THALITONE

Absorption THALITONE (chlorthalidone USP) has been formulated with PVP (povidone polyvinylpyrrolidone), a bioavailability enhancer that provides 104% to 116% bioavailability relative to an oral solution of chlorthalidone [see Clinical Studies (14)]. THALITONE cannot be substituted with other formulations of chlorthalidone.

DistributionIn the blood, approximately 75% of the drug is bound to plasma proteins over a concentration range of 0.2 to 7.7 ug/mL.

EliminationThe mean plasma half-life of c...

Two similarly designed, 12-week, double-blind, parallel group, placebo-controlled multicenter studies were conducted to compare THALITONE 15 mg to the standard chlorthalidone 25 mg in terms of reduction in blood pressure and metabolic disturbances. Collectively, a total of 222 patients with long-standing diastolic blood pressure between 90 and 104 mm Hg were randomized to receive THALITONE 15 mg (N=71), standard chlorthalidone 25 mg (N=75), or placebo (N=76). THALITONE 15 mg has the advantage of demonstrating potentially fewer metabolic disturbances (Table 1) in particular, lowered glucose lev...

The following adverse reactions are described in more detail elsewhere in the label;

• Hypotension [see Warnings and Precautions (5.1)]
• Impaired Renal Function [see Warnings and Precautions (5.2)]
• Electrolyte Abnormalities [see Warnings and Precautions (5.3)]
• Metabolic Disturbances [see Warnings and Precautions (5.4)] 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 R...

THALITONE is contraindicated in patients with anuria or hypersensitivity to chlorthalidone or other sulfonamide-derived drugs.

• Anuria (4).
• Hypersensitivity (4).

• Hypotension: Higher risk for patients with impaired sympathetic response, volume-depletion or salt restriction (5.1).
• Renal Impairment: Patients with pre-existing kidney disease may be at higher risk. (5.2).
• Monitor serum electrolytes periodically (5.3). 5.1 Hypotension THALITONE may cause symptomatic hypotension. Patients with impaired sympathetic response, volume-depletion or who are salt restricted may be at increased risk for developing hypotension. If hypotension occurs, place the pat...

7 DRUG INTERACTIONS Effect of chlorthalidone on other drugs Chlorthalidone may add to or potentiate the action of other antihypertensive drugs. Chlorthalidone and related drugs may increase the responsiveness to tubocurarine. Lithium renal clearance is reduced by chlorthalidone, increasing the risk of lithium toxicity. Monitor serum lithium levels during concomitant use.

• Antihypertensive drugs: ...