TRAMADOL HYDROCHLORIDE capsule, extended release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)

Tilgjengelig fra:

Aidarex Pharmaceuticals LLC

INN (International Name):

TRAMADOL HYDROCHLORIDE

Sammensetning:

TRAMADOL HYDROCHLORIDE 150 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tramadol Hydrochloride Extended-Release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Tramadol Hydrochloride Extended-Release is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of Tramadol Hydrochloride Extended-Release, or opioids. Reactions range from pruritis to fatal anaphylactoid reactions [see WARNINGS AND PRECAUTIONS (5.4)]. Tramadol Hydrochloride Extended-Release is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. Tramadol Hydrochloride Extended-Release is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Use Tramadol Hydroc

Produkt oppsummering:

Tramadol Hydrochloride Extended-Release capsules are supplied as opaque white hard gelatin capsules, imprinted as follows. 150 mg Capsules: White capsule imprinted with gold ink “G 322 ” on cap and “150 ” between lines on the body Bottle of 30 capsules: NDC 33261-0880-30 Bottle of 60 capsules: NDC 33261-0880-60 Bottle of 90 capsules: NDC 33261-0880-90 Storage Dispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children. Distributed by:        KLE 2 Inc.                        Culver City, CA 90232 Repacked By: Aidarex Pharmaceuticals, LLC Corona, CA 92880

Autorisasjon status:

New Drug Application

Preparatomtale

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
AIDAREX PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRAMADOL
HYDROCHLORIDE EXTENDED-RELEASE.
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE (TRAMADOL HYDROCHLORIDE)
EXTENDED-RELEASE CAPSULES
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Tramadol Hydrochloride Extended-Release is an opioid agonist indicated
for the management of moderate to moderately
severe chronic pain in adults who require around-the-clock treatment
of their pain for an extended period of time. (1)
DOSAGE AND ADMINISTRATION
Tramadol Hydrochloride Extended-Release must be swallowed whole, and
must not be split, chewed, dissolved or
crushed. (2.1)
Do not exceed a daily dose of 300 mg tramadol. Do not use with other
tramadol products. (2.1)
Adults not on tramadol Immediate-Release (IR): Initiate Tramadol
Hydrochloride Extended-Release at a dose of 100
mg once daily, then titrate up by 150 mg, 200 mg and 300 mg, every 5
days according to need and tolerance. (2.1)
Adults on tramadol IR: Calculate total 24-hr IR dose, initiate
Tramadol Hydrochloride Extended-Release at a dose
rounded down to next lower dose; then adjust dose according to need
and tolerance. (2.1)
Patients >65 years of age: Initiate dosing cautiously; use even
greater caution in patients >75 years. (2.3)
May be taken without regard to meals. (12.3)
DOSAGE FORMS AND STRENGTHS
Extended-Release Capsules: 150 mg (3)
CONTRAINDICATIONS
Patients who have previously demonstrated hypersensitivity to
tramadol, any other component of this product or
opioids. (4)
Patients with significant respiratory depression in unmonitored
settings or the absence of resuscitative equipment. (4)
Patients with acute or severe bronchial asthma or hypercapnia in
unmonitored settings or the absence of resuscitative
equipment. (4)
All other opioid contraindic