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In addition to requiring new labeling on these prescript"...
(hydrocodone bitartrate and ibuprofen) Tablets 7.5 mg/200 mg
Each VICOPROFEN (hydrocodone and ibuprofen) tablet contains:
Hydrocodone Bitartrate, USP 7.5 mg
Ibuprofen, USP 200 mg
VICOPROFEN (hydrocodone and ibuprofen) is supplied in a fixed combination tablet form for oral administration. VICOPROFEN (hydrocodone and ibuprofen) combines the opioid analgesic agent, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.
Hydrocodone bitartrate is a semisynthetic and centrally acting opioid analgesic. Its chemical name is: 4,5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: C18H21NO3•C4H6O6•2½H2O, and the molecular weight is 494.50. Its structural formula is:
Ibuprofen is a nonsteroidal anti-inflammatory agent [non-selective COX inhibitor] with analgesic and antipyretic properties. Its chemical name is: (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is: C13H18O2, and the molecular weight is: 206.29. Its structural formula is:
Inactive ingredients in VICOPROFEN (hydrocodone and ibuprofen) tablets include: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.
What are the possible side effects of hydrocodone and ibuprofen (Ibudone, Reprexain, Vicoprofen)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using hydrocodone and ibuprofen and call your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech;
- chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- bloody or tarry...
What are the precautions when taking hydrocodone and ibuprofen (Vicoprofen)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to ibuprofen or hydrocodone; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or to narcotic pain medications (such as codeine, morphine, hydromorphone); 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: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), low red blood cell count (anemia), bleeding or clotting problem, brain disorders (such as head injury, tumor, seizures, stroke), breathing...
Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.
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