Drug Use in Pregnancy & Lactation

Question 1

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Boxed Warnings:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:
Counseling to patients:

Answer 1

class:
Indications:
MOA:
Dosage forms:
Dosing:
Max dose:
Contraindications:
Warnings:
Side Effects:
Monitoring:
Pearls/Notes:
Drug-Drug/Food interactions:

Question 2

Pregnancy typically lasts _____

Answer 2

37-40 weeks

Question 3

pregnancy is divided into 3 trimesters:

Trimester 1:

Trimester 2:

Trimester 3:

Answer 3

Trimester 1: (0 - 12 weeks), when most organ development occurs. Embryo most susceptible to birth defects caused by Teratogens.

Trimester 2: (13 - 27 Weeks)

Trimester 3: (28 - birth)

“3 months span of time”

Question 4

A test positive (+) for ______ indicates pregnancy.

Answer 4

hCG

Question 5

PK changes during pregnancy can require dose and regimen changes.

For example, in women being treated for hypothyroidism, an increased dose of levothyroxine will be required in order to keep thyroid hormones within normal limits.

Question 6

(ACOG) American College of Obstetricians and Gynecologists:

Answer 6

is an organization that publishes guidelines for safe and effective use in conditions impacting women, including pregnancy.

Question 7

A patient’s obstetric history can be described using gravida AND para:

(G) gravida:

(P) para:

Answer 7

(G) gravida: is the number of times the person HAS BEEN PREGNANT.

(P) para: is the number of times a patient HAS GIVEN BIRTH.

For example: (G3, P1)

G3 = gravida 3 = has been pregnant 3 times

P1 = para 1 = has given birth once

Question 8

Lifestyle modifications:
- should always be considered 1st when treating pregnant patients.
- includes encouragement to stop using recreational drugs, alcohol, and tobacco, EACH OF WHICH IS TERATOGENIC.
- Behavioral intervention is a safe and sometimes effective strategy for prenatal smoking cessation.

Question 9

Vitamin and Mineral Supplementation:

Adult requirements for Folate: _________

During Pregnancy, Folate requirements:_____

Answer 9

Adult requirements for Folate: 400mcg of dietary folate equivalents (DFE) per day

During Pregnancy, Folate requirements: 600mcg of dietary folate equivalents

Question 10

Vitamin and Mineral Supplementation:

During Pregnancy, Calcium requirements:_______

During pregnancy, Vitamin D requirements:______

Answer 10

1000mg/day of calcium

15mcg/day (600 IU/day)

Question 11

Vitamin and Mineral Supplementation:

Question 12

Vitamin and Mineral Supplementation:

Question 13

___________- deficiency causes birth defects of the brain and spinal cord (neural tube defects).

Answer 13

Folate (folic acid, vitamin B9)

• is found in many healthy foods, including fortified flour and cereals, dried beans, green leafy vegtables and orange juice.

Question 14

Previous Pregnancy Categories:

Category A-

Answer 14

• Controlled studies in ANIMALS & WOMEN show NO RISK in the first trimester.
• Risk of fetal harm is remote (unlikely to occur)

Question 15

Previous Pregnancy Categories:

Category B-

Answer 15

• ANIMAL studies have NOT demonstrated a fetal risk.
  BUT
  –NO WELL CONTROLLED STUDIES IN PREGNANT WOMEN.

Question 16

Previous Pregnancy Categories:

Category C-

Answer 16

• ANIMAL studies HAVE SHOWN HARM TO THE FETUS.

-NO WELL CONTROLLED STUDIES IN PREGNANT WOMEN.
- Use only if potential benefit outweighs the risk.

Question 17

Previous Pregnancy Categories:

Category D-

Answer 17

• POSITIVE EVIDENCE of risk to the HUMAN FETUS is available.
• but the benefits may outweigh the risk with life-threatening or serious diseases.

Question 18

Previous Pregnancy Categories:

Category X-

Answer 18

-Studies in ANIMALS OR HUMANS show fetal abnormalities.
- The risks involved clearly outweigh potential benefits; USE IN PREGNANCY IS CONTRAINDICATED.

Question 19

** The Updated labeling is intended to provide patients and clinicians with more detailed benefit/risk data on prescription drugs in order to make informed decisions. **

Question 20

Updated Pregnancy Sections in Package Inserts:

8.1 Pregnancy-

Answer 20

A pregnancy risk category is required for ALL medications that includes the:

• risk of adverse development outcomes based on human and animal data
  AND
• the drug’s pharmacology.
• Includes any dose adjustments, maternal/fetal adverse reactions and disease risks.
• Includes pregnancy exposure registry information.
• Pregnant women SHOULD BE ENCOURAGED to participate in registries, which exist for select disease states and drugs. The regietries collect health information from women who take prescription drugs and vaccines when pregnant and breastfeeding. Information is also collected on the newborn baby.

Question 21

Updated Pregnancy Sections in Package Inserts:

8.2 Lactation-

Answer 21

• includes whether the drug/metabolites are present in human milk, the effects on the breastfed infant, and the effects on milk production.
• If applicable, ways to minimize exposure and monitor for adverse reactions are included.

Question 22

Updated Pregnancy Sections in Package Inserts:

8.3 Females & Males of Reproductive Potential-

Answer 22

• Includes any effects on fertility and requirements for pregnancy testing and contraception.

Question 23

Drug Treatment:

“If possible, use lifestyle measures to treat medical conditions in pregnant women. When this is impossible or ineffective, choose drugs carefully.”

Question 24

There are 2 immunizations that are routinely recommended for pregnant patients:

1)

2)

Answer 24

1- the inactivated influenza vaccine (NOT LIVE) is recommended during any trimester at the beginning of flu season.

2- a single dose of Tdap should be administered during each pregnancy

“ALL LIVE VACCINES ARE CONTRAINDICATED IN PREGNANCY”.

Question 25

Common Teratogens:

Teratogenic drugs SHOULD BE DISCONTINUED prior to pregnancy, if possible, BUT about half of pregnancies are NOT planned.

Teratogens- are hazardous drugs according to the (NIOSH)____________, and require special handling to avoid risk to healthcare workers

Answer 25

(NIOSH) National Institute for Occupational Safety and Health

Question 26

Drug treatment:

“With any medication, the drug’s potential harm must be WEIGHED AGAINST THE RISK OF THE CONDITION not being adequately treated.

Answer 26

For example, the use of lamotrigine in pregnancy carries the risk of congenital malformations, but seizures cause damage to both the mother and child.

Question 27

Drug treatment Resources:

-** Always check reputable, up-to-date resources when prescribing/dispensing to pregnant women.

** Briggs Drugs in Pregnancy and Lactation**

Question 28

Preeclampsia-

What is it?

What happens if not treated?

Is there a cure?

Answer 28

• is a complication of pregnancy that presents with ELEVATED BLOOD PRESSURE and evidence of organ damage, most often to the kidneys or liver.
• usually presents after the first trimester of pregnancy and can occur in women with previously normal blood pressure.
• IF NOT TREATED, PREECLAMPSIA can progress to ECLAMPSIA, which can lead to seizures and death.
• the only cure for preeclampsia is delivery of the baby.

Question 29

Preeclampsia- “Prevention”

• To prevent preeclampsia, ACOG and American Diabetes Association (ADA) guidelines recommend:

-

Answer 29

• adding daily low dose aspirin at the end of the first trimester for pregnant women at risk for preeclampsia.
  [e.g. Type 1 or 2 diabetes*, renal disease, Hx of preeclampsia, chronic hypertension].

Question 30

MORNING SICKNESS, NAUSEA, VOMITING

Preferred Management During Pregnancy:

Drug of Choice:

Answer 30

**Lifestyle modifications first:
eat smaller, more frequent meals, drink plenty of water, avoid spicy or odorus foods, take more frequent naps, and reduce stress, including working long hours.

IF LIFESTYLE MEASURES FAIL, ACOG recommends:
- pyridoxine (vitamin B6)
- (+/-) doxylamine [First line]

• (Rx) (Bonjesta, Diclegis)—–[doxylamine + pyridoxine]
  —————————————————————————– Ginger is rated as possible effective for treating morning sickness

Question 31

GERD/HEARTBURN

Preferred Management During Pregnancy:

Drug of Choice:

Answer 31

**Lifestyle modifications first:
- eat smaller, more frequent meals, avoid foods that worsen GERD. If symptoms occur while sleeping recommend elevating the head of the bed and not eating 3 hours prior to sleep.

IF LIFESTYLE MEASURES FAIL, recommend
- antacids, calcium antacids, such as CALCIUM CARBONATE (TUMS), are a good choice since calcium intake is often deficient.

—————————————————————————–IF heartburn symptoms are not relieved by Tums, H2 receptor antagonists or PPIs can be considered for add-on therapy.

Question 32

FLATULENCE

Preferred Management During Pregnancy:

Drug of Choice:

Answer 32

simethicone (Gas-X, Mylicon)

Question 33

CONSTIPATION

Preferred Management During Pregnancy:

Drug of Choice:

Answer 33

**Lifestyle modifications first:
- INCREASING fluid intake
- INCREASING dietary fiber
- INCREASING physical activity

IF LIFESTYLE MEASURES FAIL:
- Fiber (psyllium, calcium polycarbophil, methylcellulose), with adequate amounts of fluid, is preferred.

• Docusate and polyethylene glycol are used to prevent and treat constipation.

[constipation is such a prevalent issue in pregnancy that many prenatal vitamins contain docusate]

Question 34

COUGH, COLD, ALLERGIES

Preferred Management During Pregnancy:

Drug of Choice:

Answer 34

FIRST LINE- cromolyn

Second line- 1st generation antihistamines
Drug of Choice- Chlorpheniramine, diphenhydramine is also commonly used.

The non-sedating 2nd generation antihistamine agents loratadine and cetirizine are often recommended by obstetricians during the second and third trimesters.

IF NASAL STEROIDS ARE NEEDED for chronic allergy symptoms, all intranasal steroids are considered to be safe.
- BUDESONIDE (Rhinocort Allergy) & BECLOMETHASONE (Beconase AQ) are preferred.

—————————————————————————– ORAL DECONGESTANTS SHOULD NOT BE RECOMMENDED DURING THE 1st trimester

• the cough-suppressant dextromethorphan and the mucolytic guaifenesin have limited safety data in pregnancy and lactation, but are sometimes used. AVOID LIQUID FORMULATIONS THAT CONTAIN ALCOHOL.

Question 35

PAIN

Preferred Management During Pregnancy:

Drug of Choice:

DO NOT USE:

Answer 35

Non-drug options such as hot/cold packs, light massage or physical therapy can help limit or avoid the use of analgesics.

ACOG recommends acetaminophen first-line for mild pain during pregnancy because it has a better safety profile than NSAIDs and opioids.

AVOID NSAIDs, including aspirin (except for low-dose aspirin for preeclampsia prevention), especially at 20 weeks gestation or later.
— During pregnancy, NSAID use can cause PREMATURE CLOSURE of the fetal ductus arteriosus AND kidney problems in the fetus (leading to low amniotic fluid).

=============================================================
Postpartum pain:

can be adequately treated with acetaminophen and ibuprofen.

DO NOT USE Codeine AND tramadol in breast feeding mothers due to RISK OF EXCESSIVE sleepiness, breathing difficultly and/or death in the infant.

Breastfed infants have died, especially in mothers taking codeine who were CYP2D6 ULTRA-RAPID METABOLIZERS.

Question 36

ASTHMA

Preferred Management During Pregnancy:

Drug of Choice:

Answer 36

MAINTENANCE therapy: Budesonide is preferred BUT
ALL inhaled corticosteroids are considered safe for use in pregnancy.

Rescue therapy- (short acting beta agonist): inhaled albuterol.

————————————————————————————————————- Budesonide is also the preferred steroid for infants; the Respules are used in a nebulizer**

Question 37

IRON DEFICIENCY ANEMIA

Preferred Management During Pregnancy:

Drug of Choice:

Answer 37

Supplementation iron, prenatal vitamins with iron.

Iron worsens constipation

Question 38

HYPERTENSION

Preferred Management During Pregnancy:

Drug of Choice:

Answer 38

Labetalol, Methyldopa, nifedipine

————————————————————————————————————Contraindicated: ACE inhibitors, ARBs, aliskiren and Entresto are NOT TO BE USED IN PREGNANCY.

— LOW dose aspirin is recommended for preeclampsia prevention in HIGH-risk groups.

Question 39

DIABETES

Preferred Management During Pregnancy:

Drug of Choice:

Answer 39

INSULIN is PREFERRED, if NOT controlled with lifestyle.

METFORMIN and GLYBURIDE are commonly used.

————————————————————————————————————LOW-dose aspirin is recommended for preeclampsia prevention in both Type 1 and Type 2 diabetes.

remember if diabetes develops during pregnancy, this is called gestational diabetes.

Question 40

HYPOTHYROIDISM

Preferred Management During Pregnancy:

Drug of Choice:

Answer 40

patients with hypothyroidism and are pregnant, will require a 30-50% DOSE INCREASE during pregnancy.

*Hypothyroidism must be treated during pregnancy; if left untreated, severe consequences could include miscarriage or stillbirth, preeclampsia, low birth weight, cognitive impairment and growth retardation.

Question 41

HYPERTHYROIDISM

Preferred Management During Pregnancy:

Drug of Choice:

Answer 41

• Mild cases will not require treatment.
• Preferable to normalize the mother’s thyroid function prior to pregnancy. Contraception should be used until the condition is controlled.

IF DRUGS ARE NECESSARY:
— (e.g. Graves Disease) then PTU (propylthiouracil is preferred if trying to conceive OR in the 1st trimester. After that, the decision is individualized, as BOTH PTU and METHIMAZOLE carry potential fetal risks.
Historically, the patient would be SWITCHED TO METHIMAZOLE for the remainder of the pregnancy.

– Both PTU & METHIMAZOLE have a high risk for LIVER DAMAGE, readily cross the placenta and can cause congenital defects.

– UNCONTROLLED maternal hyperthyroidism can cause premature delivery and low birth weight.

Radioactive iodine is TERATOGENIC and is NOT USED IN PREGNANCY.

Question 42

Conditions Requiring ANTICOAGULATION:

Preferred Management During Pregnancy:

Drug of Choice:

Answer 42

———–(VTE) Venous Thromboembolism———–:

Prophylaxis: Pneumatic Compression devices (+/-) LMWH

TREATMENT: (LMWH) Low Molecular Weight Heparin IS PREFERED over UFH

The risk of developing a VTE is increased during pregnancy and for the first 6 weeks postpartum.

Monitor- peak anti-Xa levels, drawn 4 hours post dose (LMWH) or an aPTT (heparin)

Warfarin is TERATOGENIC DO NOT USE IN PREGNANCY

The oral factor Xa inhibitors and direct thrombin inhibitors have not been adequately studied in pregnancy and are NOT RECOMMEDED.

———————————————————————————————————————— MECHANICAL VALVE——————

Question 43

INFECTION

Preferred Management During Pregnancy:

Drug of Choice:

Answer 43

GENERALLY considered safe to use:
- Penicillins (including amoxicillin and ampicillin), cephalosporins, erythromycin and azithromycin.

DO NOT USE:
QUINOLONES (due to cartilage damage) and tetracyclines (due to teeth discoloration).

Question 44

INFECTION

VAGINAL FUNGAL INFECTIONS

Preferred Management During Pregnancy:

Drug of Choice:

Answer 44

TOPICAL ANTIFUNGALS (creams, suppositories) x 7days

————————————————————————————————————- AVOID FLUCONAZOLE

Question 45

INFECTION

URINARY TRACT INFECTIONS

Preferred Management During Pregnancy:

Drug of Choice:

Answer 45

Cephalexin 500mg PO Q6H x 7 days

Ampicillin 500mg PO Q6H x 7 days

Nitrofurantoin and SMP/TMP, SHOULD BE CONSIDERED LAST LINE during the 1st trimester and SHOULD NOT BE USED IN THE LAST 2 weeks of pregnancy.

Must treat bacteriemia, even if asymptomatic, with negative urinalysis. Untreated bacteriuria can lead to premature birth, pyelonephritis and neonatal meningitis.

Question 46

INFECTION

Preferred Management During Pregnancy:

Drug of Choice:

Question 47

HIV

INFECTION

Preferred Management During Pregnancy:

Drug of Choice:

Answer 47

• Breastfeeding is NOT RECOMMEDED for women with documented HIV infection in the United States, including those receiving antiretroviral therapy.

Question 48

The American Academy of Pediatrics (AAP) recommends that babies be exclusively breastfed for the first 6 months of life, as long as it is mutually desired by the mother and baby and if safety risks are not present.

Answer 48

babies should receive 400 IU of vitamin D daily.

Human milk contains very little iron (unlike formula), so breast fed babies require 1mg/kg daily of iron during months 4-6.

Question 49

____________ and ____________ can be used to check for drug safety during breastfeeding.

Answer 49

LactMed
&
Briggs’ Drugs in Pregnancy and Lactation

Question 50

-
-

Answer 50

-non ionized
-small molecular weight
- low volume of distribution
- high lipid solubility