TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Boleh didapati daripada:

AvPAK

INN (Nama Antarabangsa):

TRAMADOL HYDROCHLORIDE

Komposisi:

TRAMADOL HYDROCHLORIDE 37.5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Tramadol hydrochloride and acetaminophen tablets, USP are indicated for the short-term (five days or less) management of acute pain. Tramadol hydrochloride and acetaminophen tablets, USP should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, USP, acetaminophen, USP, any other component of this product, or opioids. Tramadol hydrochloride and acetaminophen 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 and acetaminophen tablets, USP may worsen central nervous system and respiratory depression in these patients. Abuse Tramadol has mu-opioid agonist activity. Tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, 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, 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 and acetaminophen tablets 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 and acetaminophen tablets are intended for oral use only. Dependence 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 and acetaminophen tablets.

Ringkasan produk:

Tramadol hydrochloride and acetaminophen tablets, USP are beige colored, film-coated, biconvex capsule shaped tablets with “AN 617” debossed on one side and plain on the other side and are available as follows: NDC 50268-774-15 (10 tablets per card, 5 cards per carton) Dispensed in Unit Dose package. For Institutional Use Only. 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]. Rx only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 07-2014-01 AV 01/15 (P) AvPAK

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- TRAMADOL HYDROCHLORIDE
AND ACETAMINOPHEN TABLET
AVPAK
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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, USP CIV
DESCRIPTION
Tramadol hydrochloride and acetaminophen tablets, USP combine two
analgesics,
tramadol, USP 37.5 mg and acetaminophen, USP 325 mg.
The chemical name for tramadol hydrochloride, USP is (±) _cis_-2-
[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol
hydrochloride. Its structural
formula is:
The molecular weight of tramadol hydrochloride, USP is 299.84.
Tramadol hydrochloride,
USP is a white, bitter, crystalline and odorless powder.
The chemical name for acetaminophen, USP is _N_-acetyl-
_p_-aminophenol. Its structural
formula is:
The molecular weight of acetaminophen, USP is 151.17. Acetaminophen,
USP is an
analgesic and antipyretic agent which occurs as a white, odorless,
crystalline powder,
possessing a slightly bitter taste.
Tramadol hydrochloride and acetaminophen tablets, USP contain 37.5 mg
tramadol
hydrochloride, USP and 325 mg acetaminophen, USP and are beige in
color. Inactive
ingredients in the tablets are carnauba wax, crospovidone, iron oxide
black, iron oxide
red, iron oxide yellow, microcrystalline cellulose, pregelatinized
starch, polyethylene
glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic
acid, talc and titanium
dioxide.
DISSOLUTION METHOD: TEST 2
CLINICAL PHARMACOLOGY
The following information is based on studies of tramadol alone or
acetaminophen alone,
except where otherwise noted:
_PHARMACODYNAMICS_
Tramadol hydrochloride and acetaminophen tablets contain tramadol
hydrochloride and
acetaminophen. Tramadol 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