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Ultracet

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Ultracet

ULTRACET®
(tramadol hydrochloride/acetaminophen) Tablets

Ultracet

HEPATOTOXICITY

ULTRACET® contains tramadol HCl and acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).

DRUG DESCRIPTION

ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets combines two analgesics, tramadol 37.5 mg and acetaminophen 325 mg.

The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

Tramadol hydrochloride Structural Formula Illustration

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:

Acetaminophen Structural Formula Illustration

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 tramadol hydrochloride and 325 mg acetaminophen and are light yellow in color. Inactive ingredients in the tablet are powdered cellulose, pregelatinized corn starch, sodium starch glycolate, corn starch, magnesium stearate, hypromellose, polyethylene glycol, polysorbate 80, titanium dioxide, iron oxide, and carnauba wax.

Meets USP Dissolution Test 2

What are the possible side effects of acetaminophen and tramadol (Ultracet)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acetaminophen and tramadol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • a red, blistering, peeling skin rash; or
  • shallow breathing, weak pulse.

Less serious side...

Read All Potential Side Effects and See Pictures of Ultracet »

What are the precautions when taking tramadol (Ultracet)?

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to tramadol or acetaminophen; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, suicidal thoughts), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage,...

Read All Potential Precautions of Ultracet »

Last reviewed on RxList: 11/4/2013
This monograph has been modified to include the generic and brand name in many instances.

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Ultracet - User Reviews

Ultracet User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ultracet sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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