TRAMADOL HYDROCHLORIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medsource Pharmaceuticals

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 pregna

Product summary:

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 Repackaged by: Medsource Pharmaceuticals Rancho Santa Margarita, CA 92688 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.

Authorization status:

New Drug Application

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
MEDSOURCE PHARMACEUTICALS
----------
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 co