TRAMADOL HYDROCHLORIDE tablet, coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

NuCare Pharmaceuticals, Inc.

Designació comuna internacional (DCI):

TRAMADOL HYDROCHLORIDE

Composición:

TRAMADOL HYDROCHLORIDE 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults. Tramadol hydrochloride tablets, USP should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride 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 tablets, USP may worsen central nervous system and respiratory depression in these patients. Abuse Tramadol has mu-opioid agonist activity. Tramadol hydrochloride tablets 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

Resumen del producto:

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 6 tablets: NDC 66267-843-06 Bottles of 12 tablets: NDC 66267-843-12 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.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
NUCARE PHARMACEUTICALS, INC.
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TRAMADOL HYDROCHLORIDE TABLETS, USP CIV
RX ONLY
DESCRIPTION
Tramadol hydrochloride tablets, USP are a centrally acting analgesic.
The chemical name for tramadol
hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl)
cyclohexanol hydrochloride. Its
structural formula is:
The molecular formula of tramadol hydrochloride is C
H
NO
•HCl and its molecular weight 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, USP intended for oral
administration contains 50 mg of tramadol
hydrochloride. In addition, it also contains the following inactive
ingredients: hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
pregelatinized starch, sodium starch glycolate, and titanium dioxide.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Tramadol Hydrochloride contains tramadol, 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 re-
uptake 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,
Pharmacokineti