TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

TRAMADOL HYDROCHLORIDE

Composition:

TRAMADOL HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tramadol hydrochloride is 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. 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 one or more of the following: impaired control over d

Product summary:

Tramadol hydrochloride tablets 50 mg are supplied as unscored, white, round film coated tablets debossed “AN” over “627”. They are supplied as follows: Bottles of 12 Tablets: NDC 35356-659-12 Bottles of 15 tablets: NDC 35356-659-15 Bottles of 20 tablets: NDC 35356-659-20 Bottles of 30 tablets: NDC 35356-659-30 Bottles of 60 tablets: NDC 35356-659-60 Bottles of 90 tablets: NDC 35356-659-90 Bottles of 100 tablets: NDC 35356-659-00 Bottles of 120 tablets: NDC 35356-659-01 Bottles of 180 tablets: NDC 35356-659-18 Bottles of 240 tablets: NDC 35356-659-24 Bottles of 8 tablets:    NDC 35356-659-08 Dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 – 86°F). Manufactured by: Amneal Pharmaceuticals Paterson, New Jersey 07504 Amneal Pharmaceuticals Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42164 Rev. 11-2009 Repackage by: Quality Care Products, LLC Temperance, MI 48182

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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TRAMADOL HYDROCHLORIDE TABLETS
FULL PRESCRIBING INFORMATION
DESCRIPTION
Tramadol hydrochloride tablets is 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 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
_PHARMACOKINETICS_
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_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
concentrations of each compound (se