See Supplemental Patient Information
- NSAIDs increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. To minimize this risk use the lowest effective dose for the shortest duration possible [US Black Box Warning]
- NSAIDs cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine. To minimize this risk use the lowest effective dose for the shortest duration possible [US Black Box Warning]
- Patients with a prior history of peptic ulcer disease and/or GI bleeding, concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status are at higher risk of GI bleed
- Onset of new hypertension or worsening of preexisting hypertension has been reported with NSAIDs therapy. Use cautiously in patients with hypertension and closely monitor the blood pressure before starting the therapy and periodically throughout the course of therapy
- NSAIDs can cause fluid retention and edema, hence use cautiously in patients with fluid retention or heart failure
- Hydrocodone is an opioid agonist and is a Schedule III controlled substance. It has the potential for being abused and is sought by abusers and people with addiction disorders, and is subject to diversion. Hence physician or pharmacist should be concerned about an increased risk of misuse, abuse or diversion when prescribing or dispensing hydrocodone or its combination
- Hydrocodone can produce dose-related respiratory depression when used in high dose or in sensitive patients, by acting directly on the brain stem respiratory center, also the center that controls respiratory rhythm and produce irregular and periodic breathing
- Use of narcotics in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure, markedly exaggerates its respiratory depressant effects and its capacity to elevate cerebrospinal fluid pressure and further more produce adverse reactions which may obscure the clinical course of patients with head injuries
- The diagnosis or clinical course of patients with acute abdominal conditions is obscured with the administration of narcotics
- Long term use of NSAIDS can cause renal papillary necrosis and other renal injury. Patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly are at higher risk. It recovers to the pretreatment state on discontinuation of therapy
- Severe allergic reactions are associated with usage of NSAIDs. Patients allergic to aspirin are more susceptible. Asthma (wheezing), blisters, facial swelling, hives, rash, shock and skin reddening are the associated symptoms. On development of allergic reactions stop usage of this drug and provide appropriate treatment
- Avoid in late pregnancy, as it can cause premature closure of the ductus arteriosus
- Hydrocodone suppresses the cough reflex, use cautiously in patient with pulmonary diseases and postoperatively
- Borderline elevations of one or more liver enzymes have been reported with NSAIDs therapy. Evaluate the patients for the evidence of more severe hepatic reactions, if symptoms or signs suggest liver dysfunction and abnormal liver test has occurred. Discontinue the therapy if liver disease develops, or if systemic manifestations occurs
- Anemia has been reported in some patients receiving NSAIDs. This may be due to fluid retention, occult or gross GI blood loss. Check hemoglobin or hematocrit regularly in patients on long term therapy with NSAIDs including ibuprofen
- NSAIDs inhibit platelet aggregation and prolong the bleeding time in some patients. Patients with coagulation disorders or receiving anticoagulants are at higher risk
- Aseptic meningitis with fever and coma has been observed rarely. If signs or symptoms of meningitis develops consider its possibility being related to ibuprofen
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Hypertension
- Fluid retention
- Heart failure
- Hypothyroidism
- Addison's disease
- Prostatic hypertrophy
- Urethral stricture
- Elderly or debilitated patients
- History of PUD or GI bleeding
- Asthma
- Pulmonary diseases
- Head injury
- Increased intracranial pressure
- Intracranial lesion
- Alcohol abuse
- Prolong use
- Smokers
- Coagulation disorder
Supplemental Patient Information
- Advise patients to avoid potentially hazardous tasks such as driving a car or operating machinery as hydrocodone like other opioids impairs the mental and/or physical abilities for performing these tasks
- Advise patients to avoid alcohol and other CNS depressants as they produce an additive CNS depression
Pregnancy Category:C
Breastfeeding: Extremely low levels of ibuprofen is excreted in breastmilk, due to its shorter half-life and use in infants in doses much higher than those excreted in breastmilk, prefer ibuprofen as an analgesic or anti inflammatory agent in nursing mothers. Hydrocodone: Maternal use of maximum dosages of oral narcotics while breastfeeding can cause infant drowsiness in breastfed infants, particularly newborns are sensitive to even small dosages of narcotic analgesics, in the first week of life, however small volumes of colostrum is secreted in the first 2 to 3 days postpartum hence newborn's dosage is limited. Once the mother's milk comes in, it is best to avoid oral hydrocodone (and combinations) and administer nonnarcotic analgesic if necessary. Maximum recommended dosage is 30 mg/day. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, immediately contact the physician if baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 20 May 2011). Because of the potential for serious adverse reactions in nursing infants manufacturer recommends, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
- Ibudone
- Reprexain
- Vicoprofen
US Availability
hydrocodone/ibuprofen (generic)
- TABS
- 2.5 mg/200 mg
- 5 mg/200 mg
- 7.5 mg/200 mg
- 10 mg/200 mg
Ibudone (hydrocodone/ibuprofen)
Reprexain (hydrocodone/ibuprofen)
- TABS
- 2.5 mg/200 mg
- 5 mg/200 mg
- 10 mg/200 mg
Vicoprofen (hydrocodone/ibuprofen)
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Reprexain 2.5-200 MG TABS [Bottle] (HAWTHORN PHARMACEUTICALS)
100 mg = $75.81
300 mg = $205.77 - Reprexain 5-200 MG TABS [Bottle] (HAWTHORN PHARMACEUTICALS)
100 mg = $79.44
300 mg = $215.31 - Vicoprofen 7.5-200 MG TABS [Bottle] (ABBOTT)
30 mg = $91.99
90 mg = $249.98 - Hydrocodone-Ibuprofen 7.5-200 MG TABS [Bottle] (AMNEAL PHARMACEUTICALS)
30 mg = $33.99
90 mg = $82.97 - Reprexain 10-200 MG TABS [Bottle] (HAWTHORN PHARMACEUTICALS)
100 mg = $110.85
300 mg = $313.72
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
