TRAMADOL HYDROCHLORIDE - tramadol hydrochloride tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Citron Pharma LLC

DCI (Denominação Comum Internacional):

TRAMADOL HYDROCHLORIDE

Composição:

TRAMADOL HYDROCHLORIDE 50 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Tramadol hydrochloride tablets, USP are indicated for the management of moderate to moderately severe pain in adults. Tramadol hydrochloride tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride 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 tablets 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 fo

Resumo do produto:

Tramadol Hydrochloride Tablets USP, 50 mg are white to off-white, capsule shaped, coated tablet, debossed ‘T’ on one side and ‘03’ on the other side.                Bottles of 100                  NDC 57237-238-01                Bottles of 500                  NDC 57237-238-05                Bottles of 1,000                NDC 57237-238-99 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Tylenol® is a registered trademark of McNeil Cons. Tylox® is a registered trademark of Ortho McNeil Pharm. Distributed by: Citron Pharma LLC Suite -1101 2 Tower Center Blvd East Brunswick NJ 08816 Code No.: DRUGS/AP/22/2009 Made in India Issued: 01/2016

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TRAMADOL HYDROCHLORIDE - TRAMADOL HYDROCHLORIDE TABLET, FILM COATED
CITRON PHARMA LLC
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TRAMADOL HYDROCHLORIDE TABLETS, USP CIV
RX ONLY
FULL PRESCRIBING INFORMATION
DESCRIPTION
Tramadol hydrochloride tablets 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:
The molecular weight of tramadol hydrochloride is 299.8. Tramadol
hydrochloride USP is a white,
crystalline 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, USP contain 50 mg of
tramadol hydrochloride USP and are white in color. Inactive
ingredients in the tablet are carnauba wax,
corn starch, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate, povidone, sodium starch glycolate,
and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
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 of each compound (see CLINICAL PHARMACOLOGY,
PHARMACOKINETICS).
Tramadol has been shown to inhibit reuptake of norepinephrine and
serotonin _i