Sumavel DosePro

DRUG DESCRIPTION

Sumatriptan, the active component of Sumavel DosePro, is a selective 5hydroxy-tryptamine receptor subtype 1 (5-HT1) agonist. Sumatriptan delivered as the succinate salt is chemically designated as 3-[2-(dimethylamino)ethyl]-Nmethyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:

Sumavel DosePro (sumatriptan) Structural Formula Illustration

The empirical formula is C14H21N3O2S C4H6O4, representing a molecular weight of 413.5.

Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Sumatriptan solution is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous delivery. Each 0.5 mL of solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP, in water for injection, USP. The pH range of the solution is approximately 4.2 to 5.3. The osmolality of the solution is 291 mOsmol.

Sumavel DosePro is a pre-filled, single-use, disposable, needle-free subcutaneous delivery system delivering sterile sumatriptan injection. Sumavel DosePro consists of the following components: a gray plastic handle and snap-off tip, a green lever, and a glass medication chamber that is pre-filled with 6 mg per0.5 mL sumatriptan injection. Utilizing pressure from a compressed nitrogen gas source in the handle, Sumavel DosePro delivers the medication by pushing it through a small, precise hole in the glass medication chamber. The resulting stream of medication is propelled through the skin and is delivered subcutaneously without a needle, following a biphasic pressure profile.

What are the precautions when taking sumatriptan injection (Sumavel DosePro)?

See also How to Use section.

Before using sumatriptan, tell your doctor or pharmacist if you are allergic to it; or to other triptan drugs (e.g., zolmitriptan, rizatriptan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be taken if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: heart disease (e.g., chest pain, heart attack), decreased blood flow in the brain (e.g., stroke, transient ischemic attack), blood circulation disease (e.g., ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or...

Read All Potential Precautions of Sumavel DosePro


Sumavel DosePro Consumer (continued)

SIDE EFFECTS: Pain, swelling, bleeding, or bruising at the injection site may occur. Flushing, sensations of tingling/numbness/prickling/heat, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Chest/jaw/neck tightness can commonly occur shortly after using sumatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction related to a lack of blood flow to the heart, brain or other parts of the body. Seek immediate medical attention if any of these unlikely but very serious (rarely fatal) side effects occur: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blue fingers/toes/nails, cold sensation of hands/feet, hearing changes, mental/mood changes, seizures.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is taken with certain other drugs such as other "triptans" used to treat migraine headaches (e.g., rizatriptan, zolmitriptan), certain antidepressants including SSRIs (e.g., citalopram, fluoxetine, paroxetine) and NSRIs (e.g., duloxetine, venlafaxine), or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, high fever, severe nausea/vomiting/diarrhea, twitchy muscles.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also How to Use section.

Before using sumatriptan, tell your doctor or pharmacist if you are allergic to it; or to other triptan drugs (e.g., zolmitriptan, rizatriptan); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be taken if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: heart disease (e.g., chest pain, heart attack), decreased blood flow in the brain (e.g., stroke, transient ischemic attack), blood circulation disease (e.g., ischemic bowel disease), uncontrolled high blood pressure (hypertension), certain types of headaches (hemiplegic or basilar migraine), liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain blood circulation disorders (e.g., Raynaud's disease), seizures.

Tell your doctor if you have the following risk factors for heart disease: diabetes, family history of heart disease, high blood pressure (controlled), high cholesterol, overweight, smoker, female after menopause, male over age 40.

If you are at high risk for heart disease, your doctor may want to check your heart before prescribing sumatriptan.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

The risk of heart disease, liver disease, and high blood pressure increases with age. The manufacturer does not recommend the use of sumatriptan in the elderly since they may be more sensitive to the side effects, including an increase in blood pressure.

This medication should be taken only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Avoid breastfeeding for at least 12 hours after using sumatriptan. Consult your doctor before breast-feeding.



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