TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

RxChange Co.

INN (Διεθνής Όνομα):

TRAMADOL HYDROCHLORIDE

Σύνθεση:

TRAMADOL HYDROCHLORIDE 37.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain. 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. 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, with genetic,

Περίληψη προϊόντος:

Tramadol hydrochloride tablets, USP 50 mg are supplied as unscored, white, round film coated tablets debossed “AN” over “627”. They are supplied as follows: Bottles of 10 count:  NDC 65162-627-01 Bottles of 100 count:  NDC 65162-627-10 Bottles of 500 count:  NDC 65162-627-50 Bottles of 1000 count: NDC 65162-627-11 Dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Manufactured by: Amneal Pharmaceuticals Hauppauge, New York 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 07-2014-00

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
RXCHANGE CO.
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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP CIV
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
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 hi