Anemia has occurred in patients receiving NSAIDs. This may be due to fluid retention, occult or gross gastrointestinal blood loss, or an incompletely described effect upon erythropoiesis. If a patient treated with sumatriptan and naproxen sodium has signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including sumatriptan and naproxen sodium, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see Drug Interactions (7)].
A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, sumatriptan and naproxen sodium is contraindicated in patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma [see Contraindications (4)].
When sumatriptan and naproxen sodium is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.
Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent. Sumatriptan and naproxen sodium should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
The pharmacological activity of sumatriptan and naproxen sodium in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.
Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [see Warnings and Precautions (5.2, 5.7, 5.12)].
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)]
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 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.
|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|
|Pain and other pressure sensations|
|Chest discomfort/chest pain||3||<1||2||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.
|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|
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.