TRAMADOL HYDROCHLORIDE capsule extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

SA3, LLC

INN (Nome Internazionale):

TRAMADOL HYDROCHLORIDE

Composizione:

TRAMADOL HYDROCHLORIDE 150 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
SA3, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TRAMADOL HYDROCHLORIDE EXTENDED-
RELEASE CAPSULES.
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 Capsules 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 to 150 mg, 200 mg and 300 mg, every 5
days according to need tolerance. (2.2)
Adults on tramadol IR: Calculate total 24-hour IR dose, initiate
Tramadol Hydrochloride Extended-Release at a dose
rounded down to next lower dose; then adjust dose according to need
and tolerance. (2.3)
Patients >65 years of age: Initiate dosing cautiously, use even
greater caution in patients >75 years. (2.4)
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 contraindications, including intoxication with