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mckesson corporation dba sky packaging - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam oral solution  is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam oral solution  is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam oral solution  is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.10)] . teratogenic effects pregnancy category c   there are no adequate and controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of dev

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mckesson corporation dba sky packaging - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended

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mckesson corporation dba sky packaging - lorazepam (unii: o26fzp769l) (lorazepam - unii:o26fzp769l) - lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. lorazepam is contraindicated in patients with - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma.

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mckesson corporation dba sky packaging - brompheniramine maleate (unii: ixa7c9zn03) (brompheniramine - unii:h57g17p2fn), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. hypersensitivity to any of the ingredients. do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. do not use dextromethorphan in patients receiving monoamine oxidase (maoi) inhibitors (see precautions - drug interactions). antihistamines should not be used to treat lower respiratory tract conditions including asthma.

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mckesson corporation dba sky packaging - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol tablets, usp are 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 methocarbamol has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol tablets are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

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mckesson corporation dba sky packaging - midodrine hydrochloride (unii: 59jv96ytxv) (midodrine - unii:6ye7pbm15h) - midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (oh). because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (bp > 200 mmhg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. the indication is based on midodrine hydrochloride tablets' effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. at present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. after initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement. midodrine hydrochloride tablets are contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. midodrine hydrochloride tablets should not be used in patients with persistent and excessive supine hypertension.

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mckesson corporation dba sky packaging - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg - naproxen tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea naproxen is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] risk summary use of nsaids, including naproxen, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction lea

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mckesson corporation dba sky packaging - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 40 mg - pantoprazole sodium delayed-release tablets, usp are indicated for: pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole is indicated for maintenance of healing of ee and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. - pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. hypersensitivity reactions may include

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mckesson corporation dba sky packaging - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 10 mg - paroxetine tablets are indicated in adults for the treatment of: • major depressive disorder (mdd) • obsessive compulsive disorder (ocd) • panic disorder (pd) • social anxiety disorder (sad) • generalized anxiety disorder (gad) • posttraumatic stress disorder (ptsd) paroxetine tablets are contraindicated in patients: • taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. • taking thioridazine because of risk of qt prolongation [see warnings and precautions (5.3) and drug interactions (7)] • taking pimozide because of risk of qt prolongation [see warnings and precautions (5.3), drug interactions (7)]. • with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets [see adverse reactions (6.1),

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mckesson corporation dba sky packaging - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)]. mirtazapine tablets are contraindicated in patients: • taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.3), drug interactions (7)]. • with a known hypersensitivity to mirtazapine or to any of the excipients in mirtazapine tablets. severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (dress), stevens-johnson syndrome, bullous dermatitis, erythema multiforme and toxic epidermal necrolysis have been reported following the use of mirtazapine tablets [see warnings and precautions (5.6), adverse reactions (6.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. risk summary prolonged experience with mirtazapine in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks associated with untreated depression in pregnancy (see clinical considerations). in animal reproduction studies, oral administration of mirtazapine to pregnant rats and rabbits during the period of organogenesis revealed no evidence of teratogenic effects up to 20 and 17 times the maximum recommended human dose (mrhd) of 45 mg, respectively, based on mg/m2 body surface area. however, in rats, there was an increase in post implantation loss at 20 times the mrhd based on mg/m2 body surface area. oral administration of mirtazapine to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths and a decrease in pup birth weights at doses 20 times the mrhd based on mg/m2 body surface area (see data). 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 u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. data animal data mirtazapine was administered orally to pregnant rats and rabbits during the period of organogenesis at doses of 2.5, 15, and 100 mg/kg/day and 2.5, 10, and 40 mg/kg/day, respectively, which are up to 20 and 17 times the maximum recommended human dose (mrhd) of 45 mg based on mg/m2 body surface area, respectively. no evidence of teratogenic effects was observed. however, in rats, there was an increase in post implantation loss in dams treated with mirtazapine at 100 mg/kg/day which is 20 times the mrhd based on mg/m2 body surface area. oral administration of mirtazapine at doses of 2.5, 15, and 100mg/kg/day to pregnant rats during pregnancy and lactation resulted in an increase in pup deaths during the first 3 days of lactation and a decrease in pup birth weights at 20 times the mrhd based on mg/m2 body surface area. the cause of these deaths is not known. the no effect dose level is 3 times the mrhd based on mg/m2 body surface area. risk summary data from published literature report the presence of mirtazapine in human milk at low levels with relative infant doses for mirtazapine ranging between 0.6 and 2.8% of the maternal weight-adjusted dose (see data). no adverse effects on the breastfed infant have been reported in most cases of maternal use of mirtazapine. there are no data on the effects of mirtazapine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mirtazapine and any potential adverse effects on the breastfed infant from mirtazapine or from the underlying maternal condition. data in a published pooled analysis of 8 breastfeeding mother-infant pairs, the mean (min, max) total relative infant doses for mirtazapine and its desmethyl metabolite were 1.5% (0.6%, 2.8%) and 0.4% (0.1%, 0.7%) of the maternal weight-adjusted dose (median (min, max) dose of 38 mg (30 mg, 120 mg), respectively). no adverse drug effects were reported for any of the infants. the safety and effectiveness of mirtazapine tablets have not been established in pediatric patients with mdd. two placebo-controlled trials in 258 pediatric patients with mdd have been conducted with mirtazapine tablets, and the data were insufficient to establish the safety and effectiveness of mirtazapine tablets in pediatric patients with mdd. antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning and warnings and precautions (5.1)]. in an 8-week-long clinical trial in pediatric patients receiving doses between 15 to 45 mg per day, 49% of mirtazapine tablets-treated patients had a weight gain of at least 7%, compared to 5.7% of placebo- treated patients. the mean increase in weight was 4 kg (2 kg sd) for mirtazapine tablets-treated patients versus 1 kg (2 kg sd) for placebo-treated patients [see warnings and precautions (5.7)]. approximately 190 patients≥ 65 years of age participated in clinical studies with mirtazapine tablets. mirtazapine tablets are known to be substantially excreted by the kidney (75%), and the risk of decreased clearance of this drug is greater in patients with impaired renal function. pharmacokinetic studies revealed a decreased clearance of mirtazapine in the elderly [see clinical pharmacology (12.3)] sedating drugs, including mirtazapine tablets, may cause confusion and over-sedation in the elderly. elderly patients may be at greater risk of developing hyponatremia. caution is indicated when administering mirtazapine tablets to elderly patients [see warnings and precautions (5.12), (5.15) and clinical pharmacology (12.3)]. in general, dose selection for an elderly patient should be conservative, 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. the clearance of mirtazapine is reduced in patients with moderate to severe renal or hepatic impairment. consequently, plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in patients without renal or hepatic impairment. dosage decrease may be necessary when administering mirtazapine tablets to patients with moderate to severe renal or hepatic impairment [see warnings and precautions (5.13), use in specific populations (8.5), and clinical pharmacology (12.3)].