Patient Information Sumatriptan
(soo ma TRIP tan) Nasal Spray, USP
Read this Patient Information before you start using sumatriptan nasal spray, USP 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 nasal spray, USP?
Sumatriptan can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking sumatriptan nasal spray, USP 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 nasal spray, USP is not for people with risk factors for
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 show your healthcare provider or pharmacist when you get a new medicine.
How should I use sumatriptan nasal spray, USP?
- Certain people should use their first dose of sumatriptan nasal spray, USP in their healthcare provider’s office or in another medical Ask your healthcare provider if you should use your first dose in a medical setting.
- Use sumatriptan nasal spray, USP exactly as your healthcare provider tells you to use
- Your healthcare provider may change your Do not change your dose without first talking with your healthcare provider.
- If you do not get any relief after your first nasal spray, do not use a second nasal spray without first talking with your
heart disease unless a heart exam is done and shows no problem.
healthcare provider.
- If your headache comes
back after the first nasal spray or
You have a higher risk for heart disease if you: you only get some relief from your headache, you can use a
|
second nasal spray 2 hours after the first nasal spray.
, USP
What is sumatriptan nasal spray, USP?
Sumatriptan nasal spray, USP is a prescription medicine used to treat acute migraine headaches with or without aura in adults.
Sumatriptan nasal spray, USP 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 nasal spray, USP is not used to prevent or decrease the number of migraine headaches you have.
It is not known if sumatriptan nasal spray, USP is safe and effective to treat cluster headaches.
It is not known if sumatriptan nasal spray, USP is safe and effective in children under 18 years of age.
Do not use sumatriptan nasal spray, USP if you have:
- heart problems or a history of heart problems
Do not use more than 40 mg of sumatriptan nasal spray in a 24-hour period.
- It is not known how using sumatriptan nasal spray, USP for a long time affects the nose and
- If you use too much sumatriptan nasal spray, USP, 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 use sumatriptan nasal spray, USP so you can talk with your healthcare provider about how sumatriptan nasal spray, USP is working for
What should I avoid while using sumatriptan nasal spray, USP? Sumatriptan nasal spray, USP 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 nasal spray, USP?
Sumatriptan nasal spray, USP may cause serious side effects. See “What is the most important information I should know about sumatriptan nasal spray, USP?”
These serious side effects include:
- changes in color or sensation in your fingers and toes
- narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease)
- uncontrolled high blood pressure
- severe liver problems
- hemiplegic migraines or basilar If you are not sure if you have these types of migraines, ask your healthcare
(Raynaud’s syndrome)
- stomach and intestinal problems (gastrointestinal and colonic ischemic events).
Symptoms of gastrointestinal and colonic ischemic events include:
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 nasal spray, USP. See the end of this leaflet for a complete list of ingredients in sumatriptan nasal spray,
Before you use sumatriptan nasal spray, USP, tell your healthcare provider about all of your medical conditions, including if you:
- have high blood
- have high
- have
- are
- have heart problems or family history of heart problems or
- have kidney
- have liver
- have had epilepsy or
- are not using effective birth
- are pregnant or plan to become It is not known if sumatriptan nasal spray, USP can harm your unborn baby.
- are breastfeeding or plan to breastfeed. Sumatriptan passes into your breast 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 use sumatriptan nasal spray, USP.
- 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 Some people who use too many sumatriptan nasal sprays may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan nasal spray, USP.
- serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan, especially if sumatriptan nasal spray, USP 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
- local irritation. Some people who use sumatriptan nasal spray, USP may have irritation of their throat and nose. Symptoms of local irritation of the throat and nose include: burning, numbness, tingling sensation, nasal discharge, pain or soreness
- hives (itchy bumps); swelling of your tongue, mouth, or
- Seizures have happened in people taking sumatriptan nasal spray, USP who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan nasal spray, USP.
|
Instructions for Use
Sumatriptan (soo ma TRIP tan) Nasal Spray, USP
For use in the nose only. Do not spray in your eyes.
Step 1. Remove the Sumatriptan Nasal Spray unit from the plastic pack (see Figure A).
Do not remove the unit until you are ready to use. The unit contains only 1 spray. Do not test before use.
Figure A
Figure B
Step 2. While sitting down, gently blow your nose to clear your nasal passages (see Figure B).
Step 3. Keeping your head in an upright position, gently close 1 nostril with your index finger and breathe out gently through your mouth (see Figure C).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Figure C
Figure D
Figure E
Figure F
Step 4. With your other hand, hold the container with your thumb supporting the container at the bottom, and your index and middle fingers on either side of the nozzle (see Figure D).
Insert the nozzle into your open nostril about ½ inch.
Do not press the plunger yet. NOTE: Plunger color may vary.
Step 5. Keep your head upright and close your mouth. While gently taking a breath in through your nose, press the plunger firmly, straight up toward the nozzle, in one rapid motion to release the dose of Sumatriptan Nasal Spray (see Figure E). The plunger may feel stiff and you may hear a click.
Step 6. Keep your head level and remove the nozzle from your nostril. While holding your head level, gently breathe in through your nose and out through your mouth for 10 to 20 seconds (see Figure F).
Do not breathe in deeply.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Manufactured for:
Lannett Company, Inc. Philadelphia, PA 19136
Manufactured by: Summit Biosciences, Inc. Lexington, KY 40511
509701 Rev. 05/2019