TRAMADOL HYDROCHLORIDE tablet, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Lake Erie Medical DBA Quality Care Products LLC

DCI (Dénomination commune internationale):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 300 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Tramadol hydrochloride extended-release 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 extended-release tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride extended-release 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 extended-release tablets may worsen central nervous system and respiratory depression in these patients. Tramadol hydrochloride extended-release tablet 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 com

Descriptif du produit:

Tramadol hydrochloride extended-release tablets are supplied in the following package and dose strength forms: 100 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “531” with black ink on one side and plain on other side. 200 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “533” with black ink on one side and plain on other side. 300 mg: White, round shape, biconvex, beveled edge, coated tablet with release portal on the center of the tablet on any one side, imprinted “537” with black ink on one side and plain on other side. 35356-790-30 Bottles of 30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container. Warning: keep out of reach of children.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS
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:
Figure 1
The molecular weight of tramadol hydrochloride is 299.84. It is a
white, crystalline
powder that is freely soluble in water and methanol, very slightly
soluble in acetone 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 tablets contain 100 mg, 200 mg
or 300 mg of
tramadol hydrochloride, USP in an extended-release formulation. The
tablets are white in
color and contain the inactive ingredients pregelatinized starch,
hypromellose, mannitol,
magnesium stearate, cellulose acetate and polyethylene glycol.
Imprinting ink contains, shellac glaze, iron oxide black, N-butyl
alcohol, ammonium
hydroxide and propylene glycol.
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 of ea