Sumatriptan and Naproxen Sodium (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sumatriptan and Naproxen Sodium Tablets, 85 mg/500 mg contain 119 mg of sumatriptan succinate USP equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium USP and is supplied as white to off-white, modified capsule shaped, film-coated, matted finish tablets debossed with “J78” on one side and plain on the other side.
Bottles of 9 NDC 65862-928-36

Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

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 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 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. 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, 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 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 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 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, 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 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 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 may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan and naproxen sodium [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. Patients with a history of aspirin-sensitive asthma should not take sumatriptan and naproxen sodium [see Contraindications (4), Warnings and Precautions (5.18)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of sumatriptan and naproxen sodium 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 until they talk to their healthcare provider [see Drug Interactions (7)].

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

MEDICATION GUIDE


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
  • smoke
  • have diabetes
  • have high cholesterol levels
  • are overweight
  • have a family history of heart disease

Sumatriptan and naproxen sodium tablets c an 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”
  • more frequent use
  • drinking alcohol
  • having poor health
  • advanced liver disease
  • bleeding problems
  • longer use
  • smoking
  • older age

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
  • rash
  • problems breathing or swallowing
  • blisters or bleeding of your lips, eye lids, mouth, nose, or genitals
  • swelling of your lips, tongue, throat or body
  • fainting
  • reddening of your skin with blisters or peeling

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 s umatriptan 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 relief from your headache:
    • For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 2 doses of sumatriptan and naproxen sodium tablets 85/500 mg in a 24-hour period.
    • For children 12 to 17 years of age: it is not known if taking more than 1 dose of sumatriptan and naproxen sodium tablets in 24 hours is safe and effective. Talk to your healthcare provider about what to do if your headache does not go away or comes back.
  • If you take too much sumatriptan and naproxen sodium, call your healthcare provider or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take sumatriptan and naproxen sodium tablets so you can talk with your healthcare provider about how sumatriptan and naproxen sodium tablets are working for you.

What should I avoid while taking sumatriptan and naproxen sodium tablets?
Sumatriptan and naproxen sodium tablets can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of sumatriptan and naproxen sodium tablets?

Sumatriptan and naproxen sodium tablets may cause serious side effects. See “What is the most important information I should know about sumatriptan and naproxen sodium tablets?”

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • new or worse high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • low red blood cells (anemia)
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • stomach pain after meals
  • nausea or vomiting
  • bloody diarrhea
  • sudden or severe stomach pain
  • weight loss
  • constipation or diarrhea
  • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in 1 or both legs or feet
  • medication overuse headaches. Some people who use too many sumatriptan and naproxen sodium tablets may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan and naproxen sodium tablets.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan and naproxen sodium tablets, especially if sumatriptan and naproxen sodium tablets are used with antidepressant medicines called SSRIs or SNRIs.

Stop taking sumatriptan and naproxen sodium tablets and call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:

  • changes in blood pressure
  • tight muscles
  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • high body temperature
  • trouble walking
  • seizures. Seizures have happened in people taking sumatriptan, one of the ingredients in sumatriptan and naproxen sodium tablets, who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan and naproxen sodium tablets.

The most common side effects of sumatriptan and naproxen sodium tablets include:

  • dizziness
  • pain, discomfort, or stiffness in your neck, throat, jaw, or chest
  • tingling or numbness in your fingers or toes
  • dry mouth
  • heartbeat problems
  • feeling weak, drowsy, or tired
  • nausea
  • heartburn
  • feeling hot
  • muscle tightness

Stop sumatriptan and naproxen sodium tablets and call your healthcare provider right away if you have any of the following symptoms:

  • nausea that seems out of proportion to your migraine
  • vomit blood
  • yellow skin or eyes
  • more tired or weaker than usual
  • itching
  • swelling of the arms, legs, hands, and feet
  • sudden or severe stomach pain
  • blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • flu-like symptoms
  • diarrhea
  • tenderness in your upper right side

Tell your healthcare provider if you have any side effects that bother you or do not go away.

These are not all of the side effects of sumatriptan and naproxen sodium tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store sumatriptan and naproxen sodium tablets?

Store sumatriptan and naproxen sodium tablets at room temperature between 68° to 77°F (20° to 25°C).

Keep sumatriptan and naproxen sodium tablets and all medicines out of the reach of children.

General information about the safe and effective use of sumatriptan and naproxen sodium tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sumatriptan and naproxen sodium tablets for a condition for which it was not prescribed. Do not give sumatriptan and naproxen sodium tablets to other people, even if they have the same problem you have. They may harm them.

This Medication Guide summarizes the most important information about sumatriptan and naproxen sodium tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sumatriptan and naproxen sodium tablets that is written for healthcare professionals.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in sumatriptan and naproxen sodium tablets?

Active ingredients: sumatriptan succinate and naproxen sodium.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, dextrose monohydrate, lecithin (soya), maltodextrin, microcrystalline cellulose, silicified microcrystalline cellulose, povidone, sodium bicarbonate, sodium carboxymethyl cellulose, sodium stearyl fumarate, talc, and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse Aurobindo Pharma Limited or its products.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 05/2021

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides

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