Rx Item-Alsuma 6mg 0.5ml Kit 2 By Pfizer Pharma

ALSUMA- sumatriptan injection, solution
Pfizer Laboratories Div Pfizer Inc
DESCRIPTION
ALSUMA contains sumatriptan succinate, selective 5- HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1)

Mechanism of Action
Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
INDICATIONS AND USAGE
ALSUMA? (sumatriptan injection) is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache.
Limitations of Use:
Use only if clear diagnosis of migraine or cluster headache has been established. If patient has no response to the first migraine attack treated with ALSUMA, reconsider the diagnosis of migraine before ALSUMA is administrated to treat any subsequent attacks.
ALSUMA is not indicated for the prevention of migraine attacks.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing info.
The maximum single recommended dose of ALSUMA is mg injected subcutaneously.
The maximum recommended dose that may be given in 24 hours is two doses of ALSUMA separated by at least hour. Controlled clinical trials have failed to show clear benefit with the administration of second mg dose in patients who have failed to respond to first dose. second mg dose should only be considered if some response to first injection was observed.
DOSAGE FORMS AND STRENGTHS
ALSUMA contains mg of sumatriptan (as 8.4 mg sumatriptan succinate), which is delivered as subcutaneous injection in single dose.
ALSUMA is supplied as single-use auto-injector pre-filled with sumatriptan succinate drug solution and fully-assembled for use.
How to Use ALSUMA
ALSUMA is pre-filled, fully-assembled, single-use device intended to deliver 6 mg dose of sumatriptan.
Provide patients instruction on the proper use of ALSUMA if they are able to self-administer ALSUMA in medically unsupervised situation.
Inform patients that the injection is only intended to be given subcutaneously. Intramuscular or intravascular delivery should be avoided. Instruct patients to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle (e.g. lateral thigh or upper arms).
Manufactured by :
Meridian Medical Technologies, Inc., Columbia, MD 21046
A Pfizer Inc. company
ALSUMA is trademark of Meridian Medical Technologies? Inc.

Rx Item-Alsuma 6mg 0.5ml Kit 2 By Pfizer
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SUMATRIPTAN SUCCINATE SUB
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