IMPORTANT SAFETY INFORMATION
This Patient Information should be read before you start taking sumatriptan and each time you get a refill. There may be new information. This information does not
take the place of talking with your healthcare provider about your medical condition or treatment. What is the most important information I should know about sumatriptan injection? Sumatriptan can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking sumatriptan and get emergency medical help right away if you have any of the following symptoms of a heart attack:
• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
Sumatriptan is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:
• have a family history of heart disease
What is sumatriptan?
Sumatriptan is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed
with migraine or cluster headaches. Sumatriptan is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine
with aura) migraines. Sumatriptan is not used to prevent or decrease the number of migraine or cluster headaches you have. It is not known if sumatriptan is safe and effective in children under 18 years of age. Who should not take sumatriptan injection? Do not take sumatriptan injection if you have:
• heart problems or a history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
• taken any of the following medicines in the last 24 hours:
- ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
- dihydroergotamine (D.H.E. 45®, MIGRANAL®)
Ask your healthcare provider if you are not sure if your medicine is listed above.
• an allergy to sumatriptan or any of the ingredients in sumatriptan injection. See the end of this leaflet for a complete list of ingredients in sumatriptan injection.
What should I tell my healthcare provider before taking sumatriptan injection?
Before you take sumatriptan, tell your healthcare provider about all of your medical conditions, including if you:
• have heart problems or family history of heart problems or stroke
• are not using effective birth control
• become pregnant while taking sumatriptan
• are breastfeeding or plan to breastfeed. Sumatriptan passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best
way to feed your baby if you take sumatriptan.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Using sumatriptan with certain other medicines can affect each other, causing serious side effects. Especially tell your healthcare provider if you take antidepressant medicines called:
• selective serotonin reuptake inhibitors (SSRIs)
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• monoamine oxidase inhibitors (MAOIs)
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take sumatriptan injection?
• Certain people should take their first dose of sumatriptan injection in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you
should take your first dose in a medical setting.
• Use sumatriptan injection exactly as your healthcare provider tells you to use it.
• Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider
• For adults, the usual dose is a single injection given just below the skin.
• You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine attack.
• If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider.
• You can take a second injection 1 hour after the first injection, but not sooner, if your headache came back after your first injection.
• Do not take more than 12 mg in a 24 hour period.
• If you use too much sumatriptan injection, call your healthcare provider or go to the nearest hospital emergency room right away.
• You should write down when you have headaches and when you take sumatriptan injection so you can talk with your healthcare provider about how sumatriptan
What should I avoid while taking sumatriptan injection?
Sumatriptan can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert. What are the possible side effects of sumatriptan injection?
Sumatriptan may cause serious side effects. See "What is the most important information I should know about sumatriptan injection?"
• changes in color or sensation in your fingers and toes (Raynaud's syndrome)
• stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
• problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
- feeling of heaviness or tightness in your leg muscles
- burning or aching pain in your feet or toes while resting
- numbness, tingling, or weakness in your legs
- cold feeling or color changes in 1 or both legs or feet
• medication overuse headaches. Some people who use too many sumatriptan injections may have worse headaches (medication overuse headache). If your
headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan.
• serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan injection, especially if sumatriptan injection is
used with antidepressant medicines called SSRIs or SNRIs.
Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
- mental changes such as seeing things that are not there (hallucinations), agitation, or coma
• seizures. Seizures have happened in people taking sumatriptan injection who have never had seizures before. Talk with your healthcare provider about your chance
of having seizures while you take sumatriptan injection.
The most common side effects of sumatriptan injection include:
• pain or redness at your injection site
• tingling or numbness in your fingers or toes
• warm, hot, burning feeling to your face (flushing)
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sumatriptan injection. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800-FDA-1088. How should I store sumatriptan injection?
• Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
• Store your medicine away from light.
• Keep your medicine in the packaging or carrying case provided with it.
Keep sumatriptan injection and all medicines out of the reach of children. General information about the safe and effective use of sumatriptan injection
Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use sumatriptan injection for a condition for which it was
not prescribed. Do not give sumatriptan injection to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about sumatriptan injection. If you would like more information, talk with your healthcare
provider. You can ask your healthcare provider or pharmacist for information about sumatriptan injection that is written for healthcare professionals. For more information, call 1-888-375-3784. What are the ingredients in sumatriptan injection? Active ingredient: sumatriptan succinate USP Inactive ingredients: sodium chloride, water for injection The other brands listed are trademarks of their respective owners and are not trademarks of Dr. Reddy's Laboratories Limited. The makers of these brands are not
affiliated with and do not endorse Dr. Reddy's Laboratories Limited or its products. INDICATION
Sumatriptan Injection USP is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have
been diagnosed with migraine or cluster headaches.