Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
H.J. Harkins Company, Inc.
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE 150 mg
ORAL
PRESCRIPTION DRUG
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
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 500 capsules: NDC 76218-0708-5 Bottle of 1000 capsules: NDC 76218-0708-1 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: H.J. Harkins Company, Inc. Grover Beach, CA 93433
New Drug Application
TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE H.J. HARKINS COMPANY, INC. ---------- 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 Citiți documentul complet