"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
(hydrocodone bitartrate and acetaminophen) Tablets, USP
7.5 mg/750 mg
Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5α -epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:
C18H21NO3·C4H6O6·2½H2O M.W.= 494.50
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8H9NO2 M.W. 151.16
Each VICODIN ES (hydrocodone bitartrate and acetaminophen) Tablet contains:
Hydrocodone Bitartrate 7.5 mg
Acetaminophen 750 mg
Meets USP Dissolution Test 2.
What are the possible side effects of acetaminophen and hydrocodone?
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.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- feeling light-headed, fainting;
- confusion, fear, unusual thoughts or behavior;
- seizure (convulsions);
- problems with urination; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or...
What are the precautions when taking hydrocodone bitartrate and acetaminophen (Vicodin ES)?
See also Warning section.
Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as hydromorphone, morphine, codeine); 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, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol,...
Last reviewed on RxList: 3/14/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Vicodin ES Information
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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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