Data from FDA - Curated by EPG Health - Last updated 22 December 2016

Indication(s)

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of CATAFLAM® (diclofenac potassium immediate-release tablets) and other treatment options before deciding to use CATAFLAM. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).

CATAFLAM is indicated: For treatment of primary dysmenorrhea For relief of mild to moderate pain For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis

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Advisory information

contraindications

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, Serious Skin Reactions).

History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNINGS; Anaphylactic Reactions, Exacerbation of Asthma Related to Aspirin Sensitivity).

In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS; Cardiovascular Thrombotic Events).

Special warnings and precautions

PRECAUTIONS General CATAFLAM® (diclofenac potassium immediate-release tablets) can not be expected to substitute for corticosteroids or to treat corticosteroid insufficiency.

Abrupt discontinuation of corticosteroids may lead to disease exacerbation.

Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids and the patient should be observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis.

The pharmacological activity of CATAFLAM in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Adverse reactions

ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see WARNINGS) GI Bleeding, Ulceration and Perforation (see WARNINGS) Hepatotoxicity (see WARNINGS) Hypertension (see WARNINGS) Heart Failure and Edema (see WARNINGS) Renal Toxicity and Hyperkalemia (see WARNINGS) Anaphylactic Reactions (see WARNINGS) Serious Skin Reactions (see WARNINGS) Hematologic Toxicity (see WARNINGS) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 718 patients treated for shorter periods, i.e., 2 weeks or less, with CATAFLAM® (diclofenac potassium immediate-release tablets), adverse reactions were reported one-half to one-tenth as frequently as by patients treated for longer periods.

In a 6-month, double-blind trial comparing CATAFLAM (N=196) versus Voltaren® (diclofenac sodium delayed-release tablets) (N=197) versus ibuprofen (N=197), adverse reactions were similar in nature and frequency.

In patients taking CATAFLAM or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 % - 10 % of patients are: Gastrointestinal experiences 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 experiences reported occasionally include: Body as a Whole: fever, infection, sepsis Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia Metabolic and Nutritional: weight changes Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory System: asthma, dyspnea Skin and Appendages: alopecia, photosensitivity

sweating increased Special Senses: blurred vision Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure Other adverse reactions, which occur rarely are: Body as a Whole: anaphylactic reactions, appetite changes, death Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia Metabolic and Nutritional: hyperglycemia Nervous System: convulsions, coma, hallucinations, meningitis Respiratory System: respiratory depression

pneumonia Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria Special Senses: conjunctivitis, hearing impairment

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of CATAFLAM® (diclofenac potassium immediate-release tablets) and other treatment options before deciding to use CATAFLAM. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).

After observing the response to initial therapy with CATAFLAM, the dose and frequency should be adjusted to suit an individual patient 's needs.

For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg three times a day.

With experience, physicians may find that in some patients an initial dose of 100 mg of CATAFLAM, followed by 50-mg doses, will provide better relief.

For the relief of osteoarthritis the recommended dosage is 100-150 mg/day in divided doses, 50 mg twice a day or three times a day.

For the relief of rheumatoid arthritis the recommended dosage is 150-200 mg/day in divided doses, 50 mg three times a day or four times a day.

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.

Pregnancy and lactation

Nursing Mothers Risk Summary Based on available data, diclofenac may be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother 's clinical need for CATAFLAM and any potential adverse effects on the breastfed infant from the CATAFLAM or from the underlying maternal condition.

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).

Interactions

Drug Interactions Studies Voriconazole: When co-administered with voriconazole (inhibitor of CYP2C9, 2C19 and 3A4 enzyme), the Cmax and AUC of diclofenac increased by 114 % and 78 %, respectively (see PRECAUTIONS; Drug Interactions).

Aspirin: When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered.

The clinical significance of this interaction is not known.

See Table 2 for clinically significant drug interactions of NSAIDs with aspirin (see PRECAUTIONS; Drug Interactions).

More information

Category Value
Authorisation number NDA020142
Orphan designation No
Product NDC 0078-0436
Date Last Revised 09-05-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 855944
Marketing authorisation holder Novartis Pharmaceuticals Corporation
Warnings

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).

CATAFLAM® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS).

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).