Drug Catalog - Product Detail
KETOROLAC TROMETHAMINE TB 10MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-1134-01 | MYLAN | 100 | 10MG | TABLET |
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Description
DESCRIPTION Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is: Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide and triacetin. MM1
How Supplied
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.
Indications & Usage
INDICATIONS & 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
DOSAGE & 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 less then 40 mg/day Patients age less then 65, renally impaired, and/or weight greater then 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not less then 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 greater then 17 years Oral not approved Adult Age 17 to 64 years 20 mg once, then 10 mg q4 to 6 hours prn not less then 40 mg/day Adult Age less then 65 years, renally impaired and/or weight greater then 50 kg 10 mg once, then 10 mg q4 to 6 hours prn not less then 40 mg/day