TRAMADOL HYDROCHLORIDE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Dispensing Solutions, Inc.

ИНН (Международная Имя):

TRAMADOL HYDROCHLORIDE

состав:

TRAMADOL HYDROCHLORIDE 50 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 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. Tramadol has mu-opioid agonist activity. Tramadol Hydrochloride Tablet 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

Обзор продуктов:

Tramadol hydrochloride tablet, USP 50 mg are available as white capsule shaped film coated tablets, debossed with “377” on one side and plain on the other side. NDC 66336-0915-60 NDC 66336-0915-62 Dispense in tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 -86°F).

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET
DISPENSING SOLUTIONS, INC.
----------
TRAMADOL HYDROCHLORIDE TABLETS, USP
50 MG - RX ONLY
DESCRIPTION
Tramadol hydrochloride tablet, USP is a centrally acting analgesic.
The chemical name for tramadol
hydrochloride, USP is
(±)_cis_-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol
hydrochloride. Its structural formula is:
Molecular formula is C
H NO •HCl
The molecular weight of tramadol hydrochloride, USP is 299.8. Tramadol
hydrochloride, USP 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
pH7. Tramadol hydrochloride
tablets, USP for oral administration contain 50 mg of tramadol
hydrochloride, USP. In addition, each
tablet contains the following inactive ingredients: pregelatinized
starch, lactose anhydrous, magnesium
stearate, microcrystalline cellulose, polyethylene glycol, sodium
starch glycolate, 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 norepine