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

cardinal health 107, llc - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 50 mg - savella is indicated for the management of fibromyalgia.  savella is not approved for use in pediatric patients [see use in specific populations (8.4)] . the use of maois intended to treat psychiatric disorders with savella or within 5 days of stopping treatment with savella is contraindicated because of an increased risk of serotonin syndrome. the use of savella within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.5), warnings and precautions (5.2)] . starting savella in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.6), warnings and precautions (5.2)] . pregnancy category c risk summary there are no adequate or well-controlled studies in pregnant women. neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine (such as savella), or selective serotonin reuptake

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

unit dose services - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 25 mg - savella is indicated for the management of fibromyalgia. savella is not approved for use in pediatric patients [see use in specific populations (8.4)] . the use of maois intended to treat psychiatric disorders with savella or within 5 days of stopping treatment with savella is contraindicated because of an increased risk of serotonin syndrome. the use of savella within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.5), warnings and precautions (5.2)] . starting savella in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.6), warnings and precautions (5.2)] . pregnancy category c risk summary there are no adequate or well-controlled studies in pregnant women. neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine (such as savella), or selective serotonin reuptake i

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

lake erie medical & surgical supply dba quality care products llc - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 50 mg - savella is indicated for the management of fibromyalgia. savella is not approved for use in pediatric patients [see use in specific populations (8.4)]. concomitant use of savella in patients taking monoamine oxidase inhibitors (maois) is contraindicated. in patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (maoi), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. these reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an maoi. some cases presented with features resembling neuroleptic malignant syndrome. the effects of combined use of savella and maois have not been evaluated in humans. therefore, it is recommended that savella should not be used in combination wit

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

rebel distributors corp - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 25 mg - savella is indicated for the management of fibromyalgia. savella is not approved for use in pediatric patients [see use in specific populations (8.4) ]. concomitant use of savella in patients taking monoamine oxidase inhibitors (maois) is contraindicated. in patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (maoi), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. these reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an maoi. some cases presented with features resembling neuroleptic malignant syndrome. the effects of combined use of savella and maois have not been evaluated in humans. therefore, it is recommended that savella should not be used in combination wi

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

stat rx usa llc - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 25 mg - savella is indicated for the management of fibromyalgia. savella is not approved for use in pediatric patients [see use in specific populations (8.4) ]. concomitant use of savella in patients taking monoamine oxidase inhibitors (maois) is contraindicated. in patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (maoi), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. these reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an maoi. some cases presented with features resembling neuroleptic malignant syndrome. the effects of combined use of savella and maois have not been evaluated in humans. therefore, it is recommended that savella should not be used in combination wi

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

physicians total care, inc. - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 50 mg - savella is indicated for the management of fibromyalgia. savella is not approved for use in pediatric patients [see use in specific populations (8.4)]. concomitant use of savella in patients taking monoamine oxidase inhibitors (maois) is contraindicated. in patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (maoi), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. these reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an maoi. some cases presented with features resembling neuroleptic malignant syndrome. the effects of combined use of savella and maois have not been evaluated in humans. therefore, it is recommended that savella should not be used in combination wit

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

allergan, inc. - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 12.5 mg - savella is indicated for the management of fibromyalgia.  savella is not approved for use in pediatric patients [see use in specific populations ( 8.4 )] . the use of maois intended to treat psychiatric disorders with savella or within 5 days of stopping treatment with savella is contraindicated because of an increased risk of serotonin syndrome. the use of savella within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.5 ), warnings and precautions ( 5.2 )] . starting savella in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration ( 2.6 ), warnings and precautions ( 5.2 )] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to savella during pregnancy.  physicians are advised to recommend that pregnant patients taking savella enroll in the savella pregnancy registry. enrollment is voluntary and may be initiated by pregnant patients or their healthcare providers by contacting the registry at 1-877-643-3010 or by email at pregnancyregistries@incresearch.com. data forms may also be downloaded from the registry website at www.savellapregnancyregistry.com. risk summary based on data from published observational studies, exposure to snris, 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 ( 5.2 )] . the available data on savella use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks associated with exposure to serotonin and norepinephrine reuptake inhibitors (snris) and selective-serotonin reuptake inhibitors (ssris), including savella, during pregnancy (see clinical considerations). animal reproduction studies have been performed in rats, rabbits and mice. milnacipran was shown to increase embryofetal and perinatal lethality in rats and the incidence of a minor skeletal variation in rabbits at doses below (rat) or approximately equal to (rabbit) the maximum recommended human dose (mrhd) of 200 mg/day on a mg/m2 basis. no effects were seen in mice when treated with milnacipran during the period of organogenesis at doses up to 3 times the mhrd on a mg/m2 basis (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%-4% and 15%-20%, respectively. clinical consideration maternal adverse reactions use of savella in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions ( 5.9 )]. fetal/neonatal   adverse reactions neonates exposed to snris or ssris, including savella, 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, tremor, jitteriness, irritability, and constant crying. these findings are consistent with either direct toxic effect of ssris and snris 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 ( 5.2 , 5.7 )]. data animal data studies were conducted in rats, rabbits and mice with dosing of milnacipran during the period of organogenesis. in rats, milnacipran was shown to increase embryofetal lethality at doses of 5 mg/kg/day (0.25 times the mrhd on a mg/m2 basis). in rabbits, dose-dependent increases in the incidence of the skeletal variation of an extra single rib were observed in several pups from multiple litters in the absence of maternal toxicity at 15 mg/kg/day (1.5 times the mrhd on a mg/m2 basis). the clinical significance of this finding is unknown. in mice, no embryotoxic or teratogenic effects were seen at doses up to 125 mg/kg/day (3 times the mhrd on a mg/m2 basis). with peri- and postnatal exposure to oral milnacipran in rats, decreases in viability and body weight were observed on postpartum day 4 at a dose of 5 mg/kg/day (approximately 0.25 times the mrhd on a mg/m2 basis). the no-effect dose for maternal and offspring toxicity was 2.5 mg/kg/day (approximately 0.1 times the mrhd on a mg/m2 basis). risk summary milnacipran is present in human milk [see data] . there are no reports on the effects of milnacipran on the breastfed child and on milk production/excretion. however, there are reports of agitation, irritability, poor feeding, and poor weight gain in infants exposed to ssris or snris through breast milk (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for savella and any potential adverse effects on the breastfed child from savella or from the underlying maternal conditions. clinical considerations monitor infants exposed to milnacipran for agitation, irritability, poor feeding and poor weight gain. data human data milnacipran is present in the milk of lactating women treated with milnacipran. in a lactation pharmacokinetic study with milnacipran, a single, oral dose of 50 mg milnacipran hcl tablet was administered to 8 lactating women who were at least 12 weeks postpartum and weaning their infants. the milk/plasma auc ratio of milnacipran was 1.85 ± 0.38. the maximum estimated weight adjusted daily infant dose for milnacipran from breast milk (assuming mean milk consumption of 150 ml/kg/day) was 5% of the maternal dose based on peak plasma concentrations.   safety and effectiveness of savella in a fibromyalgia pediatric population below the age of 18 have not been established [see boxed warning , indications and usage ( 1 ),   and warnings and precautions ( 5.1 )] . the use of savella is not recommended in pediatric patients. in controlled clinical studies of savella, 402 patients were 60 years or older, and no overall differences in safety and efficacy were observed between these patients and younger patients. in view of the predominant excretion of unchanged milnacipran via kidneys and the expected decrease in renal function with age, renal function should be considered prior to use of savella in the elderly [see dosage and administration ( 2.2 )] . snris, ssris, and savella, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions ( 5.8 )] . milnacipran is not a controlled substance. milnacipran did not produce behavioral signs indicative of abuse potential in animal or human studies. milnacipran produces physical dependence, as evidenced by the emergence of withdrawal symptoms following drug discontinuation, similar to other snris and ssris. these withdrawal symptoms can be severe. thus, taper savella and do not abruptly discontinue after extended use [see warnings and precautions ( 5.7 )] .

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

save-a-lot food stores ltd - dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots), guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq) - dextromethorphan hydrobromide 20 mg in 10 ml - cough suppressant expectorant

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

save-a-lot food stores ltd - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - acid reducer

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

shelys pharmaceuticals limited, tanzania - dextrose , sodium chloride , sodium citrate , potassium - powder for oral solution - 13.5mg+2.6mg + 2.9mg+1.5mg