Sumatriptan

What it is used for

Sumatriptan Injection, USP is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Injection reconsider the diagnosis before Sumatriptan Injection is administered to treat any subsequent attacks.

Sumatriptan Injection is not indicated for the prevention of migraine attacks or cluster headache attacks. Sumatriptan injection, USP is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults Acute treatment of cluster headache in adults Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established Not indicated for the prophylactic therapy of migraine or cluster headache attacks

The most important thing to know

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

How to take it

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 mg/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 many sumatriptan and naproxen sodium tablets, 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.

Side effects, and when to stop

Sumatriptan and naproxen sodium tablets may cause serious side effects. 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: sudden or severe stomach pain stomach pain after meals weight loss nausea or vomiting constipation or diarrhea bloody 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 fast heartbeat tight muscles high body temperature mental changes such as seeing things that are not there (hallucinations), agitation, or coma 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 feeling weak, drowsy, or tired pain, discomfort, or stiffness in your neck, throat, jaw, or chest nausea tingling or numbness in your fingers or toes heartburn dry mouth feeling hot heartbeat problems 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 sudden or severe stomach pain vomit blood blood in your bowel movement or it is black and sticky like tar yellow skin or eyes unusual weight gain more tired or weaker than usual flu-like symptoms itching diarrhea swelling of the arms, legs, hands, and feet 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.

Who should not take it

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 migra

What to say before you start

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.

What to avoid

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.

Storing it

Store sumatriptan and naproxen sodium tablets at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Sumatriptan and naproxen sodium tablets come in a child-resistant package. Keep sumatriptan and naproxen sodium tablets and all medicines out of the reach of children.