Learning Objectives: 1. Relation of Drugs and Lactation 2. Factors Modifying Passage of Drugs in Milk 3

Total Page:16

File Type:pdf, Size:1020Kb

Learning Objectives: 1. Relation of Drugs and Lactation 2. Factors Modifying Passage of Drugs in Milk 3 Learning Objectives: 1. Relation of drugs and lactation 2. Factors modifying passage of drugs in milk 3. Effects of drugs on milk production 4. Role of lactation on drugs excretion This lecture was done by: 5. Drug safety during lactation / use of Abdullah Saleh Bawazir safe drugs 6. Drugs contraindicated during lactation And reviewed by: Tuqa Alkaff Lactaon: • Breast feeding is very important because breast milk is the healthiest form of milk for babies. • It provides the baby with immunoglobulins (IgA, IgM) that are essenAal for protecAon against gastroenteriAs. Drugs & Lactaon: . Most drugs administered to breast feeding woman are detectable in milk. The concentraon of drugs achieved in breast milk is usually low (< 1 %). However, even small amounts of some drugs may be of significance for the suckling child. (all the execratory mechanisms are going down in babies) Pediatric populaon are classified into: • Newborn: less than one month old – Preterm neonates: born before 38 weeks of pregnancy (it's the harmful stage) – Full-term neonates: 38-42 weeks of gestaonal age • Infants (babies): 1 month – 12 months of age • Children: 1 -12 years of age – Toddler (young child): 1-5 years – Older child: 6-12 years • Adolescent: 13-18 years 2 Pharmacokine%cs in pediatric: • Higher gastric PH • Higher concentraon of free drug • Higher percenrage of body water • Neonate’s especially premature babies have limited capacity for metabolism and excreAon. • Neonates have very limited rate of metabolism due to immaturity of liver enzymes. • Renal clearance is less efficient: ( decrease Renal blood flow – decrease GFR). • The epithelium of the breast alveolar cells is most permeable to drugs during the 1st week postpartum, so drug transfer to milk may be greater during the 1st week of an infant’s life. Physiologic Differences between Neonates and Adults of Pharmacokine%c Importance (Hilligoss 1980) Neonate Adult Gastric acid output (mEq/10kg/hr) 0.15 ↓ 2 Gastric emptying me (min) 87 ↑ 65 Total body water 78 ↑ 60 (% of body weight) 12 ↓ Adipose %ssue (% of b.wt.) 12-25 3.7 ↓ Serum albumin (gm/dL) 4.5 Glomerular filtraon rate (ml/min/m2) 3 11 ↓ 70 Factors that affect passage of drugs into breast milk: Factors related to drugs Molecular weight: Lipid solubility of the drug: pH of drug: weight:Very small molecules (< 200 Daltons) such Lipid soluble drugs pass as alcohol, equilibrate rapidly between plasma more freely into .pH of milk is slightly more acidic than and breast milk via the aqueous channels the breast milk than water maternal blood. surrounding alveoli. soluble drugs.can easily .Weak basic drugs tend to concentrate Large molecules drugs (>800 Daltons) are less cross any membrane in breast milk and become trapped likely to be transferred to breast milk than low Degree of ionizaon: secondary to ionizaon. molecular weight. .Ionized form of drugs are Insulin: MW > 6,000 daltons less likely to be transferred .Weak acidic drugs don't enter the Heparin: MW 40,000 daltons into breast milk. milk to a significant extent and tend to Monoclonal anAbodies, pass very poorly into milk .e.g., heparins pass poorly be concentrated in plasma.maternal aer the first 1st week postpartum. into breast milk circulaon The epithelium of the breast alveolar cells is most permeable to drugs during the 1st week Plasma protein binding of postpartum, so drug transfer to milk may drugs be greater during the 1st week of an infants life. Drugs circulate in maternal Volume of distribuon Transfer of drug from circulaon in unbound (free) or bound forms to maternal blood to milk is low with drugs that have albumin. large volume of distribuAon (Vd)to prevent from Only unbound form gets staying from blood.let it stay in Assues. into maternal milk. Half life of drug DefiniAon of good protein binding > 90% Avoid the use of drugs with long half lives 4 e.g. warfarin also heparin short half life (t ½) are preferable. could be prescribed Oxazepam vs diazepam Factors that affect passage of drugs into breast milk: Factors related to mother Route of administra%on (to minimize exposure of drug) Health status Breaseeding is contraindicated .Route of administraon affect the concentraon of the in case of: drug in maternal blood. Mother HIV AcAve, untreated TB in mother .Maternal use of topical preparaons (creams, nasal sprays or inhalers) are expected to carry less risk to a Herpes on breast breasged infant than systemically administered drugs. Use of illegal drugs by mother Time of breaseeding Certain medicaons .The concentraon of the drug in the milk at the Ame of feeding. .Lactang mother should take medicaon just aer nursing and 3-4 hours before the next feeding.(injecAon-minutes) (to allow Ame for drug to be cleared from the mother’s blood – drug concentraon in milk will be low). 5 Factors that affect passage of drugs into breast milk: Factors related to neonates Age -Body weight(premature lower body weight than mature)- Health status The amount of a drug to which the baby is exposed as a result of breast feeding depends on: The amount of milk consumed. The amount of drug absorbed from GI. The ability of the baby to eliminate the drug. Age & Health status Special cauons are required in - Premature infants - Low birth weight(even those with full term-gestaon) - Infants with G6PD deficiency- Infants with impaired ability to metabolize /excrete drugs e.g. hyperbilirubinemia.(physiological jaundice) Pathological condions Neonatal hyperbilirubinemia Neonatal Methemoglobinemia Premature infants or infants with inherited Infants under 6 months of age are G6PD(found in RBC’s membrance(anoxidant) parAcularly deficiency are suscepAble to oxidizing drugs that can prone to develop methemoglobinemia upon cause → hemolysis of RBCS →↑ bilirubin exposure to some oxidizing drugs. (hyperbilirubinemia) →↑ Kernicterus(go BBB) Examples for oxidizing drugs: Methemoglobin is an oxidized form of An%bio%cs6 sulfonamides, trimethoprim hemoglobin that has a decreased affinity for An%malarials: Primaquine oxygen → ssue hypoxia. Drugs contraindicated during lactaon: An%cancer CNS acng Lithium (an Atenolol Radioaph Potassium drugs drugs manic Drug) armaceu iodide cals Risk of Growth Amphetamine, high concentraon of Risk of RadioacAve risk of retardaon heroin, cocaine , the drug will pass with Bradycradia and iodine Hypothyroidism Doxorubicin, BZDs , the milk and appear Hypoglycemia cyclophosphamid Bulbutarates & as skin rash on the e, methotrexate even Smoking baby Chloramphenic ol antibiotic Remember gray baby syndrome Drugs that can suppress lactaon: (does not produce harmful ac%ons) >> reduce prolac%n Levodopa Bromocripn Androgens Estrogen,combi Thiazide Ergot e ned oral diure%cs derivaves contracepves (dopamine precursor). (dopamine that contain high- anA Migraine Dopamine will Inhibit agonists ). dose of estrogen and Drugs ProlacAn leading to Same AcAon as a progesn.take mini Milk Suppression Dopamine pills or progestrins only 7 Also, Pyridoxine, and MAO inhibitors suppress lactaon Drugs to be avoided during lactaon: Barbiturates: Benzodiazepi An%thyroid Hormonal Analgesics : An%bio%cs: Phenobarbito nes: drugs: contracepv Aspirin Tetracyclines ne diazepam carbamizole es: estrogen only Note: These drugs are contraindicated also but they can be used under some restricons when there’s no other choice Dopamine antagonists: they sAmulate prolacAn secreAon (Hyper-ProlacAnemia) such as: like anA- Drugs that can augment lactaon: physicoAcs,have risk parkinsonism Metoclopramide Haloperidol Phenothiazin Methyl dopa Theophylline Domperidone (aneme%c) (anpsychoc) e (anhypertensive (used in (aneme%c) drug) asthma) *preferred in Has narrow pregnancy also therapuc index Note: Infant with G6PD deficiency may develop hemolysis and hyperbilirubinemia with sulphonamides8 and anmalarial drug primaquine Some anbiocs are contraindicated in lactang women e.g. chloramphenicol Antibiotics Penicillins No significant adverse effect Ampicillin allergic reacAons, diarrhea (!st prescribed) amoxacillin Cephalosporins If she’s allergic to penicllins or the baby has diarreah Macrolides erythromycin No significant adverse effect clarithromycin Alteraons to infant bowel flora hyperbilirubinemia -neonatal jaundice Should be avoided in premature Sulfonamides (co-trimoxazole) infants or infants with G6PD deficiency Quinolones TheoreAcal risk of arthropathies Should be avoided Chloramphenicol “Gray baby” syndrome avoid Tetracyclines AbsorpAon by the baby is probably prevented by chelaon with milk calcium. Avoid due to possible risk of teeth discoloraon.theoriAcally not proven hyperbilirubinemia -neonatal jaundice Should be avoided in premature Sulfonamides infants or infants with G6PD deficiency (co-trimoxazole) 9 Sedative/hypnotics Barbiturates Lethargy, sedaon, poor suck reflexes with prolonged (phenobarbitone) use.(addicAon to mom&baby) Benzodiazepines Single use of low doses is probably safe. Diazepam Lethargy, sedaon in infants with prolonged use. Lorazepam Oral contraceptives Non hormonal method should be used Avoid estrogens containing pills Estrogens ↓ milk quanAty ProgesAn only pills or minipills are preferred for birth control. 10 Antidiabetics Insulin safe Oral anAdiabeAcs compable Megormin avoid due to lacAc acidosis Analgesics Paracetamol safe Ibuoprofen compable Aspirin avoid due to theoreAcal risk of Reye's syndrome 11 AnAthyroid drugs Propylthiouracil May suppress thyroid funcAon in infants. Carbimazole Methimazole Propylthiouracil should be used rather potassium iodide than carbimazole or methimazole. AnAcoagulants Safe, not present in breast milk.
Recommended publications
  • Clinical an Urgent Care Approach to Complications and Conditions of Pregnancy Part 2
    Clinical An Urgent Care Approach to Complications and Conditions of Pregnancy Part 2 Urgent message: From pregnancy confirmation to the evaluation of bleeding, urgent care centers are often the initial location for management of obstetric-related issues. Careful use of evidence-based guidelines is the key to successful outcomes. DAVID N. JACKSON, MD, FACOG and PETAR PLANINIC, MD, FACOG Introduction rgent care providers are called upon to manage a Uvariety of complaints in pregnancy. Some conditions can be managed at the urgent care center whereas others require stabilization and transport to a center with expert obstetrical capabilities. In all situations, practitioners should consider that a gestational age of fetal viability (many centers now use 23 to 24 weeks) is best served with referral for continuous fetal monitor- ing if there is bleeding, trauma, significant hypertension, relative hypoxemia (O2 saturation less than 95% for pregnant women), or contractions. Part 2 of this two- part series will discuss: Ⅲ Bleeding in pregnancy Ⅲ Ectopic gestation Ⅲ Trauma and pregnancy Ⅲ Acute abdominal pain in pregnancy Dr. Jackson is Professor of Maternal-Fetal Medicine at the University of Nevada, School of Medicine, Las Vegas, Nevada. Dr. Planinic is Assistant Professor of Obstetrics and Gynecology at the University of Nevada, School of Medicine, Las Vegas, Nevada. © gettyimages.com www.jucm.com JUCM The Journal of Urgent Care Medicine | September 2013 9 AN URGENT CARE APPROACH TO COMPLICATIONS AND CONDITIONS OF PREGNANCY Figure 1. Bleeding endocervical polyp with Evaluation of vaginal bleeding should follow a sys- inflammation tematic process. History of last menses and sexual activ- ity determines the possibility of pregnancy.
    [Show full text]
  • USMLE – What's It
    Purpose of this handout Congratulations on making it to Year 2 of medical school! You are that much closer to having your Doctor of Medicine degree. If you want to PRACTICE medicine, however, you have to be licensed, and in order to be licensed you must first pass all four United States Medical Licensing Exams. This book is intended as a starting point in your preparation for getting past the first hurdle, Step 1. It contains study tips, suggestions, resources, and advice. Please remember, however, that no single approach to studying is right for everyone. USMLE – What is it for? In order to become a licensed physician in the United States, individuals must pass a series of examinations conducted by the National Board of Medical Examiners (NBME). These examinations are the United States Medical Licensing Examinations, or USMLE. Currently there are four separate exams which must be passed in order to be eligible for medical licensure: Step 1, usually taken after the completion of the second year of medical school; Step 2 Clinical Knowledge (CK), this is usually taken by December 31st of Year 4 Step 2 Clinical Skills (CS), this is usually be taken by December 31st of Year 4 Step 3, typically taken during the first (intern) year of post graduate training. Requirements other than passing all of the above mentioned steps for licensure in each state are set by each state’s medical licensing board. For example, each state board determines the maximum number of times that a person may take each Step exam and still remain eligible for licensure.
    [Show full text]
  • HHS Public Access Author Manuscript
    HHS Public Access Author manuscript Author Manuscript Author ManuscriptObstet Gynecol Author Manuscript. Author Author Manuscript manuscript; available in PMC 2016 January 12. Published in final edited form as: Obstet Gynecol. 2013 October ; 122(4): 885–900. doi:10.1097/AOG.0b013e3182a5fdfd. Prophylaxis and Treatment of Anthrax in Pregnant Women: A Systematic Review of Antibiotics Dana Meaney-Delman, MD MPH1, Sonja A. Rasmussen, MD MS1, Richard H. Beigi, MD2, Marianne E. Zotti, DrPH1, Yalonda Hutchings, MD MPH1, William A. Bower, MD1, Tracee A. Treadwell, DVM MPH1, and Denise J. Jamieson, MD MPH1 1Centers for Disease Control and Prevention, Atlanta, Georgia 2Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Reproductive Infectious Diseases and Obstetric Specialties, Magee-Women’s Hospital of the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania Abstract Objective—To review the safety and pharmacokinetics of antibiotics recommended for anthrax post-exposure prophylaxis and treatment in pregnant women. Data Sources—Articles were identified in the PUBMED database from inception through December 2012 by searching the keywords ([“pregnancy]” and [generic antibiotic name]). Additionally, hand searches of references from REPROTOX, TERIS, review articles and Briggs’ Drugs in Pregnancy and Lactation were performed. Methods of Study Selection—Articles included in the review contain primary data related to the safety and pharmacokinetics among pregnant women of five antibiotics recommended for anthrax post-exposure prophylaxis and treatment (ciprofloxacin, levofloxacin, moxifloxacin, doxycycline, amoxicillin), and of nine additional antibiotics recommended as part of the treatment regimen (penicillin, ampicillin, linezolid, clindamycin, meropenem, doripenem, rifampin, chloramphenicol, or vancomycin). Tabulation, Integration and Results—The PUBMED search identified 3850 articles for review.
    [Show full text]
  • Effect of Synbiotic on the Treatment of Jaundice in Full Term Neonates: a Randomized Clinical Trial
    Pediatr Gastroenterol Hepatol Nutr. 2019 Sep;22(5):453-459 https://doi.org/10.5223/pghn.2019.22.5.453 pISSN 2234-8646·eISSN 2234-8840 Original Article Effect of Synbiotic on the Treatment of Jaundice in Full Term Neonates: A Randomized Clinical Trial Shokoufeh Ahmadipour ,1,2 Parastoo Baharvand ,3 Parisa Rahmani ,4 Amin Hasanvand ,5 and Azam Mohsenzadeh 2 1Razi Herbal Medicine Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran 2Department of Pediatrics, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran 3Department of Social Medicine, School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran 4Pediatric Gastroenterology and Hepatology Research Center, Tehran University of Medical Sciences, Tehran, Iran 5Department of Pharmacology and Toxicology, Faculty of Pharmacy, Lorestan University of Medical Sciences, Khorramabad, Iran Received: Jun 27, 2018 Revised: Mar 28, 2019 ABSTRACT Accepted: Apr 8, 2019 Purpose: Jaundice accounts for most hospital admissions in the neonatal period. Nowadays, Correspondence to in addition to phototherapy, other auxiliary methods are used to reduce jaundice and the Azam Mohsenzadeh length of hospitalization. This study aimed to investigate the effect of probiotics on the Department of Pediatrics, Faculty of Medicine, Lorestan University of Medical Sciences, treatment of hyper-bilirubinemia in full-term neonates. Anooshirvan Rezaei Square, Khorramabad, Methods: In this randomized clinical trial, 83 full-term neonates, who were admitted to the Lorestan 6813833946, Iran. hospital to receive phototherapy in the first 6 months of 2015, were randomly divided into E-mail: [email protected] two groups: synbiotic (SG, n=40) and control (CG, n=43). Both groups received phototherapy Copyright © 2019 by The Korean Society of but the SG also received 5 drops/day of synbiotics.
    [Show full text]
  • Anti-Infective Drug Development in Neonates September 15, 2016
    Anti-Infective Drug Development in Neonates September 15, 2016 Page 1 1 FOOD AND DRUG ADMINISTRATION (FDA) 2 3 PUBLIC WORKSHOP: 4 FACILITATING ANTI-INFECTIVE DRUG DEVELOPMENT FOR 5 NEONATES AND YOUNG INFANTS 6 7 September 15, 2016 8 9 10 Sheraton Silver Spring 11 8777 Georgia Avenue 12 Silver Spring, Maryland 20910 13 14 15 16 17 18 19 20 21 Reported by: Chaz Bennett 22 Capital Reporting Company www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 2 1 P A R T I C I P A N T S 2 3 John Alexander, MD, MPH 4 Deputy Director 5 Division of Pediatric and Maternal Health (DPMH) 6 Office of Drug Evaluation IV (ODEIV), CDER 7 Food and Drug Administration, Silver Spring, Maryland 8 9 Gerri Baer, MD 10 Medical Officer, Office of Pediatric Therapeutics 11 Food and Drug Administration, Silver Spring, Maryland 12 13 Danny Benjamin, MD, PhD, MPH 14 Kiser-Arena Distinguished Professor of Pediatrics 15 Chair, Pediatric Trials Network 16 Faculty Associate Director, Duke Clinical 17 Research Institute 18 Duke University, Durham, North Carolina 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Anti-Infective Drug Development in Neonates September 15, 2016 Page 3 1 P A R T I C I P A N T S 2 (Continued) 3 4 John Bradley, MD 5 Professor and Chief of the Division of Infectious 6 Diseases in the Department of Pediatrics 7 University of California, San Diego 8 9 Maria Fernandez Cortizo 10 PDCU 11 12 John Farley, MD, MPH 13 Deputy Director 14 Office of Antimicrobial Products (OAP), CDER 15 Food and Drug Administration, Silver Spring, Maryland 16 17 William Hope, PhD 18 Professor of Therapeutics and Infectious Diseases 19 University of Liverpool, Liverpool, U.K.
    [Show full text]
  • Iatrogenic Complications in the Neonatal Intensive Care Unit
    Journal of Perinatology (2010) 30, S51–S56 r 2010 Nature America, Inc. All rights reserved. 0743-8346/10 www.nature.com/jp REVIEW Iatrogenic complications in the neonatal intensive care unit KC Sekar Department of Pediatrics, Neonatal-Perinatal Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA In neonatal medicine, significant iatrogenic events leading With the introduction of novel technologies and approaches in neonatal to severe morbidity and death have been identified and addressed. care and the lack of appropriately designed and well-executed randomized Low incubator temperature leading to death (1930); irradiation clinical trials to investigate the impact of these interventions, iatrogenic causing thyroid cancer, and excess oxygen exposure causing complications have been increasingly seen in the neonatal intensive care retinopathy of prematurity and blindness (1940); excess unit. In addition, increased awareness and the introduction of more synthetic vitamin K, sulfisoxazole and chloramphenicol causing appropriate quality control measures have resulted in higher levels of kernicterus and gray baby syndrome (1950); intrauterine suspicion about and increased recognition of complications associated with exposure to thalidomide causing limb defects (1960); umbilical delivery of care. The incidence of complications also rises with the increased arterial catheter, tolazoline and total parenteral nutrition (TPN) length of hospital stay and level of immaturity. Approximately half of the causing thrombosis, hypotension and essential fatty acid deficiency, iatrogenic complications are related to medication errors. The other respectively (1970); vitamin E and propylene glycol causing complications are due to nosocomial infections, insertion of invasive organ damage, hyperosmolarity and seizures (1980); and catheters, prolonged mechanical ventilation, administration of parenteral mechanical ventilation and systemic corticosteroid administration nutrition solution, skin damage and environmental complications.
    [Show full text]
  • Is Pediatric Labeling Really Necessary?
    Is Pediatric Labeling Really Necessary? Michael L. Christensen, PharmD; Richard A. Helms, PharmD; and Russell W. Chesney, MD ABBREVIATIONS. FDA, US Food and Drug Administration; For solid dosage forms, parents often must divide FDCA, Food, Drug and Cosmetic Act; GFR, glomerular filtration adult tablets in halves or quarters to get an appro- rate; BSA, body surface area. priate dose for their child. This results in imprecise dosing that can lead to poor therapeutic response. abeling refers to the label on the drug container Practitioners are left to use empiric therapy in and all printed materials, including the pack- treating their pediatric patients because of the inad- age insert, that accompanies the product. La- equate information available for prescribing of L drugs. They often must choose between not treating beling of a drug indicates that there is substantial evidence from adequate and well controlled clinical children with potentially beneficial medications be- trials for the safe and effective use of that drug. cause they are not approved for use in children, or to Labeling provides important information on clinical treat them with these medications based on adult pharmacology, indications and usage, contraindica- studies and limited or anecdotal experience in chil- tions, precautions, adverse effects, dosage, and ad- dren. In either case, children may not be prescribed ministration. Unfortunately for children, most drug optimal therapy. labeling contains the precautionary disclaimer, be- cause safety and efficacy in children have not been FOOD, DRUG AND COSMETIC ACT established. Concern for the risk to public health and safety The availability of safe and effective drugs has with unsanitary food and adulterated drugs, a com- been directly responsible for the improvement in mon problem during that time, lead to passage of health over the past 50 years.
    [Show full text]
  • Abortus, 4 Absolute Neutrophil Count, 146 Absorption
    Index A on respiratory syncytial virus, 158, 160 on sedation management, 112 Abortus, 4 on systemic corticosteroids, 88 Absolute neutrophil count, 146 on vaccinations, 187 Absorption, 17 on Vitamin K IM, 10-11 extravascular, 18 American College of Chest Physicians, 159 gastrointestinal, 18 American College of Emergency Physicians, 159 intramuscular, 18 American College of Obstetrics and Gynecology, 61 percutaneous, 19 American Congress of Obstetricians and rectal, 19 Gynecologists, 145 Academy of Breastfeeding Medicine, 49, 61 American Society for Parenteral and Enteral Acetaminophen, 21, 119, 126 Nutrition, 30, 34 PDA and, 103-104 American Society of Health-System Pharmacists vaccination response and, 191-192 (ASHP), 34 Acid ionization constant, breast milk and, 47 American Thoracic Society, 159 Acid-base balance, 32 Amino acids, 30, 34-35 Activity, 5 Aminoglycoside(s), 19, 134, 172 Acute lung injury, 84-85 Aminophylline, 69 Acyclovir, 46 Aminosyn, 30 parenteral, 147-148 Amoxicillin-sulbactam, 172 Addiction, maternal, 61 Amphotericin B, 137 Adverse drug events, methylxanthine toxicity, 71 Ampicillin, 6, 134, 172 Adverse effects, neonatal abstinence treatment, 60 Ampicillin-sulbactam, 172 Airway patency maintenance, 68 Anaerobic antibiotic therapy, 172 Albuterol, 87, 161 Analgesia Alcohol, 48 common agents for, 127-129 Alginate, 181 pharmacologic agents for, 118-119 Alpha agonists, 115-116 principles of, 116-117 Aluminum toxicity, 36-37 Analgesics, 123 American Academy of Pediatrics, 45 reversal of, 121 acyclovir shortage recommendations,
    [Show full text]
  • Evidence of Drug Safety in Pregnancy
    DRUGS IN PREGNANCY Evidence of drug safety in pregnancy For an area as complex as prescribing in pregnancy, unfortunately, there is very little information in the literature to support practice. Newer antimicrobials are trialled excluding pregnant women for reasons of risk-avoidance and, therefore, prescribers must rely on post-marketing surveillance data. For some medications, this takes the form of a formal registry (for example, the antiretroviral pregnancy registry). Obviously, prospective safety data from Phase I/II clinical trials is preferable, but in the absence of this, registry data provides some reassurance. Older antibiotics, on the other hand, may have many years of practical experience to suggest their safety, but little robust scientific evidence to support their safe use. Evidence of treatment efficacy in pregnancy Large prospective trials of treatment in pregnancy are conspicuously absent from the literature. There have been a number of Cochrane reviews on different topics in the treatment of infections in pregnancy – from asymptomatic bacteriuria to bacterial vaginosis. All of the reviews have in common very heterogeneous primary articles and cautious recommendations based on lack of data. In general, antibiotics are effective at treating the infection in question, but studies are underpowered to provide information on optimum therapy or fetal safety. 1 Done by : Pharm.D –Neda'Rwashdeh Infection and pregnancy Immune tolerance’ in pregnancy is widely discussed and there are some data to suggest that pregnant women are at slightly higher risk of developing disease from some infections (including poliomyelitis, smallpox, hepatitis A and falciparum malaria). Also, the risk of severe disease and death are increased for some infections.
    [Show full text]
  • A Pediatric Perspective on the Unique
    A Pediatric Perspective on the Unique Vulnerability and Resilience of the Embryo and the Child to Environmental Toxicants: The Importance of Rigorous Research Concerning Age and Agent Robert L. Brent, MD, PhD*; Susanne Tanski, MD‡; and Michael Weitzman, MD‡ 1 ABBREVIATIONS. PCB, polychlorinated biphenyl; MPE, maximal cal agents. In fact, the publication edited by Miller permissible exposure; NOAEL, no observable adverse effect level. was primarily devoted to exposures to the embryo and the fetus. Because the embryo and the child are growing and their tissues and organs are differenti- here is realistic concern about the impact of ating, deleterious effects may occur at lower expo- environmental influences on the health of hu- sures to some chemicals, drugs, and physical agents Tman populations. First, exposure to environ- and produce more severe effects than those seen in mental agents continues despite successes in reduc- adults. In fact, some effects may not occur in adults. ing exposures to known toxicants such as lead, Thus, maximal permissible exposures (MPEs) for polychlorinated biphenyls (PCBs) and tobacco some environmental chemicals should be lower for smoke. Second, there has been increasing concern the embryo and the child. about the cause of autism and other neurodevelop- It is important to note that children and adoles- mental problems and hypotheses that environmental cents have better recuperative capacities than adults influences may play a role in the prevalence of these for many toxic agents, and, similarly, appropriate and other such childhood and adult conditions as drug dosages may be lower or higher on a mg/kg or asthma and obesity.
    [Show full text]
  • CHLORAFAST, Eye Drops, Solution, 0.5 %W/V
    NEW ZEALAND DATA SHEET 1. PRODUCT NAME CHLORAFAST, Eye drops, solution, 0.5 %w/v 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains 5mg of chloramphenicol equivalent to 0.5%w/v. Excipient with known effect: phenyl mercuric nitrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. CHLORAFAST is a colourless to faint yellow aqueous solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications For the treatment of bacterial conjunctivitis and other superficial ocular infections caused by chloramphenicol-sensitive organisms. 4.2 Dose and method of administration Adults and children (including the Elderly) Instil 1 or 2 drops in the affected eye(s) every two to six hours for two to three days. The interval between applications may then be increased. Treatment should be continued for at least 48 hours after the eye appears normal. Information for patients In order to minimise systemic absorption of CHLORAFAST eye drops, apply gentle pressure to the tear duct for approximately one minute immediately after application. Care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Do not touch dropper tip to any surface, as this may contaminate the solution. 4.3 Contraindications CHLORAFAST is contraindicated in individuals with a history of hypersensitivity to any excipients and/or toxic reaction to the medicine (refer section 6.1). 4.4 Special warnings and precautions for use Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following local application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.
    [Show full text]
  • PEDIATRICS in Last Minutes
    Prelims_2.pdf Chapter-01_Pediatrics in Last Minutes.pdf Chapter-02_Pre Neet Pediatric Questions.pdf Chapter-03_Pre Neet Pediatric Answers.pdf Chapter-04_Previous Years Questions of DNB.pdf Pre NEET Pediatrics Taruna Mehra MBBS MD PEDIATRICS (MAMC) ® JAYPEE BROTHERS MEDICAL PUBLISHERS (P) LTD New Delhi • Panama City • London • Dhaka • Kathmandu ® Jaypee Brothers Medical Publishers (P) Ltd Headquarters Jaypee Brothers Medical Publishers (P) Ltd 4838/24, Ansari Road, Daryaganj New Delhi 110 002, India Phone: +91-11-43574357 Fax: +91-11-43574314 Email: [email protected] Overseas Offices J.P. Medical Ltd Jaypee-Highlights Medical Publishers Inc. 83, Victoria Street, London City of Knowledge, Bld. 237, Clayton SW1H 0HW (UK) Panama City, Panama Phone: +44-2031708910 Phone: +507-301-0496 Fax: +02-03-0086180 Fax: +507-301-0499 Email: [email protected] Email: [email protected] Jaypee Brothers Medical Publishers (P) Ltd Jaypee Brothers Medical Publishers (P) Ltd 17/1-B Babar Road, Block-B, Shaymali Shorakhute, Kathmandu Mohammadpur, Dhaka-1207 Nepal Bangladesh Phone: +00977-9841528578 Mobile: +08801912003485 Email: [email protected] Email: [email protected] Website: www.jaypeebrothers.com Website: www.jaypeedigital.com © 2013, Jaypee Brothers Medical Publishers All rights reserved. No part of this book may be reproduced in any form or by any means without the prior permission of the publisher. Inquiries for bulk sales may be solicited at: [email protected] This book has been published in good faith that the contents provided by the author contained herein are original, and is intended for educational purposes only. While every effort is made to ensure accuracy of information, the publisher and the author(s) specifically disclaim any damage, liability, or loss incurred, directly or indirectly, from the use or application of any of the contents of this work.
    [Show full text]