Side Effects of Diabinese (chlorpropamide)

Diabinese (chlorpropamide) is an oral blood sugar-lowering drug in the sulfonylurea class used to manage type II diabetes. It is commonly referred to as a first-generation sulfonylurea. 

The primary difference between the first and second-generation sulfonylureas is in the way they are eliminated from the body. Second-generation sulfonylureas usually are taken less frequently each day than first-generation sulfonylureas and generally are preferred when there is poor function of the kidneys.  

All sulfonylureas lower blood sugar (glucose) by increasing the release of insulin from the pancreas. (Insulin is the hormone that lowers the blood sugar level.) 

Approximately 90% of patients with diabetes have type II diabetes, formerly called non-insulin-dependent diabetes mellitus. Type II diabetes usually occurs in adults and is associated with obesity and a strong family history of diabetes. 

The inability to control blood glucose in type II diabetes is caused by reduced insulin release by the pancreas as well as decreased removal of glucose from the blood by the body's cells.

Drug interactions of Diabinese include blood thinners, chloramphenicol, clofibrate, alcohol, monoamine oxidase inhibitors (MAOIs), nonsteroidal anti-inflammatory drugs (NSAIDs), sulfonamides, and drugs that make urine more acidic including ammonium chloride because they can increase the risk of hypoglycemia.

• Diuretics including hydrochlorothiazide and furosemide may increase blood glucose, reducing the effect of Diabinese.
• Alcohol may interact with Diabinese, to cause moderate to severe facial flushing and an increase in facial temperature.
• Beta-blockers may lower or increase glucose levels when used alone.
• When used with sulfonylureas, beta-blocking drugs may interfere with glucose-lowering by the sulfonylureas.
• In addition, beta-blockers can blunt some of the body's protective responses to hypoglycemia, for example, increased heart rate, thus making it difficult for patients to recognize hypoglycemia. This notwithstanding, beta-blockers have been used successfully in diabetic patients and have been associated with improved survival in diabetics with high blood pressure. 

No adequate safety and efficacy studies of Diabinese, have been conducted in humans. Sulfonylureas generally are not a good choice for pregnant women. 

Diabinese is excreted in breast milk. Because hypoglycemia may occur in the infant who breastfeeds from a mother taking Diabinese, either formula feedings or discontinuation of Diabinese, is strongly recommended in females who are breastfeeding.

What are the common side effects of Diabinese?

Common side effects of Diabinese include

• nausea,
• vomiting,
• heartburn,
• diarrhea,
• headache,
• hypoglycemia (symptoms include hunger, nausea, tiredness, sweating, headache, heart palpitations, numbness around the mouth, tingling of the fingers, tremors, muscle weakness, blurred vision, cold sensation, excessive yawning, irritability, confusion, or loss of consciousness),
• weight gain,
• sun sensitivity (skin rash), and
• allergic-type skin-reactions such as itching and hives.

What are the serious side effects of Diabinese?

Serious side effects of Diabinese rarely include

• blood disorders such as low white cell counts or low red cell counts and fluid retention and
• swelling of the body due to jaundice, hepatitis, or
• a low blood sodium concentrate.

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.

• Body as a Whole: Disulfiram-like reactions have rarely been reported with Diabinese (chlorpropamide).
• Central and Peripheral Nervous System: Dizziness and headache.
• Hypoglycemia: See prescribing information.
• 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, aplastic anemia, pancytopenia, and eosinophilia have been reported with sulfonylureas.
• Metabolic/Nutritional Reactions: Hypoglycemia. Hepatic porphyria and disulfiram-like reactions have been reported with Diabinese (chlorpropamide) . See Drug Interactions section below.
• 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.