Sumatriptan Injection, USP (DR Reddy's Laboratories): Uses, Side Effects and Dosage

What Sumatriptan Injection, USP is used for:

Sumatriptan Injection, USP is used in adults to relieve migraine headaches. These migraine headaches may or may not be accompanied by an aura. This is when you may see black spots, flashes of light or shimmering spots or stars. Sumatriptan Injection, USP should not be used to prevent or reduce the number of headaches you experience. Use Sumatriptan Injection, USP only to treat an actual migraine headache attack.

How Sumatriptan Injection, USP works:

Migraine headache is believed to be caused by a widening of the blood vessels in the head. Sumatriptan Injection, USP narrows these vessels and relieves the symptoms of migraine headache.

The ingredients in Sumatriptan Injection, USP are:

Medicinal ingredients: sumatriptan succinate

Non-medicinal ingredients: sodium chloride and water for injection.

Sumatriptan Injection, USP comes in the following dosage forms:

Sumatriptan Injection, USP comes as a prefilled syringe within a disposable one-time use autoinjector device.

Each prefilled syringe contains 0.5 mL of solution containing 6 mg of Sumatriptan (as succinate).

Each carton contains 2 autoinjectors, each with an associated single-dose prefilled syringe.

The stopper and needle shield are not made with natural rubber latex.

Do not use Sumatriptan Injection, USP if:

• you are allergic to sumatriptan or to any of the ingredients in Sumatriptan Injection, USP. (See “The ingredients in Sumatriptan Injection, USP are”).
• if you have a heart problem such as heart failure or chest pains (angina), or have already had a heart attack.
• you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA).

• you have a history, symptoms or signs of peripheral vascular disease. This is a reduced blood flow to the limbs and organs other than the heart and brain, such as ischemic bowel disease

  • and Raynaud’s syndrome.
• you have uncontrolled or severe high blood pressure.
• you are taking or have taken within the past 2 weeks, a monoamine oxidase inhibitor (MAO) inhibitor, medication (such as phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline).
• You are taking or have taken within the past 24 hours, medication containing ergotamine, dihydroergotamine, methysergide, or another triptan used to treat migraine headaches. If you are not sure if you have been prescribed these types of medications, ask your healthcare professional.
• you have severe liver problems.

• you have certain other types of migraine headaches including:

  • hemiplegic migraines. These are migraine headaches where you have weakness on one side of your body, or
  • basilar migraines. These are migraine headaches that start in the lower part of the brain, or
  • ophthalmoplegic migraines. These are migraine headaches where you have pain around the eyes.

If you are not sure if you have these types of migraines, ask your healthcare professional.

Sumatriptan Injection, USP should not be used for the treatment of other types of headaches that are different from migraine attacks.

Sumatriptan Injection, USP should not be given intravenously, but only into the tissues just below the skin (on the outside of the thigh or in the upper arm).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sumatriptan Injection, USP. Talk about any health conditions or problems you may have, including if you:

• are pregnant, think you might be pregnant, or are trying to become pregnant.

• are breastfeeding. The active ingredient in Sumatriptan Injection, USP, sumatriptan, will pass into your breast milk. Avoid breastfeeding for 24 hours after taking Sumatriptan Injection, USP. If you express any breast milk during this time, discard the milk and don’t give it to your baby.
• have risk factors for heart disease. This includes high blood pressure, high cholesterol, obesity, diabetes, smoking, strong family history of heart disease, or you are postmenopausal or a male over 40.
• have ever had to stop taking this or any other medication because of an allergy or other problems, or you are allergic to drugs containing sulphonamides.
• are under 18 years of age
• are over 65 years of age.
• had or have any liver or kidney problems.
• had or have epilepsy or seizures.
• experience a headache that is different from your usual migraine attacks

Other warnings you should know about:

Taking Sumatriptan Injection, USP can cause serious side effects, including:

• Serious heart problems
• Long term eye problems
• Raynaud’s Syndrome

See the Serious side effects and what to do about them table, below for more information on these and other serious side effects.

Serotonin toxicity (also known as Serotonin syndrome): Sumatriptan Injection, USP can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take Sumatriptan Injection, USP with certain medication to treat depression.

Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Continuous use of Sumatriptan Injection, USP: Sumatriptan Injection, USP should not be used continuously to prevent or reduce the number of attacks you experience. Use Sumatriptan Injection, USP only to treat an actual migraine headache attack. If you use Sumatriptan Injection, USP too often, it may make your migraine headaches worse. If this happens, your healthcare professional may tell you to stop taking Sumatriptan Injection, USP.

Driving and Operating Machines: Sumatriptan Injection, USP can cause dizziness which may affect your ability to drive or use machines. Wait to see how you respond to Sumatriptan Injection, USP before you drive or use machines.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Sumatriptan Injection, USP:

• Medicines used to treat depression such as MAO Inhibitors, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitors (SNRIs).
• Other medicines used to treat migraine headaches such as triptans, 5-HT₁ agonists, ergotamine, dihydroergotamine, and methysergide.

How to use Sumatriptan Injection, USP:

• Sumatriptan Injection, USP is available as a prefilled syringe within a disposable one-time use Autoinjector device.
• Before using the Sumatriptan Injection, USP Autoinjector System, see the instructions below
• Sumatriptan Injection, USP Autoinjector System is given as a single injection into the tissues just below the skin on the outside of the thigh or the upper arm.
• Sumatriptan Injection, USP can be taken at any time during your migraine headache.
• It may take up to 15 minutes for Sumatriptan Injection, USP to start working.
• If after taking Sumatriptan Injection, USP you need more pain relief, you can take another pain medication. This medication should not contain ergotamine. If you are not sure which medications you can use talk to your healthcare professional.

Remember, this medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.

Instructions For Use of your Sumatriptan Disposable Autoinjector

TRUCTIONS FOR USE OF THE SUMATRIPTAN DISPOSABLE AUTOINJECTOR

The Instructions for use explains how to use the Sumatriptan Autoinjector System. Read them several times to make sure you understand them, before you begin the first step. If you have any questions, ask your healthcare professional.

• Use the device immediately once the cap has been removed; do NOT postpone the injection.
• Keep the Sumatriptan Autoinjector System out of the reach of children

Important things that you need to know

This device is called an Autoinjector pen. Here we use the shorter name 'pen'.

1. 1. Follow these step-by-step instructions every time you use the pen.
2. 2. Only use each pen once - do not try to use more than once.
3. A. ABOUT THE AUTOINJECTOR PEN

B. GETTING READY

Getting ready for the injection.

1. 1. Wash your hands.
2. 2. Choose an area with an adequate fatty tissue layer such as upper arm or thigh (see below).
3. 3.

   Clean the skin area to be injected with alcohol or a new sterile swab (see Figure A).

Getting the pen ready.

1. 4. Take the pen out of the package.
2. 5. Check the expiration date on the pen. Do not use if the expiration date has passed.
3. 6.

   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 up.to the light and check.
   • Do not inject the medicine if the liquid inside the pen looks discolored, cloudy, contains particles, or if there are any signs of leakage.
   • 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.

1. 7.

   Pull the grey cap off the pen.

   • Do not twist the cap.
   • Pull it straight off (see Figure D).

1. 8.

   Look inside the cap, check that the grey needle cover is inside (see Figure E).

   1. • Do NOT use the pen if the grey needle cover is not inside the cap

1. 9. Do not try to put the cap back
2. • If you try to put it back, this will damage the needle.

You are now ready to inject the medicine, go to step 10

C. INJECTING THE MEDICINE

1. 10. Without pressing the blue button, push the pen firmly against your skin until you feel the stop point (see Figure F).
2. • Pushing to the stop point unlocks the blue button. Do NOT push the blue button until you are ready to inject.
3. • When the pen is firmly pressed against the skin, the safety lock is deactivated. So, if the button is pressed by accident, the pen could fire unintentionally.
4. • Do not attempt to reengage the safety lock at any time.
5. • Keep the pen pressed against your skin for the next steps.

11.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.

  

• 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 more seconds (see Figure I). If you take the pen off before, not all of the medicine will be injected.

1. 13.

   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

1. 14. 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 an adhesive bandage.
2. 15. Visually check that there is no liquid left at the bottom of the medicine window. If there is liquid, consult your healthcare professional.

E. DISPOSE THE AUTOINJECTOR PEN

1. 16. Discard the whole Sumatriptan Injection, USP pen after use and discard the cap.
2. • Discard the whole Sumatriptan Injection, USP pen and cap as instructed by your pharmacist. Do not discard in regular home waste.

Do not try to reuse the autoinjector pen. To avoid any injury, never try to touch the needle.

Usual dose:

• The usual adult dose is 6 mg / 0.5 mL. Do not exceed the usual adult dose.
• If you do not respond to the first dose of Sumatriptan Injection, USP, do not take a second dose for the same attack.
• If your symptoms come back, and it has been 1 or more hour since your first injection, you may take a second injection.
• DO NOT take more than 12 mg (two 6 mg injections) in any 24-hour period.

Overdose:

If you think you, or a person you are caring for, have taken too much Sumatriptan Injection, USP contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Possible side effects from using Sumatriptan Injection, USP:

These are not all the possible side effects you may feel when taking Sumatriptan Injection, USP. If you experience any side effects not listed here, contact your healthcare professional.

The most commonly reported side effects of Sumatriptan Injection, USP are:

• flushing (redness of the face lasting for a short time)
• feeling sick or vomiting
• dizziness
• drowsiness
• tiredness
• weakness
• temporary increase in blood pressure
• temporary pain at the site of injection
• stinging or burning, redness, swelling, bruising and bleeding at the site of injection

Other side effects include:

• trouble with eyesight, such as blind spots, flashes of light, and seeing two images of a single object.
• shaking, tremors or uncontrolled movements.
• loss of normal colour in the fingers and toes.
• sweating.
• breast pain

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep Sumatriptan Injection, USP away from heat and light. Always keep Sumatriptan Injection, USP in the carton provided and store between 15°C and 30°C.

Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will throw away any medicines that are no longer being used. These measures will help protect the environment.

Needles and syringes may be hazardous and should be disposed of safely and hygienically.

Keep out of reach and sight of children.

If you want more information about Sumatriptan Injection, USP:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes the

  Patient Medication Information by visiting the Health Canada Drug Product Database website:(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.drreddys.com or by calling 1-855-845-1739

Date of Authorization: 2026-03-27