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larasan pharmaceutical corporation - camphor, 3%, menthol, 2.52% - topical analgesic for temporary relief of minor aches and pains of muscle and joints associated with simple arthritis, strains, bruises, and sprains

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novartis pharmaceuticals corporation - basiliximab (unii: 9927mt646m) (basiliximab - unii:9927mt646m) - basiliximab 10 mg in 2.5 ml - simulect® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, usp (modified), and corticosteroids. the efficacy of simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated. simulect® (basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. see composition of simulect under description. simulect® (basiliximab) should be administered under qualified medical supervision. patients should be informed of the potential benefits of therapy and the risks associated with administration of immunosuppressive therapy. while neither the incidence of lymphoproliferative disorders nor opportunistic infections was higher in simulect-treated patients than in placebo-treated patients, patients on immunosuppressive therapy are at increased risk for dev

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preferred pharmaceuticals, inc - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide anhydrous 0.5 mg in 2.5 ml - ipratropium bromide inhalation solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

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izun pharmaceuticals corporation - hydrocotyle asiatica (unii: 7m867g6t1u) (hydrocotyle asiatica - unii:7m867g6t1u) - hydrocotyle asiatica 0.50 g in 1 ml

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tya pharmaceuticals - 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 mirtazap

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aidarex pharmaceuticals llc - 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 hospital

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nephron pharmaceuticals corporation - racepinephrine hydrochloride (unii: 336096p2we) (racepinephrine - unii:gr0l9s3j0f) - racepinephrine 11.25 mg in 0.5 ml - bronchodilator for temporary relief of mild symptoms of intermittent asthma: - wheezing - tightness of chest - shortness of breath

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padagis israel pharmaceuticals ltd - fluticasone propionate (unii: o2gmz0lf5w) (fluticasone - unii:cut2w21n7u) - fluticasone propionate 0.05 mg in 1 g - fluticasone propionate ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adult patients. fluticasone propionate ointment is contraindicated in patients with a history of hypersensitivity to any of the components in the preparation. risk summary there are no available data on fluticasone propionate ointment use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of greater than 300 grams of potent or very potent topical corticosteroids during pregnancy (see data) . advise pregnant women that fluticasone propionate ointment may increase the risk of having a low birthweight infant and to use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, subcutaneous administration of fluticasone propionate to pregnant mice, rats, and rabbits during organogenesis caused malformations characteristic of corticosteroids in each species (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of fluticasone propionate observed in animal studies to the systemic exposure that would be expected in humans after topical use of fluticasone propionate ointment. the background risk of major birth defects and miscarriage for the indicated population(s) 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. data human data available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. however, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 grams during the entire pregnancy, maternal use was associated with an increased risk of low birth weight infants. animal data in embryo-fetal development studies, pregnant rabbits, rats, and mice received subcutaneous doses of fluticasone propionate during organogenesis at doses up to 4, 100, and 150 μg/kg/day, respectively. a malformation characteristic of corticosteroids (cleft palate) was noted at the high dose in each species. additional adverse effects were noted in rats and rabbits. decreased fetal weights and retarded skeletal ossification were noted in rabbits at 4 μg/kg/day and rats at 100 μg/kg/day. maternal toxicity and omphalocele were also noted in rats at 100 μg/kg/day. no malformations or developmental toxicity was noted in rabbits at 0.57 μg/kg/day, in rats at 10 μg/kg/day, or in mice at 15 μg/kg/day. fluticasone propionate crossed the placenta following administration of a subcutaneous or an oral dose of 100 μg/kg tritiated fluticasone propionate to pregnant rats. risk summary there are no data on the presence of fluticasone propionate in human milk, its effects on the breastfed infant, or its effects on milk production. it is not known whether topical administration of fluticasone propionate ointment could result in sufficient systemic absorption to produce detectable quantities in human milk (see clinical considerations ). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fluticasone propionate ointment and any potential adverse effects on the breastfed child from fluticasone propionate ointment or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use fluticasone propionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply fluticasone propionate ointment directly to the nipple and areola prior to breastfeeding to avoid direct infant exposure [see use in specific populations (8.4) ]. the safety and effectiveness of fluticasone propionate ointment have not been established in pediatric patients. use of fluticasone propionate ointment in pediatric patients is not recommended. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic effects when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see warnings and precautions (5.1) ]. in a trial of 35 pediatric subjects treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 subjects who had normal testing prior to treatment. it is not known if these subjects had recovery of adrenal function because follow-up testing was not performed. the decreased responsiveness of cosyntropin testing was not correlated to age of subject, amount of fluticasone propionate ointment used, or serum levels of fluticasone propionate. in the above trial, telangiectasia on the face was noted in one subject on the eighth day of a 4-week treatment period. facial use was discontinued and the telangiectasia resolved. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. a limited number of patients above 65 years of age (n=203) have been treated with fluticasone propionate ointment in us and non-us clinical trials. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.

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rij pharmaceutical corporation - bismuth subsalicylate (unii: 62tey51rr1) (bismuth cation - unii:zs9cd1i8ye) - bismuth subsalicylate 262 mg in 15 ml - anti-diarrheal - controls diarrhea - reduce number of bowel movements - help firm stool

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ethex corporation - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - liquid - 7.5 mg in 15 ml - hydrocodone bitartrate and acetaminophen oral solution is indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. patients known to be hypersensitive to other opioids may exhibit cross sensitivity to hydrocodone. hydrocodone bitartrate and acetaminophen oral solution is classified as a schedule iii controlled substance. hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution appropriate to the use of other oral narcotic medications. however, psychological dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen oral solution are used for a short time for the treatment