TRAMADOL HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

St. Mary's Medical Park Pharmacy

INN (International Name):

TRAMADOL HYDROCHLORIDE

Sammensetning:

TRAMADOL HYDROCHLORIDE 50 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 hydrochloride is a Schedule IV controlled substance. 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 drug use, compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. "Drug-seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of tramadol hydrochloride tablet can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Concerns about abuse and addiction should not prevent the proper management of pain. However all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of this product. Tramadol hydrochloride tablet is intended for oral use only. Tolerance is the need for increasing doses of drugs to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist (see also WARNINGS, Withdrawal). The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with tramadol hydrochloride tablet.

Produkt oppsummering:

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. NDCs 60760-377-09 BOTTLES OF 9 60760-377-20 BOTTLES OF 20 60760-377-30 BOTTLES OF 30 60760-377-50 BOTTLES OF 50 60760-377-60 BOTTLES OF 60 60760-377-90 BOTTLES OF 90 60760-377-98 BOTTLES OF 180 - INACTIVE Dispense in tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 -86°F).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TRAMADOL HYDROCHLORIDE- TRAMADOL HYDROCHLORIDE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
----------
TRAMADOL HYDROCHLORIDE TABLETS, USP, CIV
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,
hypromellose and polysorbate 80.
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
16
13
2
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).
Tra