness in children have not been established.

Ability to Drive and Use Machines

The effect of DIABINESE (chlorpropamide) on the ability to drive or operate machinery has not been studied. However, there is no evidence to suggest that DIABINESE (chlorpropamide) may affect these abilities. Patients should be aware of the symptoms of hypoglycemia and take caution while driving and operating machinery.

Last reviewed on RxList: 3/25/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage of sulfonylureas including DIABINESE (chlorpropamide) can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that 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 diagnosed or suspected, 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 that 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

DIABINESE (chlorpropamide) is contraindicated in patients with:

  1. Known hypersensitivity to any component of this medicine.
  2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.

Last reviewed on RxList: 3/25/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

DIABINESE (chlorpropamide) 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 DIABINESE (chlorpropamide) lowers blood glucose during long-term administration has not been clearly established. Extra-pancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. While chlorpropamide is a sulfonamide derivative, it is devoid of antibacterial activity.

DIABINESE (chlorpropamide) may also prove effective in controlling certain patients who have experienced primary or secondary failure to other sulfonylurea agents.

A method developed which permits easy measurement of the drug in blood is available on request.

Chlorpropamide does not interfere with the usual tests to detect albumin in the urine.

DIABINESE (chlorpropamide) is absorbed rapidly from the gastrointestinal tract. Within one hour after a single oral dose, it is readily detectable in the blood, and the level reaches a maximum within two to four hours. It undergoes metabolism in humans and it is excreted in the urine as unchanged drug and as hydroxylated or hydrolyzed metabolites. The biological half-life of chlorpropamide averages about 36 hours. Within 96 hours, 80-90% of a single oral dose is excreted in the urine. However, long-term administration of therapeutic doses does not result in undue accumulation in the blood, since absorption and excretion rates become stabilized in about 5 to 7 days after the initiation of therapy.

DIABINESE (chlorpropamide) exerts a hypoglycemic effect in healthy subjects within one hour, becoming maximal at 3 to 6 hours and persisting for at least 24 hours. The potency of chlorpropamide is approximately six times that of tolbutamide. Some experimental results suggest that its increased duration of action may be the result of slower excretion and absence of significant deactivation.

Last reviewed on RxList: 3/25/2011
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 DIABINESE (chlorpropamide) 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 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.

Patients should be instructed to contact their physician promptly if they experience symptoms of hypoglycemia or other adverse reactions.

Physician Counseling Information for Patients

In initiating treatment for type 2 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. Use of DIABINESE (chlorpropamide) or other antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution 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 DIABINESE (chlorpropamide) or other antidiabetic medications. Maintenance or discontinuation of DIABINESE (chlorpropamide) or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.

Last reviewed on RxList: 3/25/2011
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 DIABINESE (chlorpropamide) 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 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.

Patients should be instructed to contact their physician promptly if they experience symptoms of hypoglycemia or other adverse reactions.

Physician Counseling Information for Patients

In initiating treatment for type 2 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. Use of DIABINESE (chlorpropamide) or other antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution 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 DIABINESE (chlorpropamide) or other antidiabetic medications. Maintenance or discontinuation of DIABINESE (chlorpropamide) or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.

Last reviewed on RxList: 3/25/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Diabinese 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.

CHLORPROPAMIDE - ORAL

(klor-PROE-pa-mide)

COMMON BRAND NAME(S): Diabinese

USES: Chlorpropamide 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. Chlorpropamide 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 as directed by your doctor. 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 each day.

Disclaimer

Diabinese Consumer (continued)

SIDE EFFECTS: Nausea, loss of appetite, diarrhea, 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, painful bowel movements, bloody or black stools.

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 and eat frequent small meals for at least 3-5 days after an episode of hypoglycemia with chlorpropamide because this drug has a long effect in your body. Consult your doctor for further instructions.

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 Diabinese (chlorpropamide) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking chlorpropamide, tell your doctor or pharmacist if you are allergic to it; or to other sulfonylurea drugs (e.g., 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).

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.

Avoid alcohol while taking this medication because it can increase the risk of developing hypoglycemia. Also, alcohol can interact with chlorpropamide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain.

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, or 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 and fluid/mineral imbalance.

This medication should be used only when clearly needed during pregnancy. It is not recommended for use for at least 1 month 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.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Diabinese 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 all your medicines (e.g., cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about the safe use of those products.

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, use 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 below 86 degrees F (30 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.

Diabinese Patient Information Including Side Effects

Brand Names: Diabinese

Generic Name: chlorpropamide (Pronunciation: klor PROE pa mide)

What is chlorpropamide (Diabinese)?

Chlorpropamide is an oral diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin.

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

Chlorpropamide should not be used by itself to treat type 1 (insulin-dependent) diabetes.

Chlorpropamide may also be used for purposes not listed in this medication guide.

Chloropropamide 250 mg-MYL

round, green, imprinted with MYLAN 210, 250

Chlorpropamide 100 mg-MYL

round, green, imprinted with 100, MYLAN 197

What are the possible side effects of chlorpropamide (Diabinese)?

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 chlorpropamide. Symptoms include headache, hunger, weakness, sweating, tremors, 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.

Stop taking chlorpropamide and call your doctor at once if you have a serious side effect such as:

  • easy bruising or bleeding, unusual weakness;
  • pale or yellowed skin, dark colored urine, stomach pain, fever, confusion;
  • trouble concentrating, memory problems, loss of appetite, feeling unsteady, hallucinations, or fainting;
  • throbbing headache, sweating, severe nausea, trouble breathing, fast or pounding heartbeats, blurred vision, spinning sensation, feeling light-headed, fainting; or
  • sore throat and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea;
  • mild hunger; or
  • mild skin rash, redness, or itching.

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 Diabinese (chlorpropamide) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about chlorpropamide (Diabinese)?

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

Before taking chlorpropamide, tell your doctor if you have kidney or liver disease, a disorder of your pituitary or adrenal glands, a history of heart disease, or if you are malnourished.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with chlorpropamide.

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, tremors, 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 chlorpropamide dose.

Chlorpropamide 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

Diabinese Patient Information including How Should I Take

What should I discuss with my doctor before taking chlorpropamide (Diabinese)?

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

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

  • liver disease;
  • kidney disease;
  • a disorder of your pituitary or adrenal glands;
  • a history of heart disease; or
  • if you are malnourished.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with chlorpropamide.

FDA pregnancy category C. It is not known whether chlorpropamide 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.

Chlorpropamide can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking chlorpropamide.

How should I take chlorpropamide (Diabinese)?

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.

Chlorpropamide is usually taken once per day with breakfast. 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, tremors, irritability, or trouble concentrating. Hypoglycemia can occur if you skip a meal, exercise too long, drink alcohol, or are under stress.

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. 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.

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.

Ask your doctor how to adjust your chlorpropamide dose if needed. Do not change your medication dose or schedule without your doctor's advice.

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

Store at room temperature away from moisture, heat, and light.

Side Effects Centers

Diabinese Patient Information including If I Miss a Dose

What happens if I miss a dose (Diabinese)?

Take the missed dose as soon as you remember (take the medication with food if your doctor instructs you to). 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 (Diabinese)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.A chlorpropamide 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 chlorpropamide (Diabinese)?

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

Avoid exposure to sunlight or tanning beds. Chlorpropamide can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect chlorpropamide (Diabinese)?

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

  • isoniazid;
  • diuretics (water pills);
  • steroids (prednisone and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • seizure medicines (Dilantin and others);
  • diet pills; and
  • medicines to treat asthma, colds or allergies.

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

  • exenatide (Byetta);
  • probenecid (Benemid);
  • some nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • sulfa drugs (Bactrim and others);
  • a monoamine oxidase inhibitor (MAOI);
  • beta-blockers (Tenormin and others);
  • a blood thinner (warfarin, Coumadin and others); and
  • other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

This list is not complete and other drugs may interact with chlorpropamide. 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 chlorpropamide.


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: 4.02. 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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