Diabinese

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

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

Contraindications

Type I diabetes

Diabetes ketoacidosis

Hypersensitivity, sulfa allergy

Severe renal impairment

Cautions

Half life prolonged in renal failure

Efficacy may decrease with prolonged use

Patients with risk of severe hypoglycemia, especiall elderly, debilitated, or malnourished patients, patients with risk factors for cardiovascular events, severe liver impairment

Pregnancy Category: C

Lactation: Excretion in milk unknown/not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Diabinese is part of the drug class:

• Sulfonamides, urea derivatives

Before taking Diabinese, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Diabinese or to any of its ingredients
• have a sulfa allergy
• have kidney problems
• have liver problems
• have Type 1 diabetes or diabetic ketoacidosis, with or without a coma. These conditions should be treated with insulin.
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Diabinese has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Diabinese, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

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.

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You should not use chlorpropamide if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

Contraindications

• Known hypersensitivity to chlorpropamide or any ingredient in formulation.189

• Diabetic ketoacidosis with or without coma.189 a

• Monotherapy for type 1 diabetes mellitus.189 a

Warnings/Precautions

Warnings

Increased cardiovascular mortality reported with certain other antidiabetic agents (i.e., tolbutamide, phenformin).111 189 d However, ADA considers benefits of intensive glycemic control with insulin or sulfonylureas to outweigh the risks overall.112 115 128

General Precautions

Possible severe hypoglycemia, especially in geriatric, debilitated, or malnourished patients and those with adrenal, pituitary, hepatic, or renal insufficiency.189 a d Increased risk of hypoglycemia with strenuous exercise, alcohol ingestion, insufficient caloric intake, or concurrent drug use (e.g., other antidiabetic agents, agents that enhance hypoglycemic effects).189 d (See Specific Drugs under Interactions.)

Higher incidence of hypoglycemia at therapeutic dosages with chlorpropamide than other sulfonylureas;c may result from prolonged duration of action.c d (See Duration under Pharmacokinetics.)

Hypoglycemia may be difficult to recognize in geriatric patients and those receiving β-adrenergic blocking agents.189

Appropriate patient selection and careful dosing and instructions are important to avoid chlorpropamide-induced hypoglycemia.189

Hypoglycemia may result in coma, seizures, or other neurologic impairment.189 a d

If hypoglycemia occurs, immediately reevaluate patient and adjust insulin or chlorpropamide dosage.a Monitor patient for 24–48 hours;189 may require hospitalization and IV glucose.189 a Carefully supervise dose and give frequent feedings for ≥3–5 days.189

Possible loss of glycemic control during periods of stress (e.g., fever, trauma, infection, surgery).101 102 105 106 189 May require use of insulin and/or temporary discontinuance of chlorpropamide.189 a

Efficacy of therapy may decrease over time (secondary failure); evaluate patients at regular intervals.189 a

Assess patient for adequate adjustment of dose and adherence to diet before attributing inadequate response to secondary failure of the drug.189

Manufacturer recommends discontinuance of chlorpropamide if loss of satisfactory glycemic control develops.189 ADA and other clinicians recommend addition of other oral antidiabetic agents or insulin.127 146 173 175 184 185 186 191 192 (See Diabetes Mellitus under Uses.)

Specific Populations

Category C.189

Prolonged (4–10 days), severe hypoglycemia reported in some neonates born to women receiving a sulfonylurea at delivery;189 more frequent with long-acting sulfonylureas (e.g., chlorpropamide).189 Discontinue drug ≥1 month before expected delivery date to minimize the risk of neonatal hypoglycemia.189

Many experts recommend the use of insulin during pregnancy.189

Distributed into milk.189 Use not recommended.189

Safety and efficacy not established.189

Safety and efficacy not established.189 Increased risk of hypoglycemia and/or hyponatremia; hypoglycemia may be difficult to recognize.189 d Cautious dosing recommended.189 (See Geriatric Patients under Dosage and Administration.)

Diminished gluconeogenic capacity and increased risk of hypoglycemia; conservative dosing recommended.189 a (See Hepatic Impairment under Dosage and Administration.)

Monitor liver function frequently during chlorpropamide initiation.a

Increased risk of hypoglycemia; conservative dosing recommended.189 a (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Hypoglycemia,111 189 a nausea,189 a weight gain.111 142 143 144

Applies to chlorpropamide: oral tablet

General

The most commonly reported adverse reactions have included gastrointestinal disturbances such as nausea, diarrhea, vomiting, anorexia, and hunger.[Ref]

Metabolic

Rare (less than 0.1%): Disulfiram-like reactions
Frequency not reported: Hypoglycemia

Sulfonylureas:
Frequency not reported: Hepatic porphyria[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting, anorexia, hunger
Frequency not reported: Proctocolitis[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritus, allergic skin reactions (pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions)

Sulfonylureas:
Frequency not reported: Photosensitivity, porphyria cutanea tarda[Ref]

Hypersensitivity

Frequency not reported: Allergic skin reactions

Hepatic

Rare (less than 0.1%): Cholestatic jaundice, hepatitis
Frequency not reported: Hepatic porphyria[Ref]

Hematologic

Sulfonylureas:
Frequency not reported: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, pancytopenia, eosinophilia[Ref]

Cardiovascular

Sulfonylureas:
Frequency not reported: Increased cardiovascular mortality[Ref]

In the University Group Diabetes Program (UGDP) study, cardiovascular mortality rate was approximately 2.5 times higher in patients treated for 5 to 8 years with diet plus tolbutamide 1.5 g per day compared with that of patients treated with diet alone. The UGDP study was a long-term prospective clinical trial designed to evaluate the effectiveness of glucose lowering drugs in preventing or delaying vascular complications in patients with type 2 diabetes mellitus (n=823). Tolbutamide was stopped based on the increase in cardiovascular mortality; a significant increase in total mortality was not observed, but stopping the drug may have limited the ability to measure that. In view of the close similarities in mode of action and chemical structure among sulfonylureas, these results may apply to other drug in this class.[Ref]

Nervous system

Frequency not reported: Dizziness, headache[Ref]

Some side effects of Diabinese may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.