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chlorpropamide
Overview
What is Chlorpropamide?
Chlorpropamide is an oral blood-glucose-lowering drug of the sulfonylurea class. Chlorpropamide, USP is a white, crystalline powder, that has a slight odor. It is practically insoluble in water, but is soluble in alcohol. Chemically, it is 4-chloro-
-[(propyl-amino)carbonyl] benzene sulfonamide which may be represented by the following structure:
Chlorpropamide is supplied as compressed tablets containing 100 mg or 250 mg of chlorpropamide, USP and contains the following inactive ingredients: calcium carbonate, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, glycine, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.
What does Chlorpropamide look like?
What are the available doses of Chlorpropamide?
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What should I talk to my health care provider before I take Chlorpropamide?
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How should I use Chlorpropamide?
Chlorpropamide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
There is no fixed dosage regimen for the management of type 2 diabetes with 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 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.
What interacts with Chlorpropamide?
- Chlorpropamide tablets are contraindicated in patients with:
- Known hypersensitivity to any component of this medicine.
- Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.
What are the warnings of Chlorpropamide?
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 (
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 2½ 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 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 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.
What are the precautions of Chlorpropamide?
General
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There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with chlorpropamide or any other antidiabetic drug.
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Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because 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 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 chlorpropamide. Although the underlying mechanisms are unknown, abnormal renal function, drug interaction and poor nutrition appear to contribute to these events.
Information for Patients
Patients should be informed of the potential risks and advantages of 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 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 chlorpropamide or other antidiabetic medications. Maintenance or discontinuation of chlorpropamide or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.
Laboratory Tests
Blood glucose should be monitored periodically. Measurement of glycosylated hemoglobin should be performed and goals assessed by the current standard of care.
Drug Interactions
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The hypoglycemic action of sulfonylurea may be potentiated by certain drugs including non-steroidal 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 chlorpropamide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving chlorpropamide, the patient should be observed closely for loss of control.
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Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies with chlorpropamide have not been conducted to evaluate carcinogenic or mutagenic potential.
Rats treated with continuous 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 chlorpropamide in rats. The human dose of chlorpropamide is 500 mg/day (300 mg/M
). Six- and twelve-month toxicity work in the dog and rat, respectively, indicates the 150 mg/kg is well tolerated. Therefore, the safety margins based upon body-surface-area comparisons are 3 times human exposure in the rat and 10 times human exposure in the dog.
Pregnancy
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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 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 5 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 chlorpropamide on the ability to drive or operate machinery has not been studied. However, there is no evidence to suggest that chlorpropamide may affect these abilities. Patients should be aware of the symptoms of hypoglycemia and take caution while driving and operating machinery.
What are the side effects of Chlorpropamide?
Body as a Whole:
Central and Peripheral Nervous System:
Hypoglycemia:
Gastrointestinal:
Liver/Biliary:
Skin/Appendages:
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:
Metabolic/Nutritional Reactions:
Endocrine Reactions:
What should I look out for while using Chlorpropamide?
Chlorpropamide tablets are contraindicated in patients with:
What might happen if I take too much Chlorpropamide?
Overdosage of sulfonylureas including 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.
How should I store and handle Chlorpropamide?
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].Dispense in a tight container [see USP].Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].Dispense in a tight container [see USP].Chlorpropamide Tablets, USP are available containing either 250 mg of Chlorpropamide, USP.The 250 mg tablets are green round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorpropamide Tablets, USP are available containing either 250 mg of Chlorpropamide, USP.The 250 mg tablets are green round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorpropamide Tablets, USP are available containing either 250 mg of Chlorpropamide, USP.The 250 mg tablets are green round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorpropamide Tablets, USP are available containing either 250 mg of Chlorpropamide, USP.The 250 mg tablets are green round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorpropamide Tablets, USP are available containing either 250 mg of Chlorpropamide, USP.The 250 mg tablets are green round, scored tablets debossed with above the score and below the score on one side of the tablet and on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 chlorpropamide lowers blood glucose during long-term administration has not been clearly established. Extrapancreatic 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.
Chlorpropamide may also prove effective in controlling certain patients who have experienced primary or secondary failure to other sulfonylurea agents.
Chlorpropamide does not interfere with the usual tests to detect albumin in the urine.
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 2 to 4 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% to 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.
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 6 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.
Non-Clinical Toxicology
Chlorpropamide tablets are contraindicated in patients with:Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracyclines in conjunction with penicillin.
Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.
Absorption of tetracyclines is impaired by bismuth subsalicylate.
Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.
The concurrent use of tetracycline and Penthrane (methoxyflurane) has been reported to result in fatal renal toxicity.
Concurrent use of tetracycline may render oral contraceptives less effective.
Body as a Whole:
Central and Peripheral Nervous System:
Hypoglycemia:
Gastrointestinal:
Liver/Biliary:
Skin/Appendages:
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:
Metabolic/Nutritional Reactions:
Endocrine Reactions:
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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