TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

REMEDYREPACK INC.

INN (nume internaţional):

TRAMADOL HYDROCHLORIDE

Compoziție:

TRAMADOL HYDROCHLORIDE 50 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Tramadol hydrochloride tablets are indicated for the management of moderate to moderately severe pain in adults. Tramadol hydrochloride 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 hydrochloride 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 following: impaired control over drug u

Rezumat produs:

Tramadol hydrochloride tablets, USP, 50 mg, are available as white, oval, film-coated tablets debossed with" 101 " on one side and " OUYI " on the other side. Bottles of 100 tablets: NDC 69543-136-10 Bottles of 500 tablets: NDC 69543-136-50 Bottles of 1000 tablets: NDC 69543-136-11 Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 –30°C (59 – 86°F) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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TRAMADOL HYDROCHLORIDE - TRAMADOL
HYDROCHLORIDE TABLETS, USP
CIV
RX ONLY
FULL PRESCRIBING INFORMATION
DESCRIPTION
Tramadol hydrochloride tablets, USP, is 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 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 and are white in color. Inactive
ingredients in the tablet are corn starch,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, polyvinyl alcohol, sodium starch glycolate, talc and titanium
dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Tramadol hydrochloride tablets contain 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,
PHARMACOKINETICS).
Tramadol has been shown to inhibit reuptake