Onzetra Xsail, Imitrex, Imitrex Statdose, Sumatriptan

Sumatriptan Nasal Powder

(soo ma TRIP tan)

ONZETRA Xsail

It is used to treat migraine headaches.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have any of these health problems: High blood pressure or liver disease. If you have ever had any of these health problems: Chest pain or pressure; diseased arteries going to the legs or arms; heart attack; heart disease; poor blood flow in the heart, brain, bowel, or kidney; stroke or transient ischemic attack (TIA); certain migraines like hemiplegic or basilar migraines; or an abnormal heartbeat like Wolff-Parkinson-White syndrome. If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen. If you are taking another drug that has the same drug in it. If you have taken almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan in the last 24 hours. If you have taken ergotamine, methysergide, dihydroergotamine, or any drug like them in the last 24 hours. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

For all patients taking this drug: Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor. This drug is not meant to prevent or lower the number of migraine headaches you get. If you have a headache that is not like your usual migraine headaches, talk with your doctor before you take this drug. Taking more of this drug (a higher dose, more often) than your doctor told you to take may cause your headaches to become worse. Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor. Very bad and sometimes deadly heart problems like heart attack and a heartbeat that is not normal have rarely happened within a few hours of taking this drug. Call your doctor right away if you have chest, throat, neck, or jaw tightness, pain, pressure, or heaviness; break out in a cold sweat; shortness of breath; a fast heartbeat; a heartbeat that does not feel normal; or very bad dizziness or passing out. Very bad and sometimes deadly brain blood vessel problems like stroke have rarely happened with this drug. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in eyesight. If you are 65 or older, use this drug with care. You could have more side effects. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby. Children: This drug is not approved for use in children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Rarely, some allergic reactions have been deadly. Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight. Seizures. Loss of eyesight. This can be long-lasting. A burning, numbness, or tingling feeling that is not normal. Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes. Diarrhea or constipation. Severe stomach pain or bloody diarrhea. Belly pain after meals. Fever. Weight loss. Cramps and pain in legs or hips. Feeling of heaviness or tightness in the leg muscles. Feeling cold. Burning or aching pain in the feet or toes. A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Feeling dizzy, sleepy, tired, or weak. Flushing. Feeling of warmth. Upset stomach or throwing up. Change in taste. Nose or throat irritation. Runny or stuffy nose. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. If your headache does not get any better after the first dose, talk with your doctor. If your headache comes back or if you only get some relief, you may take 1 more dose if your doctor has told you to do so. Be sure you know how many hours to wait before taking another dose. This includes if a different form of this drug was used for the first dose. For the nose only. Use this drug as early as you can after the attack has started. Use nosepiece right after taking it out of the foil pouch. Only use the device that comes with this drug. Do not use any other devices. Be sure you know how to use this drug. Read the instructions that come with this drug. If you have any questions about how to use this drug, talk with the doctor or pharmacist.

This drug is taken on an as needed basis. Do not take more often than told by the doctor.

Store at room temperature. Do not refrigerate or freeze. Store in a dry place. Do not store in a bathroom. Protect from light. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.