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zydus pharmaceuticals usa inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 25 mg - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp 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 ven

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proficient rx lp - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 7.5 mg - meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see clinical studies (14.1)]. meloxicam tablet are indicated for relief of the signs and symptoms of rheumatoid arthritis [see clinical studies (14.1)]. meloxicam tablets are contraindicated in patients with known hypersensitivity (e.g. anaphylactoid reactions and serious skin reactions) to meloxicam. meloxicam tablets 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-like reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.13)]. meloxicam tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)]. there are no adequate and well-controlled studies in pregnant women. meloxicam crosses the placental barrier. prior to 30 weeks gestation, use meloxicam during

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pd-rx pharmaceuticals, inc. - clarithromycin (unii: h1250jik0a) (clarithromycin - unii:h1250jik0a) - clarithromycin 500 mg - clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , haemophilus parainfluenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage ( 1.9)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see indications and usage ( 1.9)] . clarithromycin tablets are indicated [see indications and usage ( 1.9)] for the treatment of mild to moderate infections caused by susceptible isolates due to: - haemophilus influenzae (in adults) - mycoplasma pneumoniae, streptococcus pneumoniae, chlamydophila pneumoniae (in adults and pediatric patients) clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to streptococcus pyogenes as an alternative in individuals who cannot use first line therapy. clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to staphylococcus aureus , or s treptococcus pyogenes . clarithromycin tablets are indicated in pediatric patients for the treatment of mild to moderate infections caused by susceptible isolates due to haemophilus influenzae , moraxella catarrhalis , or streptococcus pneumoniae [see clinical studies ( 14.2)] . clarithromycin tablets are indicated for the treatment of mild to moderate infections caused by susceptible isolates due to mycobacterium avium or myc obacterium intracellulare in patients with advanced hiv infection [see clinical studies ( 14.1 )] . clarithromycin tablets are given in combination with other drugs in adults as described below to eradicate h. pylori . the eradication of h. pylori has been demonstrated to reduce the risk of duodenal ulcer recurrence [see clinical studies ( 14.3 )] . - clarithromycin tablets in combination with amoxicillin and prevacid (lansoprazole) or prilosec (omeprazole) delayed-release capsules, as triple therapy, are indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or five-year history of duodenal ulcer) to eradicate h. pylori . - clarithromycin tablets in combination with prilosec (omeprazole) capsules are indicated for the treatment of patients with an active duodenal ulcer associated with h. pylori infection. regimens which contain clarithromycin tablets as the single antibacterial agent are more likely to be associated with the development of clarithromycin resistance among patients who fail therapy. clarithromycin-containing regimens should not be used in patients with known or suspected clarithromycin resistant isolates because the efficacy of treatment is reduced in this setting. there is resistance to macrolides in certain bacterial infections caused by streptococcus pneumoniae and staphylococcus aureus . susceptibility testing should be performed when clinically indicated. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see warnings and precautions ( 5.1)] . concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see drug interactions ( 7)] . there have been postmarketing reports of drug interactions when clarithromycin is co‑administered with cisapride or pimozide, resulting in cardiac arrhythmias (qt prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. fatalities have been reported. clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin. concomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment. concomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases [see warnings and precautions ( 5.4) and drug interactions ( 7)]. concomitant administration of clarithromycin tablets with hmg-coa reductase inhibitors (statins) that are extensively metabolized by cyp3a4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [see warnings and precautions ( 5.4) and drug interactions ( 7)]. concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated [see drug interactions ( 7)] . concomitant administration of clarithromycin and lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions [see drug interactions ( 7) ]. for information about contraindications of other drugs indicated in combination with clarithromycin tablets, refer to their full prescribing information (contraindications section). risk summary based on findings from animal studies, clarithromycin tablets are not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate. if pregnancy occurs while taking clarithromycin tablets, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions ( 5.7)]. limited data from a small number of published human studies with clarithromycin tablets use during pregnancy are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, administration of oral clarithromycin to pregnant mice, rats, rabbits, and monkeys during the period of organogenesis produced malformations in rats (cardiovascular anomalies) and mice (cleft palate) at clinically relevant doses based on body surface area comparison. fetal effects in mice, rats, and monkeys (e.g., reduced fetal survival, body weight, body weight gain) and implantation losses in rabbits were generally considered to be secondary to maternal toxicity (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. data animal data animal reproduction studies were conducted in mice, rats, rabbits, and monkeys with oral and intravenously administered clarithromycin. in pregnant mice, clarithromycin was administered during organogenesis (gestation day [gd] 6 to 15) at oral doses of 15, 60, 250, 500, or 1000 mg/kg/day. reduced body weight observed in dams at 1000 mg/kg/day (3 times the maximum recommended human dose [mrhd] based on body surface area comparison) resulted in reduced survival and body weight of the fetuses. at ≥ 500 mg/kg/day, increases in the incidence of post-implantation loss and cleft palate in the fetuses were observed. no adverse developmental effects were observed in mice at ≤ 250 mg/kg/day (≤ 1 times mrhd based on body surface area comparison). in pregnant sprague dawley rats, clarithromycin was administered during organogenesis (gd 6 to 15) at oral doses of 15, 50, or 150 mg/kg/day. reductions in body weight and food consumption was observed in dams at 150 mg/kg/day. increased resorptions and reduced body weight of the fetuses at this dose were considered secondary to maternal toxicity. additionally, at 150 mg/kg/day (1 times mrhd based on body surface area comparison), a low incidence of cardiovascular anomalies (complete situs inversus, undivided truncus, iv septal defect) was observed in the fetuses. clarithromycin did not cause adverse developmental effects in rats at 50 mg/kg/day (0.3 times mrhd based on body surface area comparison). intravenous dosing of clarithromycin during organogenesis in rats (gd 6 to 15) at 15, 50, or 160 mg/kg/day was associated with maternal toxicity (reduced body weight, body-weight gain, and food consumption) at 160 mg/kg/day but no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant wistar rat, clarithromycin was administered during organogenesis (gd 7 to 17) at oral doses of 10, 40, or 160 mg/kg/day. reduced body weight and food consumption were observed in dams at 160 mg/kg/day but there was no evidence of adverse developmental effects at any dose (≤ 1 times mrhd based on body surface area comparison). in pregnant rabbits, clarithromycin administered during organogenesis (gd 6 to 18) at oral doses of 10, 35, or 125 mg/kg/day resulted in reduced maternal food consumption and decreased body weight at the highest dose, with no evidence of any adverse developmental effects at any dose (≤ 2 times mrhd based on body surface area comparison). intravenously administered clarithromycin to pregnant rabbits during organogenesis (gd 6 to 18) in rabbits at 20, 40, 80, or 160 mg/kg/day (≥ 0.3 times mrhd based on body surface area comparison) resulted in maternal toxicity and implantation losses at all doses. in pregnant monkeys, clarithromycin was administered (gd 20 to 50) at oral doses of 35 or 70 mg/kg/day. dose-dependent emesis, poor appetite, fecal changes, and reduced body weight were observed in dams at all doses (≥ 0.5 times mrhd based on body surface area comparison). growth retardation in 1 fetus at 70 mg/kg/day was considered secondary to maternal toxicity. there was no evidence of primary drug related adverse developmental effects at any dose tested. in a reproductive toxicology study in rats administered oral clarithromycin late in gestation through lactation (gd 17 to post-natal day 21) at doses of 10, 40, or 160 mg/kg/day (≤ 1 times mrhd based on body surface area comparison), reductions in maternal body weight and food consumption were observed at 160 mg/kg/day. reduced body-weight gain observed in offspring at 160 mg/kg/day was considered secondary to maternal toxicity. no adverse developmental effects were observed with clarithromycin at any dose tested. risk summary based on limited human data, clarithromycin and its active metabolite 14-oh clarithromycin are present in human milk at less than 2% of the maternal weight-adjusted dose (see data). in a separate observational study, reported adverse effects on breast-fed children (rash, diarrhea, loss of appetite, somnolence) were comparable to amoxicillin (see data). no data are available to assess the effects of clarithromycin or 14-oh clarithromycin on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for clarithromycin tablets and any potential adverse effects on the breast-fed child from clarithromycin tablets or from the underlying maternal condition. data human serum and milk samples were obtained after 3 days of treatment, at steady state, from one published study of 12 lactating women who were taking clarithromycin tablets 250 mg orally twice daily. based on the limited data from this study, and assuming milk consumption of 150 ml/kg/day, an exclusively human milk fed infant would receive an estimated average of 136 mcg/kg/day of clarithromycin and its active metabolite, with this maternal dosage regimen. this is less than 2% of the maternal weight-adjusted dose (7.8 mg/kg/day, based on the average maternal weight of 64 kg), and less than 1% of the pediatric dose (15 mg/kg/day) for children greater than 6 months of age. a prospective observational study of 55 breastfed infants of mothers taking a macrolide antibacterial (6 were exposed to clarithromycin) were compared to 36 breastfed infants of mothers taking amoxicillin. adverse reactions were comparable in both groups. adverse reactions occurred in 12.7% of infants exposed to macrolides and included rash, diarrhea, loss of appetite, and somnolence. males administration of clarithromycin resulted in testicular atrophy in rats, dogs and monkeys [see nonclinical toxicology ( 13.1)]. the safety and effectiveness of clarithromycin tablets have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older. use in these indications is based on clinical trials in pediatric patients or adequate and well- controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients: - pharyngitis/tonsillitis - community-acquired pneumonia - acute maxillary sinusitis - acute otitis media [see clinical studies ( 14.2 )] - uncomplicated skin and skin structure infections the safety and effectiveness of clarithromycin tablets have been established for the prevention of disseminated mycobacterium avium complex (mac) disease in pediatric patients 20 months and older with advanced hiv infection. no studies of clarithromycin tablets for mac prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from mac pediatric treatment studies. safety and effectiveness of clarithromycin in pediatric patients under 6 months of age have not been established. the safety of clarithromycin has not been studied in mac patients under the age of 20 months. in a steady-state study in which healthy elderly subjects (65 years to 81 years of age) were given 500 mg of clarithromycin tablets every 12 hours, the maximum serum concentrations and area under the curves of clarithromycin and 14-oh clarithromycin were increased compared to those achieved in healthy young adults. these changes in pharmacokinetics parallel known age-related decreases in renal function. in clinical trials, elderly patients did not have an increased incidence of adverse reactions when compared to younger patients. consider dosage adjustment in elderly patients with severe renal impairment. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [see warnings and precautions ( 5.3)] . most reports of acute kidney injury with calcium channel blockers metabolized by cyp3a4 (e.g., verapamil, amlodipine, diltiazem, nifedipine) involved elderly patients 65 years of age or older [see warnings and precautions ( 5.4)] . especially in elderly patients, there have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, some of which occurred in patients with renal insufficiency. deaths have been reported in some patients [see contraindications ( 4.4) and warnings and precautions ( 5.4)] . clarithromycin tablets are principally excreted via the liver and kidney. clarithromycin tablets may be administered without dosage adjustment to patients with hepatic impairment and normal renal function. however, in the presence of severe renal impairment with or without coexisting hepatic impairment, decreased dosage or prolonged dosing intervals may be appropriate [see dosage and administration ( 2.5 )] .

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contract pharmacy services-pa - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. the efficacy of divalproex sodium was established in 3 week trials with patients meeting dsm-iii-r criteria for bipolar disorder who were hospitalized for acute mania [see clinical studies ( 14.1)] . the safety and effectiveness of divalproex sodium for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. therefore, healthcare providers who elect to use divalproex sodium for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. divalproex sodium

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rebel distributors corp. - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine 15 mg - amrix is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, and limitation of motion. amrix should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. amrix has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy. - hypersensitivity to any component of this product. - concomitant use of monoamine oxidase (mao) inhibitors or within 14 days after their discontinuation. - hyperpyretic crisis seizures and deaths have occurred in patients receiving cyclobenzaprine (or

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pd-rx pharmaceuticals, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients  - who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see warnings and precautions ( 5.1)] .  - with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (

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aidarex pharmaceuticals llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)]. the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.2)]. pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. zolpidem tartrate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. administration of zolpidem to pregnant rats and rabbits resul

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vivus llc - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp), topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - phentermine 3.75 mg - qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: - adults with an initial body mass index (bmi) of: 30 kg/m 2 or greater (obese), or 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia - 30 kg/m 2 or greater (obese), or - 27 kg/m 2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia - pediatric patients aged 12 years and older with an initial bmi in the 95 th percentile or greater standardized for age and sex. limitations of use - the effect of qsymia on cardiovascular morbidity and mortality has not been established. - the safety and effectiveness of qsymia in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. qsymia is contraindicated in patients: - who are pregnant [see warnings and precautions (5.1)and use in specific populations (8.1)] - with glaucoma [see warnings and precautions (5.4)] - with hyperthyroidism - taking or within 14 days of stopping a monoamine oxidase inhibitors [see drug interactions (7)] - with known hypersensitivity to phentermine, topiramate or excipient in qsymia, or idiosyncrasy to the sympathomimetic amines [see adverse reactions (6.2)]. risk summary qsymia is contraindicated in pregnant patients. the use of qsymia can cause fetal harm, and weight loss offers no clear clinical benefit to a pregnant patient (see clinical considerations) . available data from pregnancy registries and epidemiologic studies indicate an increased risk of major congenital malformations, including but not limited to cleft lip and/or cleft palate (oral clefts), and of being sga in infants exposed in utero to topiramate (see data) . when phentermine and topiramate were co-administered to rats at doses of 3.75 and 25 mg/kg, respectively [approximately 2 times the maximum recommended human dose (mrhd) based on area under the curve (auc)], or at the same dose to rabbits (approximately 0.1 times and 1 time, respectively, the clinical exposures at the mrhd based on auc), there were no drug-related malformations. however, structural malformations, including craniofacial defects and reduced fetal weights occurred in offspring of multiple species of pregnant animals administered topiramate at clinically relevant doses (see data) . advise pregnant women of the potential risk to a fetus. clinical considerations disease associated maternal and/or embryo/fetal risk weight loss during pregnancy may result in fetal harm. appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. maternal obesity increases the risk for congenital malformations, including neural tube defects, cardiac malformations, oral clefts, and limb reduction defects. fetal/neonatal adverse reactions qsymia can cause metabolic acidosis [see warnings and precautions (5.8)] . the effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the fetus' ability to tolerate labor. data human data data evaluating the risk of major congenital malformations, oral clefts, and being sga with topiramate exposure during pregnancy is available from the north american antiepileptic drug (naaed) pregnancy registry and from several larger retrospective epidemiologic studies. major congenital malformations the naaed pregnancy registry indicates an increased risk of major congenital malformations, including but not limited to oral clefts in infants exposed to topiramate during the first trimester of pregnancy. other than oral clefts, no specific pattern of major congenital malformations or grouping of major congenital malformation types were observed. in the naaed pregnancy registry, when topiramate-exposed infants with only oral clefts were excluded, the prevalence of major congenital malformations (4.1%) was higher than that in infants exposed to a reference antiepileptic drug (aed) (1.8%) or in infants with mothers without epilepsy and without exposure to aeds (1.1%). oral clefts in the naaed pregnancy registry, the prevalence of oral clefts among topiramate-exposed infants (1.4%) was higher than the prevalence in infants exposed to a reference aed (0.3%) or the prevalence in infants with mothers without epilepsy and without exposure to aeds (0.11%). it was also higher than the background prevalence in united states (0.17%) as estimated by the centers for disease control and prevention (cdc). the relative risk of oral clefts in topiramate-exposed pregnancies in the naaed pregnancy registry was 12.5 (95% confidence interval [ci] 5.9-26.37) as compared to the risk in a background population of untreated women. the uk epilepsy and pregnancy register reported a prevalence of oral clefts among infants exposed to topiramate monotherapy (3.2%) that was 16 times higher than the background rate in the uk (0.2%). larger retrospective epidemiology studies showed that topiramate monotherapy exposure in pregnancy is associated with an approximately two to five-fold increased risk of oral clefts. the fortress study found an excess risk of 1.5 (95% ci = -1.1 to 4.1) oral cleft cases per 1,000 infants exposed to topiramate during the first trimester. small for gestational age data from the naaed pregnancy registry and population-based birth registry cohort indicate that exposure to topiramate in utero is associated with an increased risk of sga newborns (birth weight <10 th percentile). in the naaed pregnancy registry, 19.7% of topiramate-exposed newborns were sga compared to 7.9% of newborns exposed to a reference aed and 5.4% of newborns of mothers without epilepsy and without aed exposure. in the medical birth registry of norway, a population-based pregnancy registry, 25% of newborns in the topiramate monotherapy exposure group were sga compared to 9% in the comparison group unexposed to aeds. the long-term consequences of the sga findings are not known. animal data phentermine/topiramate embryo-fetal development studies have been conducted in rats and rabbits with combination phentermine and topiramate treatment. phentermine and topiramate co-administered to rats during the period of organogenesis (gestation day (gd) 6 through 17) caused reduced fetal body weights but did not cause fetal malformations at the maximum dose of 3.75 mg/kg phentermine and 25 mg/kg topiramate [approximately 2 times the maximum recommended human dose (mrhd) based on area under the curve (auc) estimates for each active ingredient]. in a similar study in rabbits in which the same doses were administered from gd 6 through 18, no effects on embryo-fetal development were observed at approximately 0.1 times (phentermine) and 1 time (topiramate) clinical exposures at the mrhd based on auc. significantly lower maternal body weight gain was recorded at these doses in rats and rabbits. a pre- and post-natal development study was conducted in rats with combination phentermine and topiramate treatment. there were no adverse maternal or offspring effects in rats treated throughout organogenesis and lactation with 1.5 mg/kg/day phentermine and 10 mg/kg/day topiramate (approximately 2- and 3-times clinical exposures at the mrhd, respectively, based on auc). treatment with higher doses of 11.25 mg/kg/day phentermine and 75 mg/kg/day topiramate (approximately 5 and 6 times maximum clinical doses based on auc, respectively) caused reduced maternal body weight gain and offspring toxicity. offspring effects included lower pup survival after birth, increased limb and tail malformations, reduced pup body weight and delayed growth, development, and sexual maturation without affecting learning, memory, or fertility and reproduction. the limb and tail malformations were consistent with results of animal studies conducted with topiramate alone. phentermine animal reproduction studies have not been conducted with phentermine. limited data from studies conducted with the phentermine/topiramate combination indicate that phentermine alone was not teratogenic but resulted in lower body weight and reduced survival of offspring in rats at 5-fold the mrhd of qsymia, based on auc. topiramate topiramate causes developmental toxicity, including teratogenicity, at clinically relevant doses in multiple animal species. developmental toxicity, including teratogenicity, occurred at clinically relevant doses in multiple animal species in which topiramate was administered during the period of organogenesis (gd 6 – 15 in rodents, gd 6 – 18 in rabbits. in these studies, fetal malformations (primarily craniofacial defects such as cleft palate), limb malformations (ectrodactyly, micromelia, and amelia), rib/vertebral column anomalies, and/or reduced fetal weights were observed at dosages ≥ 20 mg/kg in mice (approximately 2 times the mrhd of topiramate in qsymia 15 mg/92 mg on a mg/m 2 basis), 20 mg/kg in rats (2 times the mrhd of qsymia based on estimated auc), and 35 mg/kg in rabbits (2 times the mrhd based on estimated auc). when rats were administered topiramate from gd 15 through lactation day 20, reductions in pre- and/or post-weaning weights occurred at dosages ≥ 2 mg/kg (2 times the mrhd of qsymia based on estimated auc). risk summary topiramate and phentermine are present in human milk. there are no data on the effects of topiramate and phentermine on milk production. diarrhea and somnolence have been reported in breastfed infants with maternal use of topiramate. there are no data on the effects of phentermine in breastfed infants. because of the potential for serious adverse reactions, including changes in sleep, irritability, hypertension, vomiting, tremor, and weight loss in breastfed infants with maternal use of phentermine, advise patients that breastfeeding is not recommended during qsymia therapy. pregnancy testing pregnancy testing is recommended in patients who can become pregnant before initiating qsymia and monthly during qsymia therapy [see warnings and precautions (5.1), use in specific populations (8.1)] . contraception females qsymia can cause fetal harm when administered to a pregnant patient [see use in specific populations (8.1) ]. advise patients who can become pregnant to use effective contraception during therapy with qsymia. for patients taking combined oral contraceptives (cocs), use of qsymia may cause irregular bleeding [see drug interactions (7)] . advise patients not to discontinue taking their coc and to contact their healthcare provider. the safety and effectiveness of qsymia as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with a bmi in the 95th percentile or greater standardized for age and sex have been established. use of qsymia for this indication is supported by a 56-week, double-blind, placebo-controlled study in 223 pediatric patients aged 12 years and above, a pharmacokinetic study in pediatric patients, and studies in adults with obesity [see clinical pharmacology (12.3)and clinical studies (14)] . in a pediatric clinical trial, there was one episode of serious suicidal ideation in a qsymia-treated patient requiring hospitalization and pharmacologic treatment [see warnings and precautions (5.3)] ; more patients treated with qsymia versus placebo reported adverse reactions related to mood (e.g., depression, anxiety) and sleep disorders (e.g., insomnia) [see warnings and precautions (5.5)] . increases in bone mineral density and linear growth were attenuated in qsymia- versus placebo-treated patients [see warnings and precautions (5.7)] . serious adverse reactions seen in pediatric patients using topiramate include acute angle glaucoma, oligohidrosis and hyperthermia, metabolic acidosis, cognitive and neuropsychiatric reactions, hyperammonemia and encephalopathy, and kidney stones. the safety and effectiveness of qsymia in pediatric patients below the age of 12 years have not been established. in the qsymia clinical trials, a total of 254 (7%) of the patients were 65 to 69 years of age; no patients 70 years of age or older were enrolled. clinical studies of qsymia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting 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. compared to healthy volunteers with normal renal function, patients with moderate and severe renal impairment as estimated by the cockcroft-gault equation had higher exposures to phentermine and topiramate. the recommended dosage of qsymia in patients with mild renal impairment (crcl greater or equal to 50 and less than 80 ml/min) is the same as the recommended dosage for patients with normal renal function. in patients with moderate (crcl greater than or equal to 30 to less than 50 ml/min) and severe (crcl less than 30 ml/min) renal impairment, the maximum recommended dosage is qsymia 7.5 mg/46 mg once daily. qsymia has not been studied in patients with end-stage renal disease on dialysis. avoid qsymia in this patient population [see dosage and administration (2.5)and clinical pharmacology (12.3)] . in patients with mild (child-pugh 5 - 6) and moderate (child-pugh 7 - 9) hepatic impairment, exposure to phentermine was higher compared to healthy volunteers with normal hepatic function. exposure to topiramate was similar among patients with mild and moderate hepatic impairment and healthy volunteers. the recommended dosage of qsymia in patients with mild hepatic impairment (child-pugh 5 - 6) is the same as the recommended dosage in patients with normal hepatic function. in patients with moderate hepatic impairment, the maximum recommended dosage is qsymia 7.5 mg/46 mg once daily. qsymia has not been studied in patients with severe hepatic impairment (child-pugh score 10 - 15). avoid qsymia in this patient population [see dosage and administration (2.6)and clinical pharmacology (12.3)] . qsymia contains phentermine, a schedule iv controlled substance, and topiramate, which is not a controlled substance. phentermine has a known potential for abuse. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. phentermine is related chemically and pharmacologically to amphetamines. amphetamines and other stimulant drugs have been extensively abused. abuse of amphetamines and related drugs (e.g., phentermine) may be associated with impaired control over drug use and severe social dysfunction. there are reports of patients who have increased the dosage of these drugs to many times higher than recommended. assess the risk of abuse prior to prescribing qsymia as part of a chronic weight management program. physical dependence may occur in patients treated with qsymia. 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. the following adverse reactions have been associated with the abrupt discontinuation of the individual components of qsymia: - for topiramate, abrupt discontinuation has been associated with seizures in patients without a history of seizures or epilepsy [see warnings and precautions (5.12)] . - for phentermine, abrupt discontinuation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on a sleep electroencephalogram. thus, in situations where rapid withdrawal of qsymia is required, appropriate medical monitoring is recommended. patients discontinuing qsymia 15 mg/92 mg should be gradually tapered to reduce the possibility of precipitating a seizure [see dosage and administration (2.4)] .

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

aurobindo pharma limited - didanosine (unii: k3gdh6oh08) (didanosine - unii:k3gdh6oh08) - didanosine 125 mg - didanosine delayed-release capsules, also known as ddi, in combination with other antiretroviral agents are indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ] . didanosine delayed-release capsules are contraindicated when coadministered with the following medications: - stavudine- potential for serious and/or life-threatening events, notably pancreatitis, lactic acidosis, hepatotoxicity, and peripheral neuropathy [see warnings and precautions (5.1, 5.2, 5.3, 5.5)] . - allopurinol- systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity [see clinical pharmacology (12.3) ]. - ribavirin- exposures of the active metabolite of didanosine (dideoxyadenosine 5′-triphosphate) are increased. fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin. pregnancy exposure registry there is a preg

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

pd-rx pharmaceuticals, inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 20 mg - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance