Amerika Serikat - Inggris - NLM (National Library of Medicine)

mylan institutional inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.5 mg - clonazepam tablets are useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. in some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. in some cases, dosage adjustment may reestablish efficacy. clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir category of panic disorder (see

Amerika Serikat - Inggris - NLM (National Library of Medicine)

par pharmaceutical - penicillin v potassium (unii: 146t0tu1jb) (penicillin v - unii:z61i075u2w) - penicillin v 250 mg - penicillin v potassium tablets, usp and penicillin v potassium for oral solution, usp, are indicated in the treatment of mild to moderately severe infections due to penicillin g- sensitive microorganisms. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. note: severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin v during the acute stage. indicated surgical procedures should be performed. the following infections will usually respond to adequate dosage of penicillin v: streptococcal infections (without bacteremia): mild-to-moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. note: streptococci in groups a, c, g, h, l, and m are very sensitive to penicillin. other groups, including group d (enterococcus) are resistant. pneumococcal infections : mild to moderately severe infections of the respiratory tract. staphylococcal infections - penicillin g sensi

Amerika Serikat - Inggris - NLM (National Library of Medicine)

par pharmaceutical - ampicillin trihydrate (unii: hxq6a1n7r6) (ampicillin - unii:7c782967rd) - ampicillin 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules, ampicillin for oral suspension and other antibacterial drugs, ampicillin capsules and ampicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.  when culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy. ampicillin capsules and ampicillin for oral suspension are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below: infections of the genitourinary tract including gonorrhea - e. coli, p. mirabilis , enterococci, shigella, s. typhosa and other salmonella and nonpenicillinase-producing n. gonorrhoeae . infections of the respiratory tract - nonpenicillinase-producing

Amerika Serikat - Inggris - NLM (National Library of Medicine)

acetris health, llc - cefuroxime axetil (unii: z49qdt0j8z) (cefuroxime - unii:o1r9fj93ed) - cefuroxime 250 mg - cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of streptococcus pyogenes . limitations of use - the efficacy of cefuroxime axetil tablets in the prevention of rheumatic fever was not established in clinical trials. - the efficacy of cefuroxime axetil tablets in the treatment of penicillin-resistant strains of streptococcus pyogenes has not been demonstrated in clinical trials. cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of streptococcus pneumoniae, haemophilus influenzae (including β-lactamase–producing strains), moraxella catarrhalis (including β-lactamase–producing strains), or streptococcus pyogenes . cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-mode

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

stallergenes greer new zealand ltd - allergen extracts 10 ir/ml (d. glomerate (20%), f. elatior (20%), l. perenne (20%), a. odoratum (20%), p. pratense (20%) extract) - solution for injection - 10 ir/ml - active: allergen extracts 10 ir/ml (d. glomerate (20%), f. elatior (20%), l. perenne (20%), a. odoratum (20%), p. pratense (20%) extract) excipient: aluminium hydroxide gel mannitol phenol sodium chloride water - alustal treatment is indicated for patients with type 1 allergy (gell and coombs classification), particularly presenting as seasonal or perennial rhinitis, conjunctivitis, rhinoconjunctivitis with or without associated asthma.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

mylan institutional inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam 5 mg - diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodi

Amerika Serikat - Inggris - NLM (National Library of Medicine)

novitium pharma llc - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam is indicated for management of osteoarthritis pain. meloxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summary use of nsaids, including meloxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of meloxicam use between about 20 and 30 weeks of gestation, and avoid meloxicam use at about 30 weeks of gestation and later in

Amerika Serikat - Inggris - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets are indicated for the: methadone hydrochloride tablets are contraindicated in patients with: risk summary the majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the children of women who take methadone during pregnancy. information is limited regarding dose and duration of methadone use during pregnancy, and most maternal exposure in these studies appears to occur after the first trimester of pregnancy (see data ). neonatal opioid withdrawal syndrome (nows) is an expected and treatable outcome of use of opioids for an extended period of time during pregnancy [see warnings and precautions (5.5)]. in published animal reproduction studies, methadone administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) in the hamster at doses 2 times the human daily oral dose of 120 mg/day on a mg/m2 basis (hdd) and in mice at doses equivalent to the hdd. administration of methadone to pregnant animals during organogenesis and through lactation resulted decreased litter size, increased pup mortality, decreased pup body weights, developmental delays, and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the hdd. administration of methadone to male rodents prior to mating with untreated females resulted in increased neonatal mortality and significant differences in behavioral tests in the offspring at exposures comparable to and less than the hdd (see data ). based on animal data, advise pregnant women of the potential risk to a fetus. 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. clinical considerations disease-associated maternal and embryo-fetal risk: untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. in addition, untreated opioid addiction often results in continued or relapsing illicit opioid use. dosage adjustment during pregnancy: dosage adjustment using higher doses or administering the daily dose in divided doses may be necessary in pregnant women treated with methadone hydrochloride tablets. pregnant women appear to have significantly lower trough plasma methadone concentrations, increased plasma methadone clearance, and shorter methadone half-life than after delivery [see dosage and administration (2.9) and clinical pharmacology (12.3)] . withdrawal signs and symptoms should be closely monitored and the dose adjusted as necessary. fetal/neonatal adverse reactions: neonatal opioid withdrawal syndrome may occur in newborn infants of mothers who are receiving treatment with methadone hydrochloride tablets. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight. signs of neonatal withdrawal usually occur in the first days after birth. the duration and severity of neonatal opioid withdrawal syndrome may vary. observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.5)] . labor or delivery: opioid-dependent women on methadone maintenance therapy may require additional analgesia during labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data human data: the majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. findings regarding specific major malformations, decreased fetal growth, premature birth and sudden infant death syndrome have been inconsistent. children prenatally exposed to methadone have been reported to demonstrate mild but persistent deficits in performance on psychometric and behavioral tests and visual abnormalities. in a multicenter, double-blind, randomized, controlled trial [maternal opioid treatment: human experimental research (mother)] designed primarily to assess neonatal opioid withdrawal effects, opioid-dependent pregnant women were randomized to buprenorphine (n=86) or methadone (n=89) treatment, with enrollment at an average gestational age of 18.7 weeks in both groups. a total of 28 of the 86 women in the buprenorphine group (33%) and 16 of the 89 women in the methadone group (18%) discontinued treatment before the end of pregnancy. among women who remained in treatment until delivery, there was no difference between methadone-treated and buprenorphine-treated groups in the number of neonates requiring nows treatment or in the peak severity of nows. buprenorphine-exposed neonates required less morphine (mean total dose, 1.1 mg vs. 10.4 mg), had shorter hospital stays (10.0 days vs. 17.5 days), and shorter duration of treatment for nows (4.1 days vs. 9.9 days) compared to the methadone-exposed group. there were no differences between groups in other primary outcomes (neonatal head circumference,) or secondary outcomes (weight and length at birth, preterm birth, gestational age at delivery, and 1-minute and 5-minute apgar scores), or in the rates of maternal or neonatal adverse events. the outcomes among mothers who discontinued treatment before delivery and may have relapsed to illicit opioid use are not known. because of the imbalance in discontinuation rates between the methadone and buprenorphine groups, the study findings are difficult to interpret. animal data: formal reproductive and developmental toxicology studies for methadone have not been conducted. exposure margins for the following published study reports are based on a human daily dose (hdd) of 120 mg methadone using a body surface area comparison. in a published study in pregnant hamsters, a single subcutaneous dose of methadone ranging from 31 mg/kg (2 times the hdd) to 185 mg/kg on gestation day 8 resulted in a decrease in the number of fetuses per litter and an increase in the percentage of fetuses exhibiting neural tube defects including exencephaly, cranioschisis, and “various other lesions.” the majority of the doses tested also resulted in maternal death. in a study in pregnant jbt/jd mice, a single subcutaneous dose of 22 to 24 mg/kg methadone (approximately equivalent to the hdd) administered on gestation day 9 produced exencephaly in 11% of the embryos. in another study in pregnant mice, subcutaneous doses up to 28 mg/kg/day methadone (equivalent to the hdd) administered from gestation day 6 to 15 resulted in no malformations, but there were increased postimplantation loss and decreased live fetuses at 10 mg/kg/day or greater (0.4 times the hdd) and decreased ossification and fetal body weight at 20 mg/kg/day or greater (0.8 times the hdd). in a second study of pregnant mice dosed with subcutaneous doses up to 28 mg/kg/day methadone from gestation day 6 to 15, there was decreased pup viability, delayed onset of development of negative phototaxis and eye opening, increased righting reflexes at 5 mg/kg/day or greater (0.2 times the hdd), and decreased number of live pups at birth and decreased pup weight gain at 20 mg/kg/day or greater (0.8 times the hdd). no effects were reported in a study of pregnant rats and rabbits at oral doses up to 40 mg/kg (3 and 6 times, respectively, the hdd) administered from gestation days 6 to 15 and 6 to 18, respectively. when pregnant rats were treated with intraperitoneal doses of 2.5, 5, or 7.5 mg/kg methadone from one week prior to mating, through gestation until the end of lactation period, 5 mg/kg or greater (0.4 times the hdd) methadone resulted in decreases in litter size and live pups born and 7.5 mg/kg (0.6 times the hdd) resulted in decreased birth weights. furthermore, decreased pup viability and pup body weight gain at 2.5 mg/kg or greater (0.2 times the hdd) were noted during the preweaning period. additional animal data demonstrate evidence for neurochemical changes in the brains of offspring from methadone-treated pregnant rats, including changes to the cholinergic, dopaminergic, noradrenergic and serotonergic systems at doses below the hdd. other animal studies have reported that prenatal and/or postnatal exposure to opioids including methadone alters neuronal development and behavior in the offspring including alterations in learning ability, motor activity, thermal regulation, nociceptive responses, and sensitivity to drugs at doses below the hdd. treatment of pregnant rats subcutaneously with 5 mg/kg methadone from gestation day 14 to 19 (0.4 times the hdd) reduced fetal blood testosterone and androstenedione in males. published animal data have reported increased neonatal mortality in the offspring of male rodents that were treated with methadone at doses comparable to and less than the hdd for 1 to 12 days before and/or during mating (with more pronounced effects in the first 4 days). in these studies, the female rodents were not treated with methadone, indicating paternally-mediated developmental toxicity. specifically, methadone administered to the male rat prior to mating with methadone-naïve females resulted in decreased weight gain in progeny after weaning. the male progeny demonstrated reduced thymus weights, whereas the female progeny demonstrated increased adrenal weights. behavioral testing of these male and female progeny revealed significant differences in behavioral tests compared to control animals, suggesting that paternal methadone exposure can produce physiological and behavioral changes in progeny in this model. examination of uterine contents of methadone-naïve female mice bred to methadone-treated male mice (once a day for three consecutive days) indicated that methadone treatment produced an increase in the rate of preimplantation deaths in all post-meiotic states at 1 mg/kg/day or greater (0.04 times the hdd). chromosome analysis revealed a dose-dependent increase in the frequency of chromosomal abnormalities at 1 mg/kg/day or greater. studies demonstrated that methadone treatment of male rats for 21 to 32 days prior to mating with methadone-naïve females did not produce any adverse effects, suggesting that prolonged methadone treatment of the male rat resulted in tolerance to the developmental toxicities noted in the progeny. mechanistic studies in this rat model suggest that the developmental effects of “paternal” methadone on the progeny appear to be due to decreased testosterone production. these animal data mirror the reported clinical findings of decreased testosterone levels in human males on methadone maintenance therapy for opioid addiction and in males receiving chronic intraspinal opioids. risk summary based on two small clinical studies, methadone was present in low levels in human milk, but the exposed infants in these studies did not show adverse reactions. based on an average milk consumption of 150 ml/kg/day, an infant would consume approximately 17.4 mcg/kg/day which is approximately 2 to 3% of the oral maternal dose. there have been rare case reports of sedation and respiratory depression in infants exposed to methadone through breast milk (see data ). monitor infants exposed to methadone through breastmilk for excess sedation and respiratory depression. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for methadone and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. data in a study of ten breastfeeding women maintained on oral methadone doses of 10 to 80 mg/day, methadone concentrations from 50 to 570 mcg/l in milk were reported, which, in the majority of samples, were lower than maternal serum drug concentrations at steady state. peak methadone levels in milk occur approximately 4 to 5 hours after an oral dose. in a study of twelve breastfeeding women maintained on oral methadone doses of 20 to 80 mg/day, methadone concentrations from 39 to 232 mcg/l in milk were reported. based on an average milk consumption of 150 ml/kg/day, an infant would consume approximately 17.4 mcg/kg/day, which is approximately 2 to 3% of the oral maternal dose. methadone has been detected in very low plasma concentrations in some infants whose mothers were taking methadone. infertility the effect of methadone on fertility is unknown. use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6), clinical pharmacology (12.2), nonclinical pharmacology (13.1)] . reproductive function in human males may be decreased by methadone treatment. reductions in ejaculate volume and seminal vesicle and prostate secretions have been reported in methadone-treated individuals. in addition, reductions in serum testosterone levels and sperm motility, and abnormalities in sperm morphology have been reported. in published animal studies, methadone produces a significant regression of sex accessory organs and testes of male mice and rats and administration of methadone to pregnant rats reduced fetal blood testosterone and androstenedione in male offspring [see nonclinical toxicology (13)]. the safety, effectiveness, and pharmacokinetics of methadone in pediatric patients below the age of 18 years have not been established. clinical studies of methadone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently compared to younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients. elderly patients (aged 65 years or older) may have increased sensitivity to methadone. in general, use caution when selecting a dosage for an elderly patient, 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. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of methadone hydrochloride tablets slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.10)] . methadone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug 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. methadone pharmacokinetics have not been extensively evaluated in patients with hepatic insufficiency. methadone is metabolized by hepatic pathways; therefore, patients with liver impairment may be at risk of increased systemic exposure to methadone after multiple dosing. start these patients on lower doses and titrate slowly while carefully monitoring for signs of respiratory and central nervous system depression. methadone pharmacokinetics have not been extensively evaluated in patients with renal insufficiency. since unmetabolized methadone and its metabolites are excreted in urine to a variable degree, start these patients on lower doses and with longer dosing intervals and titrate slowly while carefully monitoring for signs of respiratory and central nervous system depression. methadone hydrochloride tablets contain methadone, a schedule ii controlled substance. methadone hydrochloride tablets contain methadone, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions ( 5.1 )] . misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of methadone hydrochloride tablets increase risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of methadone hydrochloride tablets with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of methadone hydrochloride tablets abuse include those with a history of prolonged use of any opioids, including products containing methadone, those with a history of drug or alcohol abuse, or those who use methadone hydrochloride tablets in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. methadone hydrochloride tablets, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of methadone hydrochloride tablets abuse of methadone hydrochloride tablets poses a risk of overdose and death. the risk is increased with concurrent use of methadone hydrochloride tablets with alcohol and/or other cns depressants. methadone hydrochloride tablets are approved for oral use only. inappropriate intravenous, intramuscular, or subcutaneous use of methadone hydrochloride tablets can result in death, local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, and embolism. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a 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. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue methadone hydrochloride tablets in a patient physically dependent on opioids. rapid tapering of methadone hydrochloride tablets in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing methadone hydrochloride tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of methadone hydrochloride tablets the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration ( 2.6 ), and warnings and precautions (5.16)] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] .

Amerika Serikat - Inggris - NLM (National Library of Medicine)

novitium pharma llc - fluphenazine hydrochloride (unii: zou145w1xl) (fluphenazine - unii:s79426a41z) - fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation. phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states.  the presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

janssen biotech, inc. - daratumumab (unii: 4z63yk6e0e) (daratumumab - unii:4z63yk6e0e) - daratumumab 100 mg in 5 ml - darzalex is indicated for the treatment of adult patients with multiple myeloma: - in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. - in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. - in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant. - in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. - in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. - in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. - as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are double-refractory to a pi and an immunomodulatory agent. darzalex is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylactic reactions) to daratumumab or any of the components of the formulation [see warnings and precautions (5.1)] . risk summary darzalex can cause fetal harm when administered to a pregnant woman. the assessment of associated risks with daratumumab products is based on the mechanism of action and data from target antigen cd38 knockout animal models (see data) . there are no available data on the use of darzalex in pregnant women to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted. 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. the combination of darzalex and lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child. lenalidomide, pomalidomide, and thalidomide are only available through a rems program. refer to the lenalidomide, pomalidomide, or thalidomide prescribing information on use during pregnancy. clinical considerations fetal/neonatal adverse reactions immunoglobulin g1 (igg1) monoclonal antibodies are transferred across the placenta. based on its mechanism of action, darzalex may cause depletion of fetal cd38 positive immune cells and decreased bone density. defer administering live vaccines to neonates and infants exposed to darzalex in utero until a hematology evaluation is completed. data animal data mice that were genetically modified to eliminate all cd38 expression (cd38 knockout mice) had reduced bone density at birth that recovered by 5 months of age. data from studies using cd38 knockout animal models also suggest the involvement of cd38 in regulating humoral immune responses (mice), feto-maternal immune tolerance (mice), and early embryonic development (frogs). risk summary there is no data on the presence of daratumumab in human milk, the effects on the breastfed child, or the effects on milk production. maternal immunoglobulin g is known to be present in human milk. published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. because of the potential for serious adverse reactions in the breastfed child when darzalex is administered with lenalidomide, pomalidomide, or thalidomide, advise women not to breastfeed during treatment with darzalex. refer to lenalidomide, pomalidomide, or thalidomide prescribing information for additional information. darzalex can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing with the combination of darzalex with lenalidomide, pomalidomide, or thalidomide, refer to the lenalidomide, pomalidomide, or thalidomide labeling for pregnancy testing requirements prior to initiating treatment in females of reproductive potential. contraception advise females of reproductive potential to use effective contraception during treatment with darzalex and for 3 months after the last dose. additionally, refer to the lenalidomide, pomalidomide, or thalidomide labeling for additional recommendations for contraception. safety and effectiveness of darzalex in pediatric patients have not been established. of the 2,459 patients who received darzalex at the recommended dose, 38% were 65 to 74 years of age, and 15% were 75 years of age or older. no overall differences in effectiveness were observed between these patients and younger patients. the incidence of serious adverse reactions was higher in older than in younger patients [see adverse reactions (6.1)] . among patients with relapsed and refractory multiple myeloma (n=1,213), the serious adverse reactions that occurred more frequently in patients 65 years and older were pneumonia and sepsis. within the dkd group in candor, fatal adverse reactions occurred in 14% of patients 65 years and older compared to 6% of patients less than 65 years. among patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (n=710), the serious adverse reaction that occurred more frequently in patients 75 years and older was pneumonia.