Sumatriptan And Naproxen Sodium
Generic Name: sumatriptan and naproxen sodium
Brand Names:
Sumatriptan And Naproxen Sodium
11 DESCRIPTION Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 (5-HT 1 ) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs.
Overview
11 DESCRIPTION Sumatriptan and naproxen sodium tablets contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 (5-HT 1 ) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of NSAIDs.
Uses
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.
Dosage
2 DOSAGE AND ADMINISTRATION Adults Recommended dosage: 1 tablet of 85 mg/500 mg. (2.1) Maximum dosage in a 24-hour period: 2 tablets of 85 mg/500 mg; separate doses by at least 2 hours. (2.1) Pediatric Patients 12 to 17 years of Age Maximum dosage in a 24-hour period: 1 tablet of 85/500 mg. 2.1 Dosage in Adults The recommended dosage for adults is 1 tablet of sumatriptan and naproxen sodium tablets 85 mg/500 mg. Sumatriptan and naproxen sodium tablets 85 mg/500 mg contains a dose of sumatriptan higher than the lowest effective dose.
Side Effects
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....
Interactions
7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking sumatriptan and naproxen sodium tablets with drugs that interfere with hemostasis. Concomitant use of sumatriptan and naproxen sodium tablets and analgesic doses of aspirin is not generally recommended. (7.1) ACE Inhibitors and ARBs: Concomitant use with sumatriptan and naproxen sodium tablets in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. (7.1) Diuretics: NSAIDs can reduce natriuretic effect of loop and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Warnings
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)] . 5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events: Perform cardiac evaluation in patients with cardiovascular risk factors. (5.1) Arrhythmias: Discontinue sumatriptan and naproxen sodium tablets if occurs. (5.3) Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. (5.4) Cerebrovascular Events: Discontinue sumatriptan and naproxen sodium tablets if occurs. (5.5) Other Vasospasm Reactions: Discontinue sumatriptan and naproxen sodium tablets if non-coronary vasospastic reaction occurs. (5.6) Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. 4 CONTRAINDICATIONS Sumatriptan and naproxen sodium tablets are contraindicated in the following patients: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1)].
Pregnancy
8.1 Pregnancy Risk Summary Use of NSAIDs, including sumatriptan and naproxen sodium tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of sumatriptan and naproxen sodium tablets use between about 20 and 30 weeks of gestation, and avoid sumatriptan and naproxen sodium tablets use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan and naproxen sodium tablets contain 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP and are supplied as blue, oval, biconvex, film-coated tablets debossed with “410” on one side and plain on other side.
Frequently Asked Questions
What is Sumatriptan And Naproxen Sodium used for?▼
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.
What are the side effects of Sumatriptan And Naproxen Sodium?▼
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....
Can I take Sumatriptan And Naproxen Sodium during pregnancy?▼
8.1 Pregnancy Risk Summary Use of NSAIDs, including sumatriptan and naproxen sodium tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of sumatriptan and naproxen sodium tablets use between about 20 and 30 weeks of gestation, and avoid sumatriptan and naproxen sodium tablets use at about 30 weeks of gestation and later in pregnancy ( see Clinical Considerations, Data ).
What are the important warnings for Sumatriptan And Naproxen Sodium?▼
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)] . 5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events: Perform cardiac evaluation in patients with cardiovascular risk factors. (5.1) Arrhythmias: Discontinue sumatriptan and naproxen sodium tablets if occurs. (5.3) Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. (5.4) Cerebrovascular Events: Discontinue sumatriptan and naproxen sodium tablets if occurs. (5.5) Other Vasospasm Reactions: Discontinue sumatriptan and naproxen sodium tablets if non-coronary vasospastic reaction occurs. (5.6) Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. 4 CONTRAINDICATIONS Sumatriptan and naproxen sodium tablets are contraindicated in the following patients: Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.