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|Sumatriptan Spray

Sumatriptan Spray

Sumatriptan Spray is used for:

The treatment of migraine headaches with or without aura (eg, flashing lights, wavy lines, dark spots). It may also be used for other conditions as determined by your doctor.

Sumatriptan Spray is a serotonin 5-HT ₁receptor agonist ("triptan"). It works by narrowing blood vessels in the brain, which helps to relieve migraines.

Do NOT use Sumatriptan Spray if:

• you are allergic to any ingredient in Sumatriptan Spray
• you have a history of ischemic heart disease (eg, angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)
• you have uncontrolled high blood pressure or severe liver problems
• you have certain types of migraines (eg, hemiplegic, basilar)
• you are taking or have taken a monamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
• you have used certain other migraine medicines within the past 24 hours. These include an ergot derivative (eg, dihydroergotamine, methysergide) or another serotonin 5-HT ₁ receptor agonist (eg, eletriptan, rizatriptan)
• you are taking sibutramine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Sumatriptan Spray:

Some medical conditions may interact with Sumatriptan Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have history of liver or kidney problems, seizures (eg epilepsy), heart problems, or other types of headaches (eg, cluster headaches)
• if you have shortness of breath, chest pain, or a history of high blood pressure, heart attack, stroke, high cholesterol, diabetes, or smoking
• if you are a woman who is past menopause
• if you are a man who is older than 40 years of age
• if you are very overweight
• if a family member has had heart disease

Some MEDICINES MAY INTERACT with Sumatriptan Spray. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (eg, duloxetine), orsibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea
• MAOIs (eg, phenelzine) because they may increase the risk of Sumatriptan Spray"s side effects
• Ergot derivatives (eg, dihydroergotamine, methysergide) or other serotonin 5-HT ₁ receptor agonists (eg, eletriptan, rizatriptan) because the risk of their side effects may be increased by Sumatriptan Spray

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sumatriptan Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Sumatriptan Spray:

Use Sumatriptan Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Sumatriptan Spray. Talk to your pharmacist if you have questions about this information.
• A health care provider will teach you how to use Sumatriptan Spray. Be sure you understand how to use Sumatriptan Spray. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Sumatriptan Spray should be inhaled into the nose. Do not get it in your mouth or eyes. If you get it in your eyes, rinse right away with cool tap water.
• To use Sumatriptan Spray, remove the nasal spray unit from the plastic pack. Do not remove it until you are ready to use it.
• The unit contains only 1 spray. Do NOT test it before use.
• Sit down. Gently blow your nose to clear the nasal passages. Keep your head in an upright position, gently close 1 nostril with your index finger, and breathe out gently through the mouth. With your other hand, hold the container with your thumb at the bottom and your index and middle finger on either side of the nozzle. Insert the nozzle into your open nostril about ½ inch. Do not press the blue plunger yet.
• Keep your head upright and close your mouth. Gently take a breath through your nose and at the same time firmly press the blue plunger.
• Remove the nozzle from your nostril. Keep your head level for 10 to 20 seconds while gently breathing in through your nose and out through your mouth. Do NOT breathe in deeply.
• It is best to use a dose of Sumatriptan Spray as soon as you notice symptoms of a migraine attack.
• If your migraine symptoms go away and then come back, you may use a second dose as directed by your doctor. Wait at least 2 hours between doses.
• If your symptoms do not improve after the first dose, do not use a second dose for the same attack. Contact your doctor.
• Do not use more than the amount prescribed by your doctor in a 24-hour period or treat more than 4 headaches within 30 days without checking with your doctor.
• If you miss a dose of Sumatriptan Spray and you still have a headache, follow your doctor"s dosing instructions. Contact your doctor if you are unsure of what to do if you miss a dose. Do not use Sumatriptan Spray more often than prescribed. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sumatriptan Spray.

Important safety information:

• Sumatriptan Spray may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sumatriptan Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Rarely, serious heart problems (eg, heart attack, irregular heartbeat) have been reported within a few hours of using Sumatriptan Spray. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.
• Sumatriptan Spray should not be used to prevent or reduce the number of migraine headaches you have. If you have a headache that is different than your usual migraine headaches, check with your doctor before using Sumatriptan Spray.
• Lab tests, including heart function tests, may be performed while you use Sumatriptan Spray. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Sumatriptan Spray should not be used in the ELDERLY; the risk of serious side heart and blood pressure side effects may be increased.
• Sumatriptan Spray should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Sumatriptan Spray can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sumatriptan Spray while you are pregnant. Sumatriptan Spray is found in breast milk. If you are or will be breast-feeding while you use Sumatriptan Spray, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Sumatriptan Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad or unusual taste; burning, numbness, tingling, discharge, pain, or soreness of the nose, throat, or sinuses; dizziness; drowsiness; feeling of heaviness or pressure; mild, temporary flushing; nausea; sick feeling; tingling; tiredness; vomiting; warm/hot sensation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; chest pain; confusion; fainting; fast or irregular heartbeat; hearing problems; numbness or tingling of an arm or leg; one-sided weakness; pain, tightness, or pressure in the jaw, neck, or chest; seizures; severe headache, dizziness, or vomiting; severe or prolonged flushing; severe stomach pain; shortness of breath; speech changes; very cold or blue fingers or toes; vision changes or loss of vision; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact the US national poison control center (1-800-222-1222), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; seizures; slowed breathing; tremor.

Store Sumatriptan Spray between 36 and 86 degrees F (2 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store at temperatures above 86 degrees F (30 degrees C). Do not store in the bathroom. Keep Sumatriptan Spray in the case provided. Throw away expired medicine as directed by your doctor (the expiration date is printed on the treatment pack). Keep Sumatriptan Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Sumatriptan Spray, please talk with your doctor, pharmacist, or other health care provider.
• Sumatriptan Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Sumatriptan Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.