TRAMADOL HYDROCHLORIDE tablet, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Dispensing Solutions, Inc.

Designación común internacional (DCI):

TRAMADOL HYDROCHLORIDE

Composición:

TRAMADOL HYDROCHLORIDE 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Tramadol hydrochloride ER tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride ER tablets 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 ER tablets may worsen central nervous system and respiratory depression in these patients Tramadol hydrochloride is a mu-agonist opioid. Tramadol, like other opioids used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk

Resumen del producto:

Tramadol hydrochloride extended-release tablets are supplied in the following package and dose strength forms: 100 mg, round, white to off-white tablets, imprinted with “Par 821” on one side of the tablet in black ink Bottle of 30 tablets – NDC 49884-821-11 Bottle of 500 tablets – NDC 49884-821-05 200 mg, round, white to off-white tablets, imprinted with “Par 822” on one side of the tablet in black ink Bottle of 30 tablets – NDC 49884-822-11 Bottle of 500 tablets – NDC 49884-822-05 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Manufactured by: Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Issued: 11/09

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
DISPENSING SOLUTIONS, INC.
----------
RX ONLY
DESCRIPTION
Tramadol hydrochloride is a centrally acting synthetic analgesic in an
extended-release formulation.
The chemical name is (±)
cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol
hydrochloride. Its structural formula is:
The molecular weight of tramadol hydrochloride is 299.8. It is a
white, bitter, crystalline and odorless
powder that 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. Tramadol hydrochloride
Extended-Release (ER) tablets
contain 100 mg or 200 mg of tramadol hydrochloride in an
extended-release formulation. The tablets
are white to off-white in color and contain the inactive ingredients
colloidal silicone dioxide, dibutyl
sebacate, ethylcellulose, magnesium stearate, polyvinyl alcohol,
povidone K-90, and an imprinting
agent, Opacode S-1-17823 black, which contains the following
ingredients: shellac, iron oxide black,
isopropyl alcohol, n-butyl alcohol, propylene glycol, and ammonium
hydroxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
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