April 29, 2016
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Cambia

"Most of us get headaches from time to time. Some are mild. Others cause throbbing pain. They can last for minutes or days. There are many different types of headaches. How you treat yours depends on which kind you have.

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Cambia




Indications
Dosage
How Supplied

INDICATIONS

Acute Treatment Of Migraine

CAMBIA (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 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.

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

Individual CAMBIA Packets - NDC 13913-011-91
Boxes of nine (9) CAMBIA Packets - NDC 13913-011-19

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: Depomed, Inc. Newark, CA 94560. Revised: Jan 2014

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

Last reviewed on RxList: 3/9/2016

Indications
Dosage
How Supplied

Cambia - User Reviews

Cambia User Reviews

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