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Cambia

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Cambia

Cambia

INDICATIONS

Acute Treatment of Migraine

CAMBIA (diclofenac potassium for oral solution) ™ (Diclofenac Potassium for Oral Solution) is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).

Important Limitations

  • CAMBIA (diclofenac potassium for oral solution) is not indicated for the prophylactic therapy of migraine.
  • The safety and effectiveness of CAMBIA (diclofenac potassium for oral solution) 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 (diclofenac potassium for oral solution) ™ for the acute treatment of migraine. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 mL) of water, mix well and drink immediately. Do not use liquids other than water.

Taking CAMBIA (diclofenac potassium for oral solution) with food may cause a reduction in effectiveness compared to taking CAMBIA (diclofenac potassium for oral solution) 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.

Interchangeability with Other Formulations of Diclofenac

Different formulations of oral diclofenac (e.g., CAMBIA (diclofenac potassium for oral solution) , 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 (diclofenac potassium for oral solution) .

HOW SUPPLIED

Dosage Forms And Strengths

CAMBIA (diclofenac potassium for oral solution) is available in individual packets each designed to deliver a 50 mg dose when mixed in water.

CAMBIA™ 50 mg (Diclofenac Potassium for Oral Solution) is 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.

CAMBIA (diclofenac potassium for oral solution) is a white to off-white, buffered, flavored, powder for oral solution packaged in individual unit dose packets.

Individual CAMBIA (diclofenac potassium for oral solution) ™ Packets - NDC 66869-513-01

Boxes of nine (9) CAMBIA (diclofenac potassium for oral solution) ™ Packets - NDC 66869-513-09

Store at 25°C (77°F) Excursions permitted from 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]

Manufactured by: MIPHARM S.p.A. Via Bernardo Quaranta, 12 20141 Milan, Italy. Manufactured for: Kowa Pharmaceuticals America, Inc. 530 Industrial Park Blvd. Montgomery, AL. Issued June 2009

Last reviewed on RxList: 7/7/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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