United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 dosage for the shortest duration consistent with individual patient treatment goals (see warnings: cardiovascular thrombotic events, gastrointestinal bleeding, ulceration, and perforation) . do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see warnings: addiction, abuse, and misuse) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., non-opioid anal

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 dosage for the shortest duration consistent with individual patient treatment goals ( s e e   warnings: cardiovascular thrombotic events , gastrointestinal bleeding, ulceration, and perforation ) . do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( s e e   warnings: addiction, abuse, and misuse ) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., n

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 2.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use 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 dosage for the shortest duration consistent with individual patient treatment goals (see warnings: cardiovascular thrombotic events, gastrointestinal bleeding, ulceration, and perforation ) . do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (see warnings ) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): - have not been tolerated or are not expected to be tolerated, - have not provided adequate analgesia or are not expected to provide adequate analgesia hydrocodone bitartrate and ibuprofen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with: - significant respiratory depression (see warnings: life-threatening respiratory depression ) . - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings: life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients ) . - known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings: risks of use in patients with gastrointestinal conditions ) . - known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product (see warnings: anaphylactic reactions, serious skin reactions ) . patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients (see warnings: anaphylactic reactions, exacerbation of asthma related to aspirin sensitivity ) . - in the setting of coronary artery bypass graft (cabg) surgery (see warnings: cardiovascular thrombotic events ) . controlled substance hydrocodone bitartrate and ibuprofen contains hydrocodone, a schedule ii controlled substance. abuse hydrocodone bitartrate and ibuprofen contains hydrocodone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction (see warnings ) . misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of hydrocodone bitartrate and ibuprofen increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of hydrocodone bitartrate and ibuprofen with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of hydrocodone bitartrate and ibuprofen abuse include those with a history of prolonged use of any opioid, including products containing hydrocodone, those with a history of drug or alcohol abuse, or those who use hydrocodone bitartrate and ibuprofen in combination with other abused drugs. “drug seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. hydrocodone bitartrate and ibuprofen, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of hydrocodone bitartrate and ibuprofen abuse of hydrocodone bitartrate and ibuprofen poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and ibuprofen with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. dependence both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue hydrocodone bitartrate and ibuprofen in a patient physically dependent on opioids. rapid tapering of hydrocodone bitartrate and ibuprofen in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing hydrocodone bitartrate and ibuprofen, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and ibuprofen the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper (see dosage and administration, and   warnings ) . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs (see pregnancy ) .

United States - English - NLM (National Library of Medicine)

american health packaging - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use 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 dosage for the shortest duration consistent with individual patient treatment goals (see warnings: cardiovascular thrombotic events, gastrointestinal bleeding, ulceration, and perforation ). do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see warnings: addiction, abuse, and misuse ), reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom a

United States - English - NLM (National Library of Medicine)

aurolife pharma, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use 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 dosage for the shortest duration consistent with individual patient treatment goals (see warnings: cardiovascular thrombotic events, gastrointestinal bleeding, ulceration, and perforation ). do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (seewarnings: addiction, abuse, and misuse ), reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment opti

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - indications and usage 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. contraindications hydrocodone bitartrate and ibuprofen tablets is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taki

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 2.5 mg - 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. hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rar

United States - English - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - 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. hydrocodone bitartrate and ibuprofen tablets is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rare

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - 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. hydrocodone bitartrate and ibuprofen tablets is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rare

United States - English - NLM (National Library of Medicine)

stat rx usa llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - hydrocodone bitartrate 7.5 mg - 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. hydrocodone bitartrate and ibuprofen tablets are contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rar