"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...
Thalitone® (chlorthalidone USP) is indicated in the management of hypertension either alone or in combination with other antihypertensive drugs. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Chlorthalidone is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see WARNINGS below). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease) but that is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest.In these cases,a short course of diuretics may provide relief and may be appropriate.
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.
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.
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.
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).
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. FDA Rev date: 6/1/2004This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/16/2008
Additional Thalitone Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.