"The US Food and Drug Administration (FDA) has approved diclofenac sodium injection (Dyloject, Hospira Inc), a proprietary nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate pain, and for the management of mod"...
TIVORBEX is indicated for treatment of mild to moderate acute pain in adults.
DOSAGE AND ADMINISTRATION
General Dosing Instructions
Carefully consider the potential benefits and risks of TIVORBEX and other treatment options before deciding to use TIVORBEX. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
For treatment of mild to moderate acute pain, the dosage is 20 mg three times daily or 40 mg two or three times daily.
Non-Interchangeability With Other Formulations Of Indomethacin
Different dose strengths and formulations of oral indomethacin are not interchangeable. This difference should be taken into consideration when changing strengths or formulations.
Dosage Forms And Strengths
TIVORBEX (indomethacin) Capsules 20 mg – dark blue body and light blue cap (imprinted IP-201 on the body and 20 mg on the cap in white ink).
TIVORBEX (indomethacin) Capsules 40 mg – dark blue body and blue cap (imprinted IP202 on the body and 40 mg on the cap in white ink).
Storage And Handling
TIVORBEX (indomethacin) are supplied as:
- 20 mg, dark blue body and light blue cap (imprinted IP-201 on the body and 20 mg on the cap in white ink)
NDC 42211-201-23, Bottles of 30 capsules
NDC 42211-201-29, Bottles of 90 capsules
- 40 mg, dark blue body and blue cap (imprinted IP-202 on the body and 40 mg on the cap in white ink)
NDC 42211-202-23, Bottles of 30 capsules
NDC 42211-202-29, Bottles of 90 capsules
Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Store in the original container and keep the bottle tightly closed to protect from moisture and light. Dispense in a tight container if package is subdivided.
Manufactured (under license from iCeutica Pty Ltd.) for and Distributed by: Iroko Pharmaceuticals, LLC Philadelphia, PA 19112. Revised: May/2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/23/2016
Additional Tivorbex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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