Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

physicians total care, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 10 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml) are formulations of morphine, an opioid analgesic, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients w

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

nostrum laboratories, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 100 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

aurolife pharma, llc - hydromorphone hydrochloride (unii: l960up2krw) (hydromorphone - unii:q812464r06) - hydromorphone hydrochloride 2 mg - hydromorphone hydrochloride 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 and precautions (5.2)], reserve hydromorphone hydrochloride 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 hydromorphone hydrochloride tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.7)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.7)] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnin

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

apotex corp. - butorphanol tartrate (unii: 2l7i72ruhn) (butorphanol - unii:qv897jc36d) - butorphanol tartrate 10 mg in 1 ml - butorphanol tartrate nasal spray is 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 dosage or duration [see warnings] reserve butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray 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. butorphanol tartrate nasal spray is contraindicated in: - patients with significant respiratory depression [see warnings] - patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings] - patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings] - patients with hypersensitivity to butorphanol tartrate, the preservative benzethonium chloride, or any of the formulation excipients (e.g., anaphylaxis) [see warnings]) controlled substance butorphanol tartrate nasal spray contains butorphanol, a schedule iv controlled substance.   abuse butorphanol tartrate nasal spray contains butorphanol tartrate, a substance with a 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 butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray abuse include those with a history of prolonged use of any opioid, including products containing butorphanol tartrate, those with a history of drug or alcohol abuse, or those who use butorphanol tartrate nasal spray 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.     butorphanol tartrate nasal spray, 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 butorphanol tartrate nasal spray abuse of butorphanol tartrate nasal spray poses a risk of overdose and death. the risk is increased with concurrent use of butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray in a patient physically dependent on opioids. rapid tapering of butorphanol tartrate nasal spray 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 butorphanol tartrate nasal spray, gradually taper the dosage using a patient-specific plan that considers the following: the dose of butorphanol tartrate nasal spray 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].

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

redpharm drug, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 15 mg - morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)], reserve morphine sulfate extended-release for use in patients for whom alternative treatment options (e.g., non- opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. morphine sulfate extended-release is not indicated as an as-needed (prn) analgesic. morphine sulfate extended-release is contraindicated in patients with: significant respiratory depression [see warnings and precautions (5.2)] acute or severe bronchial asthma in an unmonitored setting or

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

paddock laboratories, llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 100 mg in 5 ml - morphine sulfate oral solution is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is indicated for the relief of acute and chronic pain in opioid-tolerant patients. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.2) ], reserve morphine sulfate oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: morphine sulfate oral solution is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.5) ]. there are no available data with morphine sulfate oral solution in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. published s

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

safecor health, llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 20 mg in 1 ml - morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. morphine sulfate is contraindicated in any patient who has

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

bryant ranch prepack - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 15 mg - morphine sulfate tablets are indicated for the management of acute and chronic 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 and precautions (5.1)] , reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: morphine sulfate tablets are contraindicated in patients with: risk summary: prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)]. there are no available data with morphine sulfate tablets in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see human data]. in published animal rep

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

nostrum laboratories, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 10 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml ) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. no formal studies to assess the teratogenic effects of morphine in animals have been conducted.  it is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  morphine should be given to a pregnant woman only if clearly needed. in humans, the frequency

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

padagis us llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 5 mg - morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and 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 and precautions (5.1)] , reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: morphine sulfate suppositories are contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.3)] . there are no available data with morphine sulfate suppositories in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see human data] . i