TOLBUTAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TOLBUTAMIDE (UNII: 982XCM1FOI) (TOLBUTAMIDE - UNII:982XCM1FOI)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

TOLBUTAMIDE

Composition:

TOLBUTAMIDE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tolbutamide tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (type II) whose hyperglycemia cannot be controlled by diet alone. In initiating treatment for non-insulin-dependent 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. If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered. Use of tolbutamide tablets must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary res

Product summary:

Tolbutamide Tablets, USP are available containing 500 mg of tolbutamide, USP. The tablets are white to off-white round, scored tablets debossed with M to the left of the score and 13 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0215-01 bottles of 100 tablets NDC 0378-0215-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED FEBRUARY 2009 TOLB:R14

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TOLBUTAMIDE- TOLBUTAMIDE TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Tolbutamide is an oral blood-glucose-lowering drug of the sulfonylurea
class. Tolbutamide is a pure,
white, crystalline compound which is practically insoluble in water.
The chemical name is
benzenesulfonamide, N-[(butylamino)-carbonyl]-4-methyl-. Its structure
can be represented as follows:
M.W. 270.35 C H N O S
Tolbutamide is supplied as compressed tablets containing 500 mg of
tolbutamide, USP.
Each tablet for oral administration contains 500 mg of tolbutamide and
the following inactive
ingredients: colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, sodium lauryl
sulfate and sodium starch glycolate.
CLINICAL PHARMACOLOGY
ACTIONS
Tolbutamide 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 tolbutamide lowers blood glucose during long-term administration
has not been clearly
established. With chronic administration in Type II diabetic patients,
the blood-glucose-lowering effect
persists despite a gradual decline in the insulin secretory response
to the drug. Extrapancreatic effects
may be involved in the mechanism of action of oral sulfonylurea
hypoglycemic drugs.
Some patients who are initially responsive to oral hypoglycemic drugs,
including tolbutamide, may
become unresponsive or poorly responsive over time. Alternatively,
tolbutamide may be effective in
some patients who have become unresponsive to one or more of the other
sulfonylurea drugs.
PHARMACOKINETICS
When administered orally, tolbutamide is readily absorbed from the
gastrointestinal tract. Absorption is
not impaired and glucose lowering and insulin releasing effects are
not altered if the drug is taken with
food. Detectable levels are present in the plasma within 20 minutes
after oral ingestion of a 500 mg
tolbutamide tablet, with peak levels occurring at 3 to 4 hours and
only small amounts detectable