SUMATRIPTAN (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sumatriptan Nasal Spray 5 mg (NDC 66993-081-69) and 20 mg (NDC 66993-082-69) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20 mg, respectively, of sumatriptan.

Store between 2°C and 30°C (36°F and 86°F). Protect from light.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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

Inform patients that Sumatriptan Nasal Spray 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)].

Anaphylactic/Anaphylactoid Reactions

Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving Sumatriptan Nasal Spray. 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 (5.10)].

Concomitant Use with Other Triptans or Ergot Medications

Inform patients that use of Sumatriptan Nasal Spray 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 Nasal Spray 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 Nasal Spray may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of Sumatriptan Nasal Spray.

Local Irritation

Inform patients that they may experience local irritation of their nose and throat. The symptoms will generally resolve in less than 2 hours.

How to Use Sumatriptan Nasal Spray

Provide patients instruction on the proper use of Sumatriptan Nasal Spray. Caution patients to avoid spraying the contents of the device in their eyes.
Manufactured by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

SNS-PS:1PI

PATIENT INFORMATION

Sumatriptan Nasal Spray

(soo” ma trip’ tan)

What is the most important information I should know about Sumatriptan Nasal Spray?

Sumatriptan Nasal Spray can cause serious side effects, including:

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

Stop taking Sumatriptan Nasal Spray 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 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 Nasal Spray?

Sumatriptan Nasal Spray is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Sumatriptan Nasal Spray 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 is not used to prevent or decrease the number of migraine headaches you have.

It is not known if Sumatriptan Nasal Spray is safe and effective to treat cluster headaches.

It is not known if Sumatriptan Nasal Spray is safe and effective in children under 18 years of age.

Do not use Sumatriptan Nasal Spray if you have:

heart problems or a history of heart problems
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 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:
o
almotriptan (AXERT)
o
frovatriptan (FROVA)
o
rizatriptan (MAXALT, MAXALT-MLT)
o
ergotamines (CAFERGOT, ERGOMAR, MIGERGOT)
o
dihydroergotamine (D.H.E. 45, MIGRANAL)
o
eletriptan (RELPAX)
o
naratriptan (AMERGE)
o
sumatriptan and naproxen (TREXIMET)
o
sumatriptan (IMITREX, ALSUMA, SUMAVEL, DosePro, ZECUITY)
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. See the end of this leaflet for a complete list of ingredients in Sumatriptan Nasal Spray.

Before you use Sumatriptan Nasal Spray, 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 Nasal Spray can harm your unborn baby.
are breastfeeding or plan to breastfeed. Sumatriptan Nasal Spray 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 use Sumatriptan Nasal Spray.

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

Sumatriptan Nasal Spray 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?

Certain people should use their first dose of Sumatriptan Nasal Spray in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should use your first dose in a medical setting.
Use Sumatriptan Nasal Spray 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.
If you do not get any relief after your first nasal spray, do not use a second nasal spray without first talking with your healthcare provider.
If your headache comes back after the first nasal spray or you only get some relief from your headache, you can use a second nasal spray 2 hours after the first nasal spray.
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 for a long time affects the nose and throat.
If you use too much Sumatriptan Nasal Spray, 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 so you can talk with your healthcare provider about how Sumatriptan Nasal Spray is working for you.

What should I avoid while using Sumatriptan Nasal Spray?

Sumatriptan Nasal Spray 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?

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

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:
o
sudden or severe stomach pain
o
stomach pain after meals
o
weight loss
o
fever
o
nausea or vomiting
o
constipation or diarrhea
o
bloody diarrhea
problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
o
cramping and pain in your legs or hips
o
feeling of heaviness or tightness in your leg muscles
o
burning or aching pain in your feet or toes while resting
o
numbness, tingling, or weakness in your legs
o
cold feeling or color changes in 1 or both legs or feet
medication overuse headaches. 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.
serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using Sumatriptan Nasal Spray, especially if Sumatriptan Nasal Spray 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:
o
mental changes such as seeing things that are not there (hallucinations), agitation, or coma
o
fast heartbeat
o
changes in blood pressure
o
high body temperature
o
tight muscles
o
trouble walking
local irritation. Some people who use Sumatriptan Nasal Spray 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 throat.
seizures. Seizures have happened in people taking Sumatriptan Nasal Spray who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take Sumatriptan Nasal Spray.

The most common side effects of Sumatriptan Nasal Spray include:

unusual or bad taste in your mouth
nausea
vomiting
dizziness
warm, hot, burning feeling

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 Nasal Spray.

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 Nasal Spray?

Store Sumatriptan Nasal Spray between 36°F to 86°F (2°C to 30°C).
Store your medicine away from light.

Keep Sumatriptan Nasal Spray and all medicines out of the reach of children.

General information about the safe and effective use of Sumatriptan Nasal Spray.

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

What are the ingredients in Sumatriptan Nasal Spray?

Active ingredient: sumatriptan

Inactive ingredients: monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and purified water USP.

Brands listed are trademarks of their respective owners.
Manufactured by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

SNS-PS:1PPI

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised December 2019

Instructions for Use

Sumatriptan Nasal Spray

(soo”ma trip’tan)

For use in the nose only. Do not spray in your eyes.

Figure A
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
(click image for full-size original)
Step 2. While sitting down, gently blow your nose to clear your nasal passages (see Figure B).

Figure B

Figure C
(click image for full-size original)
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).

Figure C

Figure D

Figure D

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 blue plunger yet.
Figure E
(click image for full-size original)

Figure E

Step 5. Keep your head upright and close your mouth. While gently taking a breath in through your nose, press the blue plunger firmly to release the dose of Sumatriptan Nasal Spray (see Figure E).
Figure F
(click image for full-size original)

Figure F

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 by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

December 2019

SNS-PS:1PIL

Principal Display Panel

NDC 66993-081-69

Sumatriptan

Nasal Spray

PRASCO

0.1 mL per unit

For Intranasal Use Only

Each unit dose nasal spray contains 5 mg of sumatriptan.

1 Spray per unit.

Do not test before use.

Rx Only

6 Nasal Spray Units

5 mg

Made in India

Rev. 11/19

62000000045655

Sumatriptan Nasal Spray 5 mg carton
(click image for full-size original)

Principal Display Panel

NDC 66993-082-69

Sumatriptan

Nasal Spray

PRASCO

0.1 mL per unit

For Intranasal Use Only

Each unit dose nasal spray contains 20 mg of sumatriptan.

1 Spray per unit.

Do not test before use.

Rx Only

6 Nasal Spray Units

20 mg

Made in India

Rev. 11/19

62000000045654

Sumatriptan Nasal Spray 20 mg carton
(click image for full-size original)
SUMATRIPTAN
sumatriptan spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-081
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN (SUMATRIPTAN) SUMATRIPTAN 5 mg in 100 uL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SULFURIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-081-69 6 CONTAINER in 1 BOX contains a CONTAINER
1 100 uL in 1 CONTAINER This package is contained within the BOX (66993-081-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020626 07/01/2020
SUMATRIPTAN
sumatriptan spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-082
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SUMATRIPTAN (SUMATRIPTAN) SUMATRIPTAN 20 mg in 100 uL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
SULFURIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66993-082-69 6 CONTAINER in 1 BOX contains a CONTAINER
1 100 uL in 1 CONTAINER This package is contained within the BOX (66993-082-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020626 07/01/2020
Labeler — Prasco Laboratories (065969375)

Revised: 12/2019 Prasco Laboratories

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