"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
(tramadol hydrochloride/acetaminophen) Tablets
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).
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:
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:
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...
What are the precautions when taking tramadol hydrochloride and acetaminophen tablets (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,...
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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