TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

可用日期:

Direct Rx

INN（国际名称）:

TRAMADOL HYDROCHLORIDE

组成:

TRAMADOL HYDROCHLORIDE 37.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain. Close Tramadol hydrochloride and acetaminophen tablets, USP should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, USP, acetaminophen, USP, any other component of this product, or opioids. Tramadol hydrochloride and acetaminophen tablets, USP are 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 and acetaminophen tablets, USP may worsen central nervous system and respiratory depression in these patients. Close Abuse Tramadol has mu-opioid agonist activity. Tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, w

產品總結:

Tramadol hydrochloride and acetaminophen tablets, USP, 37.5 mg/325 mg, are beige colored, film-coated, biconvex capsule shaped tablets with “AN 617” debossed on one side and plain on the other side. They are available as follows:                                  Bottles of 30:                                      NDC 53746-617-30 Bottles of 100:                                    NDC 53746-617-01 Bottles of 500:                                    NDC 53746-617-05 Bottles of 1000:                                  NDC 53746-617-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Rx only Manufactured by:                                                                   Amneal Pharmaceuticals Co. (I) Pvt. Ltd.  Ahmedabad, INDIA 382220 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 07-2014-00 Close

授权状态:

Abbreviated New Drug Application

产品特点

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
DIRECT RX
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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
DESCRIPTION
Tramadol hydrochloride and acetaminophen tablets, USP combine two
analgesics, tramadol, USP 37.5
mg and acetaminophen, USP 325 mg.
The chemical name for tramadol hydrochloride, USP is
(±)cis-2-[(dimethylamino)methyl]-1-(3-
methoxyphenyl) cyclohexanol hydrochloride.
Its structural formula is:
The molecular weight of tramadol hydrochloride, USP is 299.84.
Tramadol hydrochloride, USP is a
white, bitter, crystalline and odorless powder.
The chemical name for acetaminophen, USP is N-acetyl-p-aminophenol.
Its structural formula is:
The molecular weight of acetaminophen, USP is 151.17. Acetaminophen,
USP is an analgesic and
antipyretic agent which occurs as a white, odorless, crystalline
powder, possessing a slightly bitter
taste.
Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg
tramadol hydrochloride, USP
and 325 mg acetaminophen, USP and are beige in color. Inactive
ingredients in the tablets are carnauba
wax, crospovidone, iron oxide black, iron oxide red, iron oxide
yellow, microcrystalline cellulose,
pregelatinized starch, polyethylene glycol, polyvinyl alcohol,
povidone, sodium starch glycolate,
stearic acid, talc and titanium dioxide.
Dissolution Method: Test 2
Close
CLINICAL PHARMACOLOGY
The following information is based on studies of tramadol alone or
acetaminophen alone, except where
otherwise noted:
_PHARMACODYNAMICS_
Tramadol hydrochloride and acetaminophen tablets contain tramadol
hydrochloride and acetaminophen.
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 bindin