Rx Item-Cambia 50mg Powder 9 By Asserto Therapeutics

CAMBIA- diclofenac potassium powder, for solution
Depomed, Inc.

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1) ].
CAMBIA is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].


Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ].
1 INDICATIONS AND USAGE

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.
2 DOSAGE AND ADMINISTRATION

2.1 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 (12.3) ].

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.

2.2 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.

3 DOSAGE FORMS AND STRENGTHS

CAMBIA is available in individual packets each designed to deliver a 50 mg dose when mixed in water.

Rx Item-Cambia 50mg Powder 9 By Depomed
Item No.: RX581886 NDC No.50192011309 UPC No.:350192113096 NDC No. New 13913-0012-03 63323-0311-61 UPC/GTIN No. 350192-113096 3-50192-11309-6 MPN No. 31161 Only Lic.-Physician, Pharmacy, Dentist, Dr

Cambia 50Mg Powder 9 By Depomed
BRAND: CAMBIA NDC: 50192-0113-09,50192011309 UPC: 3-50192-11309-6,350192113096 Depomed Inc

DICLOFENAC POTASSIUM ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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