Carefully consider the potential benefits and risks of TORADOL (ketorolac tromethamine) and other treatment options before deciding to use TORADOL (ketorolac tromethamine) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Acute Pain in Adult Patients

TORADOL (ketorolac tromethamine) ^ORAL is indicated for the short-term ( ≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine, and TORADOL (ketorolac tromethamine) ^ORAL is to be used only as continuation treatment, if necessary.

The total combined duration of use of TORADOL (ketorolac tromethamine) ^ORAL and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but TORADOL (ketorolac tromethamine) ^ORAL therapy is not to exceed 5 days.

Carefully consider the potential benefits and risks of TORADOL (ketorolac tromethamine) and other treatment options before deciding to use TORADOL (ketorolac tromethamine) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and TORADOL (ketorolac tromethamine) ^ORAL is not to exceed 5 days. In adults, the use of TORADOL (ketorolac tromethamine) ^ORAL is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.

Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose TORADOL (ketorolac tromethamine) ^ORAL:

Patients age 17 to 64: 20 mg PO once followed by 10 mg q4-6 hours prn not > 40 mg/day

Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4-6 hours prn not > 40 mg/day

Note:

Oral formulation should not be given as an initial dose

Use minimum effective dose for the individual patient

Do not shorten dosing interval of 4 to 6 hours

Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and TORADOL (ketorolac tromethamine) ^ORAL is not to exceed 5 days.

The following table summarizes TORADOL (ketorolac tromethamine) ^ORAL dosing instructions in terms of age group:

Table 4 :Summary of Dosing Instructions

TORADOL (ketorolac tromethamine) ^ORAL10 mg tablets are round, white, film-coate d, red printed tablets. There is a large T printed on both sides of the tablet, with TORADOL (ketorolac tromethamine) on one side, and ROCHE on the other, available in bottles of 100 tablets (NDC 0004-0273-01).

Storage

Store bottles at 15°to 30°C (59°to 86°F).

Distributed by: Roche Laboratories Inc.340 Kingsland Street, Nutley, New Jersey 07110 - 1199. FDA revision date: 11/13/2007

Last reviewed on RxList: 12/17/2007
This monograph has been modified to include the generic and brand name in many instances.