Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp. - lisdexamfetamine dimesylate (unii: sjt761gegs) (lisdexamfetamine - unii:h645gul8kj) - lisdexamfetamine dimesylate capsules are indicated for the treatment of: - attention deficit hyperactivity disorder (adhd) in adults and pediatric patients 6 years and older [see clinical studies (14.1)] - moderate to severe binge eating disorder (bed) in adults [see clinical studies (14.2)] . limitations of use: - pediatric patients with adhd younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see use in specific populations (8.4)] . - lisdexamfetamine dimesylate capsules are not indicated or recommended for weight loss. use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. the safety and effectiveness of lisdexamfetamine dimesylate capsules for the treatment of obesity have not been established [see warnings and precautions (5.2)] . lisdexamfetamine dimesylate capsules are contraindicated in patients with: - known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules. anaphylactic reactions, stevens-johnson syndrome, angioedema, and urticaria have been observed in postmarketing reports [see adverse reactions (6.2)] . - patients taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and precautions (5.7) and drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to adhd medications during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and%20researchprograms/pregnancyregistry/adhd-medications/. risk summary the limited available data from published literature and postmarketing reports on use of lisdexamfetamine dimesylate capsules in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines [see clinical considerations]. in animal reproduction studies, lisdexamfetamine dimesylate (a prodrug of d-amphetamine) had no effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis. pre- and postnatal studies were not conducted with lisdexamfetamine dimesylate. however, amphetamine (d- to l- ratio of 3:1) administration to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. in addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine [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 fetal/neonatal adverse reactions amphetamines, such as lisdexamfetamine dimesylate capsules, cause vasoconstriction and thereby may decrease placental perfusion. in addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. infants born to amphetamine-dependent mothers have an increased risk of premature delivery and low birth weight. monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. data animal data lisdexamfetamine dimesylate had no apparent effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 40 and 120 mg/kg/day, respectively. these doses are approximately 5.5 and 33 times, respectively, the maximum recommended human dose (mrhd) of 70 mg/day given to adults, on a mg/m2  body surface area basis. a study was conducted with amphetamine (d- to l- enantiomer ratio of 3:1) in which pregnant rats received daily oral doses of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. all doses caused hyperactivity and decreased weight gain in the dams. a decrease in pup survival was seen at all doses. a decrease in pup body weight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks, such as preputial separation and vaginal opening. increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. when pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg. a number of studies from the literature in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-) at doses similar to those used clinically can result in long­-term neurochemical and behavioral alterations. reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. risk summary lisdexamfetamine is a pro-drug of dextroamphetamine. based on limited case reports in published literature, amphetamine (d-or d, l-) is present in human milk, at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. there are no reports of adverse effects on the breastfed infant. long-term neurodevelopmental effects on infants from amphetamine exposure are unknown. it is possible that large dosages of dextroamphetamine might interfere with milk production, especially in women whose lactation is not well established. because of the potential for serious adverse reactions in nursing infants, including serious cardiovascular reactions, blood pressure and heart rate increase, suppression of growth, and peripheral vasculopathy, advise patients that breastfeeding is not recommended during treatment with lisdexamfetamine dimesylate capsules. adhd safety and effectiveness of lisdexamfetamine dimesylate capsules have been established in pediatric patients with adhd ages 6 to 17 years [see dosage and administration (2.3), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)] . safety and effectiveness of lisdexamfetamine dimesylate capsules have not been established in pediatric patients below the age of 6 years. safety and efficacy of lisdexamfetamine dimesylate capsules were evaluated in a double-blind, randomized, parallel-group, placebo-controlled, fixed-dose study in pediatric patients ages 4 to 5 years with adhd, followed by a 1-year open-label extension study. in these studies, patients experienced elevated rates of adverse reactions, including weight loss, decreased bmi, decreased appetite, insomnia, infections (upper respiratory and nasopharyngitis), irritability, and affect lability. with the same lisdexamfetamine dimesylate capsules dose, mean steady state exposure of dextroamphetamine was approximately 44% higher in pediatric patients ages 4 to 5 years compared to the pediatric patients ages 6 to 11 years. bed safety and effectiveness of lisdexamfetamine dimesylate capsules have not been established in pediatric patients with bed less than 18 years of age. growth suppression growth should be monitored during treatment with stimulants, including lisdexamfetamine dimesylate capsules, and pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see warnings and precautions (5.5) and adverse reactions (6.1)] . juvenile animal data studies conducted in juvenile rats and dogs at clinically relevant doses showed growth suppression that partially or fully reversed in dogs and female rats but not in male rats after a four-week drug-free recovery period. a study was conducted in which juvenile rats received oral doses of 4, 10, or 40 mg/kg/day of lisdexamfetamine dimesylate from day 7 to day 63 of age. these doses are approximately 0.3, 0.7, and 3 times the maximum recommended human daily dose of 70 mg on a mg/m2 basis for a child. dose-related decreases in food consumption, bodyweight gain, and crown-rump length were seen; after a four-week drug-free recovery period, bodyweights and crown-rump lengths had significantly recovered in females but were still substantially reduced in males. time to vaginal opening was delayed in females at the highest dose, but there were no drug effects on fertility when the animals were mated beginning on day 85 of age. in a study in which juvenile dogs received lisdexamfetamine dimesylate for 6 months beginning at 10 weeks of age, decreased bodyweight gain was seen at all doses tested (2, 5, and 12 mg/kg/day, which are approximately 0.5, 1, and 3 times the maximum recommended human daily dose on a mg/m2  basis for a child). this effect partially or fully reversed during a four- week drug-free recovery period. clinical studies of lisdexamfetamine dimesylate capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience and pharmacokinetic data [see clinical pharmacology (12.3)] have not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should start 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. due to reduced clearance in patients with severe renal impairment (gfr 15 to < 30 ml/min/1.73 m2 ), the maximum dose should not exceed 50 mg/day. the maximum recommended dose in esrd (gfr < 15 ml/min/1.73 m2 ) patients is 30 mg/day [see clinical pharmacology (12.3)] . lisdexamfetamine and d-amphetamine are not dialyzable. lisdexamfetamine dimesylate capsules contains lisdexamfetamine, a prodrug of amphetamine, a schedule ii controlled substance. lisdexamfetamine dimesylate capsules has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see warnings and precautions (5.1)]. lisdexamfetamine dimesylate capsules 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 lisdexamfetamine, a prodrug of amphetamine, 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 lisdexamfetamine dimesylate capsules, can result in overdose and death [see overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. studies of lisdexamfetamine dimesylate capsules in drug abusers a randomized, double-blind, placebo-control, cross-over, abuse liability study in 38 patients with a history of drug abuse was conducted with single-doses of 50, 100, or 150 mg of lisdexamfetamine dimesylate capsules, 40 mg of immediate-release d-amphetamine sulphate (a controlled ii substance), and 200 mg of diethylpropion hydrochloride (a controlled iv substance). lisdexamfetamine dimesylate capsules 100 mg produced significantly less “drug liking effects” as measured by the drug rating questionnaire-subject score, compared to d-amphetamine 40 mg; and 150 mg of lisdexamfetamine dimesylate capsules demonstrated similar “drug-liking effects” compared to 40 mg of d-amphetamine and 200 mg of diethylpropion. intravenous administration of 50 mg lisdexamfetamine dimesylate to individuals with a history of drug abuse produced positive subjective responses on scales measuring "drug liking", "euphoria", "amphetamine effects", and "benzedrine effects" that were greater than placebo but less than those produced by an equivalent dose (20 mg) of intravenous d-amphetamine. physical dependence lisdexamfetamine dimesylate capsules 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 lisdexamfetamine dimesylate capsules include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.   tolerance lisdexamfetamine dimesylate capsules 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).

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp - paroxetine hydrochloride (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 12.5 mg - paxil cr is indicated in adults for the treatment of: - major depressive disorder (mdd) - panic disorder (pd) - social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) paxil cr is 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), 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 to any of the inactive ingredients in paxil cr [see adverse reactions (6.1, 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 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/ pregnancyregistry/antidepressants/. risk summary   based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.5) and clinical considerations] . paxil cr is associated with a less than 2-fold increase in cardiovascular malformations when administered to a pregnant woman during the first trimester. while individual epidemiological studies on the association between paroxetine use and cardiovascular malformations have reported inconsistent findings, some meta-analyses of epidemiological studies have identified an increased risk of cardiovascular malformations (see data). there are risks of persistent pulmonary hypertension of the newborn (pphn) (see data) and/or poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including paxil cr, during pregnancy. there also are risks associated with untreated depression in pregnancy (see clinical considerations). for women who intend to become pregnant or who are in their first trimester of pregnancy, paroxetine should be initiated only after consideration of the other available treatment options. no evidence of treatment related malformations was observed in animal reproduction studies, when paroxetine was administered during the period of organogenesis at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m2 basis. when paroxetine was administered to female rats during the last trimester of gestation and continued through lactation, there was an increase in the number of pup deaths during the first four days of lactation. this effect occurred at a dose of 1 mg/kg/day which is less than the mrhd on an mg/m2 basis (see data). the estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the us 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 of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. maternal adverse reactions use of paxil cr in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.5)] . fetal/neonatal adverse reactions neonates exposed to paxil cr and other ssris late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of ssris or possibly a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.4)] . data human data published epidemiological studies on the association between first trimester paroxetine use and cardiovascular malformations have reported inconsistent results; however, meta-analyses of population-based cohort studies published between 1996-2017 indicate a less than 2-fold increased risk for overall cardiovascular malformations. specific cardiac malformations identified in two meta-analyses include approximately 2 to 2.5-fold increased risk for right ventricular outflow tract defects. one meta-analysis also identified an increased risk (less than 2- fold) for bulbus cordis anomalies and anomalies of cardiac septal closure, and an increased risk for atrial septal defects (pooled or 2.38, 95% ci 1.14-4.97). important limitations of the studies included in these meta-analyses include potential confounding by indication, depression severity, and potential exposure misclassification. exposure to ssris, particularly later in pregnancy, may have an increased risk for pphn. pphnoccurs in 1-2 per 1000 live births in the general population and is associated with substantialneonatal morbidity and mortality. animal data   reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m2 basis. these studies have revealed no evidence of malformations. however, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. this effect occurred at a dose of 1 mg/kg/day which is less than the mrhd on an mg/m2 basis. the no‑effect dose for rat pup mortality was not determined. the cause of these deaths is not known. risk summary data from the published literature report the presence of paroxetine in human milk (see data).there are reports of agitation, irritability, poor feeding and poor weight gain in infants exposedto paroxetine through breast milk (see clinical considerations). there are no data on the effectsof paroxetine on milk production. the developmental and health benefits of breastfeeding shouldbe considered along with the mother's clinical need for paxil cr and any potential adverse effects on the breastfed infant from paxil cr or the underlying maternal condition. clinical considerations infants exposed to paxil cr should be monitored for agitation, irritability, poor feeding andpoor weight gain. data published literature suggests the presence of paroxetine in human milk with relative infant dosesranging between 0.4% to 2.2%, and a milk: plasma ratio of <1. no significant amounts weredetected in the plasma of infants after breastfeeding. infertility male based on findings from clinical studies, paroxetine may affect sperm quality which may impairfertility; it is not known if this effect is reversible [see nonclinical toxicology (13.1)]. the safety and effectiveness of paxil cr in pediatric patients have not been established [see boxed warning, warnings and precautions (5.1)].    three placebo-controlled trials in 752 pediatric patients with mdd have been conducted with immediate-release paroxetine, and effectiveness was not established in pediatric patients.   decreased appetite and weight loss have been observed in association with the use of ssris.     in placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with immediate-release paroxetine hydrochloride and at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. adverse reactions upon discontinuation of treatment with immediate-release paroxetine hydrochloride in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain. ssris and snris, including paxil cr, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions (5.9)].   in premarketing clinical trials with immediate‑release paroxetine hydrochloride, 17% of paroxetine treated patients (approximately 700) were 65 years or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between these subjects and younger subjects [see dosage and administration (2.5) and clinical pharmacology (12.3)]. increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. the initial dosage of paxil cr should be reduced in patients with severe renal impairment and patients with severe hepatic impairment [see dosage and administration (2.5) and clinical pharmacology (12.3)].

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp. - calcitonin salmon (unii: 7sfc6u2vi5) (calcitonin salmon - unii:7sfc6u2vi5) - calcitonin salmon 200 [iu] - calcitonin salmon (synthetic origin) nasal spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. fracture reduction efficacy has not been demonstrated. calcitonin salmon (synthetic origin) nasal spray should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). - due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see warnings and precautions (5.4)] . - calcitonin salmon (synthetic origin) nasal spray has not been shown to increase spinal bone mineral density in early postmenopausal women. hypersensitivity to calcitonin salmon or any of the excipients. reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see warnings and precautions (5.1)] . risk summary calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. there are no data with the use of calcitonin salmon nasal spray in pregnant women. in an animal reproduction study, subcutaneous administration of calcitonin-salmon to pregnant rabbits during organogenesis at 418 times the recommended parenteral human dose caused a decrease in fetal birth weights. no adverse developmental outcome was observed in the rat with subcutaneous administration of calcitonin-salmon at 9 times the recommended human parenteral dose based on body surface area (see data).   data animal data calcitonin salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4 to 18 times the parenteral dose (of 54 international units/m2 ) and 70 to 278 times the intranasal dose recommended for human use based on body surface area.   no embryo/fetal toxicities related to calcitonin salmon nasal spray were reported from maternal subcutaneous daily doses in rats up to 80 international units/kg/day from gestation day 6 to 15. risk summary calcitonin salmon nasal spray is not indicated for use in females of reproductive potential. there is no information on the presence of calcitonin-salmon in human milk, the effects on the breastfed child, or the effects on milk production. calcitonin has been shown to inhibit lactation in rats. safety and effectiveness in pediatric patients have not been established. in a multi-centered, double-blind, randomized clinical study of calcitonin salmon nasal spray, 279 patients were less than 65 years old, while 467 patients were 65 to 74 years old and 196 patients were 75 years old and older. compared to subjects less than 65 years old, the incidence of nasal adverse reactions (rhinitis, irritation, erythema, and excoriation) was higher in patients over the age of 65, particularly among those over the age of 75. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. calcitonin salmon (synthetic origin) (kal" si toe' nin) nasal spray for nasal use only. important information about your calcitonin salmon (synthetic origin) nasal spray: - a single spray of calcitonin salmon (synthetic origin) nasal spray contains 1 daily dose of medicine. - each calcitonin salmon (synthetic origin) nasal spray bottle contains the right amount of medicine. the bottle may not be completely filled to the top. this is normal. - this package contains 1 bottle of calcitonin salmon (synthetic origin) nasal spray with attached pump. - store unopened bottles of calcitonin salmon (synthetic origin) nasal spray in the refrigerator between 2°c to 8°c (36°f to 46°f). do not freeze. - after you open your bottle of calcitonin salmon (synthetic origin) nasal spray, store it at room temperature between 20°c to 25°c (68°f to 77°f) in an upright position. do not shake the bottle. - to make sure you get the right dose of calcitonin salmon (synthetic origin) nasal spray medicine you must prime each new bottle and pump before you use it for the first time. - check to see if the bottle and pump has already been primed by pressing on the pump 1 time. see figure 2. - if you see a full spray from the pump, the bottle and pump has already been primed for you. - if you do not see a full spray, you must prime the bottle and pump. - hold the bottle upright with your pointer finger and middle finger on the 2 side arms of the pump, and your thumb on the bottom of the bottle. firmly press down on the arms of the pump and press down again if needed until you see a full spray of medicine. see figure 2. - now your calcitonin salmon (synthetic origin) nasal spray is ready for you to use. - do not prime the pump before you use it each day because this will waste your medicine. - keep your head upright. carefully tilt the bottle and place the nose spray pump into 1 side of your nose. - give 1 spray of calcitonin salmon (synthetic origin) nasal spray, 1 time daily, in 1 side of your nose (nostril). spray your medicine in a different side of your nose each day. - you do not need to breathe or inhale while you are giving your dose. - you may not feel the spray inside your nose. - some of the medicine may drip out of your nose. this is normal, and you are still getting all of the medicine you need. - dry the nose spray pump with a clean cloth. - be careful not to push down on the pump while you are putting the cap back on it. - do not refrigerate calcitonin salmon (synthetic origin) nasal spray between doses. - store calcitonin salmon (synthetic origin) nasal spray upright. - do not shake the bottle. when should i throw away calcitonin salmon (synthetic origin) nasal spray? - unopened, refrigerated bottles can be used until the expiration date stamped on the bottle and box. - throw away calcitonin salmon (synthetic origin) nasal spray after you use 14 doses (2 ml fill) or 30 doses (3.7 ml fill) (sprays). - throw away calcitonin salmon (synthetic origin) nasal spray bottles left at room temperature (opened or unopened) for more than 30 days (2 ml fill) or 35 days (3.7 ml fill). for more information on calcitonin salmon (synthetic origin) nasal spray, call apotex corp. at 1-800-706-5575. this patient information and instructions for use has been approved by the u.s. food and drug administration. apotex inc. calcitonin salmon (synthetic origin) nasal spray revised: november 2017

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lake erie medical medical dba quality care products llc - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine 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 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 effectiveness of mirtazapine tablets in h

Združene države Amerike - angleščina - NLM (National Library of Medicine)

mckesson corporation dba rx pak - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 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 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 effectivenes

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp. - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. buprenorphine and naloxone sublingual film is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.9) ] . risk summary the data on use of buprenorphine, one of the active ingredients in buprenorphine and naloxone sublingual film, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine exposure. there are limited data from randomized clinical trials in women maintained on buprenorphine that were not designed appropriately to assess the risk of major malformations [see data] . observational studies have reported on congenital malformations a

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp. - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. when indicated, glycopyrrolate injection may be used intraoperatively to counteract surgically or drug- induced or vagal reflexes associated arrhythmias. glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants. for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated. known hypersensitivity to glycopyrrolate or any of its inactive ingredients. in addition, in the management of peptic ulcer patients, because of the longer duration of therapy, glycopyrrolate injection may be contraindicated in patients with the following concurrent conditions: glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14 )]. vilazodone is contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2 ) , drug interactions ( 7 ) ] . 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 there are no adequate and well-controlled studies of vilazodone in pregnant women. the background risk of major birth defects and miscarriage for the indicated population is

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp. - deferoxamine mesylate (unii: v9tko7eo6k) (deferoxamine - unii:j06y7mxw4d) - deferoxamine mesylate for injection, usp, is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. acute iron intoxication deferoxamine mesylate is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis. chronic iron overload deferoxamine mesylate can promote iron excretion in patients with secondary iron overload from multiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). long-term therapy with deferoxamine mesylate slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis. iron mobilization with deferoxamine mesylate is relatively poor in patients under the age of 3 years with relatively little iron overload. the drug should ordinarily not be given to such patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated. deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder. known hypersensitivity to the active substance. deferoxamine mesylate is contraindicated in patients with severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney. (see warnings).

Združene države Amerike - angleščina - NLM (National Library of Medicine)

apotex corp. - deferoxamine mesylate (unii: v9tko7eo6k) (deferoxamine - unii:j06y7mxw4d) - deferoxamine mesylate for injection, usp, is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias. acute iron intoxication deferoxamine mesylate is an adjunct to, and not a substitute for, standard measures used in treating acute iron intoxication, which may include the following: induction of emesis with syrup of ipecac; gastric lavage; suction and maintenance of a clear airway; control of shock with intravenous fluids, blood, oxygen, and vasopressors; and correction of acidosis. chronic iron overload deferoxamine mesylate can promote iron excretion in patients with secondary iron overload from multiple transfusions (as may occur in the treatment of some chronic anemias, including thalassemia). long-term therapy with deferoxamine mesylate slows accumulation of hepatic iron and retards or eliminates progression of hepatic fibrosis. iron mobilization with deferoxamine mesylate is relatively poor in patients under the age of 3 years with relatively little iron overload. the drug should ordinarily not be given to such patients unless significant iron mobilization (e.g., 1 mg or more of iron per day) can be demonstrated. deferoxamine mesylate is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder. known hypersensitivity to the active substance. deferoxamine mesylate is contraindicated in patients with severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney. (see warnings).