Bandaríkin - enska - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 2 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) thr

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

supagas pty ltd - oxygen, quantity: 100 % v/v - gas, medicinal - excipient ingredients: - oxygen for medical use. to increase supply of oxygen to the lungs. for respiratory support where there is a requirement for medical oxygen to treat or prevent hypoxemia.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - doxycycline hyclate, quantity: 116.3 mg (equivalent: doxycycline, qty 100 mg) - capsule, modified release - excipient ingredients: microcrystalline cellulose; purified water; hypromellose phthalate; povidone; diethyl phthalate; magnesium stearate; wheat starch; hypromellose; lactose monohydrate; hyprolose; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis mayne pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

mayne pharma international pty ltd - doxycycline hyclate, quantity: 58.15 mg (equivalent: doxycycline, qty 50 mg) - capsule, modified release - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; hypromellose phthalate; hypromellose; hyprolose; povidone; wheat starch; diethyl phthalate; purified water; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis manye pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

air liquide healthcare pty ltd - nitrous oxide, quantity: 1 l/l - gas, medicinal - excipient ingredients: - indications as at 1 november 2001: nitrous oxide is indicated in adults and children for: 1. general anaesthesia, usually as an adjuvant to other volatile or intravenous anaesthetics; 2. analgesia (with oxygen) eg. dentistry and obstetrics.

Ástralía - enska - Department of Health (Therapeutic Goods Administration)

air liquide healthcare pty ltd - carbon dioxide, quantity: 1 ml/ml - gas, medicinal - excipient ingredients: - as an anaesthetic supplement in various clinical circumstances to maintain optimum blood carbon levels, facilitate blind intubations and rapidly increase depth of anaesthesia with volatile agents. as a respiratory stimulant after apnoea or after relief of chronic respiratory obstruction. to prevent hypocapnia during hyperventilation. use in clinical and physiological investigations including use as insufflation gas.

Bandaríkin - enska - NLM (National Library of Medicine)

amneal pharmaceuticals llc - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 20 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of ee  and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison (ze) syndrome. - pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see warnings and precautions (5.2) , adverse reactions (6)] . - proton pump inhibitors (ppis), including pantoprazole sodium, are contraindicated in patients receiving rilpivirine-containing products [see drug interactions (7)] . risk summary available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. in animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. reproduction studies have been performed in rats at oral doses up to 450 mg/kg/day (about 88 times the recommended human dose) and rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see data) . a pre-and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (gd) 6 through lactation day (ld) 21. changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (pnd) 4 through pnd 21 [see use in specific populations (8.4)] . there were no drug-related findings in maternal animals. advise pregnant women of the potential risk of fetal harm. 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use. methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. in a prospective study by the european network of teratology information services, outcomes from a group of 53 pregnant women administered median daily doses of 40 mg pantoprazole were compared to a control group of 868 pregnant women who did not take any proton pump inhibitors (ppis). there was no difference in the rate of major malformations between women exposed to ppis and the control group, corresponding to a relative risk (rr)=0.55, [95% confidence interval (ci) 0.08 to 3.95]. in a population-based retrospective cohort study covering all live births in denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to pantoprazole in 549 live births. a meta-analysis that compared 1,530 pregnant women exposed to ppis in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to ppis (for major malformations or=1.12 ([95% ci 0.86 to 1.45] and for spontaneous abortions or=1.29 [95% ci 0.84 to 1.97]). animal data reproduction studies have been performed in rats at oral pantoprazole doses up to 450 mg/kg/day (about 88 times the recommended human dose based on body surface area) and in rabbits at oral doses up to 40 mg/kg/day (about 16 times the recommended human dose based on body surface area) with administration of pantoprazole sodium during organogenesis in pregnant animals. the studies have revealed no evidence of impaired fertility or harm to the fetus due to pantoprazole. a pre- and postnatal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day on a body surface area basis) were administered to pregnant females from gestation day (gd) 6 through lactation day (ld) 21. on postnatal day (pnd 4) through pnd 21, the pups were administered oral doses at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (auc) in humans at a dose of 40 mg). there were no drug-related findings in maternal animals. during the preweaning dosing phase (pnd 4 to 21) of the pups, there were increased mortality and/or moribundity and decreased body weight and body weight gain at 5 mg/kg/day (approximately equal exposures (auc) in humans receiving the 40 mg dose) and higher doses. on pnd 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (auc) in humans at the 40 mg dose) and higher doses. the femur findings included lower total area, bone mineral content and density, periosteal and endosteal circumference, and cross-sectional moment of inertia. there were no microscopic changes in the distal femur, proximal tibia, or stifle joints. changes in bone parameters were partially reversible following a recovery period, with findings on pnd 70 limited to lower femur metaphysis cortical/subcortical bone mineral density in female pups at 5 mg/kg/day (approximately equal exposures (auc) in humans at the 40 mg dose) and higher doses. risk summary pantoprazole has been detected in breast milk of a nursing mother after a single 40 mg oral dose of pantoprazole. there were no effects on the breastfed infant (see data) . there are no data on pantoprazole effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pantoprazole sodium and any potential adverse effects on the breastfed child from pantoprazole or from the underlying maternal condition. data the breast milk of a 42-year-old woman receiving 40 mg of oral pantoprazole, at 10 months postpartum, was studied for 24 hours, to demonstrate low levels of pantoprazole present in the breast milk. pantoprazole was detectable in milk only 2 and 4 hours after the dose with milk levels of approximately 36 mcg/l and 24 mcg/l, respectively. a milk-to-plasma ratio of 0.022 was observed at 2 hours after drug administration. pantoprazole was not detectable (<10 mcg/l) in milk at 6, 8 and 24 hours after the dose. the relative dose to the infant was estimated to be 7.3 mcg of pantoprazole, which is equivalent to 0.14% of the weight-adjusted maternal dose. no adverse events in the infant were reported by the mother. the safety and effectiveness of pantoprazole sodium for short-term treatment (up to eight weeks) of ee associated with gerd have been established in pediatric patients 1 year through 16 years of age. effectiveness for ee has not been demonstrated in patients less than 1 year of age. in addition, for patients less than 5 years of age, there is no appropriate dosage strength in an age-appropriate formulation available. therefore, pantoprazole sodium is indicated for the short-term treatment of ee associated with gerd for patients 5 years and older. the safety and effectiveness of pantoprazole sodium for pediatric uses other than ee have not been established. 1 year through 16 years of age use of pantoprazole sodium in pediatric patients 1 year through 16 years of age for short-term treatment (up to eight weeks) of ee associated with gerd is supported by: a) extrapolation of results from adequate and well-controlled studies that supported the approval of pantoprazole sodium for treatment of ee associated with gerd in adults, and b) safety, effectiveness, and pharmacokinetic studies performed in pediatric patients [see clinical studies (14.1) , and clinical pharmacology (12.3)] . safety of pantoprazole sodium in the treatment of ee associated with gerd in pediatric patients 1 through 16 years of age was evaluated in three multicenter, randomized, double-blind, parallel-treatment studies, involving 249 pediatric patients, including 8 with ee (4 patients ages 1 year to 5 years and 4 patients 5 years to 11 years). the children ages 1 year to 5 years with endoscopically diagnosed ee (defined as an endoscopic hetzel-dent score ≥ 2) were treated once daily for 8 weeks with one of two dose levels of pantoprazole sodium (approximating 0.6 mg/kg or 1.2 mg/kg). all 4 of these patients with ee were healed (hetzel-dent score of 0 or 1) at 8 weeks. because ee is uncommon in the pediatric population, predominantly pediatric patients with endoscopically-proven or symptomatic gerd were also included in these studies. patients were treated with a range of doses of pantoprazole sodium once daily for 8 weeks. for safety findings [see adverse reactions (6.1)] . because these pediatric trials had no placebo, active comparator, or evidence of a dose response, the trials were inconclusive regarding the clinical benefit of pantoprazole sodium for symptomatic gerd in the pediatric population. the effectiveness of pantoprazole sodium for treating symptomatic gerd in pediatric patients has not been established. although the data from the clinical trials support use of pantoprazole sodium for the short-term treatment of ee associated with gerd in pediatric patients 1 year through 5 years, there is no commercially available dosage formulation appropriate for patients less than 5 years of age [see dosage and administration (2)] . in a population pharmacokinetic analysis, clearance values in the children 1 to 5 years old with endoscopically proven gerd had a median value of 2.4 l/h. following a 1.2 mg/kg equivalent dose (15 mg for ≤ 12.5 kg and 20 mg for > 12.5 to < 25 kg), the plasma concentrations of pantoprazole were highly variable and the median time to peak plasma concentration was 3 to 6 hours. the estimated auc for patients 1 to 5 years old was 37% higher than for adults receiving a single 40 mg tablet, with a geometric mean auc value of 6.8 mcg•hr/ml. neonates to less than one year of age pantoprazole sodium was not found to be effective in a multicenter, randomized, double-blind, placebo-controlled, treatment-withdrawal study of 129 pediatric patients 1 through 11 months of age. patients were enrolled if they had symptomatic gerd based on medical history and had not responded to non-pharmacologic interventions for gerd for two weeks. patients received pantoprazole sodium daily for four weeks in an open-label phase, then patients were randomized in equal proportion to receive pantoprazole sodium treatment or placebo for the subsequent four weeks in a double-blind manner. efficacy was assessed by observing the time from randomization to study discontinuation due to symptom worsening during the four-week treatment-withdrawal phase. there was no statistically significant difference between pantoprazole sodium and placebo in the rate of discontinuation. in this trial, the adverse reactions that were reported more commonly (difference of ≥ 4%) in the treated population compared to the placebo population were elevated ck, otitis media, rhinitis, and laryngitis. in a population pharmacokinetic analysis, the systemic exposure was higher in patients less than 1 year of age with gerd compared to adults who received a single 40 mg dose (geometric mean auc was 103% higher in preterm infants and neonates receiving single dose of 2.5 mg of pantoprazole sodium, and 23% higher in infants 1 through 11 months of age receiving a single dose of approximately 1.2 mg/kg). in these patients, the apparent clearance (cl/f) increased with age (median clearance: 0.6 l/hr, range: 0.03 to 3.2 l/hr). these doses resulted in pharmacodynamic effects on gastric but not esophageal ph. following once daily dosing of 2.5 mg of pantoprazole sodium in preterm infants and neonates, there was an increase in the mean gastric ph (from 4.3 at baseline to 5.2 at steady-state) and in the mean % time that gastric ph was > 4 (from 60% at baseline to 80% at steady-state). following once daily dosing of approximately 1.2 mg/kg of pantoprazole sodium in infants 1 through 11 months of age, there was an increase in the mean gastric ph (from 3.1 at baseline to 4.2 at steady-state) and in the mean % time that gastric ph was > 4 (from 32% at baseline to 60% at steady-state). however, no significant changes were observed in mean intraesophageal ph or % time that esophageal ph was < 4 in either age group. because pantoprazole sodium was not shown to be effective in the randomized, placebo-controlled study in this age group, the use of pantoprazole sodium for treatment of symptomatic gerd in infants less than 1 year of age is not indicated. animal toxicity data in a pre- and post-natal development study in rats, the pups were administered oral doses of pantoprazole at 5, 15, and 30 mg/kg/day (approximately 1, 2.3, and 3.2 times the exposure (auc) in children aged 6 to 11 years at a dose of 40 mg) on postnatal day (pnd 4) through pnd 21, in addition to lactational exposure through milk. on pnd 21, decreased mean femur length and weight and changes in femur bone mass and geometry were observed in the offspring at 5 mg/kg/day (approximately equal exposures (auc) in children aged 6 to 11 years at the 40 mg dose) and higher doses. changes in bone parameters were partially reversible following a recovery period. in neonatal/juvenile animals (rats and dogs) toxicities were similar to those observed in adult animals, including gastric alterations, decreases in red cell mass, increases in lipids, enzyme induction and hepatocellular hypertrophy. an increased incidence of eosinophilic chief cells in adult and neonatal/juvenile rats, and atrophy of chief cells in adult rats and in neonatal/juvenile dogs, was observed in the fundic mucosa of stomachs in repeated-dose studies. full to partial recovery of these effects were noted in animals of both age groups following a recovery period. in short-term us clinical trials, ee healing rates in the 107 elderly patients (≥ 65 years old) treated with pantoprazole sodium were similar to those found in patients under the age of 65. the incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.

Bandaríkin - enska - NLM (National Library of Medicine)

epic pharma, llc - sulindac (unii: 184sns8vuh) (sulindac - unii:184sns8vuh) - sulindac 150 mg - carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). sulindac is indicated for acute or long-term use in the relief of signs and symptoms of the following: 1. osteoarthritis 2. rheumatoid arthritis** 3. ankylosing spondylitis 4. acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) 5. acute gouty arthritis **the safety and effectiveness of sulindac tablets usp have not been established in rheumatoid arthritis patients who are designated in the american rheumatism association classification as functional class iv (incapacitated, largely or wholly bedridden, or confined to wheelchair, little or no self-care). sulindac is contraindicated in patients with known hypersensitivity to sulindac or the excipients (see description ). sulindac should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic/anaphylactoid reactions to nsaids have been reported in such patients (see warnings – anaphylactic/anaphylactoid reactions , and precautions – preexisting asthma ). sulindac is contraindicated in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

Bandaríkin - enska - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see 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 efficacy of venla

Bandaríkin - enska - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see clinical studies (14)]. none. teratogenic effects pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. caut