TRAMADOL HYDROCHLORIDE capsule, extended release

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

NuCare Pharmaceuticals, Inc.

INN (Mezinárodní Name):

TRAMADOL HYDROCHLORIDE

Složení:

TRAMADOL HYDROCHLORIDE 150 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

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 Bottles of 15 NDC 68071-1978-1 Bottles of 30 NDC 68071-1978-3 Bottles of 60 NDC 68071-1978-6 Bottles of 90 NDC 68071-1978-9 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: STA3, LLC Los Angeles, CA 90064 USA To report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical [phone] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Stav Autorizace:

New Drug Application

Charakteristika produktu

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
NUCARE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAMADOL HYDROCHLORIDE
EXTENDED-RELEASE CAPSULESSAFELY 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 Extanded-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 ramadol,
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