Sumatriptan Succinate (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sumatriptan succinate injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:

Product No. NDC No. Strength
271301 63323-273-01 6 mg (sumatriptan) 0.5 mL 0.5 mL single dose vial, packaged individually.

Store between 2° and 25°C (36° and 77°F). Protect from light.

The container closure is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information leaflet).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events

Inform patients that sumatriptan succinate injection may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions ( 5.1, 5.2, 5.4, 5.5, 5.8)] .

Anaphylactic/Anaphylactoid Reactions

Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan succinate injection. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Warnings and Precautions ( 5.9)] .

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions ( 5.6)] .

Pregnancy

Inform patients that sumatriptan succinate injection should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations ( 8.1)] .

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations ( 8.3)] .

Ability to Perform Complex Tasks

Since migraines or treatment with sumatriptan succinate injection may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of sumatriptan succinate injection.

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the use of sumatriptan succinate injection or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions ( 7.4)] .

How to Use Sumatriptan Succinate Injection

Provide patients instruction on the proper use of sumatriptan succinate injection if they are able to self-administer sumatriptan succinate injection in medically unsupervised situation.

Inform patients that the injection is intended to be given subcutaneously and intramuscular or intravascular delivery should be avoided. Instruct patients to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.

SUMATRIPTAN SUCCINATE

( soo´mətrip´tan suk´sənāt´)

INJECTION

Read this Patient Information leaflet before you start taking sumatriptan succinate injection 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 succinate injection?

Sumatriptan succinate injection can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking sumatriptan succinate injection 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
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Sumatriptan succinate injection 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 high blood pressure
  • have high cholesterol levels
  • smoke
  • are overweight
  • have diabetes
  • have a family history of heart disease

What is sumatriptan succinate injection?

Sumatriptan succinate injection 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 succinate injection 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 succinate injection is not used to prevent or decrease the number of migraine or cluster headaches you have.

It is not known if sumatriptan succinate injection is safe and effective in children under 18 years of age.

Who should not take sumatriptan succinate injection?

Do not take sumatriptan succinate 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)
  • uncontrolled high blood pressure
  • 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:
  • almotriptan (AXERT ®)
  • eletriptan (RELPAX ®)
  • frovatriptan (FROVA ®)
  • naratriptan (AMERGE ®)
  • rizatriptan (MAXALT ® , MAXALT-MLT ®)
  • sumatriptan and naproxen (TREXIMET ®)
  • 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 succinate injection. See the end of this leaflet for a complete list of ingredients in sumatriptan succinate injection.

What should I tell my healthcare provider before taking sumatriptan succinate injection?

Before you take sumatriptan succinate injection, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or family history of heart problems or stroke
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • become pregnant while taking sumatriptan succinate injection
  • are breastfeeding or plan to breastfeed. Sumatriptan succinate injection 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 succinate injection.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using sumatriptan succinate injection with certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

  • selective serotonin reuptake inhibitors (SSRIs)
  • serotonin norepinephrine reuptake inhibitors (SNRIs)
  • tricyclic antidepressants (TCAs)
  • 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 succinate injection?

  • Certain people should take their first dose of sumatriptan succinate 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 succinate 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 succinate 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 succinate injection so you can talk with your healthcare provider about how sumatriptan succinate injection is working for you.

What should I avoid while taking sumatriptan succinate injection?

Sumatriptan succinate injection 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 succinate injection?

Sumatriptan succinate injection may cause serious side effects. See “What is the most important information I should know about sumatriptan succinate injection?”

These serious side effects include:

  • 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:
    • sudden or severe stomach pain
    • stomach pain after meals
    • weight loss
    • nausea or vomiting
    • constipation or diarrhea
    • bloody diarrhea
    • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • 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 succinate injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan succinate injection.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan succinate injection, especially if sumatriptan succinate injection is used with anti-depressant 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
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
  • seizures. Seizures have happened in people taking sumatriptan succinate injection who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan succinate injection.

The most common side effects of sumatriptan succinate injection include:

  • pain or redness at your injection site
  • tingling or numbness in your fingers or toes
  • dizziness
  • warm, hot, burning feeling to your face (flushing)
  • discomfort or stiffness in your neck
  • feeling weak, drowsy, or tired

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 succinate 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 succinate injection?

  • Do not store at temperatures above 77°F (25°C).
  • Store your medicine away from light.
  • Keep your medicine in the packaging or carrying case provided with it.

Keep sumatriptan succinate injection and all medicines out of the reach of children.

General information about the safe and effective use of sumatriptan succinate injection

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use sumatriptan succinate injection for a condition for which it was not prescribed. Do not give sumatriptan succinate 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 succinate injection. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sumatriptan succinate injection that is written for healthcare professionals.

What are the ingredients in sumatriptan succinate injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

The brand names mentioned in this document are the trademarks of their respective owners.

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451119C

Revised: April 2015

PACKAGE LABEL — PRINCIPAL DISPLAY — Sumatriptan 0.5 mL Single Dose Vial Label
Sumatriptan Succinate Injection
6 mg (sumatriptan) per 0.5 mL
For subcutaneous injection only.
0.5 mL Single Dose Vial
Discard unused portion.

271301 vial

PACKAGE LABEL — PRINCIPAL DISPLAY — Sumatriptan 0.5 mL Single Dose Vial Carton Panel
NDC 63323-273-01
271301
Sumatriptan Succinate Injection
6 mg (sumatriptan) per 0.5 mL
For subcutaneous injection only.
Discard unused portion.
1 x 0.5 mL
Single Dose Vial Rx only

271301 pbox
(click image for full-size original)
SUMATRIPTAN SUCCINATE sumatriptan succinate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-273
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN SUCCINATE (SUMATRIPTAN) SUMATRIPTAN 6 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 3.5 mg in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-273-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (63323-273-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079242 04/12/2011
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 manufacture (63323-273)

Revised: 10/2019 Fresenius Kabi USA, LLC

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