Sumatriptan Injection

HOW should this medicine be used?

Sumatriptan injection comes as a solution (liquid) to inject subcutaneously (just under your skin). It is usually used at the first sign of a migraine headache. If your symptoms improve after you use sumatriptan but return after 1 hour or longer, you may use a second dose of sumatriptan. However, if your symptoms do not improve after you use sumatriptan, do not use a second injection 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 take it more often than prescribed by your doctor.

Sumatriptan injection comes in a pre-filled auto-injection device and in vials to be used with disposable syringes. If you are using vials of sumatriptan injection, your doctor or pharmacist will tell you what type of syringe you should use. Do not use any other type of syringe because you may not get the right amount of medication.

You can inject your sumatriptan in the outer side of your thigh or upper arm. Do not inject sumatriptan through clothing. Never inject sumatriptan into a vein or muscle.

You may use your first dose of sumatriptan injection in a doctor's office or other medical facility where you can be monitored for serious reactions. Carefully read the instructions that come with your device, and ask your doctor or pharmacist to show you how to use it.

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

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 injection or take any other headache medication for more than 10 days per month. Call your doctor if you need to use sumatriptan injection to treat more than four headaches in 1-month period.

Do not use prefilled injection devices or vials of sumatriptan injection more than once. Dispose of used syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

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,

• tell your doctor and pharmacist if you are allergic to sumatriptan, any other medications, or any of the ingredients in sumatriptan injection.

• do not use sumatriptan injection 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 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 injection 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 prescription and nonprescription medications, vitamins, herbal products and nutritional supplements 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 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 injection.

• 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, call your doctor.

• you should know that sumatriptan injection 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 may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain or redness at the site of injection
• flushing
• tingling feeling
• feeling of warmth
• drowsiness
• upset stomach
• vomiting
• muscle cramps

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

• pain, tightness, pressure, or heaviness in chest, throat, neck, or jaw
• slow or difficult speech
• faintness
• breaking out in a cold sweat
• 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
• difficulty breathing or swallowing
• swellingof the eyes, face, lips, tongue, or throat
• rash
• hives
• hoarseness
• pain, burning, or tingling in the hands or feet
• seizures
• changes in vision

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/MedWatchhttp://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, away from light, excess heat, and moisture (not in the bathroom).

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.orghttp://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/c4Rm4phttp://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/helphttps://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.

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 injection.

Do not let anyone else take 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.