Prescription Drug Information: Sumatriptan and Naproxen Sodium (Page 3 of 9)

5.15 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as sumatriptan and naproxen sodium tablets. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue sumatriptan and naproxen sodium tablets and evaluate the patient immediately.

5.16 Fetal Toxicity

Premature Closure of Fetal Ductus Arteriosus

Avoid use of NSAIDs, including sumatriptan and naproxen sodium tablets, in pregnant women at about 30 weeks gestation and later. NSAIDs, including sumatriptan and naproxen sodium tablets, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.

Oligohydramnios/Neonatal Renal Impairment

Use of NSAIDs, including sumatriptan and naproxen sodium tablets, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.

If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit sumatriptan and naproxen sodium tablets use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if sumatriptan and naproxen sodium tablets treatment extends beyond 48 hours. Discontinue sumatriptan and naproxen sodium tablets if oligohydramnios occurs and follow up according to clinical practice [see Use in Specific Populations (8.1)].

5.17 Hematologic Toxicity

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 tablets have signs or symptoms of anemia, monitor hemoglobin or hematocrit.

NSAIDs, including sumatriptan and naproxen sodium tablets, 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)].

5.18 Exacerbation of Asthma Related to Aspirin Sensitivity

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 tablets are 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 tablets are used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

5.19 Seizures

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 tablets should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

5.20 Masking of Inflammation and Fever

The pharmacological activity of sumatriptan and naproxen sodium tablets in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

5.21 Laboratory Monitoring

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)].

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)]

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 tablets 85 mg/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 tablets 85 mg/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 mg/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 tablets 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 tablets 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 tablets 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)
VascularHot flush (i.e., hotflash[es]) 0 2 <1 0
MusculoskeletalMuscle tightness 0 0 2 0

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