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

stat rx usa llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 10 mg - endocet is indicated for the relief of moderate to moderately severe pain. endocet tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone is contraindicated in the setting of suspected or known paralytic ileus. endocet tablets are a schedule ii controlled substance. oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties re

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

mckesson rxpak inc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - percocet 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, even at recommended doses [see warnings ], reserve percocet 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 percocet is 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 ] percocet contains oxycodone, a

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

pd-rx pharmaceuticals, inc. - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - extended phenytoin sodium capsules, usp are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration and clinical pharmacology sections). phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

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

ferring pharmaceuticals pty ltd - progesterone -

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

lupin pharmaceuticals,inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate tablets usp are indicated for: 1.         narcolepsy. 2.         attention deficit disorder with hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. known hypersensitivity to amphetamine products. during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result). controlled substance dextroamphetamine sulfate is a schedule ii controlled substance. abuse dextroamphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings). dextroamphetamine sulfate can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. 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. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including dextroamphetamine sulfate, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. dependence physical dependence dextroamphetamine sulfate may produce physical dependence. 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. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including dextroamphetamine sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance dextroamphetamine sulfate may produce tolerance. 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).

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

endo pharmaceuticals inc. - testosterone (unii: 3xmk78s47o) (testosterone - unii:3xmk78s47o) - testosterone 30 mg - striant is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. these men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [fsh], luteinizing hormone [lh]) above the normal range. - hypogonadotropic hypogonadism (congenital or acquired) – gonadotropin or luteinizing hormone-releasing hormone (lhrh) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. these patients have low serum testosterone levels but have gonadotropins in the normal or low range. limitations of use: - safety and efficacy of striant in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - safety a

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

endo pharmaceuticals inc. - megestrol acetate (unii: tj2m0fr8es) (megestrol - unii:ea6ld1m70m) - megestrol acetate 125 mg in 1 ml - megace es is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids). limitations of use therapy with megace es for weight loss should only be insti­tuted after treatable causes of weight loss are sought and addressed. these treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases. megace es is not intended for prophylactic use to avoid weight loss. - history of hypersensitivity to megestrol acetate or any component of the formulation. - pregnancy [see warnings and precautions (5.2), use in specific populations (8.1, 8.3)]. risk summary based on animal data, megestrol acetate may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy [see contraindications (4)] . there are no available human data to assess for any drug-associated risks of miscar

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

endo pharmaceuticals inc. - colistin sulfate (unii: wp15dxu577) (colistin - unii:z67x93hjg1), neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), thonzonium bromide (unii: ji2b19cr0r) (thonzonium - unii:z05ze98fv8), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - colistin 3 mg in 1 ml - coly-mycin® s otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics. this product is contraindicated in those individuals who have shown hypersensitivity to any of its components. this product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (e.g., herpes simplex virus or varicella zoster virus).

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

endo pharmaceuticals, inc. - colistin sulfate (unii: wp15dxu577) (colistin - unii:z67x93hjg1), neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297), thonzonium bromide (unii: ji2b19cr0r) (thonzonium - unii:z05ze98fv8), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - cortisporin® tc otic is indicated for the treatment of superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics; and for the treatment of infections of mastoidectomy and fenestration cavities, caused by organisms susceptible to the antibiotics. this product is contraindicated in those individuals who have shown hypersensitivity to any of its components. this product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (e.g., herpes simplex virus or varicella zoster virus).

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

endo pharmaceuticals inc. - histrelin acetate (unii: qmg7hld1ze) (histrelin - unii:h50h3s3w74) - histrelin acetate 50 mg - vantas is indicated for the palliative treatment of advanced prostate cancer. vantas is contraindicated in patients who are hypersensitive to gonadotropin releasing hormone (gnrh) or gnrh agonist analogs. risk summary the safety and efficacy of vantas have not been established in females. based on findings in animal studies and its mechanism of action, vantas can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . expected hormonal changes that occur with vantas treatment increase the risk for pregnancy loss. the limited data with histrelin use in pregnant women are insufficient to determine a drug-associated risk for major birth defects or adverse developmental outcomes. in animal reproduction studies, administration of histrelin to pregnant rats and rabbits during the period of organogenesis caused an increase in fetal loss at clinically relevant exposures (see data) . advise pregnant patients and females of reproductive potential of the potential risk to the fetus. d