Sumatriptan Nasal

WHY is this medicine prescribed?

Sumatriptan nasal products are used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light). Sumatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels around the brain, stopping pain signals from being sent to the brain, and blocking the release of natural substances that cause pain, nausea, and other symptoms of migraine. Sumatriptan does not prevent migraine attacks or reduce the number of headaches you have.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Sumatriptan comes as a spray (Imitrex, Tosymra) to inhale through the nose. It also comes as a powder (Onzetra Xsail) to inhale through the nose with a breath-powered delivery device. It is usually used at the first sign of a migraine headache. If your symptoms improve after you use sumatriptan but come back, you may use a second dose of sumatriptan (Imitrex, Onzetra Xsail) at least 2 hours later, or a second or third dose of sumatriptan (Tosymra) at least 1 hour after each other, if needed. However, if your symptoms do not improve after you use sumatriptan, do not use a second dose without talking to your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use sumatriptan exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You may use your first dose of sumatriptan nasal in a doctor's office or other medical facility where you can be monitored for serious reactions.

Call your doctor if your headaches do not get better or occur more frequently after using sumatriptan nasal.

If you use sumatriptan more often or for longer than the recommended period of time, your headaches may get worse or may occur more frequently. You should not use sumatriptan nasal or take any other headache medication for more than 10 days per month. Call your doctor if you need to use sumatriptan nasal to treat more than four headaches in 1-month period.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

To use the nasal spray, follow these steps:

1. Read all of the manufacturer's instructions for using the nasal spray before you use your first dose.
2. Blow your nose gently.
3. Remove the device from the blister pack.
4. Hold the sprayer between your fingers and thumb, but be careful not to press the plunger.
5. Use your other hand to block one nostril by pressing firmly on the side of your nose.
6. Put the tip of the sprayer into your other nostril as far as feels comfortable (about one half inch). Keep your head upright and close your mouth. If you are using Tosymra, tilt your head slightly back, and point the tip of the inserted sprayer toward the outside of your nose. Be careful not to press the plunger or spray the medication in your eyes.
7. Breathe in gently through your nose. At the same time, press the plunger firmly with your thumb.
8. Keep your head level and remove the tip from your nose.
9. Breathe gently in through your nose and out through your mouth for 10 to 20 seconds. Do not breathe in deeply. It is normal to feel liquid in your nose or the back of your throat.
10. The sprayer only contains one dose of medication. After you have used it, dispose of it safely, so that is out of the reach of children and pets.

To inhale the nasal powder using an inhaler, follow these steps:

1. Read all of the manufacturer's instructions for using the nasal device before you use your first dose.
2. Remove the nosepiece from the pouch. The nosepiece contains a capsule filled with sumatriptan powder.
3. Click the nosepiece into the device body.
4. Fully press and release the white piercing button on the device body one time to pierce the capsule inside the nosepiece. It should only be pressed once.
5. Insert the first nosepiece deeply into the nostril. Keep it in the nostril as you rotate the device to put the mouthpiece into the mouth.
6. Blow forcefully with your mouth into the device for 2 to 3 seconds to deliver the medication into the nose. You may hear a vibration or rattling noise as you do this. Do not hold or press the white button while blowing.
7. Press the clear tab to remove the first nosepiece. Check the capsule in the nosepiece to ensure that the medication was given.
8. Remove and discard the nosepiece safely, so that is out of the reach of children and pets.
9. Repeat steps 2 to 8 using a second nosepiece in the other nostril to give the total dose.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using sumatriptan nasal,

• tell your doctor and pharmacist if you are allergic to sumatriptan, any other medications, or any of the ingredients in sumatriptan nasal products. Ask your pharmacist for a list of the ingredients.

• do not use sumatriptan nasal if you have taken any of the following medications in the past 24 hours: other selective serotonin receptor agonists such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or ergot-type medications such as bromocriptine (Parlodel), cabergoline, dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Hydergine), ergonovine (Ergotrate), ergotamine (Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), methysergide (Sansert), and pergolide (Permax).

• do not use sumatriptan nasal if you are taking a monoamine oxidase A (MAO-A) inhibitor such as isocarboxazid (Marplan), phenelzine (Parnate), or tranylcypromine (Nardil) or if you have taken one of these medications in the past 2 weeks.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetaminophen (Tylenol); antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); rasagiline (Azilect); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine, paroxetine (Paxil), sertraline (Zoloft), vilazodone (Viibryd), and vortioxetine (Trintellix); and selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Pristiq), duloxetine (Cymbalta), selegiline (Emsam, Zelapar); and venlafaxine (Effexor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had heart disease; a heart attack; angina (chest pain); high blood pressure; irregular heartbeats; stroke or 'mini-stroke'; circulation problems such as varicose veins, blood clots in the legs, Raynaud's disease (problems with blood flow to the fingers, toes, ears, and nose), peripheral vascular disease (poor circulation in the blood vessels that supply blood to the legs), ischemic bowel disease (bloody diarrhea and stomach pain caused by decreased blood flow to the intestines); hemiplegic migraines (migraines that make you unable to move on one side of your body), basilar migraines (a rare type of migraine), or liver disease. Your doctor may tell you not to use sumatriptan nasal products.

• tell your doctor if you smoke or are overweight; if you have or have ever had high cholesterol, diabetes, seizures, or kidney disease; if you have gone through menopause (change of life); or if any family members have or have ever had heart disease or stroke.

• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while using sumatriptan nasal, call your doctor.

• tell your doctor if you are breastfeeding. Your doctor may tell you it is best to wait 12 hours after using the medication before breastfeeding your child.

• you should know that sumatriptan nasal may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Sumatriptan nasal may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• sore or irritated nose
• sore throat
• dry mouth
• unusual taste in the mouth
• nausea
• tiredness
• dizziness
• weakness
• burning or tingling feeling
• warm feeling
• sensitivity to loud noises
• flushing
• muscle pain or weakness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• pain, tightness, pressure, discomfort, or heaviness in the chest, throat, neck, or jaw
• slow or difficult speech
• faintness
• breaking out in a cold sweat
• change in vision
• weakness or numbness of an arm or leg
• fast, pounding, or irregular heartbeat
• bloody diarrhea
• vomiting
• sudden or severe stomach pain
• sudden weight loss
• paleness or blue color of the fingers and toes
• shortness of breath
• swelling of the eyes, face, lips, tongue, or throat
• difficulty breathing or swallowing
• rash
• hives
• hoarseness
• pain, burning, or tingling in the hands or feet
• seizures
• high fever
• agitation
• hallucination (seeing or hearing things that are not there)
• difficulty moving

Sumatriptan nasal may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not store in the refrigerator or freezer.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• seizures
• shaking of the body that you can't control
• red or bluish skin
• slowed breathing
• trouble moving or walking
• inability to move
• enlarged pupils (black circle in center of eye)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor. Your blood pressure should be checked regularly.

You should keep a headache diary by writing down when you have headaches and when you use sumatriptan nasal products.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.