Diclofenac potassium
Generic: DICLOFENAC POTASSIUM
Basic Information
Manufacturer
TEVA PHARMACEUTICALS, INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
d9685883-9d0b-81da-e053-2a95a90ab8d8
Indications & Usage
1 INDICATIONS AND USAGE Diclofenac potassium capsules are indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.
Diclofenac potassium capsules are a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older ( 1 )
Diclofenac potassium capsules are a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following 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 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.12 ) ] Most common adverse reactions (incidence ≥ 1%) are gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, dizziness, headache, somnolence, pruritus, and increase sweating ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc., at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with the rates in clinical trials of another drug and may not reflect the rates observed in practice.
The safety of diclofenac potassium was evaluated in 965 adult subjects.
In patients treated with diclofenac potassium 25 mg (N = 345) or a higher dose, three or four times a day, for 4 days to 5 days, the most common adverse reactions (i.e., reported in ≥ 1% of diclofenac potassium treated patients) were as follows: gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, dizziness, headache, somnolence, pruritus, and increased sweating.
(see Table 1 ).
The safety of diclofenac potassium was evaluated in 125 pediatric patients, 12 years to 17 years of age.
Forty-nine (49) patients with mild to moderate acute pain from a surgical procedure or an acute painful condition were treated with diclofenac potassium 25 mg up to four times a day, for 4 days.
Seventy-six (76) pediatric patients who underwent insertion of either orthodontic separators or arch wires were treated with a single-dose of either diclofenac potassium 25 mg or diclofenac potassium 50 mg after completion of the procedure.
The most common adverse reactions in the multiple-dose studies were nausea (14.3%), headache (10.2%), constipation (8.2%), abdominal pain (4.1%), vomiting (4.1%), dizziness (4.1%), back pain (4.1%), and musculoskeletal pain (4.1%).
Table 1 Incidence of Treatment Emergent Adverse Reactions with Incidence ≥ 1% of Diclofenac Potassium Treated Patients in Multiple-Dose Studies *There was greater use of concomitant opioid rescue medication in placebo treated patients than in diclofenac potassium treated patients.
MedDRA System Organ Class and Preferred Term Diclofenac Potassium * 25 mg n = 345 n (%) Placebo * n = 327 n (%) Any Adverse Events 144 (41.7) 181 (55.4) Nausea 57 (16.5) 66 (20.2) Headache 43 (12.5) 56 (17.1) Abdominal Pain 24 (7.0) 11 (3.4) Vomiting 20 (5.8) 17 (5.2) Dizziness 12 (3.5) 66 (20.2) Constipation 11 (3.2) 9 (2.8) Somnolence 9 (2.6) 6 (1.8) Diarrhea 8 (2.3) 9 (2.8) Pruritus 5 (1.4) 6 (1.8) Dyspepsia 4 (1.2) 8 (2.4) Sweating Increase 4 (1.2) 2 (0.6) In patients taking other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 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 in patients taking other NSAIDs 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 in patients taking other NSAIDs, 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, liver failure, 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 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of diclofenac.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared with the rates in clinical trials of another drug and may not reflect the rates observed in practice.
The safety of diclofenac potassium was evaluated in 965 adult subjects.
In patients treated with diclofenac potassium 25 mg (N = 345) or a higher dose, three or four times a day, for 4 days to 5 days, the most common adverse reactions (i.e., reported in ≥ 1% of diclofenac potassium treated patients) were as follows: gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, dizziness, headache, somnolence, pruritus, and increased sweating.
(see Table 1 ).
The safety of diclofenac potassium was evaluated in 125 pediatric patients, 12 years to 17 years of age.
Forty-nine (49) patients with mild to moderate acute pain from a surgical procedure or an acute painful condition were treated with diclofenac potassium 25 mg up to four times a day, for 4 days.
Seventy-six (76) pediatric patients who underwent insertion of either orthodontic separators or arch wires were treated with a single-dose of either diclofenac potassium 25 mg or diclofenac potassium 50 mg after completion of the procedure.
The most common adverse reactions in the multiple-dose studies were nausea (14.3%), headache (10.2%), constipation (8.2%), abdominal pain (4.1%), vomiting (4.1%), dizziness (4.1%), back pain (4.1%), and musculoskeletal pain (4.1%).
Table 1 Incidence of Treatment Emergent Adverse Reactions with Incidence ≥ 1% of Diclofenac Potassium Treated Patients in Multiple-Dose Studies *There was greater use of concomitant opioid rescue medication in placebo treated patients than in diclofenac potassium treated patients.
MedDRA System Organ Class and Preferred Term Diclofenac Potassium * 25 mg n = 345 n (%) Placebo * n = 327 n (%) Any Adverse Events 144 (41.7) 181 (55.4) Nausea 57 (16.5) 66 (20.2) Headache 43 (12.5) 56 (17.1) Abdominal Pain 24 (7.0) 11 (3.4) Vomiting 20 (5.8) 17 (5.2) Dizziness 12 (3.5) 66 (20.2) Constipation 11 (3.2) 9 (2.8) Somnolence 9 (2.6) 6 (1.8) Diarrhea 8 (2.3) 9 (2.8) Pruritus 5 (1.4) 6 (1.8) Dyspepsia 4 (1.2) 8 (2.4) Sweating Increase 4 (1.2) 2 (0.6) In patients taking other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 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 in patients taking other NSAIDs 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 in patients taking other NSAIDs, 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, liver failure, 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 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of diclofenac.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).