Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
NCS HealthCare of KY, Inc dba Vangard Labs
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults. Tramadol hydrochloride should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride may worsen central nervous system and respiratory depression in these patients. Tramadol has mu-opioid agonist activity. Tramadol hydrochloride can be abused and may be subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Drug addiction is characterized by behaviors that include one or more of the following: impaired control over drug u
Tramadol Hydrochloride Tablets USP, 50 mg are a white, film-coated, round, unscored tablet debossed with M on one side of the tablet and T7 on the other side. They are available as follows: NDC 0615-7810-39 Blistercards of 30 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. † TYLENOL® with Codeine #3 is a registered trademark of Ortho-McNeil Pharmaceuticals. †† TYLOX® is a registered trademark of Ortho-McNeil Pharmaceuticals. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED JULY 2014 TRML:R6
Abbreviated New Drug Application
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- TRAMADOL HCL TABS 50MG DESCRIPTION Tramadol hydrochloride tablets, USP are a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)_cis_-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula and molecular formula are: C H NO · HCl The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n- octanol/water log partition coefficient (logP) is 1.35 at pH 7. Each tramadol hydrochloride tablet for oral administration contains 50 mg of tramadol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Tramadol is a centrally acting synthetic opioid analgesic. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylated metabolite M1 to µ-opioid receptors. In animal models, M1 is up to 6 times more potent than tramadol in producing analgesia and 200 times more potent in µ-opioid binding. Tramadol- induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Tramadol h Прочитајте комплетан документ