New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - enfuvirtide 108mg (includes overage 20%) - injection with diluent - 90 mg/ml - active: enfuvirtide 108mg (includes overage 20%) excipient: hydrochloric acid mannitol sodium carbonate sodium hydroxide water for injection - fuzeon (enfuvirtide) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in antiretroviral experienced patients with treatment failure due to intolerance to previous antiretroviral agents or with evidence of hiv-1 replication despite ongoing therapy. evidence to support this indication is based on surrogate endpoints (change in viral load and cd4 count) in controlled studies following 48 weeks of treatment (see clinical trials).

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

eon labs, inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - amiodarone hydrochloride is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see clinical considerations). in animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryofetal toxicity at doses less tha

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

eon labs, inc. - oxaprozin (unii: mhj80w9lrb) (oxaprozin - unii:mhj80w9lrb) - oxaprozin 600 mg - oxaprozin tablets are indicated: oxaprozin is contraindicated in the following patients: risk summary use of nsaids, including oxaprozin, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of oxaprozin use between about 20 and 30 weeks of gestation, and avoid oxaprozin use at about 30 weeks of gestation and later in pregnancy (see clinical considerations, data). premature closure of fetal ductus arteriosus use of nsaids, including oxaprozin, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. oligohydramnios/neonatal renal impairment use of nsaids at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. data from observational studies regarding other potential em

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

eon labs, inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - carisoprodol 200 mg - carisoprodol, aspirin and codeine phosphate tablets, usp are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. limitations of use carisoprodol, aspirin and codeine phosphate tablets, usp should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration (see dosage and administration ). carisoprodol, aspirin and codeine phosphate tablets are contraindicated for: • 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 ). carisoprodol, aspirin and codeine phosphate tablets are also contraindicated in patients with: carisoprodol, aspirin, and codeine phosphate tablets contains codeine. codeine in combination with carisoprodol and aspirin is a schedule iii

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

eon labs, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - indomethacin extended-release capsules are indicated for: indomethacin extended-release is contraindicated in the following patients: risk summary use of nsaids, including indomethacin extended-release, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including indomethacin extended-release, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of indomethacin extended-release in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. in animal reproduction studies retarded fetal ossification was observed with administration of indomethacin to mice and ra

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

eon labs, 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 tablets, usp 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 tablets,

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

eon labs, inc. - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 10 mg - citalopram tablets, usp are indicated for the treatment of depression. the efficacy of citalopram tablets, usp in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r 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 five of the following nine 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 antidepressant action of citalopram tablets, usp in hospitalized depressed patients has not been adequately

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

eon labs, inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.5 mg - 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 tablets, usp may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions: loss of effect ). 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 tablets, usp 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 trials ). panic disorder

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

eon labs, inc. - fluvoxamine maleate (unii: 5lgn83g74v) (fluvoxamine - unii:o4l1xpo44w) - fluvoxamine maleate 25 mg - fluvoxamine maleate tablets, usp are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd), as defined in dsm-iii-r or dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. the efficacy of fluvoxamine maleate tablets, usp was established in four trials in outpatients with ocd: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults (see clinical studies [14] ). ( see warnings and precautions [5.4 to 5.7]). the use of maois intended to treat psychiatric disorders with fluvoxamine maleate or within 14 days of stopping tr

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

eon labs, inc. - zonisamide (unii: 459384h98v) (zonisamide - unii:459384h98v) - zonisamide 25 mg - zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. zonisamide is contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. the abuse and dependence potential of zonisamide has not been evaluated in human studies (see warnings , cognitive/neuropsychiatric adverse eventscognitive subsection). in a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. monkeys did not self-administer zonisamide in a standard reinforcing paradigm. rats exposed to zonisamide did not exhibit signs of physical dependence of the cns-depressant type. rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-cns depressant type.