Australia - English - Department of Health (Therapeutic Goods Administration)

hyaluronidase -

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - hyaluronidase, quantity: 1500 iu - injection, powder for - excipient ingredients: sodium hydroxide - hypodermoclysis. obstetrics anaesthesia. prevention of postpartum haemorrhage (with ergometrine). as an aid to local anaesthesia in ophthalmology. as an aid to local anaesthesia in fracture reduction. subcutaneous administration of radiopaque substances in pyelography.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - oxazepam, quantity: 30 mg - tablet, uncoated - excipient ingredients: magnesium stearate; methylcellulose; polacrilin potassium; lactose monohydrate - indications as at 25 feb 2005 : management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety associated with depression is also responsive to murelax therapy. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the physician should periodically reassess the usefulness of the drug for the individual patient. alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

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

sun pharmaceutical industries, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol, can be abused and is subject to misuse, addiction, and criminal diversion [see warnings ]. all patients treated with o

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

actavis pharma, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - 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 acetaminophen tablets are contraindicated in patients with: - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to hydrocodone or acetaminophen

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

paddock laboratories, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), chlorpheniramine maleate (unii: v1q0o9oj9z) (chlorpheniramine - unii:3u6io1965u), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - hydrocodone bitartrate 5 mg in 5 ml - hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is indicated for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older. important limitations of use hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is contraindicated for: hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is also contraindicated in patients with: risk summary hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is not recommended for use in pregnant women, including during or immediately prior to labor. prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.13), clinical considerations ]. there are no available data with hydrocodone bitartrate, chlorpheniramine maleate and pseudo

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

proficient rx lp - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 10 mg - oxycodone and acetaminophen tablets are indicated for the management of  pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ] , reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics ] oxycodone  and acetaminophen tablets are contraindicated in patients with:  controlled substance oxycodone  and acetaminophen tablet contains oxycodone and acetaminophen, a schedule cii controlled substance. abuse oxycodone and acetaminophen tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone  and acetaminophen tablets can be abused and is   subject to misuse, addiction, and criminal diversion [see warnings ].  all patients tr

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

aidarex pharmaceuticals llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodonebitartrate and acetaminophen tablets are contraindicated in patients with: •significant respiratory depression [see warnings ] •acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] •known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] •hypersensitivity to hydrocodone or acetamin

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

quality care products llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone and acetaminophen tablets are indicated for the management of  pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings ] , reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics ] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone  and acetaminophen tablets are contraindicated in patients with:  - significant respiratory depression [see warnings ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see warnings , adverse reactions ] controlled substance oxycodone  and acetaminophen tablet contains oxycodone and acetaminophen, a schedule cii controlled substance. abuse oxycodone and acetaminophen tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone  and acetaminophen tablets can be abused and is   subject to misuse, addiction, and criminal diversion [see warnings ].  all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.  prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.  drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.  “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 health care provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.  abuse and addiction are separate and distinct from physical dependence and tolerance. health care providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction.  oxycodone and acetaminophen tablets, like other opioids, can be diverted for non-medical 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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs risks specific to abuse of oxycodone and acetaminophen tablets oxycodone  and acetaminophen tablets are for oral use only. abuse of oxycodone  and acetaminophen tablets poses a risk of overdose and death. the risk is increased with concurrent abuse of oxycodone  and acetaminophen tablets with alcohol and other central nervous system depressants. acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death  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 chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.  physical dependence results in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), 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 opioid usage.  oxycodone and acetaminophen tablets should not be abruptly discontinued in a physically-dependent patient [see dosage and administration ]. if oxycodone  and acetaminophen tablets is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.  infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see precautions ; pregnancy].

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

lupin pharmaceuticals,inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 10 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosages or duration [see warnings] , reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): - 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 acetaminophen 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 acetaminophen tablets are contraindicated in patients with: -   significant respiratory depression [see warnings ] -   acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] -   known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] -   hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see warnings, adverse reactions] controlled substance hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. abuse hydrocodone bitartrate and acetaminophen tablets 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 acetaminophen tablets 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 acetaminophen tablets 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 acetaminophen tablets 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 acetaminophen tablets 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 acetaminophen tablets, 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 acetaminophen tablets abuse of hydrocodone bitartrate and acetaminophen tablets poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and acetaminophen tablets 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 acetaminophen tablets in a patient physically dependent on opioids. rapid tapering of hydrocodone bitartrate and acetaminophen tablets 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 acetaminophen tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and acetaminophen tablets 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].