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

allergan, inc. - hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - microzide is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. unlike potassium sparing combination diuretic products, microzide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ace inhibitors. usage in pregnancy: the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through eleva

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

allergan, inc. - levomilnacipran hydrochloride (unii: 371u2zk31u) (levomilnacipran - unii:ugm0326txx) - levomilnacipran 20 mg - fetzima® is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14 )]. limitation of use: fetzima is not approved for the management of fibromyalgia. the efficacy and safety of fetzima for the management of fibromyalgia have not been established. fetzima is contraindicated: - in patients with hypersensitivity to levomilnacipran, milnacipran hcl, or to any excipient in the formulation. - with the use of maois intended to treat psychiatric disorders with fetzima or within 7 days of stopping treatment with fetzima is contraindicated because of an increased risk of serotonin syndrome. the use of fetzima within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.5 ) and warnings and precautions ( 5.2 )] . starting fetzima 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 [se

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

allergan, inc. - eluxadoline (unii: 45tpj4mbq1) (eluxadoline - unii:45tpj4mbq1) - eluxadoline 75 mg - viberzi  is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (ibs-d). viberzi is contraindicated in patients: - without a gallbladder. these patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of oddi spasm [see warnings and precautions ( 5.1, 5.2)] - with known or suspected biliary duct obstruction; or sphincter of oddi disease or dysfunction. these patients are at increased risk for sphincter of oddi spasm [see warnings and precautions   ( 5.1)]. - with alcoholism, alcohol abuse or alcohol addiction, or in patients who drink more than 3 alcoholic beverages per day. these patients are at increased risk for acute pancreatitis [see warnings and precautions ( 5.1)] . - with a history of pancreatitis; or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction. these patients are at increased risk for acute pancreatitis [see warnings and precautions ( 5.1)] . - with a known hypersensitivity r

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)

allergan, inc. - ursodiol (unii: 724l30y2qr) (ursodiol - unii:724l30y2qr) - ursodiol 300 mg - - actigall is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. safety of use of actigall beyond 24 months is not established. - actigall is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss. - actigall will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. hence, patients with such stones are not candidates for actigall therapy. - patients with compelling reasons for cholecystectomy including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula are not candidates for actigall therapy. - allergy to bile acids.

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

allergan, inc. - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 5 mg - lexapro is indicated for the treatment of: • major depressive disorder (mdd) in adults and pediatric patients 12 years of age and older. • generalized anxiety disorder (gad) in adults and pediatric patients 7 years of age and older. lexapro is contraindicated in patients: - taking maois with lexapro or within 14 days of stopping treatment with lexapro because of an increased risk of serotonin syndrome. the use of lexapro within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.7 ) and warnings and precautions ( 5.2 )] . starting lexapro 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 ) and  warnings and precautions ( 5.2 ) ]. - taking pimozide [see drug interactions ( 7 ) ] .   - with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in lexapro.

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

allergan, inc. - fluorometholone (unii: sv0csg527l) (fluorometholone - unii:sv0csg527l) - fml forte ® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. fml forte ® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. fml forte ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

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

allergan, inc. - fluorometholone (unii: sv0csg527l) (fluorometholone - unii:sv0csg527l) - fml ® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. fml ® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye, and fungal diseases of ocular structures. fml ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

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

allergan, inc. - prednisolone acetate (unii: 8b2807733d) (prednisolone - unii:9phq9y1olm) - pred mild ® is indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). pred mild ® suspension is contraindicated in acute untreated purulent ocular infections, in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. pred mild ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

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

allergan, inc. - prednisolone acetate (unii: 8b2807733d) (prednisolone - unii:9phq9y1olm) - pred forte ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. pred forte ® suspension is contraindicated in acute untreated purulent ocular infections, in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. pred forte ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.