দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
Preferred Pharmaceuticals 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 Hydroch
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 30 capsules: NDC 68788-8920-1 Bottle of 30 capsules: NDC 68788-8920-3 Bottle of 60 capsules: NDC 68788-8920-6 Bottle of 90 capsules: NDC 68788-8920-9 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 Re-Packaged By: Preferred Pharmaceuticals Inc. To report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
New Drug Application
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE PREFERRED PHARMACEUTICALS INC. ---------- 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 • • • • • • DOSAGE FORMS AND STRENGTHS Extended-Release Capsules: 150 mg (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • • • • • 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) 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 s সম্পূর্ণ নথি পড়ুন