July 2, 2016
Recommended Topic Related To:

Cambia

"Jan. 15, 2013 -- Women who have migraine with aura may have a higher risk of heart attacks, and they may face a higher risk of dangerous blood clots if they use certain hormonal contraceptives.

Those are the findings from two newly pu"...

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Cambia




Indications
Dosage
How Supplied

INDICATIONS

CAMBIA is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).

Limitations Of Use

  • CAMBIA is not indicated for the prophylactic therapy of migraine.
  • The safety and effectiveness of CAMBIA have not been established for cluster headache, which is present in an older, predominantly male population.

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.

HOW SUPPLIED

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 CAMBIA Packets
NDC 13913-012-03 Boxes of nine (9) CAMBIA Packets

Storage

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 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/23/2016

Indications
Dosage
How Supplied

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