"Medscape Medical News
August 22, 2015
The US Food and Drug Administration (FDA) has granted tentative approval to expand the label for an extended-release formulation of topiramate (Trokendi XR, Supernus "...
Limitations Of Use
DOSAGE AND ADMINISTRATION
Acute Treatment Of Migraine
Administer one packet (50 mg) of CAMBIA for the acute treatment of migraine. Empty the contents of one packet into a cup containing 1 to 2 ounces or 2 to 4 tablespoons (30 to 60 mL) of water, mix well and drink immediately.
Do not use liquids other than water.
Taking CAMBIA with food may cause a reduction in effectiveness compared to taking CAMBIA on an empty stomach [see CLINICAL PHARMACOLOGY]. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The safety and effectiveness of a second dose have not been established.
Non-Interchangeability With Other Formulations Of Diclofenac
Different formulations of oral diclofenac (e.g., CAMBIA, diclofenac sodium enteric-coated tablets, diclofenac sodium extended-release tablets, or diclofenac potassium immediate-release tablets) may not be bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulation of diclofenac to CAMBIA.
Dosage Forms And Strengths
CAMBIA is available in individual packets each designed to deliver a 50 mg dose when mixed in water.
Storage And Handling
CAMBIA (diclofenac potassium) 50 mg, is a white to off-white, buffered, flavored powder for oral solution, supplied as one or more sets of three perforated co-joined individual dose packets. Each individual packet is designed to deliver a dose of 50 mg diclofenac potassium when mixed in water.
NDC 13913-012-01 Individual
NDC 13913-012-03 Boxes of nine (9) CAMBIA Packets
Store at 25°C (77°F). Excursions permitted from 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]
Distributed by: Depomed, Inc. Newark, CA 94560. For more information, go to www. CambiaRx.com or call 1-866-458-6389. Revised: May 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/23/2016
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