NARATRIPTAN- naratriptan tablet, coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

NARATRIPTAN HYDROCHLORIDE (UNII: 10X8X4P12Z) (NARATRIPTAN - UNII:QX3KXL1ZA2)

Pieejams no:

Sandoz Inc

SNN (starptautisko nepatentēto nosaukumu):

NARATRIPTAN HYDROCHLORIDE

Kompozīcija:

NARATRIPTAN 1 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Naratriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Naratriptan is contraindicated in patients with: Risk Summary There are no adequate data on the developmental risk associated with use of naratriptan tablets in pregnant women. Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have documented outcomes in women exposed to naratriptan during pregnancy; however, due to small sample sizes, no definitive conclusions can be drawn regarding the risk of birth defects following exposure to naratriptan [see Data]. In animal studies, naratriptan produced developmental toxicity (including embryolethality and fetal abnormalities) when administered to pregnant rats and rabbits. The lowest doses producing evidence of developmental toxicity in animals were associated with plasma exposures 2.5 (rabbit) to 11 (rat) times that in humans at the maximum recommended daily dose (MRDD) [see Data]. In the U.S. genera

Produktu pārskats:

Naratriptan tablets, USP are available as follows: 1 mg, white colored ‘D’ shaped, film-coated tablets debossed with ‘SZ’ on one side and ‘247’ on other side NDC 0781-5526-37 in unit-of-use pack of 9 tablets (1 blister card containing 9 tablets in 1 carton) 2.5 mg, green colored ‘D’ shaped, film-coated tablets debossed with ‘SZ’ on one side and ‘248’ on other side NDC 0781-5527-37 in unit-of-use pack of 9 tablets (1 blister card containing 9 tablets in 1 carton) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

NARATRIPTAN- NARATRIPTAN TABLET, COATED
SANDOZ INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NARATRIPTAN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NARATRIPTAN TABLETS.
NARATRIPTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Naratriptan tablets are a serotonin (5-HT
) receptor agonist (triptan) indicated for the acute treatment of
migraine with
or without aura in adults. (1)
Limitations of Use:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg and 2.5 mg. (3, 16)
CONTRAINDICATIONS
•
•
•
•
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥2 % and > placebo) were
paresthesias, nausea, dizziness, drowsiness, malaise/fatigue,
and throat/neck symptoms. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-888-525-8747 OR FDA AT 1-800-FDA-
1088 OR www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
1B/1D
Use only if a clear diagnosis of migraine has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
Recommended dose: 1 mg or 2.5 mg. (2.1)
May repeat dose after 4 hours if needed; not to exceed 5 mg in any
24-hour period. (2.1)
Mild or moderate renal or hepatic impairment: recommended starting
dose is 1 mg not to exceed 2.5 mg in any 24-
hour period. (2.2, 2.3)
History of coronary artery disease or coronary artery vasospasm (4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction
pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar
migraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT agonist (e.g., another
triptan) or an ergotamine-containing medication
(4)
1
Hypersensitivity to naratriptan (angioedema and anaphylaxis se