USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - isoproterenol hydrochloride (unii: dia2a74855) (isoproterenol - unii:l628tt009w) - isoproterenol hydrochloride injection is indicated: - to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output - for bronchospasm occurring during anesthesia isoproterenol hydrochloride injection is contraindicated in patients with: - tachycardia - ventricular arrhythmias - angina pectoris risk summary prolonged experience with isoproterenol use in pregnant women over several decades, based on published literature, do not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. however, there are risks to the mother and fetus associated with isoproterenol use during labor or delivery (see clinical considerations). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the united states general population, the estimated background risk of major birth defects and miscarri

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr), clidinium bromide (unii: 91zqw5jf1z) (clidinium - unii:bo76jf850n) - chlordiazepoxide hydrochloride and clidinium bromide capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. chlordiazepoxide hydrochloride and clidinium bromide capsules may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. chlordiazepoxide hydrochloride and clidinium bromide capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. it is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. chlordiazepoxide hydrochloride and clidinium bromide capsules contain chlordiazepoxide hydrochloride, a schedule iv controlled substance and clidinium bromide, which is not a controlled substance. chlordiazepoxide hydrochloride and clidinium bromide capsules are exempted from schedule iv and is not controlled under the controlled substances act. chlordiazepoxide hydrochloride, a component of chlordiazepoxide hydrochloride and clidinium bromide capsules, is 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 health care 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 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. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings ). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). physical dependence chlordiazepoxide hydrochloride and clidinium bromide capsules may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of 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. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings ). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide hydrochloride and clidinium bromide capsules or reduce the dosage (see warnings and dosage and administration ). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance to chlordiazepoxide hydrochloride and clidinium bromide capsules may develop from continued 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). tolerance to the therapeutic effects of chlordiazepoxide hydrochloride and clidinium bromide capsules may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning and to treat bradyasystolic cardiac arrest. none. animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. trace amounts of atropine was found in breast milk. the clinical impact of this is not known. recommendations for use in pediatric patients are not based on clinical trials. an evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8) - folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood. folic acid is contraindicated in patients who have shown previous intolerance to the drug.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - bethanechol chloride (unii: h4qbz2lo84) (bethanechol - unii:004f72p8f4) - bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention. hypersensitivity to bethanechol chloride, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism. bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - desipramine hydrochloride (unii: 1y58do4my1) (desipramine - unii:tg537d343b) - desipramine hydrochloride 10 mg - desipramine hydrochloride tablets are indicated for the treatment of depression. the use of maois intended to treat psychiatric disorders with desipramine hydrochloride or within 14 days of stopping treatment with desipramine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of desipramine hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings  and dosage and administration ). starting desipramine hydrochloride in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see warnings  and dosage and administration ). desipramine hydrochloride is contraindicated in the acute recovery period following myocardial infarction. it should not be used in those who have shown prior hypersensitivity to the drug. cross-sensitivity between this and other dibenzazepines is a possibility.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - metaxalone (unii: 1nma9j598y) (metaxalone - unii:1nma9j598y) - metaxalone 800 mg - metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts 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. metaxalone does not directly relax tense skeletal muscles in man. known hypersensitivity to any components of this product. known tendency to drug induced, hemolytic, or other anemias. significantly impaired renal or hepatic function.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - metaxalone (unii: 1nma9j598y) (metaxalone - unii:1nma9j598y) - metaxalone 800 mg - metaxalone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts 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. metaxalone does not directly relax tense skeletal muscles in man. known hypersensitivity to any components of this product. known tendency to drug induced, hemolytic, or other anemias. significantly impaired renal or hepatic function.

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - methyltestosterone 10 mg - 1. males androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenita or acquired) — testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. - hypogonadotropic hypogonadism (congenital or acquired) — gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) if the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. safety and efficacy of methyltestosterone in men

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - fludrocortisone acetate (unii: v47if0pvh4) (fludrocortisone - unii:u0476m545b) - fludrocortisone acetate 0.1 mg - fludrocortisone acetate tablets, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in addison’s disease and for the treatment of salt-losing adrenogenital syndrome. corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.