Jane S. Ricciuti, RPh, MS


April 22, 2003

In This Article

Antihypertensive Agents

(timolol maleate-hydrochlorothiazide) Tablets

Manufacturer: Merck & Co, Inc

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/04/03)

Precautions: This supplemental application is for the addition of a "Geriatric Use" section to the labeling for Timolide (timolol maleate-hydrochlorothiazide):

Clinical studies of Timolide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

  • This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

  • Published data from single and/or multiple dose pharmacokinetic (PK) studies comparing the impact of age on the PK of hydrochlorothiazide, when given in combination with other antihypertensive drugs, were consistent. The results indicated a median increase in the Cmax and AUC for hydrochlorothiazide of approximately 40% and 100%, respectively, in elderly compared with younger subjects.

  • Timolide (timolol maleate-hydrochlorothiazide) Tablets Letter

    Timolide (timolol maleate-hydrochlorothiazide) Tablets


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