Cambia 50 mg/1

diclofenac potassium · POWDER, FOR SOLUTION · Assertio Therapeutics, Inc.

No Recall History

Plain English

Cambia is a powder, for solution containing diclofenac potassium at 50 mg/1, taken oral. Manufactured by Assertio Therapeutics, Inc..

Key Facts

Brand Name: Cambia
Generic Name: diclofenac potassium
NDC Code (Product): 13913-012
Manufacturer: Assertio Therapeutics, Inc.
Strength: 50 mg/1
Dosage Form: POWDER, FOR SOLUTION
Route: ORAL
Marketing Status
Application #: NDA022165
Marketing Start: 03/10/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,707 reports

fatigue2,445 reports

rheumatoid arthritis2,439 reports

pain2,390 reports

off label use2,377 reports

rash2,359 reports

systemic lupus erythematosus2,267 reports

joint swelling2,265 reports

wound2,161 reports

abdominal discomfort2,114 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older ( 1 ) Limitations of Use ( 1 ): CAMBIA is not indicated for the prophylactic therapy of migraine Safety and effectiveness of CAMBIA not established for cluster headache, which is present in an older, predominantly male population

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Single 50 mg dose; mix single packet contents with 1 to 2 ounces (30 to 60 mL) of water prior to administration Use the lowest effective dose for shortest duration consistent with individual patient treatment goals ( 2.1 ) 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 (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…

Contraindications

4 CONTRAINDICATIONS CAMBIA is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [ see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [ see Warnings and Precautions ( 5.1 ) ] Known hypersensitivity to diclofenac or NSAIDs or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of (CABG) surgery ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case- control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of CAMBIA with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [ see Warnings and Precautions ( 5.13 ) ] Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the us…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [ see Warnings and Precautions ( 5.10 ) ] Medication Overuse Headache [ see Warnings and Precautions ( 5.11 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.13 ) ] Most common adverse reactions (≥1% and >placebo) were nausea and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Assertio Therapeutics, Inc. at 866-458-6389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widel…

Frequently Asked Questions

What is Cambia used for?

Cambia contains diclofenac potassium. It is a powder, for solution taken oral. Consult your doctor for specific uses.

Is Cambia a controlled substance?

Cambia is not classified as a controlled substance by the DEA.

What is the generic name for Cambia?

The generic name for Cambia is diclofenac potassium. There are 12 other brand versions of diclofenac potassium.

What is the NDC code for Cambia 50 mg/1?

The NDC (National Drug Code) for Cambia 50 mg/1 is 13913-012, listed by Assertio Therapeutics, Inc..

Product NDC

13913-012

Package NDC

13913-012-02

Other Diclofenac Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)