Hydrocodone Bitartrate And Ibuprofen Recall
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Questions & Answers
I took this medication regularly for 3 years. My tolerance for it grew really quickly, and I had to take 8 pills a day. Because of this, I would get stomach ulcers, but when I tried to wean myself off, I was very moody and irritable, and had terrible hot flashes. I will never take this medication again!
Side Effects & Adverse Reactions
Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS ).
NSAID-containing products, including hydrocodone bitartrate and ibuprofen tablets, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAID-containing products, including hydrocodone bitartrate and ibuprofen tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Congestive Heart Failure and Edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Hydrocodone bitartrate and ibuprofen should be used with caution in patients with fluid retention or heart failure.
Misuse Abuse and Diversion of Opioids
Hydrocodone bitartrate and ibuprofen tablets contain hydrocodone an opioid agonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.
Hydrocodone bitartrate and ibuprofen tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and ibuprofen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).
At high doses or in opioid-sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions, which may obscure the clinical course of patients with head injuries.
Acute Abdominal Conditions
The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
NSAIDs, including hydrocodone bitartrate and ibuprofen tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develops a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease
No information is available from controlled clinical studies regarding the use of hydrocodone bitartrate and ibuprofen in patients with advanced renal disease. Therefore, treatment with hydrocodone bitartrate and ibuprofen is not recommended in patients with advanced renal disease. If hydrocodone bitartrate and ibuprofen therapy must be initiated, close monitoring of the patient's renal function is advisable.
As with other NSAID-containing products, anaphylactoid reactions may occur in patients without known prior exposure to hydrocodone bitartrate and ibuprofen. Hydrocodone bitartrate and ibuprofen should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Fatal reactions to NSAIDs have been reported in such patients (see CONTRAINDICATIONS and PRECAUTIONS - Pre-existing Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.
Products containing NSAIDs, including hydrocodone bitartrate and ibuprofen tablets, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
As with other NSAID-containing products, hydrocodone bitartrate and ibuprofen should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term (generally less than 10 days) management of acute pain. Hydrocodone bitartrate and ibuprofen tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.
There is currently no drug history available for this drug.
Hydrocodone bitartrate and ibuprofen is supplied in a fixed combination tablet form for oral administration.
Hydrocodone bitartrate and ibuprofen tablets combine the opioid analgesic agent, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.
Hydrocodone bitartrate, USP 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, USP 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 hydrocodone bitartrate and ibuprofen 2.5 mg/200 mg, 5 mg/200 mg and 7.5 mg/200 mg tablets include: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, pregelatinized starch and titanium dioxide.
Inactive ingredients in hydrocodone bitartrate and ibuprofen 10 mg/200 mg tablets include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, pregelatinized starch, titanium dioxide, triacetin and D&C Yellow #10 Aluminum Lake.
Hydrocodone Bitartrate And Ibuprofen Manufacturers
- American Health Packaging
- Stat Rx Usa Llc
- Physicians Total Care, Inc.
- St Marys Medical Park Pharmacy
- H.j. Harkins Company, Inc.
- Stat Rx Usa Llc
- Aidarex Pharmaceuticals Llc
- Lake Erie Medical Dba Quality Care Products Llc Care Producst
- Mckesson Packaging Services A Business Unit Of Mckesson Corporation
- A-s Medication Solutions Llc
- Amneal Pharmaceuticals Of New York, Llc
- Pd-rx Pharmaceuticals, Inc.
- Pd-rx Pharmaceuticals, Inc.
- Teva Pharmaceuticals Usa Inc
- Bryant Ranch Prepack
- Qualitest Pharmaceuticals
- American Health Packaging
- Sun Pharmaceutical Industries, Inc.
- Lake Erie Medical Dba Quality Care Products Llc
- Actavis Pharma, Inc.
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