THALITONE (Page 2 of 2)

ADVERSE REACTIONS

The following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency.

Gastrointestinal System Reactions: anorexia, gastric irritation, nausea, vomiting, cramping, diarrhea, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis.

Central Nervous System Reactions: dizziness, vertigo, paresthesias, headache, xanthopsia.

Hematologic Reactions: leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia.

Dermatologic-Hypersensitivity Reactions: purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis)(cutaneous vasculitis), Lyell’s syndrome (toxic epidermal necrolysis).

Cardiovascular Reaction: Orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates or narcotics.

Other Adverse Reactions: hyperglycemia, glycosuria, hyperuricemia, muscle spasm, weakness, restlessness, impotence.

Whenever adverse reactions are moderate or severe, chlorthalidone dosage should be reduced or therapy withdrawn.

OVERDOSAGE

Symptoms of acute overdosage include nausea, weakness, dizziness and disturbances of electrolyte balance. The oral LD50 of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. The minimum lethal dose (MLD) in humans has not been established. There is no specific antidote but gastric lavage is recommended, followed by supportive treatment. Where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.

DOSAGE AND ADMINISTRATION

Therapy should be initiated with the lowest possible dose, then titrated according to individual patient response. A single dose given in the morning with food is recommended; divided doses are unnecessary.

Hypertension Therapy in most patients should be initiated with a single daily dose of 15 mg. If the response is insufficient after a suitable trial, the dosage may be increased to 30 mg and then to a single daily dose of 45-50 mg. If additional control is required, the addition of a second antihypertensive drug is recommended. Increases in serum uric acid and decreases in serum potassium are dose-related over the 15-50 mg/day range and beyond.

Edema INITIATION: Adults, initially 30 to 60 mg daily or 60 mg on alternate days. Some patients may require 90 to 120 mg at these intervals or up to 120 mg daily. Dosages above this level, however, do not usually produce a greater response.

MAINTENANCE: Maintenance doses may often be lower than initial doses and should be adjusted according to the individual patient. Effectiveness is well sustained during continued use.

HOW SUPPLIED

White, kidney-shaped, compressed tablets coded M/024 containing 15 mg of chlorthalidone in bottles of 100 (NDC 61570-024-01).

Storage: Store below 30°C (86°F).

Rx Only

Prescribing Information as of January 2004.

Distributed by:

Monarch Pharmaceuticals, Inc., Bristol, TN 37620

(A wholly owned subsidiary of King Pharmaceuticals, Inc.)

Manufactured by:

King Pharmaceuticals, Inc., Bristol, TN 37620

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THALITONE
chlorthalidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-024
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORTHALIDONE (CHLORTHALIDONE) CHLORTHALIDONE 15 mg
Product Characteristics
Color WHITE (WHITE) Score no score
Shape FREEFORM (FREEFORM) Size 8mm
Flavor Imprint Code M;024
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61570-024-01 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019574 12/20/1988
Labeler — Monarch Pharmaceuticals, Inc (809587413)

Revised: 07/2011 Monarch Pharmaceuticals, Inc

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