Complete SPL Sections
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
BOXED WARNING SECTION
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)] . Sumatriptan and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) Warnings and Precautions (5.1)] . Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)] .
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
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.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Sumatriptan and naproxen sodium tablets, 85 mg/500 mg are blue, oval, biconvex, film-coated tablets, debossed with “410” on one side and plain on other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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)]. In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)] . Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.3)]. History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.5)]. Peripheral vascular disease [see Warnings and Precautions (5.6)]. Ischemic bowel disease [see Warnings and Precautions (5.6)]. Uncontrolled hypertension [see Warnings and Precautions (5.8)]. Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see Drug Interactions (7)]. Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7), Clinical Pharmacology (12.3)]. History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.13, 5.14, 5.18)]. Known hypersensitivity (e.g., anaphylactic reactions, angioedema, and serious skin reactions) to sumatriptan, naproxen, or any components of sumatriptan and naproxen sodium tablets [see Warnings and Precautions (5.14)]. Severe hepatic impairment [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
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)]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
Patients (N = 670) have received single oral doses of 140 to 300 mg of sumatriptan without significant adverse effects. Volunteers (N = 174) have received single oral doses of 140 to 400 mg without serious adverse events. Overdose of sumatriptan in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation. Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting and epigastric pain. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [see Warnings and Precautions (5.1, 5.2)] . Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).
11 DESCRIPTION
DESCRIPTION SECTION
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. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C 14 H 21 N 3 O 2 S●C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate is a white to off- white powder that is soluble in water and in saline. Naproxen sodium is chemically designated as (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, and it has the following structure: The molecular formula is C 14 H 13 NaO 3 , representing a molecular weight of 252.23. Naproxen sodium is a white-to-creamy white crystalline solid, soluble in water at neutral pH. Each sumatriptan and naproxen sodium tablet 85 mg/500 mg for oral administration contains 119 mg of sumatriptan succinate, USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium, USP. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, dibasic calcium phosphate anhydrous, FD&C Blue No. 2, FD&C Yellow No. 6, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium chloride, sodium citrate and titanium dioxide.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
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. They are supplied as follows: Bottles of 9 with Child Resistant Cap.......................................... NDC 47335-410-22 Bottles of 30 with Child Resistant Cap........................................ NDC 47335-410-83 Bottles of 100 with Child Resistant Cap...................................... NDC 47335-410-88 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with sumatriptan and naproxen sodium tablets and periodically during the course of ongoing therapy. Cardiovascular Thrombotic Events, Prinzmetal's Angina, Other Vasospasm-Related Events, Arrhythmias and Cerebrovascular Events Advise patients to be alert for the symptoms of cardiovascular thrombotic effects such as myocardial infarction or stroke, which may result in hospitalization and even death. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for signs and symptoms of chest pain, shortness of breath, weakness, irregular heartbeat, significant rise in blood pressure, weakness and slurring of speech, and should be advised to report any of these symptoms to their health care provider immediately. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.3, 5.5, 5.6, 5.8)] . Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions (5.2)] . Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop sumatriptan and naproxen sodium tablets and seek immediate medical therapy [see Warnings and Precautions (5.7)] . Anaphylactic Reactions Inform patients that anaphylactic reactions have occurred in patients receiving the components of sumatriptan and naproxen sodium tablets. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help [see Contraindications (4), Warnings and Precautions (5.13)]. Serious Skin Reactions, including DRESS Inform patients that sumatriptan and naproxen sodium tablets, like other NSAID-containing products, may increase the risk of serious skin side effects such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop taking sumatriptan and naproxen sodium tablets immediately if they develop any type of rash or fever and contact their healthcare providers as soon as possible [see Warnings and Precautions (5.14, 5.15)] . Fetal Toxicity Inform pregnant women to avoid use of sumatriptan and naproxen sodium tablets and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with sumatriptan and naproxen sodium tablets is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see Warnings and Precautions (5.16), Use in Specific Populations (8.1)] . Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)] . Female Fertility Advise females of reproductive potential who desire pregnancy that NSAIDs, including sumatriptan and naproxen sodium tablets, may be associated with a reversible delay in ovulation [see Use in Specific Populations (8.3)] . Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions (5.9)] . Concomitant Use with Other Triptans or Ergot Medications Inform patients that use of sumatriptan and naproxen sodium tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4), Drug Interactions (7.1)] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the use of sumatriptan and naproxen sodium tablets or other triptans, particularly during concomitant use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.11), Drug Interactions (7.1)] . Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.10)] . Ability to Perform Complex Tasks Treatment with sumatriptan and naproxen sodium tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan and naproxen sodium tablets [see Adverse Reactions (6.1)] . Asthma Advise patients with preexisting asthma to seek immediate medical attention if their asthma worsens after taking sumatriptan and naproxen sodium tablets. Patients with a history of aspirin-sensitive asthma should not take sumatriptan and naproxen sodium tablets [see Contraindications (4), Warnings and Precautions (5.18)] . Avoid Concomitant Use of NSAIDs Inform patients that the concomitant use of sumatriptan and naproxen sodium tablets with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see Warnings and Precautions (5.2) and Drug Interactions (7)] . Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia. Use of NSAIDS and Low-Dose Aspirin Inform patients not to use low-dose aspirin concomitantly with sumatriptan and naproxen sodium tablets until they talk to their healthcare provider [see Drug Interactions (7)] . Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India.
MEDICATION GUIDE
SPL MEDGUIDE SECTION
Sumatriptan and Naproxen Sodium Tablets (Soo-ma-TRIP-tan and na-PROX-en SOE-dee-um) Read this Medication Guide before you start taking sumatriptan and naproxen sodium tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment. What is the most important information I should know about sumatriptan and naproxen sodium tablets? Sumatriptan and naproxen sodium tablets may increase your chance of a heart attack or stroke that can lead to death. Sumatriptan and naproxen sodium tablets contain 2 medicines: sumatriptan and naproxen sodium (a nonsteroidal anti-inflammatory drug [NSAID]). This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take sumatriptan and naproxen sodium tablets right before or after a heart surgery called a “coronary artery bypass graft (CABG).” Avoid taking sumatriptan and naproxen sodium tablets after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Stop taking sumatriptan and naproxen sodium tablets and get emergency help right away if you have any of the following symptoms of a heart attack or stroke: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded weakness in one part or on one side of your body slurred speech Sumatriptan and naproxen sodium tablets are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you: have high blood pressure have high cholesterol levels smoke are overweight have diabetes have a family history of heart disease Sumatriptan and naproxen sodium tablets can cause ulcers and bleeding in the stomach and intestines at any time during your treatment. Ulcers and bleeding can happen without warning symptoms and may cause death. Your chance of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs the use of medicines called “corticosteroids,” “anticoagulants,” and antidepressant medicines called “SSRIs” or “SNRIs” longer use more frequent use smoking drinking alcohol older age having poor health advanced liver disease bleeding problems Sumatriptan and naproxen sodium tablets may cause serious allergic reactions or serious skin reactions that can be life-threatening. Stop taking sumatriptan and naproxen sodium tablets and get emergency help right away if you develop: sudden wheezing swelling of your lips, tongue, throat or body rash fainting problems breathing or swallowing reddening of your skin with blisters or peeling blisters or bleeding of your lips, eye lids, mouth, nose, or genitals Sumatriptan and naproxen sodium tablets should only be used exactly as prescribed, at the lowest dose possible for your treatment, and for the shortest time needed. Sumatriptan and naproxen sodium tablets already contain an NSAID (naproxen). Do not use sumatriptan and naproxen sodium tablets with other medicines to lessen pain or fever or with other medicines for colds or sleeping problems without talking to your healthcare provider first, because they may contain an NSAID also. What are Sumatriptan and Naproxen Sodium Tablets? Sumatriptan and naproxen sodium tablets are a prescription medicine that contains sumatriptan and naproxen sodium (an NSAID). Sumatriptan and naproxen sodium tablets are used to treat acute migraine headaches with or without aura in patients 12 years of age and older. Sumatriptan and naproxen sodium tablets are not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines. Sumatriptan and naproxen sodium tablets are not used to prevent or decrease the number of migraine headaches you have. It is not known if sumatriptan and naproxen sodium tablets are safe and effective to treat cluster headaches. Who should not take sumatriptan and naproxen sodium tablets? Do not take sumatriptan and naproxen sodium tablets if you have: heart problems, history of heart problems, or right before or after heart bypass surgery had a stroke, transient ischemic attack (TIAs), or problems with your blood circulation hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider. narrowing of blood vessels to your legs and arms (peripheral vascular disease), stomach (ischemic bowel disease), or kidneys uncontrolled high blood pressure taken any medicines in the last 24 hours that are called 5-HT1 agonists that are triptans or contain ergotamine. Ask your healthcare provider for a list of these medicines if you are not sure. taken an antidepressant medicine called a monoamine oxidase (MAO) inhibitor within the last 2 weeks. Ask your healthcare provider for a list if you are not sure. had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine an allergy to sumatriptan, naproxen, or any of the ingredients in sumatriptan and naproxen sodium tablets. See “What are the ingredients in sumatriptan and naproxen sodium tablets?” below for a complete list of ingredients. liver problems What should I tell my healthcare provider before taking sumatriptan and naproxen sodium tablets? Before you take sumatriptan and naproxen sodium tablets, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure have asthma have high cholesterol have diabetes smoke are overweight have heart problems or a family history of heart problems or stroke have kidney problems have liver problems have had epilepsy or seizures are not using effective birth control are pregnant, think you might be pregnant, or are trying to become pregnant. Taking NSAIDs, including sumatriptan and naproxen sodium tablets, at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy. are breastfeeding or plan to breastfeed. The components of sumatriptan and naproxen sodium tablets pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take sumatriptan and naproxen sodium tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sumatriptan and naproxen sodium tablets and certain other medicines can affect each other, causing serious side effects. How should I take sumatriptan and naproxen sodium tablets? Certain people should take their first dose of sumatriptan and naproxen sodium tablets in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting. Take sumatriptan and naproxen sodium tablets exactly as your healthcare provider tells you to take them. Take sumatriptan and naproxen sodium tablets whole with water or other liquids. Sumatriptan and naproxen sodium tablets can be taken with or without food. If you do not get any relief after your first dose, do not take a second dose without first talking with your healthcare provider. If your headache comes back or you only get some re...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 47335-410-22 Sumatriptan and Naproxen Sodium Tablets 85 mg/500 mg PHARMACIST: Dispense with Medication Guide to each patient. Rx only 9 Tablets SUN PHARMA