Rx Item-Amerge naratriptan 2.5mg Tab 9 By Glaxo Smith Kline

AMERGE- naratriptan hydrochloride tablet, film coated
GlaxoSmithKline LLC
DESCRIPTION
AMERGE contains naratriptan hydrochloride, selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride

Mechanism of Action
Naratriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Migraines are likely due to local cranial vasodilatation and/or to the release of sensory neuropeptides (including substance and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of AMERGE for the treatment of migraine headache is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

INDICATIONS AND USAGE
AMERGE? is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use
?
Use only if clear diagnosis of migraine has been established. If patient has no response to the first migraine attack treated with AMERGE, reconsider the diagnosis of migraine before AMERGE is administered to treat any subsequent attacks.
?
AMERGE is not indicated for the prevention of migraine attacks.
?
Safety and effectiveness of AMERGE have not been established for cluster headache.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing info.
The recommended dose of AMERGE is mg or 2.5 mg.
If the migraine returns or if the patient has only partial response, the dose may be repeated once after hours, for maximum dose of mg in 24-hour period.
The safety of treating an average of more than migraine attacks in 30?day period has not been established.
Dosage Adjustment in Patients with Renal Impairment
AMERGE is contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug
Dosage Adjustment in Patients with Hepatic Impairment
AMERGE is contraindicated in patients with severe hepatic impairment
DOSAGE FORMS AND STRENGTHS
1-mg white tablets, D-shaped, film-coated, and debossed with ?GX CE3?
2.5-mg green tablets, D-shaped, film-coated, and debossed with ?GX CE5?
HOW SUPPLIED/STORAGE AND HANDLING
AMERGE tablets containing mg and 2.5 mg of naratriptan (base) as the hydrochloride salt.
AMERGE tablets, mg, are white, D-shaped, film-coated tablets debossed with ?GX CE3? on one side in blister packs of tablets (NDC 0173-0561-00).
AMERGE tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with ?GX CE5? on one side in blister packs of tablets (NDC 0173-0562-00).
Store at controlled room temperature, 20? to 25?C (68? to 77?F) [see USP].

AMERGE and IMITREX are registered trademarks of the GSK group of companies. The other brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Rx Item-Amerge 2.5mg Tab 9 By Glaxo Smit
NDC No.00173-0562-00 UPC/GTIN No.3-01730-56200-5 MPN No. 56200 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

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Glaxo Smith Kline /Kdc

NARATRIPTAN HCL ORAL TABL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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