Adult Dosing

Type II Diabetes mellitus

• Start 1 g PO daily
• Maintenance dose: 250 mg-3g/day PO, qd or divided bid
• Max: 3 g/day

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

• In patients with non-insulin-dependent diabetes mellitus (type II) whose hyperglycemia cannot be controlled by diet alone (adjunctive therapy)

• Hypersensitivity to any of the ingredients of the product
• Diabetic ketoacidosis or diabetic coma
• Type I diabetes
• Uncontrolled infection
• Serious burns, or trauma
• Severe renal, hepatic, thyroid, or other endocrine disease

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised; dose adjustments not defined

• Results of the University Group Diabetes Program (UGDP), a long-term prospective clinical trial indicate that oral hypoglycemic drugs are associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. Patients treated for 5-8 yrs with diet plus tolbutamide (1.5 g/day) had a rate of cardiovascular mortality approximately 2.5 times that of patients treated with diet alone
• Risk of severe hypoglycemia; monitor blood glucose periodically
• Administration with alcohol may induce disulfiram-like syndrome with facial flushing and breathlessness
• Infection, stress, or changes in diet may alter requirements for control of blood sugar
• Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes

Cautions: Use cautiously in

• Hepatic or renal impairment
• Severe cardiovascular disease
• Hypoglycemia
• Malnutrition
• High fever
• Prolonged nausea or vomiting
• Impaired thyroid, pituitary, or adrenal function
• G6PD deficiency
• Geriatric patients
• Hypersensitivity to sulfonamides

Pregnancy Category:C

Breastfeeding: Poorly excreted in breast milk; unlikely to adversely affect the breastfed infant. Monitor infant's blood glucose level. This drug is compatible and considered safe with breastfeeding based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776 ) and based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 4 September 2010).

• ENDO: Hypoglycemia, hyponatremia, SIADH
• CNS: Dizziness, drowsiness, headache, weakness
• GI: Nausea, epigastric fullness, heartburn, taste alterations, increased appetite, cholestatic jaundice, vomiting, constipation, diarrhea, drug-induced hepatitis
• DERM: Rashes, photosensitivity, pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions
• METABOLIC: Hepatic porphyria, disulfiram-like reactions
• HEMA: Leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia

• Sulphonylurea; lowers blood sugar by stimulating the release of insulin from the pancreas; increases the sensitivity to insulin at receptor sites
• Mostly metabolized by the liver; CYP450: 2C9 substrate
• Renally excreted
• Half-life: 4.5-6.5 hrs

US Trade Name(s)

• Only generic available

US Availability

tolbutamide (generic )

• TABS: 500 mg

Canadian Trade Name(s)

• Only generic available

Canadian Availability

tolbutamide (generic )

• TABS: 500 mg

UK Trade Name(s)

• Only generic available

UK Availability

tolbutamide (generic )

• TABS: 500 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Endocrine/Metabolic

Antidiabetic Agents

Sulfonylureas

Pricing data from www.DrugStore.com in U.S.A.

• TOLBUTamide 500 MG TABS [Bottle] (MYLAN)
  60 mg = $37.39
  180 mg = $89.07

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Tolbutamide 500 MG Oral Tablet

Ingredient(s): Tolbutamide

Imprint: M;13

Color(s): White

Shape: Round

Size (mm): 12.00

Score: 2

Inactive Ingredient(s): colloidal silicon dioxide / magnesium stearate / microcrystalline cellulose / sodium lauryl sulfate / sodium starch glycolate

Drug Label Author:
Mylan Pharmaceuticals Inc.

DEA Schedule:
Non-Scheduled