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Drugs and lactation Jiří Slíva, MD., Ph.D. Number of breast-feeded children in the U.S. AAP, 2005 Lactation and adherence to treatment cca 90 % of women take some medication during the first week after delivery some medicaments, not exactly contraindicated during pregnancy, can decrease the intensity of lactation women tend to disrupt lactation in case of short-term therapy (e.g. antimicrobial agents), or they are non-compliant to prescribed medication approximately 7 % of women disrupt lactation up to 15 % of women do not start taking ATBs at all Frequency of ADRs in lactating women prospective trial (n = 838) with breast-feeded children, whose mothers were taking various preparations no serious adverse reaction was recorded however 11.2 % of women described non-serious ADRs – women were using: antibiotics (19.3 %) analgesics (11.2 %) antihistaminics (9.4 %) sedatives/antidepressants/antiepileptics (7,1 %) commonly recorded postantibiotic diarrhea, drowsiness after strong analgesics, antiepileptics, antidepressants, or irritability after antihistaminics Data on file Transfer of drugs to maternal milk depends on pharmacokinetics of drug in maternal body perfusion of mammary gland milk composition physico-chemical properties of drug pH of both plasma and milk amount of milk synthesis Ad pH value average plasma pH is 7.4 average pH of breast milk is lower at 7.2 thus… drugs that are weakly basic tend to concentrate to a greater extent in the more weakly acidic breast milk, as opposed to the less acidic plasma since acids attract bases weak bases are nonionized in the maternal plasma => increased ability to be transferred into breast milk weak acids are ionized in the maternal plasma => low diffusion into breast milk i.e., antihistamines and erythromycin, drugs that are weak basics, would be more likely to cross cell membranes from maternal plasma into breast milk than would penicillins, which are weak acids Transfer of drugs to maternal milk almost every drug crosses into maternal milk mostly via passive diffusion (e.g. H2 blockers, penicillins, nitrofurantoin and others.) also via active transport (e.g. cimetidine) transcellular diffusion breast-feeding can protect from abstinence syndrome in neonates, whose mothers were treated by barbiturates etc. Drugs affecting milk formation Decrease bromocriptine estrogens androgens antihistaminics barbiturates apomorphine levodopa pyridoxine Increase metoclopramide reserpine imipramine fenothiazine sulpirid TSH Drugs contraindicated during breast-feeding Cytostatics – immunosuppression, neutropenia, influence on growth?, cancerogenesis? Abused drugs – (amphetamine, cocaine, heroin, marijuana, LSD, alcohol, nicotine) – influence of CNS, maternal behavior Ergot alcaloids – (bromocriptine decreases lactation, ergotamine – risk of vomiting, diarrhea, cramps) Iodides – risk of struma, hypothyreosis Radioactive isotopes Gold Lithium – high concentration in maternal milk, possible influence of CNS Estrogens (oral contraceptives) Thiouracile – risk of struma, thyreosuppression, agranulocytosis Drugs deserving increased caution Drugs affecting CNS – antidepressants, antipsychotics, benzodiazepines Drugs with recorded serious ADRs aspirin (metabol. acidosis), atenolol (beta-blocker), carbamazepine (sedation, hyperexcitability, cholestat. hepatitis), clemastine (hyperexcitability, drowsiness), phenobarbital (sedation, methaemoglobinemia), sulfasalazine (bloody diarrhea), metronidazole (potentially cancerogenic), TTC Safe drugs during pregnancy Antibiotics/chemotherapeutics amoxicilline, phenoxymethylpenicilline, benzylpenicilline, chloramphenicol, ciprofloxacine, clindamycine, doxycycline, gentamicine, nitrofurantoin, metronidazole or vancomycine easily cross to maternal milk according to available data, tetracyclins, chloramphenicol or aminoglycosides, eventually quinolones, can be used in specific cases, but mostly contraindicated Antihypertensives ACE inhibitors, methyldopa, beta-blockers or calcium ion channel blockers are compatible with breastfeeding, i.e. they do not decrease blood pressure of children Antihistaminics risk of irritability of children Caffeine in common doses fully compatible with breastfeeding higher doses => risk of insomnia or irritation of children (half-life of caffeine: 3 to 7 hours) NSAIDs, acetaminophen Ibuprofen – compatible with breast-feeding, Acetylsalicylic acid – compatible with breast-feeding expect of higher doses (risk of metabolic acidosis), Paracetamol – compatible with breast-feeding. Currently, it is discussed in relation with increased of higher prevalence of allergic rhinoconjunctivitis PREDNISON IN PAEDIATRIC PRAXIS AND ITS MAGISTRALITER PREPARATION Indications of prednisone Respiratory system Allergy Nephrology Oncology Rheumatology Haematology Dermatology Endocrinology Ophthalmology Gastroenterology Immunology Common dosis pro infantibus ranges from 5 to 60 mg/day Corticosteroids for children available in the Czech Republic Prednisone Prednison tbl. 5 a 20 mg Rectodelt rect. supp. 100 mg ---------------------------- Methyl-prednizolone: Dexamethasone: Medrol tbl., Solu-Medrol i.v. Dexamethason supp. (IVLP) Dexamed, Dexona inj. Fortecortin tbl. Hydrocortisone Hydrokortison inj., tbl. Oral dose 5.0 mg prednisone is equal to 5.0 mg prednisolone, 4.0 mg triamcinolonu, 0.6 mg betamethasone, 0.75 mg dexamethasone a 20.0 mg hydrocortisone Prednisone suspension Raitt, J. R., Hotaling, W. H.: Preparation of stable prednisone suspension, Amer. J. Hosp. Pharm. 30:923-924 (Oct.) 1973. Prescription Rp. Prednisoni plv.…………………………..1,0 g Natrii benzoati 0,1%..............40,0 ml Tragacant-acacii mxt……………….20,0 ml Tragacant 3% Acacia 3% Natrii benzoat 0,1% Anisi (foeniculi) ol. 0,025% Sirupi ad…………………..…….100,0 ml Sirupi simplicis 67 % Sirupi aurantii 33 % Economic evaluation Vial (100 ml) CZK 1 189,75 2 161,88 3 152,59 4 150,88 5 147,51 6 147,09 7 145,23 8 143,83 9 142,74 10 141,86 Total price Price per 5 mg Prednison tbl 20x5mg 30.10 CZK 1.50 CZK Prednison susp. 100ml 189.75 CZK 0.95 CZK Useful URLs LACTMED: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT TOXNET: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT WHO: http://whqlibdoc.who.int/hq/2002/55732.pdf AAP: http://www.aap.org/healthtopics/breastfeeding.cfm Questions for independent work: 1. Try to decide: which of molecules will be transfered into maternal milk easier – warfarin or sumatriptan (based on plasma protein-binding?) 2. Try to find decide, how salicylates (i.e. acetylsalicylic acid etc.) cross into maternal milk 3. Try to find/recommend oral antiseptic drug compatible with both breast-feeding and pregnancy (AISLP, Micromedex etc.) 4. What kind of drugs (active substance/plants) are used/recommended in order to stimulate lactation? 5. Prescribe 10 suppositories with domperidone for infant (Dosis Therapeutica Singula = 10 mg) Brand Content Dosage Bylinný čaj s jestřabinou pro kojící maminky Meduňková nať, plod kopru, plod fenyklu, nať jestřabiny a nať dobromyslu 2–3x denně po celé období kojení Čaj pro kojící matky Nať jestřabiny, plod kmínu, fenyklu, nať meduňky, zlatobýlu, violky trojbarevné, list jitrocele. 2–3x denně po celé období kojení ČAJánek Na podporu kojení Nať jestřabiny lékařské, květ ibišku súdánského, plod fenyklu, listy maliníku, nať levandule lékařské 2–3x denně po celé období kojení Laktační – porcovaný bylinný čaj fenykl plod, anýz plod, kopr plod, aronie plod, kmín plod, jestřabina nať, mateřídouška nať, kopřiva list, heřmánek květ 3x denně po celé období kojení Laktační sypaný bylinný čaj dtto 3 x denně po celé období kojení. Nálev se připravuje z obsahu 1 čajové lžičky přelitím 1/4 l vroucí vody a nechá se v zakryté nádobě 15 min odstát. Laktofyt – bylinný sirup voda, cukr, bylinné extrakty z anýzu, fenyklu, kmínu, pískavce, bazalky, meduňky a ibišku, kyselina jablečná, sorban draselný Užívá se jako sirup s vodou dle chuti. WELEDA Čaj pro podporu kojení kopřiva, semena fenyklu a kmínu 3–6x denně po celé období kojení – anýzu,