Ketorolac (Ketorolac Tromethamine) - Indications and Dosage

INDICATIONS AND USAGE

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

Acute Pain in Adult Patients

Ketorolac tromethamine tablets are 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 ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.

The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets 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 ketorolac tromethamine tablet therapy is not to exceed 5 days.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use 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 ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets 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 ketorolac tromethamine tablets:

Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 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 to 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 ketorolac tromethamine tablets is not to exceed 5 days.

The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group:

Table 4: Summary of Dosing Instructions

Patient Population	Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac tromethamine)
Age < 17 years	Oral not approved
Adult Age 17 to 64 years	20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day
Adult Age ≥ 65 years, renally impaired and/or weight <50 kg	10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day

HOW SUPPLIED

Ketorolac Tromethamine Tablets, USP are available containing 10 mg of ketorolac tromethamine, USP. The tablets are white film-coated, round, unscored tablets debossed with M over 134 on one side and blank on the other side. They are available as follows:

NDC 0378-1134-01 bottles of 100 tablets

Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

PHARMACIST: Dispense a Medication Guide with each prescription.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REVISED AUGUST 2008
KTLC:R6mc