Breastfeeding
Hydrocodone and ibuprofen are excreted in breast milk, so appropriate caution should be taken when prescribing to breastfeeding mothers. Special populations
There is no evidence to support altered pharmacokinetic properties due to differences in gender or age. However, this drug combination has not been tested in children. Adverse effects
The side effects for hydrocodone/ibuprofen are a combination of the side effects of the component drugs. Side effects experienced in more than 10% of the population taking the drug include: headache, drowsiness, dizziness, constipation, nausea, and dyspepsia. Pharmacology
Pharmacokinetics
The two active components of the drug, ibuprofen and hydrocodone, do not affect each others absorption characteristics or other pharmacokinetic parameters. After an oral dose, the peak level of hydrocodone in the blood is reached 1.7 hours after administration. The blood levels of ibuprofen peak 1.8 hours after oral administration. History
Discovery and development
The patent for Vicoprofen was filed in December 1984, and U.S. patent number 4,587,252 was granted in May 1986. Although ibuprofen and hydrocodone were already available on the market at this time, the fact that they had never been supplied together in a single formulation required approval from the FDA as if it were a new drug. Knoll filed an investigational new drug application on 30 December 1986. A new drug application was later filed by Knoll on 25 April 1996, and received final approval from the FDA on 23 September 1997.
Hydrocodone/ibuprofen (INNs), sold under the brand name Vicoprofen, is a fixed-dose combination analgesic medication used in short-term therapy to relieve severe pain. Vicoprofen combines the analgesic and antitussive properties of hydrocodone with the analgesic, anti-inflammatory, and antipyretic properties of ibuprofen. In contrast to hydrocodone/acetaminophen combination analgesics such as Vicodin, this hydrocodone/ibuprofen avoids some of the liver toxicity which may occur from acetaminophen, but still presents significant dangers in hydrocodone overdose, namely respiratory depression. Vicoprofen is supplied in a fixed dose combination tablet which contains hydrocodone bitartrate, USP 7.5 mg with ibuprofen, USP 200 mg.  Additional strengths of generic Vicoprofen are now available, in combinations of 5 mg/200 mg and 10 mg/200 mg respectively. Medical uses
Hydrocodone/ibuprofen has a labeled indication for "short-term (generally <10 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate". Pregnancy
Opioids such as hydrocodone cross the placenta, and can therefore affect the fetus. Studies have shown a possible association between opioids and adverse outcomes such as birth defects, poor fetal growth, stillbirth, and preterm delivery. Prolonged use of opioids by a pregnant mother can also lead to neonatal withdrawal syndrome. NSAIDs such as ibuprofen should generally be avoided in pregnancy, as there are conflicting reports of birth defects after in utero exposure. However, it is accepted that NSAIDs prevent closure of the fetal ductus arteriosus, which happens during the later stages of pregnancy. Because of this, ibuprofen should be avoided after 30 weeks gestation.