TRAMADOL HYDROCHLORIDE tablet, coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (Alþjóðlegt nafn):

TRAMADOL HYDROCHLORIDE

Samsetning:

TRAMADOL HYDROCHLORIDE 50 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

Tramadol hydrochloride tablets, USP 50 mg are supplied as unscored, white, round film-coated tablets debossed “AN” over “627”. They are supplied as follows: Blistercards of 30 tablets:               NDC 0615-8005-39 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]. Dispense in a tight container as defined in the USP. Manufactured by: Amneal Pharmaceuticals Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 10-2015-03

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET, COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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TRAMADOL HYDROCHLORIDE TABLETS, USP CIV
RX ONLY
DESCRIPTION
Tramadol hydrochloride tablets, USP are a centrally acting analgesic.
The chemical name
for tramadol hydrochloride is
(±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl)
cyclohexanol hydrochloride. Its structural formula is:
The molecular formula of tramadol hydrochloride is C
H
NO •HCl and its molecular
weight 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.
Each tramadol hydrochloride tablet, USP intended for oral
administration contains 50 mg
of tramadol hydrochloride. In addition, it also contains the following
inactive ingredients:
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polysorbate 80, pregelatinized starch, sodium
starch glycolate, and
titanium dioxide.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Tramadol Hydrochloride contains 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
16
25
2
concentrations of each compound (see CLINICAL PHARMACO