Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - levorphanol tartrate (unii: 04wqu6t9qi) (levorphanol - unii:27618j1n2x) - levorphanol tartrate 2 mg - levorphanol tartrate 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 dosage or duration [see warnings] , reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: levorphanol tartrate 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. levorphanol tartrate tablets are contraindicated in patients with: levorphanol tartrate tablets contains levorphanol, a schedule ii controlled substance. levorphanol tartrate tablets contains levorphanol, 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 levorphanol tartrate 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 levorphanol tartrate 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 levorphanol tartrate tablets abuse include those with a history of prolonged use of any opioid, including products containing levorphanol, those with a history of drug or alcohol abuse, or those who use levorphanol tartrate 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. levorphanol tartrate 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 levorphanol tartrate tablets abuse of levorphanol tartrate tablets poses a risk of overdose and death. the risk is increased with concurrent use of levorphanol tartrate 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 levorphanol tartrate tablets in a patient physically dependent on opioids. rapid tapering of levorphanol tartrate 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 levorphanol tartrate tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of levorphanol tartrate 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].

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol 100 mg in 1 ml - the injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. robaxin injectable should not be administered to patients with known or suspected renal pathology. this caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. a much larger amount of polyethylene glycol 300 than is present in recommended doses of robaxin injectable is known to have increased pre-existing acidosis and urea retention in patients with renal impairment. although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. robaxin injectable is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol 100 mg in 1 ml - the injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of this drug has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. robaxin injectable should not be administered to patients with known or suspected renal pathology. this caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. a much larger amount of polyethylene glycol 300 than is present in recommended doses of robaxin injectable is known to have increased pre-existing acidosis and urea retention in patients with renal impairment. although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. robaxin injectable is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate is indicated in the treatment of manic episodes of bipolar disorder. bipolar disorder, manic (dsm-iv) is equivalent to manic depressive illness, manic, in the older dsm-ii terminology. lithium carbonate is also indicated as a maintenance treatment for individuals with a diagnosis of bipolar disorder. maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. when given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin injection is indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus , pseudomonas aeruginosa , serratia marcescens , escherichia coli , klebsiella pneumoniae , haemophilus influenzae , or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies (14.1) ]. levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible sta

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin 1000 ug in 1 ml - cyanocobalamin is indicated for vitamin b12 deficiencies due to malabsorption which may be associated with the following conditions: addisonian (pernicious) anemia gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy fish tapeworm infestation malignancy of pancreas or bowel folic acid deficiency it may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see drug interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. such measures remove the need for long-term administration of cyanocobalamin. requirements of vitamin b12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. cyanocobalamin injection, usp is also suitable for the vitamin b12 absorption test (schilling test ). sensitivity to cobalt and/or vitamin b12 is a contraindication.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg in 1 ml - phenergan injection is indicated for the following conditions: - amelioration of allergic reactions to blood or plasma. - in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. - for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. - for sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. - active treatment of motion sickness. - prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. - as an adjunct to analgesics for the control of postoperative pain. - preoperative, postoperative, and obstetric (during labor) sedation. - intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia. phenergan injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression ( see  warnings - respiratory depression) . phenergan injection is contraindicated in comatose states. under no circumstances should phenergan injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see warnings - severe tissue injury, including gangrene). phenergan injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. the preferred parenteral route of administration is by deep intramuscular injection. phenergan injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride injection is indicated for the following conditions: - amelioration of allergic reactions to blood or plasma. - in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. - for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. - for sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused. - active treatment of motion sickness. - prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. - as an adjunct to analgesics for the control of postoperative pain. - preoperative, postoperative, and obstetric (during labor) sedation. - intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia. promethazine hydrochloride injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression (see warnings - respiratory depression). promethazine hydrochloride injection is contraindicated in comatose states. under no circumstances should promethazine hydrochloride injection be given by intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see warnings - severe tissue injury, including gangrene). promethazine hydrochloride injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. the preferred parenteral route of administration is by deep intramuscular injection. promethazine hydrochloride injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - mitomycin (unii: 50sg953sk6) (mitomycin - unii:50sg953sk6) - mitomycin for injection, usp is not recommended as single-agent, primary therapy. it has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. mitomycin is not recommended to replace appropriate surgery and/or radiotherapy. mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. mitomycin is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - mitomycin (unii: 50sg953sk6) (mitomycin - unii:50sg953sk6) - mitomycin for injection, usp is not recommended as single-agent, primary therapy. it has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. mitomycin is not recommended to replace appropriate surgery and/or radiotherapy. mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. mitomycin is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.