Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 7.5 mg - temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. temazepam capsules contain temazepam, a schedule iv controlled substance. temazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. 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. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take

Ηνωμένες Πολιτείες - Αγγλικά - 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 ) .

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals llc - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate 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. acetaminophen and codeine phosphate 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. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age (see warnings ). all children younger than 12 years of age (see warnings ). - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings ). post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings ). acetaminophen and codeine phosphate tablets are contraindicated in patients with: - significant respiratory depression (see warnings ). significant respiratory depression (see warnings ). - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings ). acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings ). - concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days (see warnings ). concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days (see warnings ). - known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings ). known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings ). - hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) (see warnings ). hypersensitivity to codeine, acetaminophen, or any of the formulation excipients (e.g., anaphylaxis) (see warnings ). controlled substance acetaminophen and codeine phosphate tablets contain codeine. codeine in combination with acetaminophen, is a schedule iii controlled substance. abuse acetaminophen and codeine phosphate tablets contain codeine phosphate, 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 acetaminophen and codeine phosphate tablets increases risk of overdosage, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of acetaminophen and codeine phosphate 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 acetaminophen and codeine phosphate tablets abuse include those with a history of prolonged use of any opioid, including products containing codeine phosphate, those with a history of drug or alcohol abuse, or those who use acetaminophen and codeine phosphate 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. acetaminophen and codeine phosphate 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 acetaminophen and codeine phosphate tablets abuse of acetaminophen and codeine phosphate tablets poses a risk of overdose and death. the risk is increased concurrent use of acetaminophen and codeine phosphate tablets with alcohol and/or other cns depressants. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. 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 acetaminophen and codeine phosphate tablets in a patient physically dependent on opioids. rapid tapering of acetaminophen and codeine phosphate 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 acetaminophen and codeine phosphate tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of acetaminophen and codeine phosphate 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 precautions;  pregnancy) . 

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals llc - lorazepam (unii: o26fzp769l) (lorazepam - unii:o26fzp769l) - lorazepam tablets, are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of lorazepam tablets, in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. lorazepam is contraindicated in patients with: - hypersensitivity to benzodiazepines or to any components of the formulation - acute narrow-angle glaucoma. lorazepam contains lorazepam, a schedule iv controlled substance. lorazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic pu

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - methylergonovine maleate (unii: ir84jpz1rk) (methylergonovine - unii:w53l6fe61v) - following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. for control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder. hypertension; toxemia; pregnancy; and hypersensitivity. methylergonovine maleate has not been associated with drug abuse or dependence of either a physical or psychological nature.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - metyrosine (unii: doq0j0tpf7) (metyrosine - unii:doq0j0tpf7) - metyrosine capsules are indicated in the treatment of patients with pheochromocytoma for: 1.   preoperative preparation of patients for surgery. 2.   management of patients when surgery is contraindicated. 3.   chronic treatment of patients with malignant pheochromocytoma. metyrosine capsules are not recommended for the control of essential hypertension. metyrosine capsules are contraindicated in persons known to be hypersensitive to this compound.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - ethacrynic acid (unii: m5dp350vzv) (ethacrynic acid - unii:m5dp350vzv) - ethacrynic acid tablets are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable. all diuretics, including ethacrynic acid, are contraindicated in anuria. if increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the diuretic should be discontinued. in a few patients this diuretic has produced severe, watery diarrhea. if this occurs, it should be discontinued and not used again. until further experience in infants is accumulated, therapy with oral ethacrynic acid is contraindicated. hypersensitivity to any component of this product.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - metyrosine (unii: doq0j0tpf7) (metyrosine - unii:doq0j0tpf7) - metyrosine capsules are indicated in the treatment of patients with pheochromocytoma for: 1.   preoperative preparation of patients for surgery. 2.   management of patients when surgery is contraindicated. 3.   chronic treatment of patients with malignant pheochromocytoma. metyrosine capsules are not recommended for the control of essential hypertension. metyrosine capsules are contraindicated in persons known to be hypersensitive to this compound.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - sucralfate (unii: xx73205dh5) (sucralfate - unii:xx73205dh5) - sucralfate tablets are indicated in:  - short-term treatment (up to 8 weeks) of active duodenal ulcer. while healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. - maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.  sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. use in pediatric patients under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. clobetasol propionate cream, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.