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tramadol hydrochloride and acetaminophen
Overview
What is ULTRACET?
ULTRACET (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol hydrochloride and opioid agonist, and acetaminophen.
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 299.84. Tramadol hydrochloride is a white, bitter, crystalline, and odorless powder.
The chemical name for acetaminophen is N-acetyl-p-aminophenol. Its structural formula is:
The molecular weight of acetaminophen is 151.17. Acetaminophen is an analgesic and antipyretic agent which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste.
ULTRACET tablets contain 37.5 mg of tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are carnauba wax, corn starch, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized corn starch, sodium starch glycolate, and titanium dioxide.
Meets USP Dissolution Test 2.
What does ULTRACET look like?
What are the available doses of ULTRACET?
Tablets: tramadol hydrochloride 37.5 mg and acetaminophen 325 mg. (
)
What should I talk to my health care provider before I take ULTRACET?
How should I use ULTRACET?
ULTRACET tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (
)
Initiate treatment with two tablets every 4 to 6 hours as needed for pain relief; maximum of 8 tablets per day. (
)
Do not use with other acetaminophen- or tramadol-containing products. (
,
)
Severe Renal Impairment
Do not stop ULTRACET abruptly in a physically dependent patient. (
)
What interacts with ULTRACET?
Sorry No Records found
What are the warnings of ULTRACET?
Sorry No Records found
What are the precautions of ULTRACET?
Sorry No Records found
What are the side effects of ULTRACET?
Sorry No records found
What should I look out for while using ULTRACET?
ULTRACET is contraindicated for:
ULTRACET is also contraindicated in patients with:
What might happen if I take too much ULTRACET?
How should I store and handle ULTRACET?
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.ULTRACET (tramadol hydrochloride/acetaminophen) tablets containing 37.5 mg tramadol hydrochloride and 325 mg acetaminophen are light yellow, coated, capsule-shaped tablets debossed with "O-M" on one side and "650" on the other and are available as follows:Bottles of 20 (NDC 55289-617-20)ULTRACET (tramadol hydrochloride/acetaminophen) tablets containing 37.5 mg tramadol hydrochloride and 325 mg acetaminophen are light yellow, coated, capsule-shaped tablets debossed with "O-M" on one side and "650" on the other and are available as follows:Bottles of 20 (NDC 55289-617-20)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ULTRACET contains tramadol, an opioid agonist and inhibitor of norepinephrine and serotonin re-uptake, and acetaminophen. Although the mode of action of tramadol is not completely understood, the analgesic effect of tramadol is believed to be due to both binding to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin.
Opioid activity of tramadol is due to both low affinity binding of the parent compound and higher affinity binding of the
-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
.
Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin
, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol.
Acetaminophen is a non-opioid, non-salicylate analgesic. The site and mechanism for the analgesic effect of acetaminophen has not been determined but is thought to primarily involve central actions.
Non-Clinical Toxicology
ULTRACET is contraindicated for:ULTRACET is also contraindicated in patients with:
ULTRACET contains tramadol, a Schedule IV controlled substance. As an opioid, ULTRACET exposes users to the risks of addiction, abuse, and misuse .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed ULTRACET. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing ULTRACET, and monitor all patients receiving ULTRACET for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as ULTRACET, but use in such patients necessitates intensive counseling about the risks and proper use of ULTRACET along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing ULTRACET. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are discussed, or described in greater detail, in other sections:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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