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Prepared by (PRP Klinik Kesihatan Putrajaya Presint 18):

Hazirah Binti Zamri


Puteri Atdriann Binti Tilang
Tengku Putri Sharah Qistina Binti Tengku Nasiruddin
Date : 30/9/2020
Item Pregnancy Category Use in pregnancy Use in lactation
Should not be used in pregnancy as
Mothers who are breast-
Acetylsalicylic Acid 100mg + 1 it may prolong labour and
Not assigned feeding their infants should not
Glycine 45mg Tab. contribute to maternal and neonatal
take aspirin4
bleeding4
C; D (if full dose used Compatible (Low-Dose). Human
Acetylsalicylic Acid 300mg Limited Human Data—
in 3rd trimester)1 Data Suggest Risk in 1st and 3rd
Tab. Potential Toxicity3
C2 Trimesters (Full-Dose)3

Acriflavine 0.1% Lotion - Use with caution4 Use with caution 4


B1
Acyclovir 200/800mg Tab. Compatible3 Compatible3
B32
Adrenaline Acid Tartrate C1 Human and Animal data suggest No Human Data- Potential
1mg/ml Inj A2 risk3 Toxicity3
C1 Limited Human Data—
Albendazole 200mg Tab. Compatible3
D1 Probably Compatible3
C1 Limited Human Data—No Relevant Limited Human Data—
Allopurinol 300mg Tab.
B22 Animal Data3 Potential Toxicity3
Not recommended. Drugs cross the
placenta and appear in the cord
blood. Therefore, the use requires
Not recommended. Drug
that the potential benefit of the
appears in breast milk. If use of
Amiloride Hcl 5mg + Hctz B1 drug must be weight against
the drug is deemed essential,
50mg Tab C2 possible hazards to the fetus. These
the patient should stop
hazards include foetal and neonatal-
nursing4
jaundice, thrombocytopenia and
other side effects that have
occurred in the adults4
Artificial Tears/Eye Lubricant
Ophthalmic Solution (With C1 Use with caution4 Use with caution4
Preservative)
Contraindicated. Drugs that act
directly on the renin-angiotensin The proportion of the maternal
system can cause fetal/neonatal dose received by the infant has
morbidity and mortality). If this drug been estimated with an
Amlodipine 10mg + D1
is used during pregnancy, or if the interquartile range of 3 – 7%,
Valsartan 160mg Tab D2
patient becomes pregnant while with a maximum of 15%. Not
taking this drug, the patient should advisable for women who are
be apprised of the potential hazard breast-feeding4
to the fetus4
C1 Limited Human Data—Animal Data Limited Human Data—
Amlodipine 5mg/10mg Tab.
C2 Suggest Moderate Risk3 Probably Compatible3

Animal Data—No Teratogenic Effect.


Use with caution as it may lead
Limited Human Data—Avoid
Amoxycillin & Clavulanate to sensitisation, diarrhea,
B1 especially during 1st and 3rd
625mg Tab. candidiasis and skin rash in the
Trimesters, unless considered
infant4
essential by the physician4
Item Pregnancy Category Use in pregnancy Use in lactation
B1 Human Data Suggest Risk in 1st and Compatible3
Amoxycillin 500mg Capsule
A2 3rd Trimesters3
The use of unasyn during
Animal Data- No evidence of
lactation is not recommended.
impaired fertility or harm to the
Low concentrations of unasyn
fetus due to unasyn. Sulbactam
are excreted in the milk. This
Ampicillin + Sulbactam crosses the placental barrier.
B1 should be considered as the
375mg Tab (Unasyn) Limited Human Data- Unasyn should
neonate may be exposed,
be used during pregnancy only if the
particularly since renal function
potential benefits outweigh the
is not fully developed in
potential risk6
neonate6

Ascorbic Acid 100mg Tab. A1 Compatible3 Compatible3

D1 Human Data Suggest Risk in 2nd and Limited Human Data—


Atenolol 100mg Tab.
C2 3rd Trimesters3 Potential Toxicity3
X1
Atorvastatin 40mg Tab Contraindicated in 1st Trimester3 Contraindicated3
D2
Atropine Sulphate 1mg/ml C1 Limited Human Data- Probably
Human Data Suggest Low Risk3
Inj. A2 Compatible3
B1
Azithromycin 250mg Tab Compatible3 Compatible3
B12
Benzathine Penicillin 2.4MU B1
Compatible3 Compatible3
(1.8gm) Inj. A2
Benzoic & Salicylic Acids Limited Human Data—Probably No Human Data—Probably
C1
Ointment ( Whitfield's) Compatible3 Compatible3

Benzoyl Peroxide 5% Gel C1 Use with caution6 Use with caution6

Benzyl Benzoate 25%


- Contraindicated6 Contraindicated6
Emulsion

Betamethasone 17- Valerate C1 No Human Data—Probably


Compatible3
0.01-0.05% Cream B32 Compatible3
C1 No Human Data—Probably Limited Human Data—
Bisacodyl 5mg Tab.
A2 Compatible3 Probably Compatible3
Bismuth Subgallate & Benzyl No Human Data—Potential
- Human Data Suggest Low Risk3
Benzoate Suppository Toxicity3

Bisoprolol Fumarate 2.5/5 C1 Human Data Suggest Risk in 2nd and No Human Data—Potential
mg Tab. C2 3rd Trimesters3 Toxicity3
Bromhexine is expected to
Available data find no ill effects
enter breast milk, and
Bromhexine HCl 8mg Tab. A1 following oral administration.
therefore should be avoided
Precautions should be practised4
during lactation4
No clinical data on exposed Administration of Symbicort
pregnancies are available. The should only be considered if
Budesonide 160mcg + C1
lowest effective dose of budesonide the expected benefit to the
Formoterol 4.5mcg Inhaler B32
needed to maintain adequate mother is greater than any
asthma control should be used4 possible risk to the child4
Item Pregnancy Category Use in pregnancy Use in lactation
Probably compatible3
The amounts of inhaled
budesonide excreted into
Compatible3
B1 breast milk are minute and
Budesonide 64mcg Nasal This drug should be used in
A2 infant exposure is negligible.
Spray pregnancy only if the benefit
Most experts consider oral and
outweighs the risk to the fetus3
inhaled corticosteroids
acceptable to use during
breastfeeding5
C1
Calcitriol 0.25mcg Cap. Compatible3 Compatible3
B32
Calcium Carbonate 500mg
C1 Compatible3 Compatible3
Tab.
Animal studies are not available.
There is no controlled data in
human pregnancy. The background
birth defect and miscarriage risk for
Calcium Gluconate 10% Inj. C1 Infant risk cannot be ruled out7
the indicated population is not
Exempt2
known. In the US general
population, the estimated major
birth defect risk is 2 to 4% and the
miscarriage risk is 15 to 20%4
D1 Human Data Suggest Risk in 2nd and
Captopril 25mg Tab. Compatible3
D2 3rd Trimesters3
D1 Compatible—Maternal Benefit >>
Carbamazepine 200mg Tab. Compatible3
D2 Embryo–Fetal Risk3
Carbimazole 5mg Tab. D1 Human Data Suggest Risk3 Compatible3
B1
Ceftriaxone 250mg Inj. ‘ Compatible3 Compatible3
B12
Cefuroxime Axetil 250mg B1
Compatible3 Compatible3
Tab. B12
Cephalexin Monohydrate B1
Compatible3 Compatible3
250mg Capsule A2
Cetirizine Dihydrochloride B1 Limited Human Data—Animal Data No Human Data—Probably
10mg Tab. B22 Suggest Low Risk3 Compatible3
Charcoal Activated 250mg C1
Not documented4 Not documented4
Tab. B22
There is no evidence on the
Chloramphenicol 0.5% w/v safety in infants exposed via
Eye Drops breastfeeding after maternal
Compatible3 use; risks of toxicity in the
No association between topical infant are theoretical and not
Chloramphenicol 1% Eye C1
chloramphenicol in the 1st trimester supported by direct clinical
Ointment A2
of pregnancy and major congenital evidence. Therefore, the use of
malformations8 chloramphenicol via the ear or
eye can proceed with caution.
Chloramphenicol 5% w/v Ear However, it should be avoided
Drops if there is a past or family
history of blood dyscrasias9
Item Pregnancy Category Use in pregnancy Use in lactation
No Human Data—Probably
Chlorhexidine 1% Cream B1 Compatible3
Compatible3

Chlorhexidine Gluconate 5% No Human Data—Probably


B1 Compatible3
Solution Compatible3
Chlorpheniramine Maleate
10mg/ml Inj. B1 Compatible3
No Human Data—Probably
Chlorpheniramine Maleate A2
Compatible 3
4mg Tab.
Not known whether
Cinnarizine is excreted in
human milk; however, low
concentrations of other
Animal Data—No Teratogenic Effect.
antihistamine have been
Human Data—The safety of
Cinnarizine 25mg Tab. C1 dictated in human milk.
Cinnarizine in pregnancy has not
Because of the risk
been established. Not advisable4
antihistamic side effects in
infants, particularly in
neonates, patient should not
nurse while taking this drug4
The safe use of topical
corticosteroids during lactation
has not been established. If
used during lactation, should
not be applied to the breasts
There is limited data. Topical
to avoid accidental ingestion
administration of corticosteroids to
by the infant.4 Since only
pregnant animals can cause
Clobetasol Butylrate 0.05% C1 extensive application of the
abnormalities of foetal
Cream B32 most potent corticosteroids
development. Benefit should
may cause systemic effects in
outweigh risk4
the mother, it is unlikely that
short-term application of
topical corticosteroids would
pose a risk to the breastfed
infant by passage into
breastmilk5
Clotrimazole 1% Cream B1 Compatible3 Compatible3

Clotrimazole 500mg Vaginal


B1 Compatible3 Compatible3
Tablet (Pessary)
Cloxacillin is excreted in breast
milk. Althaugh no significant
Problems in humans have not been problems have been reported,
Cloxacillin Sodium 500mg
B1 documented. However, the risk- the risk benefit must be
Capsule
benefit must be considered4 considered since its use by
nursing mothers may lead to
sensitization of infants4

C1 Limited Human Data—


Colchicine 0.5mg Tab. Compatible3
D1 Probably Compatible3
Item Pregnancy Category Use in pregnancy Use in lactation
Crotamiton 10% cream C1 Use with caution6 Use with caution6

Diclofenac Sodium 50mg Prior to 30 week


Tab. gestation: C1
Starting 30 week Human data suggest risk in 1st and No human data- Probably
Diclofenac Sodium gestation: D1 3rd trimesters3 compatible3
75mg/3ml Inj. C2
Not assigned 1 Limited Human Data—
Diltiazem HCl 30mg Tab. Human Data Suggest Low Risk3
C2 Probably Compatible 3
Animal Data—No Teratogenic Effect.
Diosmin 450mg & Hesperidin 1
Not assigned Human Data—No harmful effects Not recommended4
50mg Tab.
have been reported to date4
Diphenhydramine HCl B1 Limited human data- Probably
Compatible3
12.5mg/5ml Syrup (Adult) A2 compatible3
Animal reproduction studies have
shown an adverse effect on the
Diphenoxylate 2.5mg + fetus and there are no adequate and
C1
Atropine Sulphate 25mcg well-controlled studies in humans, Use with caution6
C2
Tab. but potential benefits may warrant
use of the drug in pregnant women
despite potential risks6
-Most products: D
-Doryx(R) MPC,
Vibramycin(R), Vibra- Contraindicated in 2nd and 3rd
Doxycycline 100mg Cap. Compatible3
Tabs(R): Not Trimesters3
assigned.1
D2
Paradichlorobenzene,
Turpentine Oil & Chlorbutol - Use with caution4 Use with caution4
Ear Drops (Cerumol)

D1 Human Data Suggest Risk in 2nd and Limited Human Data—


Enalapril 5mg/10mg Tab.
D2 3rd Trimesters3 Probably Compatible3
Erythromycin Ethylsuccinate B1
Compatible3 Compatible3
400mg Tab. A2
C1 Limited Human Data—
Ethambutol HCL 400mg Tab. Compatible3
A2 Probably Compatible3
Not assigned1 Contraindicated: Remove implant if May be used after the 4th
Etonogestrel 68mg Implant
B32 pregnancy occurs4 postpartum week4
Etoricoxib is excreted in the
- milk of lactating rats. It is not
Etoricoxib 90mg Tab Contraindicated4
C2 known whether this drug is
excreted in human milk4
C1 Limited Human Data—Animal Data No Human Data—Probably
Felodipine 5mg/10mg Tab.
C2 Suggest Risk3 Compatible3

Not assigned1 Limited human data- Animal data No human data- Potential
Fenofibrate 145mg Tab
B2 suggest risk3 toxicity3
Item Pregnancy Category Use in pregnancy Use in lactation
Problems in humans have not been
Ferrous Fumarate 200mg 1 Problem in humans have not
Not assigned documented with orally intake of
Tab. been documented6
daily recommended amounts4
Fluorescein Sodium C1 Limited human data- Animal data Limited human data- Probably
Ophthalmic Strips B22 suggest low risk3 compatible3
Fluticasone Propionate C1
Use with caution6 Use with caution6
125mcg Inhaler B32
C1 Human Data Suggest Risk in 3rd Limited Human Data—
Fluvoxamine 50mg Tab.
C2 Trimester3 Potential Toxicity3
A1
Folic Acid 5mg Tab. Compatible3 Compatible3
A2
Frusemide 20mg/2ml Inj.
C1 Limited human data- Probably
Human data suggest low risk3
C2 compatible3
Frusemide 40mg Tab.

Limited human data- Probably


compatible3
An expert consensus guideline
C1 Limited human data- Animal data
Gabapentine 300mg Cap indicates that gabapentin is an
B32 suggest risk3
acceptable choice for
refractory restless leg
syndrome during lactation5
Limited Human Data—Animal Data Limited Human Data—Probably
Gamma Benzene 0.1% Lotion C1
Suggest Low Risk3 Compatible3

C1 Limited Human Data—Animal Data No Human Data—Potential


Gemfibrozil 300mg Cap.
B22 Suggest Risk3 Toxicity3

Gliclazide MR 30/60mg Tab. C1 Contraindicated6 Contraindicated6

Glycerin & Sodium Chloride


C1 Use with caution6 Use with caution6
Enema
Glyceryl Trinitrate 500mcg C1 No Human Data—Probably
Human Data Suggest Low Risk3
Tab. B22 Compatible3
It is unknown whether
There is no available data. Animal
glycopyrronium bromide is
studies do not indicate direct or
Glycopyrronium 50mcg excreted in human milk.
C1 indirect harmful effects with respect
Inhalation Powder Hard Should only be considered if
B22 to reproductive toxicity. Benefit
Capsules the expected benefit to the
should outweigh risk4
woman is greater than any
possible risk to the infant4
Microsize
formulation: X.
Ultramicrosize Limited Human Data—Probably No Human Data—Potential
Griseofulvin 125mg Tab.
formulation: Not Compatible3 Toxicity3
assigned1
D2
C1 Limited human data- Animal data Limited human data- Potential
Haloperidol 5mg/ml Inj.
C2 suggest moderate risk3 toxicity3
Item Pregnancy Category Use in pregnancy Use in lactation
Heparin Sodium 10IU/ml in C1
Compatible3 Compatible3
Sodium Chloride 0.9% Inj. C2
Hydrochlorothiazide 25mg B1
Compatible3 Compatible3
Tab. C2
C1 Limited Human Data—Probably
Hydrocortisone 1% Cream Human Data Suggest Risk3
A2 Compatible3
Limited human data- Probably
compatible3
Systemically administered
corticosteroids appear in
Human data suggest risk3
human milk and could
Have been shown to be teratogenic
suppress growth, interfere
in many species when given in doses
with endogenous
equivalent to the human dose.
corticosteroid production, or
Hydrocortisone Suc. 100mg C1 Animal studies have yielded an
cause other untoward effects.
Inj. C2 increased incidence of cleft palate in
Because of the potential for
the offspring of pregnant mice, rats,
serious adverse reactions in
and rabbits. There are no adequate
nursing infants, a decision
and well-controlled studies in
should be made whether to
pregnant women4
continue nursing, or
discontinue the drug, taking
into account the importance of
the drug to the mother4
Hyoscine N-Butylbromide Limited human data- Probably
C1 Human data suggest low risk3
10mg Tab. compatible3
Limited human data- Probably
compatible3
No information is available
during breastfeeding. Use
Human data suggest low risk3 during labor appears to have a
Hyoscine N-Butylbromide
C1 Crosses placenta. However, studies detrimental effect on newborn
20mg/ml Inj.
B2 have not been done in animals or infants' nursing behavior. Long-
(Scopolamine)
humans4 term use of scopolamine might
reduce milk production or milk
letdown, but a single systemic
is not likely to interfere with
breastfeeding5

Studies have failed to reveal


evidence that Folic acid (Iberet Folic-
Iberet-Folic 500 Tab. A1 500) increases the risk of fetal Compatible5
abnormalities if administered during
pregnancy5
C1 Human Data Suggest Risk in 1st and
Ibuprofen 100mg Tab Compatible3
C2 3rd Trimesters3
B; D (if used for >48
h/after 34 wk/near Human Data Suggest Risk in 1st and Limited Human Data—
Indomethacin 25mg Tab.
delivery) 1 3rd Trimesters3 Probably Compatible3
C2
Item Pregnancy Category Use in pregnancy Use in lactation
Insulin Aspart 30%/Aspart
B1 Limited human data- Probably
Protamine 70%(NovoMix-30) Compatible3
A2 compatible3
100 IU/ml FlexPen

Insulin Detemir (Levemir) B1


Compatible3 Compatible3
100 IU/ml FlexPen A2
Insulin Glargine (Basalog) C1
Compatible3 Compatible3
100 IU/ml Pre-filled Pen B32
Insulin Isophane (Insugen-N)
B1 Compatible3 Compatible3
100 IU/mL Penfill

Insulin Regular (Insugen-R)


B1 Compatible3 Compatible3
100 IU/mL Penfill
Insulin Regular/Isophane
(Insugen-30/70) 100 IU/mL B1 Compatible3 Compatible3
Penfill
Ipratropium Bromide 20mcg
C1 No Human Data—Probably
+ Fenoterol 50mcg/dose Human Data Suggest Low Risk3
B12 Compatible3
Inhalation

Ipratropium Bromide and


C1 No Human Data—Probably
Salbutamol Respirator Human Data Suggest Low Risk3
B12 Compatible3
Solution
Limited data indicate trace
Limited human data- Animal data amounts of iron dextran
Iron Dextran 50mg Fe/ml in C1
suggest reproductive toxicity. excreted into breastmilk5
2ml Inj. -
Benefit should outweigh risk4 It is preferable to not use
during breast-feeding4
C1 Compatible—Maternal Benefit >> Limited Human Data—
Isoniazid 100mg Tab.
A2 Embryo–Fetal Risk3 Probably Compatible3
Isosorbide Dinitrate 10mg C1 Limited Human Data—Animal Data No Human Data—Probably
Tab. B12 Suggest Moderate Risk3 Compatible3
C1 Limited human data- Potential
Itraconazole 100mg Tab. Human data suggest low risk3
B32 toxicity3

During 1st and 2nd trimester: In


mice and rats, there is no evidence
of teratogenic or embryotoxicity. In
the rabbit, slight embryotoxicity
No data are available on
likely related to maternal toxicity
excretion of ketoprofen in
has been reported.
human milk. Ketoprofen is not
C1 During 3rd trimester:
Ketoprofen 2.5% Gel recommended in nursing
C2 Contraindicated4
mothers4
Fetal toxicity can occur in response
to not only systemic, but also
transdermal administration, and
accounts well for the sustained fetal
toxicity after discontinuing the
administration of ketoprofen10
Item Pregnancy Category Use in pregnancy Use in lactation
C1 Limited Human Data—
Labetalol HCL 100mg Tab. Human Data Suggest Low Risk3
C2 Probably Compatible3
No human data- Probably No human data- Probably
Lactulose Liquid B1
compatible3 compatible3
LevoThyroxine Sodium A1
Compatible3 Compatible3
50mcg/100mcg Tab. A2
B1
Lignocaine 2% Jelly Use with caution6 Use with caution6
A2
Limited human data- Probably
compatible3
Lidocaine concentrations in
Compatible. The majority of the
milk during continuous IV
information on the drug in
infusion, epidural
pregnancy derives from its use as a
administration and in high
Lignocaine HCl (Lidocaine) B1 local anesthetic during labor and
doses as a local anesthetic are
100 mg/5 ml Inj. (2%) IV/IM A2 delivery. Reproduction studies have
low and the lidocaine is poorly
revealed no evidence of fetal harm
absorbed by the infant.
in pregnant rats a doses up to 6.6
Lidocaine is not expected to
times the human dose3
cause any adverse effects in
breastfed infants. No special
precautions are required5
Not assigned1 Limited Human Data—Animal Data Limited Human Data—
Loratadine 10mg Tab.
B12 Suggest Low Risk3 Probably Compatible3
Since loratadine and
Safe use of loratadine +
pseudoephedrine sulphate are
pseudoephedrine during pregnancy
Loratadine 5mg + excreted in breast milk, a
Not Assigned1 has not been established. Therefore,
Pseudoephedrine 120mg decision should be made
B22 the drug should be used only if
Tab. whether to discontinue nursing
potential benefit justifies the
or discontinue the use of this
potential risk to the foetus6
product6

D1 Human Data Suggest Risk in the 2nd No Human Data—Probably


Losartan 50/100mg Tab
D2 and 3rd Trimesters3 Compatible3

Compatible. Compatible.
Does not usually pose a risk to the IV magnesium increases milk
fetus or newborn. Longterm magnesium concentrations
infusions of magnesium may be only slightly and oral
Magnesium Sulfate D1 associated with sustained absorption of magnesium by
2.47gm/5ml Inj. D2 hypocalcemia in the fetus resulting the infant is poor, so maternal
in congenital rickets. Neonatal magnesium therapy is not
neurologic depression may occur expected to affect the
with respiratory depression, muscle breastfed infant's serum
weakness, and loss of reflexes3 magnesium3

D1
Magnesium Sulphate Paste Compatible3 Compatible3
D2
Item Pregnancy Category Use in pregnancy Use in lactation
Meclozine may be distributed
into breast milk. However,
problems in humans have not
been documented. Due to its
anticholinergic actions,
Meclozine may inhibit
lactation. Therefore, it is not
Meclozine is not expected to harm
recommended for lactating
an unborn baby.
women unless the expected
Meclozine HCL 25mg + Meclozine HCL: B1 Pyridoxine is considered to be safe
benefits outweigh any
Pyridoxine 50mg Tab. Pyridoxine: A1 for use during pregnancy. Pyridoxine
potential risk.
requirements increase during
Pyridoxine is excreted into
pregnancy.6
milk. While some have
expressed concern over the
inhibition of breast milk
secretion by Pyridoxine, others
have cautioned that Pyridoxine
deficiency may cause seizures
in neonate.6
Meclozine may be distributed
into breast milk. However,
problems in humans have not
been documented. Due to its
anticholinergic actions,
Meclozine may inhibit
lactation. Therefore, it is not
Meclozine is not expected to harm
recommended for lactating
an unborn baby.
women unless the expected
Meclozine HCL 25mg + Meclozine HCL: B1 Pyridoxine is considered to be safe
benefits outweigh any
Pyridoxine 50mg Tab. Pyridoxine: A1 for use during pregnancy. Pyridoxine
potential risk.
requirements increase during
Pyridoxine is excreted into
pregnancy.6
milk. While some have
expressed concern over the
inhibition of breast milk
secretion by Pyridoxine, others
have cautioned that Pyridoxine
deficiency may cause seizures
in neonate.6
Medroxyprogesterone 5mg X1
Contraindicated3 Compatible3
Tab. D2
C ;D(in 3rd trimester
Human Data Suggest Risk in 1st and Limited Human Data—
Mefenamic Acid 250mg Tab. or near delivery)1
3rd Trimesters3 Probably Compatible3
C2
Human data suggest risk in 1st and
C1
3rd trimesters3 No human data- Probably
Meloxicam 7.5mg Tab. 3rd trimester: D1
Avoid during 3rd trimester or near compatible3
C2
delivery
Metformin HCl +
B1
Glibenclamide 500/2.5mg Not recommended6 Not recommended6
C2
Tab.
Item Pregnancy Category Use in pregnancy Use in lactation
B1
Metformin HCL 500mg Tab. Human Data Suggest Low Risk3 Compatible3
C2
B1
Metformin XR 500mg Tab. Human Data Suggest Low Risk3 Compatible3
C2
B1 Limited Human Data—
Methyldopa 250 mg Tab. Compatible3
A2 Probably Compatible3
Compatible3
Metoclopramide HCL 10mg B1 Metoclopramide is excreted in
Compatible. Metoclopramide has
Tab. A2 variable amounts in breastmilk.
been used during all stages of
Although most studies have
pregnancy. No evidence of embryo,
found no adverse effects in
fetal, or newborn harm has been
breastfed infants during
Metoclopramide Hcl B1 found in human and animal studies3
maternal metoclopramide use,
10mg/2ml Inj. A2 many did not adequately
observe for side effects5
Metoprolol Tartrate 100mg C1 Human Data Suggest Risk in 2nd and Limited Human Data—
Tab. C2 3rd Trimesters3 Potential Toxicity3
Hold Breastfeeding (Single
1
B Dose) Limited. Human Data—
Metronidazole 200mg Tab. Human Data Suggest Low Risk3
B22 Potential Toxicity (Divided
Dose)3
Miconazole Nitrate 2% C1
Compatible3 Compatible3
Cream A2
No human data- Probably
compatible3
Very low levels appear in
B1 Limited human data- Probably
Montelukast 10mg Tab breastmilk. Amounts ingested
B12 compatible3
by the infant would not be
expected to cause any adverse
effects5
C1 No human data- Probably
Naloxone HCl 0.4mg/ml Inj. Compatible3
B12 compatible3
D1 No Human Data—Probably
Neomycin 0.5% Cream Human Data Suggest Low Risk3
D2 Compatible3

C1 Limited Human Data—Probably


Nifedipine 10mg Tab Human Data Suggest Low Risk3
C2 Compatible3
B1
Human Data Suggest Risk in 3rd Limited Human Data—
Nitrofurantoin 100mg Tab A (short-term
Trimester3 Probably Compatible3
therapy)2
Nystatin 100,000 IU/ml C1
Compatible3 Compatible3
Suspension A2
C1 Limited Human Data—Potential
Omeprazole 20mg Cap Human Data Suggest Low Risk3
B32 Toxicity3

B1
Paracetamol 500mg Tab Human Data Suggest Low Risk3 Compatible3
A2
Item Pregnancy Category Use in pregnancy Use in lactation

Perindopril 4mg/8mg/4mg + D1
Contraindicated6 Contraindicated6
indapamide 1.25mg D2

Phenoxymethylpenicillin B1
Compatible3 Compatible3
125mg Tab A2

Compatible—Not be used unless Compatible—Not be used


Phenytoin Sodium 100mg D1
maternal benefit outweighs risk to unless maternal benefit
Cap D2
fetus3 outweighs risk to fetus3

-
Pizotifen 0.5mg Tab. Use with caution Use with caution
B12

Potassium Chloride SR C1
Compatible3 Compatible3
600mg Tab Exempt2

Potassium Permanganate BP - Use with caution4 Use with caution4

C1 Limited Human Data—Animal Data Limited Human Data—Potential


Prazosin HCL 1mg/2mg Tab.
B22 Suggest Low Risk3 Toxicity3

C/D1
Prednisolone 5mg Tab. Human Data Suggest Risk3 Compatible3
A2

Prolase Tab. - Use with caution Use with caution

C1 Human Data Suggest Risk in 2nd and Limited Human Data—Potential


Propranolol 40mg Tab.
C2 3rd Trimesters3 Toxicity3

D1 Compatible—Maternal Benefit >>


Propylthiouracil 50mg Tab. Compatible3
C2 Embryo–Fetal Risk3

C1 Compatible—Maternal Benefit >> Limited Human Data—Probably


Pyrazinamide 500mg Tab.
Embryo–Fetal Risk3 Compatible3

A1
Pyridoxine 10mg Tab. Compatible3 Compatible3
Exempt2

Ranitidine 150mg Tab.


B1 Limited human data- Probably
Ranitidine 25mg/ml Compatible3
B12 compatible3
(2ml/amp) Inj.
Rifampicin 150mg/300mg C1
Compatible3 Compatible3
Tab. C2

Rifampicin 150mg + Isoniazid C1


Compatible3 Compatible3
75mg Tab. (Akurit-2) C2

Rifampicin 150mg, Isonizid


C1
75mg, Pyrazinamide 400mg, Limited Human Data—Probably
A2 Compatible3
Ethambutol HCL 275mg Tab. Compatible3
(Akurit-4)
Item Pregnancy Category Use in pregnancy Use in lactation

C1 Compatible—Maternal Benefit >> Limited Human Data—Potential


Risperidone 1mg/2mg Tab.
D2 Embryo–Fetal Risk3 Toxicity3

C1 No Human Data—Probably
Salbutamol 2mg Tab. Compatible3
A2 Compatible3

Concentrations in plasma after


inhaled therapeutic doses are
There is insufficient experience of
very low and therefore,
the use in human pregnancy.
concentrations in human
Reproductive toxicity studies in
breast milk are likely to be
animals revealed the foetal effects
Salmeterol 50mcg + C1 correspondingly low. This is
expected at excessive systemic
Flutisone Propionate 250mcg B32 supported by studies in
exposure levels of a potent β2-
lactating animals, in which low
adrenoreceptor agonist and
drug concentrations were
glucocorticosteroid. Benefit should
measured in milk. No data
outweigh risk4
available for human breast
milk4
No human data- Probably
compatible3
Monitoring of the breastfed
infant's blood glucose is
B1 No human data- Animal data advisable during maternal
Saxagliptin 5mg Tab.
B32 suggest low risk3 therapy with saxagliptin.
However, an alternate drug
may be preferred, especially
while nursing a newborn or
preterm infant5
Animal reproductive studies have There is no data on the
not been conducted. There is no excretion of selenium topical
Selenium Sulphide Shampoo C1 controlled data in human into human milk. Because
25mg/ml - pregnancy. Most manufacturer many drugs are secreted in
stated that their product should not human milk, caution is
be used by pregnant women4 recommended4
C1 Human Data Suggest Risk in 3rd Limited Human Data—Potential
Sertraline 50mg Tab
C2 Trimester3 Toxicity3

Silver Sulphadiazine 1% B1
Contraindicated6 Contraindicated6
Cream C2

X1
Simvastatin 10mg/40mg Contraindicated3 Contraindicated3
D2

Sodium Bicarbonate 8.4% Inj. C1 Limited human data- Animal data No human data- Potential
(10ml) - suggest low risk toxicity3

Sodium Bicarbonate, Citric - Limited Human Data—Probably Limited Human Data—Probably


Acid, Citrate & Tartaric Acid Compatible3 Compatible3
Item Pregnancy Category Use in pregnancy Use in lactation

It is not known whether


There are no adequate and well-
Sodium Cromoglicate is
controlled studies in pregnant
excreted in human milk.
Sodium Cromoglycate 2% B1 women. Therefore, use during
Therefore caution should be
Eye Drops A2 pregnancy is not recommended
exercised when the eye drops
unless the benefit outweighs the
are administered to nursing
potential risk4
mothers4

Sodium Valproate 200mg D1 Limited Human Data—Potential


Human Data Suggest Risk3
Tab D2 Toxicity3

C1 Limited Human Data—Animal Data Limited Human Data—Probably


Spironolactone 25mg Tab.
B32 Suggest Risk3 Compatible3

Sulphamethoxazole 400 mg
D1 Human Data Suggest Risk in 3rd Limited Human Data—Potential
& Trimethoprim 80 mg
D2 Trimester3 Toxicity3
(Co-Trimoxazole) Tab.

Sulpiride 200mg Tab. - Use with caution6 Use with caution6

Telmisartan 40mg/ 80mg/ D1 Human Data Suggest Risk in 2nd and No Human Data—Probably
80+12.5mg HCTZ D2 3rd Trimesters3 Compatible3

C1 No human data- Animal data No human data- Probably


Terazosin 2mg Tab.
B22 suggest low risk3 compatible3

Theophylline B.P. 250mg SR C1


Compatible3 Compatible3
Tab. A2

B1 Limited Human Data—Animal Data No Human Data—Potential


Ticlopidine 250mg Tab.
Suggest Low Risk3 Toxicity3

C1 Limited Human Data—Potential


Tramadol HCL 50mg Tab. Human Data Suggest Risk3
C2 Toxicity3

Tranexamic Acid 250mg Limited Human Data—Animal Data Limited Human Data—Probably
B1
Capsule Suggest Low 3 Compatible3

Triamcinolone 0.1% Dental C1


Use with caution6 Use with caution6
Paste B32

Itt is unknown whether


There are no data from the use of trimetazidine/metabolites are
trimetazidine in pregnant women. excreted in human milk. A risk
Trimetazidine 35mg MR Tab. - As a precautionary measure, it is to the newborns/infants
preferable to avoid the use during cannot be excluded. Should
pregnancy4 not be used during breast-
feeding4

Triprolidine & Limited Human Data—Probably


C1 Compatible3
Pseudoephedrine Tab. Compatible3
Item Pregnancy Category Use in pregnancy Use in lactation

Unknown whether
tropicamide/metabolites are
excreted in human milk. A
decision must be made
whether to discontinue
There are no or limited amount of breastfeeding or to
C1 data from the use of Tropicamide in discontinue/abstain from
Tropicamide 1% Eye Drops
B22 pregnant women. It is not tropicamide4
recommended during pregnancy4 A single dose of is not likely to
interfere with breastfeeding;
however, during long-term use,
observe the infant for signs of
decreased lactation (e.g.,
insatiety, poor weight gain)5

Valsartan 80mg & HCTZ D1 Human Data Suggest Risk in 2nd and No Human Data—Probably
12.5mg Tab. D2 3rd Trimesters3 Compatible3
D1 Human data suggest risk in 2nd and
Valsartan 80mg Tab Probably compatible 3
D2 3rd trimesters 3
C1 Limited Human Data—Probably
Verapamil HCL 40mg Tab. Compatible3
C2 Compatible3
There are no adequate data from It is unknown whether
the use of vildagliptin in pregnant vildagliptin is excreted in
women. Studies in animals have human milk. Animal studies
C1
Vildagliptin 50mg Tab shown reproductive toxicity at high have shown excretion of
B32
doses. Due to lack of human data, it vildagliptin in milk. It should
should not be used during not be used during breast-
pregnancy4 feeding4
C1
Vitamin K1 1mg/ml Inj. Compatible3 Compatible3
-

REFERENCES

1- US FDA
2. AU TGA
3. Drugs in pregnancy and lactation, 11th Edition (BRIGGS)
4. Product Information Leaflet
5. LACTMED
6.MIMS
7. Micromedex
8. Thomseth V, Cejvanovic V, Jimenez-Solem E, Petersen K, Poulsen H, Andersen J. Exposure to topical
chloramphenicol during pregnancy and the risk of congenital malformations: a Danish nationwide cohort study.
Acta Ophthalmologica. 2015;93(7):651-653.
9. United Kingdom National Health Service (NHS)
10. Tanaka S, Kanagawa T, Momma K, Hori S, Satoh H, Nagamatsu T et al. Prediction of sustained fetal toxicity
induced by ketoprofen based on PK/PD analysis using human placental perfusion and rat toxicity data. British
Journal of Clinical Pharmacology. 2017;83(11):2503-2516.
APPENDIX A: Drug safety in Pregnancy classification (US FDA)

Category A Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no
evidence of a risk in later trimesters), and the possibility of fetal harm appears remote.

Category B Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies
in pregnant women or animal-reproduction studies have shown an adverse effect that was not confirmed
in controlled studies in women in the first trimester.

Category C Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other)
and there are no controlled studies in women or studies in women and animals are not available. Drugs
should be given only if the potential benefit justifies the potential risk to the fetus.

Category D There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be
acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease
for which safer drugs cannot be used or are ineffective).

Category X Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal
risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly
outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

APPENDIX B: Drug safety in Pregnancy classification (AU TGA)

Category A Drugs which have been taken by a large number of pregnant women and women of childbearing age without
any proven increase in the frequency of malformations or other direct or indirect harmful effects on the
fetus having been observed.

Category B1 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age,
without an increase in the frequency of malformation or other direct or indirect harmful effects on the
human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.

Category B2 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age,
without an increase in the frequency of malformation or other direct or indirect harmful effects on the
human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased
occurrence of fetal damage.

Category B3 Drugs which have been taken by only a limited number of pregnant women and women of childbearing age,
without an increase in the frequency of malformation or other direct or indirect harmful effects on the
human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of
which is considered uncertain in humans.

Category C Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful
effects on the human fetus or neonate without causing malformations. These effects may be reversible.
Accompanying texts should be consulted for further details.

Category D Drugs which have caused, are suspected to have caused or may be expected to cause, an increased
incidence of human fetal malformations or irreversible damage. These drugs may also have adverse
pharmacological effects. Accompanying texts should be consulted for further details.

Category X Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in
pregnancy or when there is a possibility of pregnancy.

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