国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)
Dispensing Solutions, Inc.
TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE 50 mg
ORAL
PRESCRIPTION DRUG
Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults. Tramadol hydrochloride tablets 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 may worsen central nervous system and respiratory depression in these patients. Tramadol has mu-opioid agonist activity. Tramadol Hydrochloride Tablet 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
Tramadol hydrochloride tablet, USP 50 mg are available as white capsule shaped film coated tablets, debossed with “377” on one side and plain on the other side. NDC 66336-0915-60 NDC 66336-0915-62 Dispense in tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 -86°F).
Abbreviated New Drug Application
TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET DISPENSING SOLUTIONS, INC. ---------- TRAMADOL HYDROCHLORIDE TABLETS, USP 50 MG - RX ONLY DESCRIPTION Tramadol hydrochloride tablet, USP is a centrally acting analgesic. The chemical name for tramadol hydrochloride, USP is (±)_cis_-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Molecular formula is C H NO •HCl The molecular weight of tramadol hydrochloride, USP is 299.8. Tramadol hydrochloride, USP 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 pH7. Tramadol hydrochloride tablets, USP for oral administration contain 50 mg of tramadol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: pregelatinized starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, titanium dioxide. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Tramadol hydrochloride 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 has been shown to inhibit reuptake of norepine 阅读完整的文件