Rx Item-Naratriptan 1Mg Tab 9 By Heritage Pharma Gen Amerge

Clinical Information
Gen. Code and Des.
38275 naratriptan HCl ORAL TABLET 1 MG
GCN and Des.
81112 naratriptan HCl ORAL TABLET 1 MG
Strength
1MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28322800 SELECTIVE SEROTONIN AGONISTS
Active Ingredients
6606 naratriptan HCl 143388641
Inactive Ingredients
2432 lactose 64044515




NARATRIPTAN- naratriptan hydrochloride tablet, coated
Sandoz Inc

1 INDICATIONS AND USAGE

Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

�
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with naratriptan tablets, reconsider the diagnosis of migraine before naratriptan tablets are administered to treat any subsequent attacks.
�
Naratriptan tablets are not indicated for the prevention of migraine attacks.
�
Safety and effectiveness of naratriptan tablets have not been established for cluster headache.
2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information


The recommended dose of naratriptan tablets are 1 mg or 2.5 mg.

If the migraine returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period.

The safety of treating an average of more than 4 migraine attacks in a 30?day period has not been established.

2.2 Dosage Adjustment in Patients With Renal Impairment
Naratriptan tablets are contraindicated in patients with severe renal impairment (creatinine clearance: <15 mL/min) because of decreased clearance of the drug [see Contraindications (4), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24?hour period and a 1 mg starting dose is recommended [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.3 Dosage Adjustment in Patients With Hepatic Impairment
Naratriptan tablets are contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

In patients with mild or moderate hepatic impairment (Child-Pugh grade A or B), the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a 1-mg starting dose is recommended [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

1 mg, white colored 'D" shaped, film-coated tablets debossed with 'SZ" on one side and '247" on other side.

2.5 mg, green colored 'D" shaped, film-coated tablets debossed with 'SZ" on one side and '248" on other side. The molecular formula is C17 H25 N3 O2 S�HCl, representing a molecular weight of 371.93. Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water.

Each naratriptan tablet, USP for oral administration contains naratriptan hydrochloride equivalent to 1 mg or 2.5 mg of naratriptan, respectively. Each tablet also contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin. In addition the 2.5 mg tablet also contains FD&C blue No.2 aluminum lake and iron oxide yellow.

12 CLINICAL PHARMACOLOGY

12.1 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 P and calcitonin gene-related peptide) through nerve endings in the trigeminal system. The therapeutic activity of naratriptan 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.

RX ITEM-Naratriptan 1Mg Tab 9 By Heritag
Item No.:RX240907/m, Item No. RX240907, 240907, NDC No.: 23155-0054-19, 23155-054-19, 2315505419, 23155005419, 0054-19, 005419 UPC No. 3-23155-05419-4, 323155-054194, 323155054194

Naratriptan 1Mg Tab 9 By Heritage Pharma
Item No.:RX240907/m, Item No. RX240907, 240907, NDC No.: 23155-0054-19, 23155-054-19, 2315505419, 23155005419, 0054-19, 005419 UPC No. 3-23155-05419-4, 323155-054194, 323155054194

NARATRIPTAN HCL ORAL TABL
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