5 Prescribing in Preg.(5th May) 2003
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Transcript of 5 Prescribing in Preg.(5th May) 2003
PRESCRIBING IN PREGNANCY
Dr Vasudha Belgaumkar
Associate ProfessorDept. of DermatologyBJGMC Pune
Common Concerns ? •Contraceptive failure d/t drug
interactions
•Possible interference with conception
•Potential risk of spontaneous abortion
•Potential risk to mother/fetus
FDA Pregnancy Drug Risk Categories
X Contraindicated in pregnancyD Positive evidence for risk to fetusC Risk cannot be r/o.Human studies lackingB No risk to human fetusA Controlled studies – no fetal riskN No category assigned
Sources for InformationWHOTERISUSP-DIReproductive toxicology serviceAAP (lactation)Briggs GG et al
Before Conception
Contraceptive failure
Interference with conception
Contraceptive Failure
Azathioprine-------------- IUDNSAID---------------------IUDGriseofulvin---------------OCPRifampicin------------------OCPTetracycline----------------OCPSulphonamides-------------OCP
Interference with Conception
Cyclophosphamide
Methotrexate
Gestation (2- 2.5 wks)DRUG
Gestation (3- 8 wks)
Differentiated Cells
Congenital Anomalies
Normal Embryo
DRUG
Second TrimesterMaturation of
organ systems
Prolonged exposure to medication
e.g. Fetal hypothyroidism (iodides)
Teeth d’coloration (tetracycline)
Fetal drug metabolism slowerthan maternal
Third Trimester (Near delivery)
Nonteratogenic conditions
Sulphonamides (risk in premature
infants)
NSAIDSPersistent fetal circulationOligohydramnios
Absolutely Contraindicated Drugs
Category XRetinoidsEstrogensFinasterideFluorouracilMethotrexateStanozololThalidomide
Category DAzathioprineAspirinBleomycinColchicineCyclophosphami
deTetracyclinePotassium iodide
Category N
Griseofulvin
Spironolactone
SAFETY OF DRUGS IN PREGNANCY
Itching in Pregnancy
P.U.P.P.P.
Papular Dermatitis
Progesterone Induced Folliculitis
Atopic Eruption of Pregnancy
Cholestatic Pruritus
Herpes gestationis(Pemphigoid gestationis)
AntihistaminesChlorpheniramine (B)Cyproheptadine (B)Diphenhydramine (B)Cetrizine (B), Hydroxyzine (N)
(except 1st trimester)Loratidine (B)Fexofenadine (C )Leukotriene inhibitors – Montelukast
(Cat B)
Antibacterials
TOPICAL SYSTEMICBacitracin PenicillinsMupirocin CephalosporinsPolymyxin B ErythromycinSulphonamides AzithromycinSulphur/ResorcinolRetapamulin
ANTIBIOTIC CATEGORYFluroquinolones CSulphonamides CTetracyclines DFucidic acid/ Na-fusidate
C
TOPICAL ANTIFUNGALS
Category DrugB Clotrimazole, Naftifin,
Nystatin, Oxiconazole, Terbinafin
C Miconazole, Ketoconazole, Sulconazole, Butoconazole, Se-sulphide
C SertaconazoleC EberconazoleC LulliconazoleC Amorolfine
Systemic Antifungals
Category
Drug
B Nystatin, Terbinafine
C Fluconazole, Itraconazole, Ketaconazole
D VoriconazoleN Griseofulvin
AntiviralsAcyclovir,Valacyclovir,Famcyclovi
r =B
Cidofovir = C
Ganciclovir = C
Foscarnet = C
Acne/ Rosacea
Topical
Category
Drug
BClindamycin, Erythromycin, Azithromycin, Azelaic acid, Metronidazole
C Benzoyl peroxide, Adapalene, Tretinoin
X Tazarotene
Systemic
Category
Drug
B Erythromycin, Azithromycin
C SulphonamidesD TetracyclineX Isotretinoin
Systemic RetinoidsSpontaneous abortions
Stillbirths
Malformations – Cranial, Cardiovascular, CNS defects
“iPledge” RequirementsCompulsory registration of
Prescribers/Patients/Pharmacists
Information recorded Confirmation of pt counseling Contraception methods utilized Pregnancy test result
Female of childbearing potential: “non menopausal female who has not had a hysterectomy, bilateral oophorectomy or medically documented ovarian failure”
Telogen effluvium : Post partum hair shedding
Minoxidil (Cat.C):N/R in pregnancy/lact.
Antiscabetics & Pediculocides
Category
Drug
B Permethrin, Malathion, Lindane, Sulphur
C Crotamiton, Ivermectin
Genital Herpes (HSV) In Pregnancy
Acyclovir/ Famciclovir/ Valacyclovir
Molluscum Contagiosum
Cryotherapy, TCA, Surgical Excision
• Cryotherapy• TCA• Surgical Excision
HPV Infections
• Podophyllin- X
• Podophyllotoxin- C
• Imiquimod- C
HPV Infections (cont)
Syphilis
Benzathine Penicillin is T/t of Choice
HIV in Pregnancy
Efavirenz, Delavirdine - C/I d/t teratogenicity
Other ART drugs considered safe
Herpes gestationis : Pemphigoid GestationisBullous Pemphigoid of Pregnancy
Impetigo Herpetiformis
Systemic CorticosteroidsPreg Cat C “Therapeutic doses of cortisone during
pregnancy are unlikely to pose substantial teratogenic risk but data insufficient”
Animals studies- cleft lip/palate, placental insufficiency, spontaneous abortion, stillbirth, IUGR
Fetal HPA axis suppression near deliveryDoses > 10mg/d throughout preg a/w LBW,
hypertension & cardiovascular mortalityPrednisolone inactivated by placenta- DOC
Topical Steroids
Preg Cat ‘C’Use over limited period - not a/w
adverse effectsLarge amounts used over extensive
areas - risk of LBWFluorinated steroids should be
avoided
BiologicalsEtanercept, Infliximab, Adalimumab- Cat
‘B’
ImmunomodulatorsTacrolimus, Pimecrolimus, Cyclosporin,
MMF, Imiquimod - Cat ‘C’Interferons – Cat ‘C’
Vit. D AnaloguesPreg. Cat ‘C’
Leprosy in PregnancyDapsone
Cat ‘C’ 3rd Trimester- Neonatal hemolysis
and methemoglobinemia Folic acid 5mg/d
Rifampicin
Cat ‘C’ 1st Trimester- very high doses : teratogenic in
animals 3rd Trimester- increased risk of neonatal bleeding
Clofazimine Cat ‘C’ Brownish discoloration
Fluroquinolones & Minocycline - C/I
Clarithromycin- Safe
Lepra Rections
Systemic steroids
NSAIDS - Paracetamol, Ibuprofen (avoid preconception & 3rd trimester), Aspirin
Chloroquine/HCQS- Cat ‘C’
Colchicine- Cat ‘C’
Thalidomide - Cat ‘X’
Phototherapy & Photo-chemotherapy
PUVA- NR
NBUVB- Safe
Local anaestheticsLidocaine – B
Prilocaine – B
SUMMARY
Drugs in Pregnancy
Drugs in Pregnancy
LACTATIONControversies among various
sourcesBest sources: AAP and WHOSafe in pregnancy but not during
lactation: Eg: 1st gen.antihistaminicsSafe in lactation but not during
pregnancy: Eg: Topical Retinoids
FDA Lactation Drug Risk Categories
Discontinue “ A decision should be made
whether to discontinue the drug taking into account importance of drug to mother”
Caution “ Advised if drug is absorbed &
excreted into human breast milk & does not have known adverse reactions or tumorigenic potential”
Adverse Effects in InfantsOccur during first 6 mths of life
Sedation – 1st gen. antihistamines
Neurotoxic effects
Diarrhoea
Teratogenic drugs (Cat. D & X) contraindicated
Safe Drugs during Lactation1. Analgesics – Paracetamol2. Antibacterials – Bacitracin, Penicillins Macrolides, Cephalosporins, 3. Antifungals: Topical- Ciclopirox, Clotrimazole, Miconazole,Oxiconazole, Terbinafine (except on nipple) Systemic- Terbinafine, Fluconazole (single
dose)4. Antivirals – Acyclovir,
Famcyclovir,Valacyclovir
Safe Drugs during Lactation (cont)
5.Antiscabetics – Crotamiton, Permethrin & Lindane (controversial)
6. Antihistaminics – Loratidine, Fexofenadine
7. Corticosteroids: Oral- use Prednisolone, avoid nursing
x 4h Topical- avoid use over nipple/areola
8. Antiacne – Adapalene, BP, Tretinoin, Azelaic acid9. Calcipotriene
THANK YOU