Alsuma
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ALSUMA (sumatriptan injection) 6 mg/0.5 mL is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
ALSUMA should only be used where a clear diagnosis of migraine or cluster headache has been established. Care should be taken to exclude other potentially serious neurologic conditions before treating headache in patients not previously diagnosed with migraine or cluster headache or who experience a headache that is atypical for them.
For a given attack, if a patient does not respond to the first dose of ALSUMA, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.
ALSUMA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. [see Contraindications (4.7)]
History
There is currently no drug history available for this drug.
Other Information
Sumatriptan is a selective 5-hydroxy-tryptamine receptor subtype 1 (5-HT1) agonist. Sumatriptan delivered as the succinate salt 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 C14H21N3O2S • C4H6O4, representing a molecular weight of 413.5.
ALSUMA is a clear, colorless to pale yellow, sterile, non-pyrogenic solution for subcutaneous injection. Each 0.5 mL of ALSUMA 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 the solution is approximately 4.2 to 5.3.
Sources
Alsuma Manufacturers
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Us Worldmeds, Llc
![Alsuma ((Sumatriptan Injection) 6mg/0.5ml, Auto-injector) Injection, Solution [Us Worldmeds, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Alsuma | Us Worldmeds, Llc
ALSUMA is only for subcutaneous use.
The maximum single recommended adult dose of ALSUMA is 6 mg injected subcutaneously. The maximum recommended dose that may be given in 24 hours is two doses of ALSUMA separated by at least 1 hour. Controlled clinical trials have failed to show that clear benefit is associated with the administration of a second 6 mg dose in patients who have failed to respond to a first dose.
Since the injection is intended to be given subcutaneously, intramuscular or intravascular delivery must be avoided. Patients should be directed to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle. ALSUMA is for single use only. Discard unused portions. [see Patient Counseling Information (17.5)]
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Pfizer Laboratories Div Pfizer Inc
Alsuma | Pfizer Laboratories Div Pfizer Inc
2.1 Dosing InformationThe maximum single recommended dose of ALSUMA is 6 mg injected subcutaneously.
The maximum recommended dose that may be given in 24 hours is two doses of ALSUMA separated by at least 1 hour. Controlled clinical trials have failed to show a clear benefit with the administration of a second 6 mg dose in patients who have failed to respond to a first dose. A second 6 mg dose should only be considered if some response to a first injection was observed.
2.2 Administration Using ALSUMAALSUMA is only for subcutaneous use. Intramuscular or intravascular delivery must be avoided. Patients should be directed to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.
ALSUMA is for single use only. Visually inspect the medication for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted. Discard unused portions. [see Patient Counseling Information (17.8)]
![Alsuma (Sumatriptan) Injection, Solution [Pfizer Laboratories Div Pfizer Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=109edaaf-f13c-4d4c-aa40-0f9058379158&name=alsuma-23.jpg)
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