DICLOFENAC POTASSIUM
Generic: DICLOFENAC POTASSIUM
Basic Information
Manufacturer
Nivagen Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
eb52a015-23cd-40f6-bf83-6749fc34947c
Indications & Usage
1.
INDICATIONS AND USAGE Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
Limitations of Use: Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine.
The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.
Diclofenac potassium for oral solution 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 ): Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine Safety and effectiveness of Diclofenac potassium for oral solution not established for cluster headache, which is present in an older, predominantly male population
INDICATIONS AND USAGE Diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).
Limitations of Use: Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine.
The safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population.
Diclofenac potassium for oral solution 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 ): Diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine Safety and effectiveness of Diclofenac potassium for oral solution not established for cluster headache, which is present in an older, predominantly male population
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 Nivagen Pharmaceuticals, Inc.
at 1-877-977-0687 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience 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 diclofenac potassium for oral solution was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with diclofenac potassium for oral solution for a single migraine headache.
Following treatment with diclofenac potassium (either diclofenac potassium for oral solution 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.
The most common adverse reactions (i.e., that occurred in 1% or more of diclofenac potassium for oral solution-treated patients) and more frequent with diclofenac potassium for oral solution than with placebo were nausea and dizziness (see Table 1 ).
Table 1: Adverse Reactions With Incidence >1% and Greater Than Placebo in Studies 1 and 2 Combined Adverse Reactions Diclofenac Potassium for Oral Solution Placebo N=634 N=646 Gastrointestinal Nausea 3% 2% Nervous System Dizziness 1% 0.5% The most common adverse events resulting in discontinuation of patients following diclofenac potassium for oral solution dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%).
No withdrawals were due to a serious reaction.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of diclofenac or other NSAIDs.
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.
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.
Other less frequently occurring adverse reactions identified during post approval use of diclofenac and other NSAIDs include fixed drug eruption [see Warnings and Precautions ( 5.9 )] .
Additional adverse reactions reported in patients taking NSAIDs include occasionally: 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 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 [see Warnings and Precautions ( 5.9 )] , urticaria Special Senses: Conjunctivitis, hearing impairment
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 Nivagen Pharmaceuticals, Inc.
at 1-877-977-0687 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial Experience 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 diclofenac potassium for oral solution was evaluated in 2 placebo-controlled trials with a total of 634 migraine patients treated with diclofenac potassium for oral solution for a single migraine headache.
Following treatment with diclofenac potassium (either diclofenac potassium for oral solution 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.
The most common adverse reactions (i.e., that occurred in 1% or more of diclofenac potassium for oral solution-treated patients) and more frequent with diclofenac potassium for oral solution than with placebo were nausea and dizziness (see Table 1 ).
Table 1: Adverse Reactions With Incidence >1% and Greater Than Placebo in Studies 1 and 2 Combined Adverse Reactions Diclofenac Potassium for Oral Solution Placebo N=634 N=646 Gastrointestinal Nausea 3% 2% Nervous System Dizziness 1% 0.5% The most common adverse events resulting in discontinuation of patients following diclofenac potassium for oral solution dosing in controlled clinical trials were urticaria (0.2%) and flushing (0.2%).
No withdrawals were due to a serious reaction.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of diclofenac or other NSAIDs.
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.
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.
Other less frequently occurring adverse reactions identified during post approval use of diclofenac and other NSAIDs include fixed drug eruption [see Warnings and Precautions ( 5.9 )] .
Additional adverse reactions reported in patients taking NSAIDs include occasionally: 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 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 [see Warnings and Precautions ( 5.9 )] , urticaria Special Senses: Conjunctivitis, hearing impairment