美国 - 英文 - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 20 mg - paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine t

美国 - 英文 - NLM (National Library of Medicine)

dr. reddy's laboratories inc. - chlorthalidone (unii: q0mqd1073q) (chlorthalidone - unii:q0mqd1073q) - diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. 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 pathologic causes or from the physiologic and mechanical consequences of pregnancy. chlorthalidone is indicated in pregnancy w

美国 - 英文 - NLM (National Library of Medicine)

karalex pharma llc - fenofibrate (unii: u202363uos) (fenofibrate - unii:u202363uos) - fenofibrate 54 mg - fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated ldl-c, total-c, triglycerides and apo b, and to increase hdl-c in adult patients with primary hypercholesterolemia or mixed dyslipidemia (fredrickson types iia and iib). lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see national cholesterol education program [ncep] treatment guidelines, below). fenofibrate tablets are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (fredrickson types iv and v hyperlipidemia). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis.

美国 - 英文 - NLM (National Library of Medicine)

medimetriks pharmaceuticals, inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin 10 mg - clindacin•p® is indicated in the treatment of acne vulgaris. in view of the potential for diarrhea, bloody diarrhea and pseudo-membranous colitis, the physician should consider whether other agents are more appropriate (see contraindications, warnings and adverse reactions ). clindacin•p® is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

美国 - 英文 - NLM (National Library of Medicine)

westwood manufacturing - hydroxyzine pamoate (unii: m20215mufr) (hydroxyzine - unii:30s50ym8og) - hydroxyzine 50 mg -  for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. as a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (demerol®) and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. atropine and other belladonna alkaloids are not affected by the drug. hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. the effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should reassess periodically the usefulness of the drug for the individual patient. hydroxy

美国 - 英文 - NLM (National Library of Medicine)

paragon bioteck, inc. - tetracaine hydrochloride (unii: 5nf5d4opci) (tetracaine - unii:0619f35cgv) - tetracaine hydrochloride ophthalmic solution usp, 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. tetracaine hydrochloride ophthalmic solution, usp, 0.5% should not be used in patients with a history of hypersensitivity to any component of this preparation. risk summary there are no adequate and well-controlled studies with tetracaine hydrochloride ophthalmic solution usp, 0.5% in pregnant women. animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature. risk summary there are no data to assess whether tetracaine hydrochloride ophthalmic solution usp, 0.5% is excreted in human milk or to assess its effects on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tetracaine hydrochloride ophthalmic solution usp, 0.5% and any potential adverse effects on the breastfed child from tetracaine hydro

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

theramex ireland limited - estradiol hemihydrate; norethisterone acetate - transdermal patch - 50 microg/24h +170 microgram(s)/24 hours - natural and semisynthetic estrogens, plain; estradiol, combinations

美国 - 英文 - NLM (National Library of Medicine)

organon llc - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - singulair® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. singulair is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. singulair is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. because the benefits of singulair may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. singulair is not indicated for the treatment of an acute asthma attack. singulair is contraindicated in patients with hypersensitivity to any of its components. risk summary available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not estab

美国 - 英文 - NLM (National Library of Medicine)

winder laboratories, llc - sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o), vitamin a (unii: 81g40h8b0t) (vitamin a - unii:81g40h8b0t), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), sodium ascorbate (unii: s033eh8359) (ascorbic acid - unii:pq6ck8pd0r), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), .alpha.-tocopherol acetate, dl- (unii: wr1wpi7ew8) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), thiamine mononitrate (unii: 8k0i04919x) (thiamine ion - unii:4abt0j945j), riboflavin (unii: tlm2976ofr) (riboflavin - unii:tlm2976ofr), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - supplementation of the diet with fluoride and ten essential vitamins. multivitamin with 1.0 mg fluoride chewable tablets provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm. multivitamin with 0.5 mg fluoride chewable tablet s provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride. multivitamin with 0.25 mg fluoride chewable tablets provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride. multivitamin with fluoride chewable tablets supply significant amounts of vitamins a, c, d, e, thiamine, riboflavin, niacin, vitamin b6, vitamin b12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride. supplementation of the diet with fluoride for caries prophylaxis. the american academy of pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. children using multivitamin with fluoride chewable tablets regularly should receive semiannual dental examinations. the regular brushing of teeth and attention to good oral hygiene practices are also essential. multivitamin with fluoride chewable tablets are prescription product for the clinical dietary management of metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

美国 - 英文 - NLM (National Library of Medicine)

adamas pharma, llc - amantadine (unii: bf4c9z1j53) (amantadine - unii:bf4c9z1j53) - amantadine 68.5 mg - gocovri ® is indicated: - for the treatment of dyskinesia in patients with parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications - as adjunctive treatment to levodopa/carbidopa in patients with parkinson’s disease experiencing “off” episodes gocovri is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 ml/min/1.73 m 2 ) [see clinical pharmacology ( 12.3)]. risk summary there are no adequate data on the developmental risk associated with use of amantadine in pregnant women. animal studies suggest a potential risk for fetal harm with amantadine. in mice and rats, adverse developmental effects (embryolethality, increased incidence of malformations, and reduced fetal body weight) were observed when amantadine was administered to pregnant animals at clinically relevant doses [ see data]. 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. the background risk for major birth defects and miscarriage in patients with parkinson’s disease is unknown. data animal data the effects of amantadine on development have not been tested in studies conducted in animals using currently recommended methodology; however, developmental toxicity studies of amantadine have been reported in the published literature. in mice, oral administration of amantadine (0, 10, or 40 mg/kg/day) to pregnant animals during organogenesis (gestation days 7-12) resulted in embryolethality and reduced fetal body weight at the highest dose tested, which was associated with maternal toxicity. the no-effect dose for developmental toxicity in mice (10 mg/kg/day) is less than the recommended human dose (rhd) of 274 mg/day, based on body surface area (mg/m 2 ). in rats, oral administration of amantadine (0, 40 or 120 mg/kg/day) to pregnant animals during organogenesis (gestation days 7-12) resulted in embryolethality and reduced fetal body weight at the highest dose. the no-effect dose for developmental toxicity in this study (40 mg/kg/day) is approximately equal to the rhd on a mg/m 2 basis. in another study in pregnant rats, oral administration of amantadine during organogenesis (gestation days 7-14) resulted in an increase in visceral and skeletal malformations at oral doses of 50 and 100 mg/kg/day. the no-effect dose for teratogenicity in this study (37 mg/kg/day) is approximately equal to the rhd on a mg/m 2 basis. evaluation of parturition, lactation, and post-natal development in a limited number of litters from the mouse and rat studies described above revealed reductions in live litter size and pup weights at birth at 40 mg/kg/day in mice and 120 mg/kg/day in rats. risk summary amantadine is excreted into human milk, but amounts have not been quantified. there is no information on the risk to a breastfed infant. amantadine may alter breast milk production or excretion [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gocovri and any potential adverse effects on the breastfed infant from gocovri or from the underlying maternal condition. data in published studies, amantadine reduced serum prolactin levels and the symptoms of galactorrhea in patients taking neuroleptic drugs. the effect of amantadine on milk supply has not been evaluated in nursing mothers. the safety and effectiveness of gocovri in pediatric patients have not been established. the majority of people with parkinson’s disease are 65 years and older. in phase 3 clinical trials, the mean age of patients at study entry was 65 years. of the total number of patients in clinical studies of gocovri, 46% were less than 65 years of age, 39% were 65-74 years of age, and 15% were 75 years of age or older. hallucinations and falls occurred more frequently in patients 65 years of age or older, compared to those less than 65 years of age [see adverse reactions ( 6.1)]. no dose adjustment is recommended on the basis of age. gocovri is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration ( 2.3)]. gocovri is contraindicated for use in patients with end-stage renal disease (creatinine clearance values lower than 15 ml/min/1.73 m 2 ). for patients with moderate renal impairment (creatinine clearance between 30 and 59 ml/min/1.73 m 2 ), a 50% dose reduction of gocovri dosage to a starting daily dose of 68.5 mg daily at bedtime for a week, to a maximum dosage of 137 mg daily at bedtime is recommended. for patients with severe renal impairment (creatinine clearance between 15 and 29 ml/min/1.73 m 2 ), a daily dose of 68.5 mg at bedtime is the recommended initial and maximum dosage [see dosage and administration ( 2.3)] . creatinine clearance values are estimated by the modification of diet in renal disease (mdrd) method.