Ketorolac Tromethamine Ketorolac Tromethamine 10 MG Oral Tablet

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. 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.

Mylan Pharmaceuticals Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] headache` `[5] pain` `[6] diarrhoea` `[7] dyspnoea` `[8] insomnia` `[9] off label use` `[10] depression`

6 years ago

ROUND WHITE M 134

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 Controlled Room Temperature.] Protect from light and excessive humidity. 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.

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Ketorolac Tromethamine Ketorolac Tromethamine 10 MG Oral Tablet

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] nausea [4] headache [5] pain [6] diarrhoea [7] dyspnoea [8] insomnia [9] off label use [10] depression

ROUND WHITE M 134

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] headache` `[5] pain` `[6] diarrhoea` `[7] dyspnoea` `[8] insomnia` `[9] off label use` `[10] depression`