Sumatriptan Succinate

Dosage Forms And Strengths

• Injection: 4-mg and 6-mg single-dose prefilled syringe cartridges for use with the IMITREX STATdose Pen.
• Injection: 6-mg single-dose vial.

Storage And Handling

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

Each pack contains a Patient Information and Patient Instructions for Use leaflet.

IMITREX STATdose System®, 4 mg, containing 1 IMITREX STATdose Pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case (NDC 0173-0739-00).

IMITREX STATdose System, 6 mg, containing 1 IMITREX STATdose Pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case (NDC 0173-0479-00).

Two 4-mg single-dose prefilled syringe cartridges for use with IMITREX STATdose System (NDC 0173-0739-02).

Two 6-mg single-dose prefilled syringe cartridges for use with IMITREX STATdose System (NDC 0173-0478-00).

IMITREX Injection single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials (NDC 01730449-02).

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

GlaxoSmithKline, Research Triangle Park, NC 27709

IMITREX®
(IM-i-trex)
(sumatriptan succinate) Injection

Read this Patient Information before you start taking IMITREX 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 IMITREX?

IMITREX can cause serious side effects, including:

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

Stop taking IMITREX 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

IMITREX 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 IMITREX?

IMITREX 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.

IMITREX 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.

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

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

Who should not take IMITREX?

Do not take IMITREX 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:
  •  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 IMITREX. See the end of this leaflet for a complete list of ingredients in IMITREX.

What should I tell my healthcare provider before taking IMITREX?

Before you take IMITREX, 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
• become pregnant while taking IMITREX
• are breastfeeding or plan to breastfeed. IMITREX 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 IMITREX.

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

IMITREX and 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 IMITREX?

• Certain people should take their first dose of IMITREX 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 IMITREX 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 or cluster headache 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.
• If your headache comes back or you only get some relief after your first injection, you can take a second injection 1 hour after the first injection, but not sooner.
• Do not take more than 12 mg in a 24-hour period.
• If you use too much IMITREX, 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 IMITREX so you can talk with your healthcare provider about how IMITREX is working for you.

What should I avoid while taking IMITREX?

IMITREX 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 IMITREX?

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

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
• hives (itchy bumps); swelling of your tongue, mouth, or throat
• medication overuse headaches. Some people who use too many IMITREX injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with IMITREX.
• serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using IMITREX, especially if IMITREX 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 IMITREX who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take IMITREX.

The most common side effects of IMITREX 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 IMITREX. 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 IMITREX Injection?

• Store IMITREX between 36°F to 86°F (2°C to 30°C).
• Store your medicine away from light.
• Keep your medicine in the packaging or carrying case provided with it.

Keep IMITREX and all medicines out of the reach of children.

General information about the safe and effective use of IMITREX

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

For more information, go to www.gsk.com or call 1-888-825-5249.

What are the ingredients in IMITREX Injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Patient Instructions for Use

IMITREX STAT dose System

Read this Patient Instructions for Use before you start to use the IMITREX STATdose 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 IMITREX Injection when you start taking it and at regular checkups.

Keep the IMITREX STATdose System out of the reach of children.

Before you use the IMITREX STATdose System

When you first open the IMITREX STATdose System box, the Cartridge Pack and the IMITREX STATdose Pen® are already in the Carrying Case for your convenience.

The grey and blue Carrying Case is used for storing the unloaded Pen and the Cartridge Pack when they are not being used.

The Cartridge Pack holds 2 individually sealed Syringe Cartridges. Each Syringe  Cartridge holds 1 dose of IMITREX® (sumatriptan succinate) Injection. The Cartridge Pack for the 4-mg strength of this medicine is yellow, and the Cartridge Pack for the 6-mg strength is blue (as shown). Refill Cartridge Packs are available.

The grey and blue Pen is used to automatically inject 1 dose of medicine from a Syringe Cartridge. Do not touch the Blue Button until you have pressed the Pen against your skin to give a dose. If you press it at any other time, you might lose a dose. The Safety Catch keeps the Pen from accidentally firing until you are ready. The Pen will only work when you slide the grey part of the barrel down to the blue part. Always check to make sure that the white Priming Rod is not sticking out from the end of the Pen (as shown in Figure B) before you load a new Syringe Cartridge. If it is sticking out, you will lose that dose.

How to load the IMITREX STATdose Pen

Do not load the Pen until you are ready to give yourself an injection. Do not touch the Blue Button on top of the Pen (see Figure A) while you are loading the Pen.

Figure A

Figure B

1. Open the lid of the Carrying Case. The tamperevident seals over the 2 Syringe Cartridges are labeled “A” and “B” (see Figure A inset).

Always use the Syringe Cartridge marked “A” before the one marked “B” to help you keep track of your doses. Do not use if either seal is broken or missing when you first open the Carrying Case.

2. Tear off one of the tamper-evident seals (see Figure A). Throw away the seal. Open the lid over the Syringe Cartridge.

3. Hold the Pen by the ridges at the top. Take the Pen out of the Carrying Case (see Figure B).

Check to make sure the white Priming Rod is not sticking out from the lower end of the Pen (see Figure B inset). If it is sticking out, put the Pen back into the Carrying Case and press down firmly until you feel it click. Take the Pen out of the Carrying Case.

Figure C

4. Put the Pen in the Cartridge Pack. Turn it to the right (clockwise) until it will not turn any more (about half a turn) (see Figure C).

5. Hold the loaded Pen by the ridges and pull it straight out (see Figure D). You may need to pull hard on the Pen, but this is normal. Do not press the Blue Button yet.

Figure D

The Pen is now ready to use. Do not put the loaded Pen back into the Carrying Case because that will damage the needle.

How to use the IMITREX STAT dose Pen to take your medicine

Before injecting your medicine, choose an area with a fatty tissue layer (see Figure E or Figure F). Ask your healthcare provider if you have a question about where to inject your medicine.

To prepare the area of skin where IMITREX is to be injected, wipe the injection site with an alcohol swab. Do not touch this area again before giving the injection.

Figure E or Figure F Figure G

6. Without pushing the Blue Button, press the loaded Pen firmly against the skin so that the grey barrel slides down toward the blue section that holds the Syringe Cartridge (see Figure D). (This releases the Safety Catch that keeps the Pen from firing by mistake until you are ready.)

7. Push the Blue Button. Hold the Pen still for at least 5 seconds. If the Pen is taken away from the skin too soon, not all the medicine will come out.

8. After 5 seconds, carefully take the Pen away from your skin. The needle will be showing (see Figure G). Do not touch the needle.

How to unload the IMITREX STAT dose Pen after taking your medicine

Right after you take a dose with the Pen, you need to return the used Syringe Cartridge to the Cartridge Pack.

Figure H Figure I and Figure J

9. Push the Pen down into the empty side of the Cartridge Pack as far as it will go (see Figure H).

10. Turn the Pen to the left (counterclockwise) about half a turn until it is released from the Syringe Cartridge (see Figure I).

11. Pull the empty Pen out of the Cartridge Pack (see Figure J).

Because the Pen has now been used, the white Priming Rod will stick out from the lower end of the Pen (see Figure J).

12. Close the Cartridge Pack lid over the used Syringe Cartridge. When the used Syringe Cartridges are inserted correctly, the Cartridge Pack is a disposable, protective case to help you avoid needle sticks and use the syringes correctly.

13. Put the Pen back into the Carrying Case and press it down firmly until you feel it click. Close the Carrying Case lid. This gets the Pen ready for the next use.

If the lid will not close, push the Pen down until you feel it click. Then close the lid.

How to take out a used Cartridge Pack

After both Syringe Cartridges have been used, take the Cartridge Pack out of the Carrying Case. Never reuse or recycle a Syringe Cartridge.

Figure K Figure L

14. Open the Carrying Case lid.

15. Hold the Carrying Case with one hand and press the 2 buttons on either side of the Carrying Case (see Figure K).

16. Gently pull out the Cartridge Pack with the other hand (see Figure L).

17. Throw away the Cartridge Pack or dispose of it as instructed by your healthcare provider. There may be special state and local laws for disposing of used needles and syringes. Always keep out of the reach of children.

How to insert a new Cartridge Pack

Figure M Figure N  and Figure O

18. Take the new Cartridge Pack out of its box. Do not take off the tamper-evident seals (see Figure M).

19. Put the Cartridge Pack in the Carrying Case. Slide it down smoothly (see Figure N).

20. The Cartridge Pack will click into place when the 2 buttons show through the holes in the Carrying Case (see Figure O). Close the lid.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Your pharmacist can provide more information about sumatriptan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 13.01. Revision date: 2/5/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Vascular Headaches

Acute treatment of migraine attacks with or without aura.1 2 3 6 7 8 9 10 13 48 80 145 148 184 195 214 217 225 249 279 280

Sub-Q for acute treatment of cluster headache episodes.1 2 49 75 183 184 185 210 214 279 280 Safety and efficacy of oral or intranasal sumatriptan for this use not established.148 249

Not recommended for management of hemiplegic or basilar migraine or for prophylaxis of migraine or cluster headache.1 7 114 158

Administration

Administer orally, intranasally, or by sub-Q injection.1 12 148 249 Do not administer IM or IV; IV administration may induce coronary vasospasm.1 13 40 90 236 237 279 280

To achieve maximum relief, initiate therapy as soon as possible after onset of migraine attack.50 92 108 124 148 180 237

Oral Administration

Administer sumatriptan tablets orally with fluids; swallow tablet whole.148

Administer sumatriptan/naproxen fixed-combination tablets with or without food; do not split, crush, or chew.281

Intranasal Administration

Administer intranasally as a single spray into 1 nostril.249

Nasal solution unit contains only 1 spray; do not test before use.249

To administer, remove unit from package just before use.249 While sitting down, gently blow nose to clear nasal passages.249 Keep head in upright position and gently close 1 nostril with index finger; exhale gently through mouth.249 With other hand, hold unit with thumb supporting at bottom and index and middle fingers on either side of nozzle.249 Insert nozzle into open nostril about ½ inch.249 While gently inhaling through nose (with closed mouth), release spray by firmly pressing plunger.249 Remove nozzle from nostril while keeping head level for 10–20 seconds and gently inhaling through nose and exhaling through mouth; do not inhale deeply.249 Consult administration instructions provided by manufacturer before use.249

Sub-Q Administration

Administer only by sub-Q injection.1 279 280

Do not administer IM or IV; IV administration may induce coronary vasospasm.1 13 40 90 236 237 279 280

Autoinjection devices are available to facilitate self-administration of 4- or 6-mg dose.1 279 280

Injection pen for use with prefilled cartridges (each containing a 4- or 6-mg dose): Needle penetrates approximately 5–6 mm (¼ inch); use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length (e.g., lateral thigh, upper arm).1 284

Prefilled injection pen (containing 6-mg dose): Needle projects ¼ inch following activation of device; use injection sites with an adequate skin and subcutaneous thickness to accommodate needle length (e.g., lateral thigh, upper arm).279

Prefilled needleless injection device (containing 6-mg dose): Use administration sites on abdomen (avoiding 2-inch area around the umbilicus) or thigh with an adequate subcutaneous thickness to accommodate penetration of the solution into the subcutaneous space.280 Avoid using administration sites on upper arm, since delivered dose may be suboptimal.280

In patients receiving doses other than 4 or 6 mg, only the single-dose vials containing 6 mg/0.5 mL should be used to provide the desired dose.1

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as sumatriptan (nasal solution) and sumatriptan succinate (tablets and injection); dosage expressed in terms of sumatriptan.1 148 249

Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.1 148 249

Adults

25, 50, or 100 mg as a single dose.148 Individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 50- or 100-mg dose; 100-mg dose may not provide substantially greater effect than 50-mg dose.148

If headache recurs or partial response occurs after initial dose, additional oral doses may be administered at intervals of ≥2 hours, up to a maximum oral dosage of 200 mg daily.148

If headache recurs after an initial sub-Q dose, additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.148

Sumatriptan 85 mg (with naproxen sodium 500 mg) as a single dose.281

Efficacy of >1 dose not established.281 If a second dose is administered, allow ≥2 hours to elapse between the first and second doses.281

5, 10, or 20 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 20-mg dose.249 Doses >20 mg provide no additional benefit.249

To achieve a 10-mg dose, administer a single 5-mg dose into each nostril.249

If headache recurs, dose may be repeated once after 2 hours, up to a maximum dosage of 40 mg daily.249

≤6 mg as a single dose.1 If dose-limiting adverse effects occur with 6-mg dose, lower doses (e.g., 1–5 mg) may be given.

If headache recurs, a 6-mg sub-Q dose may be repeated once after ≥1 hour or additional oral doses may be administered at intervals ≥2 hours, up to a maximum oral dosage of 100 mg daily.1 148

If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.2 3 6 7 8 9 174 176 181 236 237

≤6 mg as a single dose.1 Manufacturers state that efficacy of doses <6 mg not established;1 however, some patients may derive benefit from such lower doses (e.g., 3 mg).13 210 285

If headache recurs, 6-mg dose may be repeated once after ≥1 hour, up to a maximum dosage of 12 mg in any 24-hour period.1

If patient does not respond to first 6-mg dose, additional doses are unlikely to provide benefit.1 2 3 6 7 8 9 174 176 181 236 237

Prescribing Limits

Adults

Maximum 200 mg daily; do not exceed 100 mg daily if following an initial sub-Q dose.148

Safety of treating an average of >4 headaches per 30-day period has not been established.148

Maximum 2 doses (total sumatriptan dosage of 170 mg) in any 24-hour period.281

Safety of treating an average of >5 headaches per 30-day period has not been established.281

Maximum 40 mg daily.249

Safety of treating an average of >4 headaches per 30-day period has not been established.249

Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1

Maximum 6 mg as a single dose; do not exceed 12 mg (i.e., two 6-mg doses given ≥1 hour apart) in any 24-hour period.1

Special Populations

Hepatic Impairment

Contraindicated in patients with severe hepatic impairment.1 148 249

Unpredictable increases in bioavailability following oral administration in patients with hepatic impairment.148 If oral therapy is deemed advisable in these patients, do not exceed 50 mg as a single dose.148 Avoid use of fixed-combination tablets containing sumatriptan 85 mg and naproxen sodium 500 mg, since sumatriptan dosage cannot be appropriately adjusted.281

Geriatric Patients

Select dosage with caution, usually starting at the low end of the dosage range.1

Storage

Oral

Sumatriptan: 2–30°C.148

Sumatriptan/naproxen: 25°C (may be exposed to 15–30°C).281 Store in original container with desiccant packet; do not repackage.281

Intranasal

2–30°C; protect from light.249

Parenteral

Cartridge, vial: 2–30°C; protect from light.1

Prefilled injection pen: 25°C (may be exposed to 15–30°C); protect from light; do not refrigerate.279

Prefilled needleless device: 20–25°C (may be exposed to 15–30°C); do not freeze.280

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Risk of serious cardiovascular or cerebrovascular events (e.g., MI, stroke) or other vasospastic reactions.1 148 249 Importance of seeking medical care if symptoms of such reactions (e.g., shortness of breath, weakness, slurring of speech, sudden or severe abdominal pain, difficulty in seeing, or tightness, pain, pressure, or heaviness in chest, throat, jaw, or neck) occur and of not taking sumatriptan again until evaluated by a clinician.1 148 249

• Risk of somnolence or dizziness; advise patient to avoid performing hazardous activities that require mental alertness (e.g., driving, operating machinery) if such effects occur.1 148 249

• Importance of contacting clinician immediately if symptoms suggestive of hypersensitivity (e.g., shortness of breath, wheezing, palpitations, rash, urticaria, swelling of mouth, tongue, or throat) occur.1 148 249

• Importance of taking sumatriptan exactly as prescribed.1 148 249

• Importance of providing patient a copy of manufacturer’s patient information.1 148 249 Importance of clinician providing adequate instructions, as well as the written administration instructions supplied with the autoinjection device or nasal spray, before first use.1 171 249 279 280

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).1 148 249

• Importance of informing patients of risk of serotonin syndrome, particularly with concurrent use of sumatriptan and an SSRI, SNRI, MAO inhibitor, or tricyclic antidepressant.1 148 249 272 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.1 148 249 272

• Overuse of drugs indicated for the management of acute migraine attacks may exacerbate headaches; importance of recording headache frequency and drug use to monitor effectiveness of treatment.1 148 249 276

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 148 249

• Importance of informing patients of other important precautionary information.1 148 249 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name