TRAMADOL HYDROCHLORIDE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)

Disponibil de la:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (nume internaţional):

TRAMADOL HYDROCHLORIDE

Compoziție:

TRAMADOL HYDROCHLORIDE 50 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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