Sumatriptan Nasal Spray

Sumatriptan nasal spray is 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 certain 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.

Before using sumatriptan,

• tell your doctor and pharmacist if you are allergic to sumatriptan, any other medications, or any of the ingredients in sumatriptan nasal spray. Ask your pharmacist for a list of the ingredients.
• do not use sumatriptan nasal spray 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 spray 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); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine, paroxetine (Paxil), and sertraline (Zoloft); and selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Pristiq), duloxetine (Cymbalta), sibutramine (Meridia), 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); irregular heartbeats; stroke or 'mini-stroke'; or 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), or ischemic bowel disease (bloody diarrhea and stomach pain caused by decreased blood flow to the intestines). Your doctor may tell you not to use sumatriptan nasal spray.
• tell your doctor if you smoke or are overweight; if you have or have ever had high blood pressure, high cholesterol, diabetes, seizures, or liver 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, plan to become pregnant, or are breast-feeding. If you plan to be sexually active while you are using this medication, talk to your doctor about effective methods of birth control. If you become pregnant while using sumatriptan nasal spray, call your doctor.
• you should know that sumatriptan nasal spray may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

IMITREX Nasal Spray (sumatriptan nasal spray) 5 mg (NDC 0173-0524-00) and 20 mg (NDC 0173-0523-00) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 and 20 mg, respectively, of sumatriptan.

Store between 36° and 86°F (2° and 30°C). Protect from light.

GlaxoSmithKline, Research Triangle Park, NC 27709. October 2007. FDA rev date: 10/13/2004

The following wording is contained in a separate leaflet provided for patients.

IMITREX® (sumatriptan nasal spray)
(sumatriptan) Nasal Spray

Read this leaflet carefully before you start to take IMITREX Nasal Spray. Keep the leaflet for reference because it gives you a summary of important information about IMITREX Nasal Spray (sumatriptan nasal spray) .

Read the leaflet that comes with each refill of your prescription because there may be new information.

This leaflet does not have all the information about IMITREX Nasal Spray (sumatriptan nasal spray) . Ask your healthcare provider for more information or advice.

What is IMITREX Nasal Spray (sumatriptan nasal spray) ?

IMITREX Nasal Spray (sumatriptan nasal spray) is a kind of medicine called a triptan. You should take it only if you have a prescription.

IMITREX Nasal Spray (sumatriptan nasal spray) is used to relieve your migraine. It is not used to prevent attacks or reduce the number of attacks you have. Use IMITREX Nasal Spray (sumatriptan nasal spray) only to treat an actual migraine attack.

The decision to use IMITREX Nasal Spray (sumatriptan nasal spray) is one that you and your healthcare provider should make together, based on your personal needs and health.

Talk with your healthcare provider before taking IMITREX Nasal Spray (sumatriptan nasal spray)

1. Risk factors for heart disease to tell your healthcare provider:

Tell your healthcare provider if you have risk factors for heart disease such as:

• high blood pressure
• high cholesterol
• being overweight
• diabetes
• smoking
• strong family history of heart disease
• you are postmenopausal
• you are a male over 40 years of age

If you do have risk factors for heart disease, your healthcare provider should check you for heart disease to see if IMITREX is right for you.

Although most of the people who have taken IMITREX have not had any serious side effects, some have had serious heart problems. Deaths have been reported, but these were rare considering the extensive worldwide use of IMITREX. Usually, serious problems happened in people with known heart disease. It was not clear whether IMITREX had anything to do with these deaths.

2. Important questions to ask yourself before you take IMITREX Nasal Spray (sumatriptan nasal spray) :

If the answer to any of the following questions is YES or if you do not know the answer, then please talk with your healthcare provider before you take IMITREX Nasal Spray (sumatriptan nasal spray) .

• Are you pregnant? Do you think you might be pregnant? Are you trying to become pregnant? Are you not using adequate contraception? Are you breastfeeding?
• Do you have any chest pain, heart disease, shortness of breath, or irregular heartbeats? Have you had a heart attack?
• Do you have risk factors for heart disease (see list above)?
• Have you had a stroke, a mini-stroke (also called a transient ischemic attack or TIA), or Raynaud syndrome?
• Do you have high blood pressure?
• Have you ever had to stop taking this or any other medicine because of an allergy or other problems?
• Are you taking any other migraine medicines, including other triptans? Are you taking any medicines containing ergotamine, dihydroergotamine, or methysergide?
• Are you taking any medicine for depression or other health problems such as a monoamine oxidase inhibitor, selective serotonin reuptake inhibitor (SSRI), or serotonin norepinephrine reuptake inhibitor (SNRI)? Common SSRIs are citalopram HBr (CELEXA®), escitalopram oxalate (LEXAPRO®), paroxetine (PAXIL®), fluoxetine (PROZAC®/SARAFEM®), olanzapine/fluoxetine (SYMBYAX®), sertraline (ZOLOFT®), and fluvoxamine. Common SNRIs are duloxetine (CYMBALTA®) and venlafaxine (EFFEXOR®).
• Have you had, or do you have, any disease of the liver or kidney?
• Have you had, or do you have, epilepsy or seizures?
• Is this headache different from your usual migraine attacks?

Remember, if you answered YES to any of the above questions, then talk with your healthcare provider about it.

Important points about IMITREX Nasal Spray (sumatriptan nasal spray)

1. The use of IMITREX Nasal Spray (sumatriptan nasal spray) during pregnancy:

Do not take IMITREX Nasal Spray (sumatriptan nasal spray) if you are pregnant, think you might be pregnant, are trying to become pregnant, or are not using adequate contraception unless you have talked with your healthcare provider about this.

2.  How to take IMITREX Nasal Spray (sumatriptan nasal spray) :

Before taking IMITREX Nasal Spray (sumatriptan nasal spray) , see the enclosed instructions leaflet.

For adults, the usual dose is a single nasal spray in 1 nostril. If your headache comes back, you can take a second nasal spray anytime after 2 hours after you took the first spray.

For any attack where you have no response to the first nasal spray, do not take a second nasal spray without first talking with your healthcare provider. Do not take more than a total of 40 mg of IMITREX Nasal Spray (sumatriptan nasal spray) in any 24-hour period. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

The effects of long-term repeated use of IMITREX Nasal Spray (sumatriptan nasal spray) on the surfaces of the nose and throat have not been specifically studied.

3. What to do if you take an overdose:

If you have taken more medicine than has been prescribed for you, contact either your healthcare provider, hospital emergency department, or nearest poison control center right away.

4. How to store your medicine:

Keep your medicine in a safe place where children cannot reach it. It may be harmful to children.

Store your medicine away from heat and light. Do not store at temperatures above 86°F (30°C) or below 36°F (2°C).

The expiration date of your medicine is printed on the packaging. If your medicine has expired, throw it away.

If your healthcare provider decides to stop your treatment, do not keep any leftover medicine unless your healthcare provider tells you to.

Some possible side effects of IMITREX Nasal Spray (sumatriptan nasal spray)

• Some patients feel pain or tightness in the chest or throat when using IMITREX Nasal Spray (sumatriptan nasal spray) . If this happens to you, tell your healthcare provider before taking any more IMITREX Nasal Spray (sumatriptan nasal spray) . If the chest pain, tightness, or pressure is severe or does not go away, call your healthcare provider right away.
• Call your healthcare provider right away if you have sudden and/or severe abdominal pain after you take IMITREX Nasal Spray (sumatriptan nasal spray) .
• Some people may have a reaction called serotonin syndrome when they take certain kinds of medicines for depression called SSRIs or SNRIs while they are taking IMITREX Nasal Spray (sumatriptan nasal spray) . Symptoms may include confusion, hallucinations, fast heartbeat, feeling faint, fever, sweating, muscle spasm, difficulty walking, and/or diarrhea. Call your healthcare provider right away if you have any of these symptoms after taking IMITREX Nasal Spray (sumatriptan nasal spray) .
• Shortness of breath; wheeziness; heart throbbing; swelling of eyelids, face, or lips; or a skin rash, skin lumps, or hives happens rarely. If it happens to you, then tell your healthcare provider right away. Do not take any more IMITREX Nasal Spray (sumatriptan nasal spray) unless your healthcare provider tells you to.
• Some people may feel tingling, heat, flushing (redness of face lasting a short time), heaviness, or pressure after taking IMITREX Nasal Spray (sumatriptan nasal spray) . A few people may feel drowsy, dizzy, tired, sick, or may experience nasal irritation. If you have any of these symptoms, tell your healthcare provider at your next visit.
• If you feel unwell in any other way or have any symptoms that you do not understand, you should contact your healthcare provider right away

Sumatriptan is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumatriptan is used to treat migraine headaches. Sumatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumatriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Sumatriptan may also be used for purposes not listed in this medication guide.

Since sumatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using sumatriptan.

After taking a sumatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 200 mg of sumatriptan tablets in 24 hours.

After using sumatriptan nasal spray, you must wait two (2) hours before using a second spray. Do not use more than 40 mg of sumatriptan nasal spray in 24 hours.

NDC 0527-1818-43

Sumatriptan Nasal Spray, USP

5 mg

Manufactured for: Lannett Company, Inc.
Made in the USA