Rosemary C. Temple MB, BS, MA, FRCP

  • Consultant Physician and Honorary Senior Lecturer
  • Elsie Bertram Diabetes Centre
  • Norfolk and Norwich University Hospital NHS Trust
  • Norwich, Norfolk, UK

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If the agent is given shortly before or during pregnancy gastritis diet 2 discount lansoprazole 30 mg buy line, the woman should be counseled as to the potential embryo­fetal risk. It is indicated for the treatment of cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome in adults and children 12 years of age. In addition, all doses increased the incidence of lumbar ribs compared with both control animals and historical control incidences. The fetus of the only monkey exposed during the later period of gestation showed multiple fusion and absence of the ribs and thoracic vertebral bodies and arches. The molecular weight (about 251,000) suggests that passive transfer will not occur, but the long circulation half-life will place the protein at the maternal­fetal interface for a prolonged period. The high molecular weight of this protein (about 251,000) suggests that excretion into mature breast milk will be inhibited. Because immunoglobulins and other high-molecular-weight substances are excreted into colostrum, exposure of the nursing infant to rilonacept might occur during the first few days after birth. However, in children and adult patients treated with this drug, an increase in infections is a common complication due to interference with the immune response. Rilonacept (Arcalyst), an interleukin-1 trap for the treatment of cryopyrin-associated periodic syndromes. The animal reproduction data suggest low risk but the absence of human pregnancy experience prevents a complete assessment of the embryo­fetal risk. In 2-year studies, no carcinogenic effects were observed in rats, but in mice hepatocellular neoplasms occurred in both males and females. The molecular weight (about 367 for the free base) and long elimination terminal half-life suggest that the drug will cross to the embryo­fetus. The molecular weight (about 367 for the free base) and long terminal elimination half-life (about 50 hours) suggest that the drug will be excreted into breast milk. Consequently, the maternal benefit appears to be much greater than the unknown embryo­fetal risk. The agent is extensively metabolized and some of the metabolites are pharmacologically active. Riluzole was not carcinogenic in mice and rats, and there was no evidence of mutagenic or clastogenic potential in multiple assays. The major active metabolite, N-hydroxyriluzole, did cause chromosomal damage in two tests, but negative results were observed in other assays. As discussed above, Riluzole impaired fertility when administered to male and female rats (1). The molecular weight of the parent drug (about 234) and long elimination half-life suggest that riluzole and its metabolite will cross to the embryo­fetus. No other information about the infant was given other than that he was in good health at the time of this report. The growth restriction may have been wholly or partially due to cigarette smoking. The molecular weight (about 234) and long elimination half-life (12 hours) suggest that the drug, and possibly its metabolites, will be excreted into breast milk.

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No adverse effects of the exposure were observed in the seven nursing infants (66) symptoms of gastritis and duodenitis trusted 30 mg lansoprazole. In a two-phase study published in 1999, the dose of paroxetine received by 10 nursing infants from breast milk was estimated (67). In six subjects sampled over 24 hours, the mean daily estimated infant dose was 1. In the second phase, milk and serum samples were obtained from four subjects around a normal infant feeding time. Paroxetine was detected (limit 2 ng/mL) in the plasma of one of the eight infants tested, but the concentration was below the level of quantification for the assay (4 ng/mL). Seven of the women had continued their prenatal paroxetine, four had started the antidepressant postpartum, and data were not available for five subjects. Milk samples were collected after a dose at 4- to 6-hour intervals over a 24-hour period. No detectable levels of paroxetine (all <2 ng/mL) were found in the infants serum, including the 10 infants who were exclusively breastfed. No adverse effects in the nursing infants were reported by the mothers upon direct interview (68). In another 2000 report, maternal serum, breast milk, and infant serum samples were obtained from 24 mother­infant pairs (mean infant age 4. All of the mothers were on a stable dose of paroxetine (10­40 mg/day for at least 30 days). One mother­infant pair was tested twice; once at 10 mg/day and again at 40 mg/day. The mean maternal serum, breast milk, and infant serum concentrations (ng/mL) were 45. In a 2002 report, the pregnancy outcomes of 55 women who had taken paroxetine during the 3rd trimester were reported (see Fetal Risk Summary) (42). Eight of the women reported adverse symptoms in their infants: alertness (N = 6), constipation (N = 3), sleepiness (N = 1), and irritability (N = 1). No adverse events were reported in 44 breastfed infants in the comparison group (42). The antidepressants taken by the women were citalopram (nine), paroxetine (six), sertraline (six), fluoxetine (one), and venlafaxine (three). The mean milk concentration was 88 nmol/L (18­152 nmol/L), resulting in a theoretical maximum infant dose that was 1. The American Academy of Pediatrics classifies paroxetine as a drug for which the effect on nursing infants is unknown but may be of concern (72). Behavioral changes in developing mice after prenatal exposure to paroxetine (Paxil) (abstract). Behavioral changes in developing mice after prenatal exposure to paroxetine (Paxil). Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors.

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Effects of perinatal loratadine exposure on male rat reproductive organ development gastritis management discount 15 mg lansoprazole mastercard. Fetal safety of loratadine use in the first trimester of pregnancy: a multicenter study. Evaluation of an association between loratadine and hypospadias-United States, 1997­2001. The long-term effects of in utero exposure on neurobehavior, especially when the exposure occurs in the latter half of pregnancy, have not been studied but are of concern. Occasional, non-dose-related malformations (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia) were observed in rabbits, but these defects have also randomly occurred in controls. Lorazepam crosses the placenta, achieving cord levels similar to maternal serum concentrations (2­5). The hypotonia, attributed to lorazepam because of the absence of such reports in pregnancies exposed to clozapine alone, resolved 5 days after birth. An abstract published in 1999 found an association between lorazepam and anal atresia (7). Using data from a French pregnancy registry, the investigators reported that among infants exposed to benzodiazepines 5 of 6 cases of anal atresia were exposed to lorazepam (p = 0. Lorazepam has been used in labor to potentiate the effects of narcotic analgesics (8). Although not statistically significant, a higher incidence of respiratory depression occurred in the exposed newborn infants. In one study, no effects on the nursing infant were reported (9), but the slight delay in establishing feeding was a cause for concern (11). In another study, 5 mg of oral lorazepam was given 1 hour before labor induction and the effects on feeding behavior were measured in the newborn infants (12). During the first 48 hours, no significant effect was observed on volume of milk consumed or duration of feeding. The effects of exposure to benzodiazepines during breastfeeding were reported in a 2012 study (13). The investigators concluded that their results supported the recommendation that the use benzodiazepines was not a reason to avoid breastfeeding (13). The American Academy of Pediatrics classifies the effects of lorazepam on the nursing infant as unknown but may be of concern if exposure is prolonged (14). Results from a hypothesis generating study of benzodiazepines and malformations (abstract). The animal reproduction data suggest moderate risk, but the absence of human pregnancy experience prevents a more complete assessment of embryo­fetal risk.

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A brief 2007 report described the pregnancy outcome of a 38-year-old woman with type 2 diabetes who was exposed to repaglinide up to the 7th week (7) gastritis pylori symptoms order 30 mg lansoprazole otc. The molecular weight (about 453) suggests that it will be excreted into breast milk, but the extensive metabolism and high plasma protein binding (>98%) suggest that the amount in milk will be limited. The effect of this exposure on a nursing infant is unknown, but hypoglycemia is a potential complication. Use of repaglinide during the first weeks of pregnancy in two type 2 diabetic women. Safety profile of repaglinide as used in general practice in England: results of a prescription-event monitoring study. The data from one source suggest that avoiding exposure in the 1st trimester would be a wise choice. Although this incidence (8%) is greater than the expected frequency of occurrence, no major category or individual malformations were identified. Malformations included the following: microcephaly (7 cases); hydronephrosis (3 cases); hydroureter (3 cases); and inguinal hernia (12 cases) (1, p. Use of reserpine near term has resulted in nasal discharge, retraction, lethargy, and anorexia in the newborn (2). Concern over the ability of reserpine to deplete catecholamine levels has appeared (3). In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 15 newborns had been exposed to reserpine during the 1st trimester (F. The animal reproduction data are not relevant because, although there was developmental toxicity (death and restricted weight), these effects occurred with maternal toxicity. However, the very low plasma concentrations suggest that there is little or no risk when the antibiotic is used topically in pregnancy. The antibiotic is isolated through fermentation from Clitopilus passeckerianus (formerly Pleurotus passeckerianus). It is indicated for the topical treatment of impetigo due to Staphylococcus aureus (methicillinsusceptible isolates only) or Streptococcus pyogenes. In 380 adult and 136 pediatric (age 2­17 years) patients undergoing treatment with twice daily applications, 11% had measurable plasma concentrations (lower limit of quantitation 0. The antibiotic is about 94% bound to plasma proteins, but the elimination half-life has not been determined due to the very low plasma concentrations. In rats, oral doses of 150 mg/kg/day (relationship to the human exposure not stated) caused maternal toxicity (decreased body weight and food consumption), decreased fetal weight, and delayed skeletal ossification. Carcinogenicity studies have not been conducted with retapamulin, but the drug was not genotoxic in multiple assays. No effects on fertility were noted in male and female rats given oral doses up to 450 mg/kg/day (1). The molecular weight (about 518) is low enough, but the very low plasma concentrations suggest that clinically significant exposure of the embryo and/or fetus is unlikely.

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A paper published in 1995 described the use of omeprazole gastritis upper left abdominal pain order lansoprazole 15 mg visa, 20 mg daily for esophageal reflux, by a woman in two consecutive pregnancies that were terminated because of severe congenital anomalies-anencephaly in one and severe talipes in the other (4). A woman with Zollinger-Ellison syndrome was treated in two of her three pregnancies with omeprazole (5). Her symptoms were controlled with omeprazole (120 mg/day) which was continued until delivery of a healthy, 2610-g girl. During the third pregnancy, she was treated throughout gestation with omeprazole (180 mg/day) and cimetidine (450 mg/day) and delivered a healthy term 2550-g male infant (5). A number of other pharmaceutical agents, identified only by drug category, were also used by these women. Twenty other offspring were exposed in utero to omeprazole combined either with cimetidine (2 infants) or ranitidine (18 infants). A 2001 study expanded the above data to 955 infants who had been exposed to omeprazole during pregnancy (7). Of these, 863 infants were exposed during the 1st trimester and 39 of these, plus an additional 92 infants, were exposed after the 1st trimester. Eight infants had cardiac defects, seven of which were considered mild or unspecified: ventricular septal defects (N = 5), unspecified (N = 2). The infant with the severe cardiac defect had tetralogy of Fallot plus an eye defect (coloboma plus posterior segment malformation). Defects that appeared two or more times were persistent ductus arteriosus at term (N = 2), hydronephrosis (N = 2), undescended testicle (N = 2), unstable hip (N = 3), and pylorostenosis (N = 2). The author thought that the slight increase in cardiac malformations and the stillbirths may have been random effects (7). A prospective cohort study published in 1998 described the pregnancy outcomes of 113 women exposed to omeprazole (101 during organogenesis) matched with 113 disease-paired controls (exposed to H2-receptor antagonists) and 113 controls who were exposed to nonteratogenic agents (8). All of the subjects and controls had contacted a teratogen information service to inquire about drug exposures during their pregnancy. Omeprazole-exposed women were from Canada (N = 59), Italy (N = 41), and France (N = 13), whereas all of the 226 controls were from Canada (Motherisk Program in Toronto). There were no significant differences between the groups in alcohol use and smoking. However, omeprazole-exposed women used significantly more antipeptic and prokinetic agents (histamine blockers, antacids, sucralfate, bismuth subsalicylate, calcium carbonate, and cisapride) than women in the two control groups. Pregnancy outcomes were determined from information supplied by the women shortly after delivery. The incidence of major anomalies in live births exposed during the 1st trimester in the three groups were 4 of 78 (5. The four malformations in omeprazole-exposed infants were ventricular septal defect, polycystic kidneys, ureteropelvic junction stenosis, and patent ductus arteriosus.

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Eighteen other pregnancies ended with either a cesarean section (N = 14) or vaginal delivery (N = 4) of a healthy infant before resection of the pheochromocytoma gastritis symptoms shortness of breath lansoprazole 15 mg purchase on line. In some of the cases the infant was growth restricted, probably secondary to uncontrolled maternal hypertension before treatment, but all survived. In one case, fetal death occurred when the mother, in her 5th to 6th month of pregnancy, died 2 days after extensive surgery to remove a metastatic pheochromocytoma (6). Therapy with phenoxybenzamine was begun, but the fetus died in utero (details of therapy were not given) (16). On the 3rd day of therapy, her membranes spontaneously ruptured followed by a hypertensive crisis requiring a phentolamine infusion. A spontaneous abortion occurred shortly thereafter of a severely growth-restricted fetus (9). The low incidences of maternal (4%; 1 of 24) and fetal (9%; 2 of 22) mortality when -blockade with phenoxybenzamine is used is much better than the mortality observed in undiagnosed pheochromocytoma complicating pregnancy. A 1971 review of 89 cases of unsuspected tumor found that maternal and fetal mortality rates were 48% and 54. A more recent review cited incidences of maternal and fetal mortality without blockade of 9% and 50%, respectively (20). Long-term follow-up of infants exposed in utero to phenoxybenzamine has only been reported in three cases (8,11,14). The follow-up periods ranged from 2 to 8 years, and all three were normal healthy children. The molecular weight of the drug (about 340) is low enough that excretion into breast milk should be expected. The potential effects of this exposure on a nursing infant, including but not limited to , hypotension are unknown. Hemodynamic observations during paroxysmal hypertension in a pregnancy with pheochromocytoma. Phaeochromocytomas in 72 patients: clinical and diagnostic features, treatment and long term results. Moreover, although the causes of the stillbirths cited in one human study were not fully elucidated and may not have been caused by maternal phentermine treatment, the high incidence is disturbing and is another reason to withhold use of the drug during pregnancy. Similar to other drugs in this class, such as the amphetamines, it is used as an appetite suppressant in the treatment of obesity. In addition to other adverse effects, hypertension has occurred in adults treated with this agent.

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Cardiovascular alterations in severe pregnancy-induced hypertension: effects of intravenous nitroglycerin coupled with blood volume expansion gastritis in spanish lansoprazole 15 mg buy low price. Glyceryl trinitrate lowers blood pressure in patients with gestational hypertension (abstract). Effects of nitroglycerin on the uterine and umbilical circulation in severe preeclampsia. The hemodynamic effects of intubation during nitroglycerin infusion in severe preeclampsia. Myocardial infarction in the third trimester of pregnancy secondary to an aortic valve thrombus. Myocardial infarction during pregnancy: management and outcome of two pregnancies. Effects of nitroglycerin and nitroprusside on the uterine vasculature of gravid ewes. Fetal cardiorespiratory effects of nitroglycerin in the near-term pregnant sheep (abstract). Intravenous nitroglycerin as a tocolytic agent for intrapartum external cephalic version. Total breech extraction of the second twin with uterine relaxation induced by nitroglycerin sublingual spray. Intravenous nitroglycerin for intrapartum internal podalic version of the second non-vertex twin. Arrest of preterm labour and prolongation of gestation with glyceryl trinitrate, a nitric oxide donor. Intravenous nitroglycerin to relieve intrapartum fetal distress related to uterine hyperactivity: a prospective observational study. Intravenous nitroglycerin for uterine relaxation in the postpartum patient with retained placenta. Nitroprusside has been used in pregnancy to produce deliberate hypotension during aneurysm surgery or to treat severe hypertension (1­8). One advantage of nitroprusside is the very rapid onset of action and the return to pretreatment blood pressure levels when the drug is stopped (8). Avoidance of prolonged use and the monitoring of serum pH, plasma cyanide, red blood cell cyanide, and methemoglobin levels in the mother were recommended. Standard doses of nitroprusside apparently do not pose a major risk of excessive accumulation of cyanide in the fetal liver (6). Case reports: sodium nitroprusside, pregnancy and multiple intracranial aneurysms. Review article: sodium nitroprusside, pregnancy and multiple intracranial aneurysms. In animals, nitrous oxide is an embryo and fetal toxin that may have long-lasting consequences.

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The growth-restricted infant did well and was discharged home on day 53 of life (2) gastritis symptoms lightheadedness buy lansoprazole 15 mg otc. The molecular weight (195) is low enough that excretion into breast milk probably occurs. However, three reviews on the use of cardiovascular drugs during pregnancy caution that too few data are available to assess the safety of this agent during pregnancy (1­3). It is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia. Depending on hepatic or renal function, the elimination half-life is in the range of about 13­25 hours (6). The drug is not teratogenic in pregnant mice, rats, and rabbits given doses up to and including maternal toxicity (4­6). Human pregnancy experience with mexiletine is limited to three women, one treated throughout gestation, one starting during the 14th week, and one at 32 weeks (7­9). The infant was fed breast milk only, and by 17 days of age, his weight had decreased to 2155 g. The weight loss was attributed to failure to feed and was corrected with maternal education and formula supplementation. Gastroesophageal reflux, presenting with seizure-like episodes but with a normal neurologic examination and electroencephalogram, was diagnosed at 8 months of age. The condition responded to corrective measures, and growth and development were appropriate at 10 months of age (7). A healthy infant (birth weight and sex not specified) was delivered 5 months later. Bradycardia, most likely as a result of propranolol, was noted in the infant during the first 6 hours after birth. Her initial dose was 100 mg 3 times daily but her symptoms required higher doses as her pregnancy progressed, eventually requiring 200 mg every 4 hours. The low 1-minute Apgar was explained by the 9-minute general anesthesia induction to delivery time. The mother had no history of diabetes and there was no glucosuria noted during pregnancy. Three cases have been reported in which a nursing infant was exposed to the drug via the milk with drug levels determined in two of these cases. All three infants had been exposed to mexiletine in utero, and no adverse effects attributable to the drug were noted.

Real Experiences: Customer Reviews on Lansoprazole

Pranck, 61 years: Urinary estriol was formerly used to assess the condition of the fetoplacental unit, with depressed levels being associated with fetal distress.

Ines, 52 years: Until human pregnancy data are available, women should be counseled that the absence of human pregnancy experience prevents an accurate assessment of the embryo­ fetal risk.

Lee, 65 years: Total parenteral nutrition for the treatment of severe hyperemesis gravidarum: maternal nutritional effects and fetal outcome.

Trano, 22 years: The drug is a tertiary amine that is a direct inhibitor of smooth muscle spasm of the urinary tract.

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  • Veronesi U, Arnone P, Veronesi P, et al. The value of radiotherapy on metastatic internal mammary nodes in breast cancer: results on a large series. Ann Oncol. 2008;19:1553-1560.
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  • Bianchi DW, Crombleholme TW, DiAlton ME: Cardiomyopathy. Fetology 2000; 45:357-363.