TRAMADOL HYDROCHLORIDE- 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:

Proficient Rx LP

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 pregnant women. Use Tramadol Hydroch

Product summary:

Tramadol Hydrochloride C-IV 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 63187-062-30 Bottle of 60 capsules: NDC 63187-062-60 Bottle of 90 capsules: NDC 63187-062-90 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

Authorization status:

New Drug Application

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PROFICIENT RX LP
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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 C-IV EXTENDED-RELEASE.
TRAMADOL HYDROCHLORIDE C-IV 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
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DOSAGE FORMS AND STRENGTHS
Extended-Release Capsules: 150 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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 hyperca