TRAMADOL HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

RedPharm Drug, Inc.

Designación común internacional (DCI):

TRAMADOL HYDROCHLORIDE

Composición:

TRAMADOL HYDROCHLORIDE 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Tramadol Hydrochloride Tablets USP, 50 mg are white to off-white, capsule shaped, biconvex, film coated tablets debossed with "ML 4" on one side and plain on other side. Bottles of 100 tablets: NDC 33342-201-11 Bottles of 500 tablets: NDC 33342-201-15 Bottles of 1000 tablets: NDC 33342-201-44 Dispense in a tight container. 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]. TYLENOL with Codeine #3 is a registered trademark of Ortho-McNeil Pharmaceuticals. TYLOX is a registered trademark of Ortho-McNeil Pharmaceuticals. Manufactured for: Macleods Pharma USA, INC. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceutical Ltd. Baddi, Himachal Pradesh, India. Issue: 3/2015

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
REDPHARM DRUG, INC.
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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 is:
[structure]
C16 H25 NO2 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.
Tramadol hydrochloride tablets contain 50
mg of tramadol hydrochloride, USP and are white to off-white in color.
Inactive ingredients in the tablet
are lactose monohydrate, microcrystalline cellulose, sodium starch
glycolate, hypromellose, colloidal
silicon dioxide, magnesium stearate, polyethylene glycol, polysorbate
80 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
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,
PHARMACOKINETICS).
Tramadol has been shown to inhibit reuptake of norepinephrine and
serotonin in vitro, as have some
other opioid analgesi