"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular thrombotic events [see Boxed Warning and WARNINGS AND PRECAUTIONS]
- Gastrointestinal effects [see Boxed Warning and WARNINGS AND PRECAUTIONS]
- Hepatic effects [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Congestive Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Effects [see WARNINGS AND PRECAUTIONS]
- Anaphylactoid Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
The most common adverse reactions reported with CAMBIA (diclofenac potassium for oral solution) are nausea and dizziness.
The most common adverse events resulting in discontinuation of patients following CAMBIA (diclofenac potassium for oral solution) dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%).
Clinical Studies Experience with CAMBIA (diclofenac potassium for oral solution)
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of a single dose of CAMBIA (diclofenac potassium for oral solution) was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with CAMBIA (diclofenac potassium for oral solution) for a single migraine headache. Following treatment with diclofenac potassium (either CAMBIA or diclofenac potassium immediate-release tablets [as a control]), 5 subjects (0.8%) withdrew from the studies; following placebo exposure, 1 subject (0.2%) withdrew. No withdrawals were due to a serious reaction.
The most common adverse reactions (i.e., that occurred in 1% or more of CAMBIA (diclofenac potassium for oral solution) -treated patients) and more frequent with CAMBIA (diclofenac potassium for oral solution) than with placebo were nausea and dizziness (see Table 1).
Table 1: Treatment-Related Adverse Reactions with Incidence > 1% and Greater than Placebo in Studies 1 and 2 Combined
|Disorder Event|| CAMBIA
Adverse reactions reported with diclofenac and other NSAIDs
In patients taking diclofenac or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1%-10% of patients are: GI reactions (including abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers [gastric/duodenal], and vomiting), abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.
Additional adverse reactions reported in patients taking NSAIDs include occasionally:
Metabolic and Nutritional: Weight changes
Special Senses: Blurred vision
Other adverse reactions in patients taking NSAIDs, which occur rarely , are:
Body as a Whole: Anaphylactic reactions, appetite changes, death
Metabolic and Nutritional: Hyperglycemia
Respiratory System: Respiratory depression, pneumonia
Special Senses: Conjunctivitis, hearing impairment.
Read the Cambia (diclofenac potassium for oral solution) Side Effects Center for a complete guide to possible side effects
When administered with aspirin, diclofenac potassium's protein binding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of CAMBIA (diclofenac potassium for oral solution) and aspirin is not generally recommended because of the potential of increased adverse effects.
The effects of anticoagulants such as warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than that with use of either drug alone.
NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking CAMBIA (diclofenac potassium for oral solution) concomitantly with ACE inhibitors.
Clinical studies, as well as post-marketing observations, have shown that diclofenac potassium can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, observe patients closely for signs of renal failure as well as to assure diuretic efficacy [see WARNINGS AND PRECAUTIONS].
NSAIDs have produced elevations of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. When CAMBIA (diclofenac potassium for oral solution) and lithium are administered concurrently, observe patients carefully for signs of lithium toxicity.
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This indicates that NSAIDs may enhance the toxicity of methotrexate. Use caution when NSAIDs are administered concomitantly with methotrexate.
CAMBIA (diclofenac potassium for oral solution) , like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with CAMBIA (diclofenac potassium for oral solution) may increase cyclosporine's nephrotoxicity. Use caution when CAMBIA (diclofenac potassium for oral solution) is administered concomitantly with cyclosporine.
Inhibitors of Cytochrome P450 2C9
Diclofenac is metabolized predominantly by Cytochrome P-450 CYP2C9. Co-administration of medications that inhibit CYP2C9 may affect the pharmacokinetics of diclofenac [see CLINICAL PHARMACOLOGY].
Read the Cambia Drug Interactions Center for a complete guide to possible interactions
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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