"Medscape Medical News
August 22, 2015
The US Food and Drug Administration (FDA) has granted tentative approval to expand the label for an extended-release formulation of topiramate (Trokendi XR, Supernus "...
Sumavel DosePro contains sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:
The empirical formula is C12H21N3O2S•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 Sumavel DosePro 8 mg/mL solution contains 4 mg of sumatriptan (base) as the succinate salt and 3.8 mg of sodium chloride, USP in Water for Injection, USP. Each 0.5 mL of Sumavel DosePro 12 mg/mL 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 both solutions is approximately 4.2 to 5.3. The osmolality of both solutions 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 lavender (4 mg) or green (6 mg) lever, and a glass medication chamber that is pre-filled with 4 mg or 6 mg per 0.5 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 possible side effects of sumatriptan injection (Alsuma, Imitrex, Imitrex Statdose, Imitrex Statdose Refill, Sumavel DosePro)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using sumatriptan and call your doctor if you have a serious side effect such as:
- feeling of pain or tightness in your jaw, neck, or throat;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- sudden numbness or weakness, especially on one side of the...
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...
Last reviewed on RxList: 6/13/2016
This monograph has been modified to include the generic and brand name in many instances.
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