Data from FDA - Curated by EPG Health - Last updated 22 December 2016
CONTRAINDICATIONS CATAFLAM® 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; Anaphylactic Reactions,
History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS; Cardiovascular Thrombotic Events).
PRECAUTIONS General CATAFLAM® (diclofenac potassium immediate-release tablets) can not be expected to substitute for corticosteroids or to treat corticosteroid
Abrupt discontinuation of corticosteroids may lead to disease
The pharmacological activity of CATAFLAM in reducing
In 718 patients treated for
In a 6-month, double-blind trial comparing CATAFLAM (N=196) versus Voltaren® (diclofenac sodium delayed-release tablets) (N=197) versus ibuprofen (N=197),
In patients taking CATAFLAM or other NSAIDs, the most frequently reported
pneumonia Skin and Appendages: angioedema,
After observing the response to initial therapy with CATAFLAM,
For treatment of
With experience, physicians may find that in some patients an initial dose of 100 mg of CATAFLAM, followed by 50-mg doses, will provide
Different formulations of diclofenac [Voltaren® (diclofenac sodium enteri-coated tablets); Voltaren®-XR (diclofenac sodium extended-release tablets); CATAFLAM® (diclofenac potassium immediate-release tablets)] are not necessarily bioequivalent even if the milligram strength is the same.
Nursing Mothers Risk Summary Based on
The developmental and health
Data One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day.
Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period).
|Date Last Revised||09-05-2016|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Novartis Pharmaceuticals Corporation|
This risk may occur early in treatment and may
CATAFLAM® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS).
Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an
These events can occur at any time during use and
Elderly patients and patients with a prior history of peptic ulcer disease and/or