Sumatriptan and Naproxen Sodium
Generic: SUMATRIPTAN AND NAPROXEN SODIUM
Basic Information
Manufacturer
Aurobindo Pharma Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
f5203c66-0a40-4263-a237-b71e930e4697
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.
If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks.
Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.
Sumatriptan and naproxen sodium tablets are a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
(1) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.
(1) Not indicated for the prophylactic therapy of migraine attacks.
(1) Not indicated for the treatment of cluster headache.
(1)
Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.
If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks.
Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache.
Sumatriptan and naproxen sodium tablets are a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.
(1) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established.
(1) Not indicated for the prophylactic therapy of migraine attacks.
(1) Not indicated for the treatment of cluster headache.
(1)
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.4) ] Cerebrovascular Events [see Warnings and Precautions (5.5) ] Other Vasospasm Reactions [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] Hypertension [see Warnings and Precautions (5.8) ] Heart Failure and Edema [see Warnings and Precautions (5.9) ] Medication Overuse Headache [see Warnings and Precautions (5.10) ] Serotonin Syndrome [see Warnings and Precautions (5.11) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.12) ] Anaphylactic Reactions [see Warnings and Precautions (5.13) ] Serious Skin Reactions [see Warnings and Precautions (5.14) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.15) ] Hematological Toxicity [see Warnings and Precautions (5.17) ] Exacerbation Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.18) ] Seizures [see Warnings and Precautions (5.19) ] The most common adverse reactions (incidence ≥2%) were: Adults: Dizziness, somnolence, nausea, chest discomfort/chest pain, neck/throat/jaw pain/tightness/pressure, paresthesia, dyspepsia, dry mouth.
(6.1) Pediatrics: Hot flush (i.e., hot flash[es]) and muscle tightness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 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 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.
Adults The adverse reactions reported below are specific to the clinical trials with sumatriptan and naproxen sodium 85/500 mg.
See also the full prescribing information for naproxen and sumatriptan products.
Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials (Study 1 and 2) in adult patients who received 1 dose of study drug.
Only adverse reactions that occurred at a frequency of 2% or more in any group treated with sumatriptan and naproxen sodium 85/500 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1.
Adverse Reactions in Pooled Placebo-Controlled Trials in Adult Patients with Migraine Adverse Reactions Sumatriptan and Naproxen Sodium Tablets 85/500 mg % (n = 737) Placebo % (n = 752) Sumatriptan 85 mg % (n = 735) Naproxen Sodium 500 mg % (n = 732) Nervous system disorders Dizziness 4 2 2 2 Somnolence 3 2 2 2 Paresthesia 2 <1 2 <1 Gastrointestinal disorders Nausea 3 1 3 <1 Dyspepsia 2 1 2 1 Dry mouth 2 1 2 <1 Pain and other pressure sensations Chest discomfort/chest pain 3 <1 2 1 Neck/throat/jaw pain/tightness/pressure 3 1 3 1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Pediatric Patients 12 to 17 Years of Age In a placebo controlled clinical trial that evaluated pediatric patients 12 to 17 years of age who received 1 dose of sumatriptan and naproxen sodium 10/60 mg, 30/180 mg, or 85/500 mg, adverse reactions occurred in 13% of patients who received 10/60 mg, 9% of patients who received 30/180 mg, 13% who received 85/500 mg, and 8% who received placebo.
No patients who received sumatriptan and naproxen sodium experienced adverse reactions leading to withdrawal from the trial.
The incidence of adverse reactions in pediatric patients 12 to 17 years of age was comparable across all 3 doses compared with placebo.
Table 2 lists adverse reactions that occurred in a placebo-controlled trial in pediatric patients 12 to 17 years of age at a frequency of 2% or more with sumatriptan and naproxen sodium and were more frequent than the placebo group.
Table 2.
Adverse Reactions in a Placebo-Controlled Trial in Pediatric Patients 12 to 17 Years of Age with Migraine Adverse Reactions Sumatriptan and Naproxen Sodium Tablets 10/60 mg % (n = 96) Sumatriptan and Naproxen Sodium Tablets 30/180 mg % (n = 97) Sumatriptan and Naproxen Sodium Tablets 85/500 mg % (n = 152) Placebo % (n = 145) Vascular Hot flush (i.e., hot flash[es]) 0 2 <1 0 Musculoskeletal Muscle tightness 0 0 2 0 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of NSAIDs, such as naproxen, which is a component of sumatriptan and naproxen sodium tablets.
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) [see Warnings and Precautions (5.14) ].
(6.1) Pediatrics: Hot flush (i.e., hot flash[es]) and muscle tightness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 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 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.
Adults The adverse reactions reported below are specific to the clinical trials with sumatriptan and naproxen sodium 85/500 mg.
See also the full prescribing information for naproxen and sumatriptan products.
Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials (Study 1 and 2) in adult patients who received 1 dose of study drug.
Only adverse reactions that occurred at a frequency of 2% or more in any group treated with sumatriptan and naproxen sodium 85/500 mg and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1.
Adverse Reactions in Pooled Placebo-Controlled Trials in Adult Patients with Migraine Adverse Reactions Sumatriptan and Naproxen Sodium Tablets 85/500 mg % (n = 737) Placebo % (n = 752) Sumatriptan 85 mg % (n = 735) Naproxen Sodium 500 mg % (n = 732) Nervous system disorders Dizziness 4 2 2 2 Somnolence 3 2 2 2 Paresthesia 2 <1 2 <1 Gastrointestinal disorders Nausea 3 1 3 <1 Dyspepsia 2 1 2 1 Dry mouth 2 1 2 <1 Pain and other pressure sensations Chest discomfort/chest pain 3 <1 2 1 Neck/throat/jaw pain/tightness/pressure 3 1 3 1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Pediatric Patients 12 to 17 Years of Age In a placebo controlled clinical trial that evaluated pediatric patients 12 to 17 years of age who received 1 dose of sumatriptan and naproxen sodium 10/60 mg, 30/180 mg, or 85/500 mg, adverse reactions occurred in 13% of patients who received 10/60 mg, 9% of patients who received 30/180 mg, 13% who received 85/500 mg, and 8% who received placebo.
No patients who received sumatriptan and naproxen sodium experienced adverse reactions leading to withdrawal from the trial.
The incidence of adverse reactions in pediatric patients 12 to 17 years of age was comparable across all 3 doses compared with placebo.
Table 2 lists adverse reactions that occurred in a placebo-controlled trial in pediatric patients 12 to 17 years of age at a frequency of 2% or more with sumatriptan and naproxen sodium and were more frequent than the placebo group.
Table 2.
Adverse Reactions in a Placebo-Controlled Trial in Pediatric Patients 12 to 17 Years of Age with Migraine Adverse Reactions Sumatriptan and Naproxen Sodium Tablets 10/60 mg % (n = 96) Sumatriptan and Naproxen Sodium Tablets 30/180 mg % (n = 97) Sumatriptan and Naproxen Sodium Tablets 85/500 mg % (n = 152) Placebo % (n = 145) Vascular Hot flush (i.e., hot flash[es]) 0 2 <1 0 Musculoskeletal Muscle tightness 0 0 2 0 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of NSAIDs, such as naproxen, which is a component of sumatriptan and naproxen sodium tablets.
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) [see Warnings and Precautions (5.14) ].