"Jan. 28, 2013 -- It may become more difficult to get prescriptions for drugs containing hydrocodone combined with other pain relievers.
An FDA panel voted 17 to 10 in favor of reclassifying hydrocodone-containing compounds, such as Vico"...
(hydrocodone bitartrate and acetaminophen) Tablets, USP 5 mg/500 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 (hydrocodone bitartrate and acetaminophen) tablet contains:
Hydrocodone Bitartrate 5 mg
Acetaminophen 500 mg
In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, starch, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, povidone, and stearic acid.
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)?
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 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), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as...
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
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