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

actavis pharma, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - oxycodone and acetaminophen tablets, usp 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 ], reserve oxycodone and acetaminophen 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 oxycodone and acetaminophen tablets are 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 produc

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

actavis pharma, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - oxycodone hydrochloride 4.8355 mg - oxycodone and aspirin 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), reserve oxycodone and aspirin 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 oxycodone and aspirin tablets are 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 or aspirin, (e.g. angioedema) (see warnings) - patients with hemophilia. - aspi

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

actavis pharma, inc. - estazolam (unii: 36s3eqv54c) (estazolam - unii:36s3eqv54c) - estazolam 1 mg - estazolam tablets, usp are indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see clinical pharmacology ). because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. there is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see clinical pharmacology ). estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by cyp3a (see warnin

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

actavis pharma, inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). - for reduction of fever in patients aged 6 months up to 2 years of age. - for relief of mild to moderate pain in patients aged 6 months up to 2 years of age. - for relief of signs and symptoms of juvenile arthritis. - for treatment of primary dysmenorrhea. - for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see precautions-drug interactions ). ibuprofen oral suspension is contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen should not be given to patients who have experienced ast

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

actavis pharma, inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.5 mg - seizure disorders: clonazepam tablets, usp are useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions:  loss of effect ). panic disorder: clonazepam tablets, usp are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir category of panic disorder (see clinical pharmacology: clinical

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

actavis pharma, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders - 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the effectiveness of mirtazapine in hospitalized depress

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

actavis pharma, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 45 mg - mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the effectiveness of mirtazapine

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

actavis pharma, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen 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 ], reserve hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets are 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 hydrocodone or acetaminophen

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actavis pharma, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children 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. speci

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

actavis pharma, inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 100 mg in 5 ml - carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). in pediatric patients, ibuprofen oral suspension is indicated: - for reduction of fever in patients aged 6 months up to 2 years of age. - for relief of mild to moderate pain in patients aged 6 months up to 2 years of age. - for relief of signs and symptoms of juvenile arthritis. in adults, ibuprofen oral suspension is indicated: - for treatment of primary dysmenorrhea. - for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see precautions-drug interactions ). ibuprofen is contraindicated in patients with known