Sumatriptan Succinate (Page 6 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows:
NDC 43598-768-23 Sumatriptan Injectin, USP Autoinjector System includes 2 Autoinjectors, each with an associated single-dose prefilled syringe which contains 6 mg of sumatriptan (as the succinate salt) and 3.5 mg of sodium chloride in 0.5 mL of solution.
Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events
Inform patients that sumatriptan 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 if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)].
Hypersensitivity Reactions
Inform patients that anaphylactic reactions have occurred in patients receiving sumatriptan 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 Contraindications (4), Warnings and Precautions (5.9)].
Concomitant Use with Other Triptans or Ergot Medications
Inform patients that use of sumatriptan injection within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4), Drug Interactions (7.1, 7.3)].
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome with the use of sumatriptan injection or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7), Drug Interactions (7.4)].
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
Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1)].
Lactation
Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)].
Ability to Perform Complex Tasks
Treatment with sumatriptan injection may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan injection.
How to Use Sumatriptan Injection
Instruct patients to read the Instructions for Use before starting therapy. Provide patients instruction on the proper use of sumatriptan injection if they are able to self-administer sumatriptan injection in medicaly unsupervised situations. Instruct patients on storage and disposal of the pen [see How Supplied/Storage and Handling (16)].
Inform patients that the needle in the sumatriptan autoinjector penetrates approximately 1/4 of an inch (5 to 6 mm). 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.
Rx Only
Distributor: Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540,
Made in India
Issued: 12/2022
PATIENT INFORMATION Sumatriptan (soo” ma trip’ tan) Injection USP 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:
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What is sumatriptan? Sumatriptan 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 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. Do not take sumatriptan injection if you have:
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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. |
Before taking sumatriptan 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 kidney problems • have liver problems • have had epilepsy or seizures • are not using effective birth control • are pregnant or plan to become pregnant. It is not known if sumatriptan can harm your unborn baby. • are breastfeeding or plan to breastfeed. Sumatriptan passes into your breast milk. It is not known if this can 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 over-the-counter medicines, vitamins, and herbal supplements. Sumatriptan and 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) • 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 showyour healthcare provider or pharmacist when you get a new medicine. |
How should I take sumatriptan injection?
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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?” These serious side effects include:
• 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 anti-depressant medicines called SSRIs or SNRIs.
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How should I store sumatriptan injection? •Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F)
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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. |
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 0123
Rx Only
Distributor: Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540,
Made in India
SUMATRIPTAN INJECTION
INSTRUCTIONS FOR USE OF DISPOSABLE SUMATRIPTAN AUTOINJECTOR SYSTEM
Read this Patient Instructions for Use before you start to use Sumatriptan Autoinjector System. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about sumatriptan injection when you start taking it and at regular checkups.
- Use the device immediately once the cap has been removed; it is advised not to postpone the injection.
- Keep the Sumatriptan Autoinjector System out of the reach of children.
INSTRUCTIONS FOR USE OF AUTOINJECTOR PEN
Important things that you need to know
This device is called an Autoinjector pen. Here we use the shorter name ‘pen’.
1.Read all of the instructions carefully before using this pen.
2. Follow these step-by-step instructions every time you use the pen, ask your doctor or pharmacist.
3. Only use each pen once — do not try to use more than once.
If you have any further questions,
A. ABOUT THE AUTOINJECTOR PEN
The parts of the pen are shown in this picture
B. GETTING READY
Getting ready for the injection
1.Wash your hands.
2.Choose an area with an adequate fatty tissue layer.
3.Clean the skin area to be injected with alcohol or a new sterile swab (see Figure A).
Getting the pen ready
4. Take the pen out of the package.
5. Look in the transparent medicine window on the pen.
- Before injection, to check that the liquid is clear (see Figure B).
- If it is difficult to see what is in the window, hold the pen upto the light and check.
- After injection, the blue plunger rod completely fills the medicine window (see Figure C).
- If the blue plunger rod can be seen through the medicine window, the device is spent and cannot be used again.
6. Pull the gray cap off thepen.
- Do not twist the cap.
- Pull it straight off (see Figure D)
7. Look inside the cap, check that the gray needle cover is inside (see Figure E).Do not use the pen if the gray needle cover is not inside the cap.
8. Do not try to put the cap back.
If you try to put it back, this will damage the needle. You are now ready to inject the medicine, go to step 9.
C. INJECTING THE MEDICINE
9. Without pressing the blue button, push the pen firmly against your skin until you feel the stop point (see FigureF).
• Pushing to the stop point unlocks the button.
• As long as the pen is firmly pressed against the skin, the safety lock is de- activated; the pen could fire unintentionally if the blue button is pressed by acciden t.
• Do not attempt to re-engage the safety lock at any time
• Keep the pen pressed against your skin for the next steps.
10 Keep pushing the pen against your skin then firmly press down the blue button on the top of the pen until it will not go further (see Figure G).
•You will hear a click, this indicates that the injection has started (see Figure G).
• If the injection did not start, release the blue button, make sure the pen is pushed down against the skin and push down harder on the blue button.
11. Do not take the pen off your skin.
- Monitor the injection through the medicine window to make sure that the entire dose is injected. The blue plunger will move down the window, completely fill it, and stop moving when the injection is done (see Figure H).
- When the injection is done, keep holding the pen against the skin for 5 seconds (see Figure I). If you take the pen off before, not all of the medicine will be injected.
12.Carefully take the pen off your skin (see Figure J).
• The protective sleeve automatically covers the needle. It is then locked and the needle is protected.
D. WHAT TO DO AFTER THE INJECTION
13. If you notice a spot of blood at the injection site, dab away with a cotton ball or tissue paper. Do not rub the injection site. If needed, you may cover the injection site with a bandage. 14. Visually check that there is no liquid left at the bottom of the medicine window. If there is liquid, consult your doctor or pharmacist.
E. DISPOSE THE AUTOINJECTOR PEN
15. Discard the whole sumatriptan injection pen after use and discard the cap.
• Put your used injection pen in a FDA-cleared sharps disposal container right away after use (see Figure K).
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
o made of a heavy-duty plastic,
o can be closed with a tight- tting, puncture-resistant lid, without sharps being able to come out, upright and stable during use,
o leak-resistant, and
o properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for speci c information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Do not try to reuse the autoinjector pen. To avoid any injury, never try to touch the needle.
T his Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
To reorder additional Patient information sheets contact Dr. Reddy’s Customer Service at 1-866-733-3952.
Rx Only
Distributor:
Dr. Reddy’s Laboratories Inc.,
Princeton, NJ 08540,
Made in India
Issued: 12/2022
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