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Pregnancy and Lactation (Indexed) Imp
Pregnancy and Lactation (Indexed) Imp
Prepared by :
Ph/Esraa nader
Ph/Omnia Abdelrahman
Presented by:
Ph/Ahmed El-Gewily
Pharmacokinetics in pregnancy
Physiological changes in pregnancy, beginning during the first trimester, and most
marked during the third trimester; alter the absorption, distribution and clearance of
drugs.
Absorption
Gastric emptying and small intestine motility are reduced in pregnancy due to
elevation of progesterone. This may increase Tmax and reduce Cmax, although
effects on total bioavailability may be relatively minor.
They may, however, reduce the efficacy of a single dose of an oral drug such as
an analgesic or anti-emetic for which Tmax and Cmax are important.
Distribution
During pregnancy there is an expansion of intravascular (plasma volume)
and extra- vascular (breasts, uterus, peripheral edema) water content.
Thus, total body water increases by up to 8 liters, creating a larger space
within which hydrophilic drugs may distribute, i.e. increasing Vd.
distribution for lipophilic drugs, but this has little practical importance.
Metabolism
Some enzymes of the hepatic cytochrome P-450 system are induced by oestrogen/
progesterone, resulting in a higher rate of metabolism (and hence elimination) of
drugs, for example, phenytoin.
Clearance of drugs, such as rifampicin, that are secreted via the biliary system, may
be attenuated due to the cholestatic property of oestrogen.
Elimination
Renal blood flow is increased by 60-80% during pregnancy, and glomerular
Elimination from the fetus is by diffusion back to the maternal com- partment.
Because most drug metabolites are polar, this favours accumulation of
metabolites within the fetus.
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 (other than a decrease in fertility) that was not confirmed in controlled
studies in women in the first trimester (and there is no evidence of a risk in later
trimesters).
Category C
Either study in animals has 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.
Lactation:
<50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours; maximum single dose:
750 mg/dose; maximum daily dose: 75 mg/kg/day (≤3.75 g/day)
≥50 kg: 650 mg every 4 hours or 1000 mg every 6 hours; maximum single dose: 1000
mg/dose; maximum daily dose: 4 g/day
Patient Education
Oral: Take with food or milk. While using this medication, do not use other
prescription or OTC medications that contain acetaminophen. This medication will not
reduce inflammation; consult prescriber for anti-inflammatory, if needed.
Aspirin is the analgesic and antipyretic of second choice in pregnancy, but this
should not be used from the early third trimester onwards.
Pregnancy risk factor: C. Low dose may be used with caution during first and second
trimester. Alternatives should be considered for analgesia. Use not recommended
during third trimester.
Patient Education
Take with food or milk. The pharmacist should advise patient to stop taking aspirin if
patient experienced ringing in ears, persistent stomach pain, unresolved nausea or
vomiting, respiratory difficulty or shortness of breath, unusual bruising or bleeding
(mouth, urine, stool), or skin rash.
Because of the lack of experience with these substances during pregnancy and
breastfeeding, selective COX-2 inhibitors should be avoided.
Ibuprofen can also be considered, but this should not be used from the early third
trimester onwards.
Dose: Analgesic, antipyretic: Oral (Brufen® tab.): 200-400 mg/dose every 4-6 hours
(maximum daily dose: 1.2 g, unless directed by physician; under physician supervision
daily doses ≤2.4 g may be used)
Patient Education
Diclofenac: pregnancy category B(The risk category will be D only if used in 3rd
trimester or near delivery) & considered safe in breast feeding
Indomethacin : category B (The risk category will be D only if used longer than 48
Lactation :
2} Cough:
1-productive cough
N-acetylcysteine, ambroxol and bromhexine are first choice mucolytics during
pregnancy and breastfeeding.
2- Non-productive cough
In the case of persistent dry cough, codeine and dextromethorphan can be given
in all trimesters of pregnancy and during lactation. Higher doses given for longer
periods, or use near delivery, can cause neonatal withdrawal symptoms and
respiratory depression.
required.
• Nebuliser solution is stable for one hour once mixed with sodium cromoglycate
or ipratropium.
Pregnancy: C
Breastfeeding: Excretion in breast milk unknown/use caution.
Terbutaline
(Aironyl® tab. ,syrup)
Patient education:
Reliever for asthma or chronic obstructive pulmonary disease; can be used to
treat an acute attack.
• If using terbutaline, ipratropium (or eformoterol,
salmeterol) and steroid inhalers, use in that order.
• Can cause tachycardia, tremor and electrolyte disturbances.
Salmeterol
(Metrovent® 200 doses inhaler 25mg/ dose)
Patient education:
Do not use to treat an acute asthma attack.
• Use regularly, usually twice a day or at least
30 minutes before exercise.
• Encourage the development of an asthma management plan.
• Increased reliance on short-acting beta-agonists indicates deterioration of
asthma control; treatment should be re-assessed.
• Can cause tachycardia and tremor.
• Provide advice on inhaler/accuhaler technique.
• Recommend use of a spacer with an inhaler.
Pregnancy: C
Formoterol
(Berotec® 200 inhaler , Foradil® 12 µgm inh. Cap.)
Patient education:
May be used for symptom relief in patients already receiving inhaled
corticosteroids and regular
formoterol or in combination with budesonide.
• Long acting—use twice a day.
• If paradoxical bronchospasm occurs, seek medical advice.
• May cause tachycardia or tremor.
• Review delivery device technique.
• Counsel on cleaning and disposal of device.
Pregnancy: C
Breastfeeding: Excretion in breast milk unknown/use caution
2-inhaled corticosteroids:
The use of beclomethasone or budesonide is preferred, because these have been
widely used in pregnancy and have a good safety record. Systemic use of the
corticosteroids, prednisone, and its metabolite, prednisolone, is indicated in case of
acute exacerbations of asthma or severe asthma during pregnancy.
For allergic rhinitis, intranasal corticoids may be used.
(Miflonide ® )
Patient Education
May take 1-2 weeks or longer before full effects are seen.
Inhaled anticholinergics:
Inhaled ipratropium bromide can be used during pregnancy and breastfeeding if
needed.
Patient education:
If using salbutamol or terbutaline, ipratropium and steroid inhalers, use in that order.
• Not for immediate relief of symptoms, dry mouth common.
• Can be mixed with other beta2 agonists for
nebulised therapy.
• Inquire about eye and vision problems as some may be caused by leakage from
mask.
Changes to urinary system: May induce or aggravate overflow incontinence
(occasionally with nebulised therapy) due to reduced detrusor activity, voiding
difficulty, urinary retention, constipation.
Pregnancy: B.
Breastfeeding: Excretion in breast milk unknown/use caution
Systemic theophylline:
Theophylline may be used during pregnancy and beastfeeding for cases where the
inhaled β2-agonists and corticosteroids are insufficient to control the asthmatic
diseases.
The use of mast cell inhibitors such as ketotifen, and azelastine should be
avoided during pregnancy.
Antileukotrienes:
Apart from selected cases, antileukotrienes should be avoided in pregnant women.
Patient Education
You may experience drowsiness, dizziness, dry mouth, or nausea. Report persistent
dizziness or sedation; swelling of face, mouth, lips, or tongue; respiratory difficulty;
lack of improvement; or worsening of condition.
Breast-Feeding Considerations
Small amounts of loratadine and its active metabolite, desloratadine, are excreted into
breast milk.
Cetirizine :Dosing range: Oral (Zyrtic® tab., syrup, drops): 5-10 mg once
daily, depending upon symptom severity
Patient Education
You may experience drowsiness, dizziness, or dry mouth. Report persistent sedation,
confusion, agitation, persistent nausea ,vomiting, blurred vision, or lack of
improvement or worsening of condition.
Patient Education
You may experience dizziness, drowsiness, blurred vision, dry mouth, constipation, or
heat intolerance.
Patient Education
Dopamine antagonists
Dopamine antagonists are widely used for treatment of NVP. Metoclopramide seems
safe and efficacious; it should probably be first choice among the dopamine
antagonists.
Patient Education
6} GERD:
Antacids & sucralfate may be used during all phases of pregnancy. The
unrestricted/long-term use of antacids during pregnancy should be avoided. Among
the aluminum-containing antacids, magaldrate and sucralfate may be considered the
drugs of choice because of their apparently limited aluminum absorption.
Antacids and ulcer therapeutics of choice during breastfeeding are the newer
aluminum combinations, such as magaldrate and sucralfate as well as aluminum-free
antacids. It is generally recommended that the serum concentration of aluminum
ormagnesium be monitored.
Ranitidine: Dosage range: Oral (Ranitak® tab.): Treatment: 150 mg twice daily,
or 300
mg once daily at bedtime
Patient Education
May take several days before you notice relief . May cause drowsiness , dizziness, or
fatigue.
Those with low concentration in breast milk should be preferred – for example,
famotidine or nizatidine.
Patient Education
OTC: Do not use for more than 2months unless recommended by prescriber. May
cause drowsiness , dizziness, constipation or diarrhea.
Omeprazole: Dosage range :Oral (Omepac® cap.): 40 mg once daily for 4-8
weeks
Patient Education
Eat a high fiber diet: Ideally, you will consume 25 to 30 grams per day of dietary
fiber from fruits, vegetables, breakfast cereals, whole grain breads, prunes and
bran.
Drink a lot of fluids: Drinking plenty of fluids is important, particularly with your
increase of fiber. Drink 10 to 12 cups of fluids each day.
When constipation needs to be treated with medication and neither bulk nor
osmotic laxatives like lactulose work effectively enough, bisacodyl is the drug
of choice throughout the entire pregnancy.
Castor oil should not be used during pregnancy because it may stimulate uterine
contraction.
Senna (can be used as last choice in pregnancy but when physician assess the
case)
9} Flatulence:
Dimeticon/simethicone and the plant-based substances which contain anise,
caraway, or peppermint, may be used throughout the pregnancy as
carminatives.
10} Hemorrhoids:
lie on your side when reading or watching TV
Dietary fiber & fluids
Sitz baths
Topical anesthetics(eg: lidocaine)
Skin protectants & astringents
# Sitz baths (hip bath) is a type of bath in which only the hips and buttocks are soaked
in water or saline solution. Its name comes from the German verb "sitzen," meaning
"to sit."
Contraindicated:
Sitting for long periods(which puts pressure on the veins in your anus and rectum)
Patient Education
Pregnant women gestational diabetes should have regular insulin, if diet alone is
insufficient for control.
For the protective action of folic acid against open neural tube defects to be effective,
–0.8 mg folic acid per day should begin as early as possible
Iron supplements:
Iron supplementation during pregnancy is indicated if the hemoglobin level is 100 g/l.
It should be given orally, using an iron (II) preparation. If for some reason parenteral
iron supplementation is necessary, this should be given intravenously with an iron (III)
preparation.
Calcium supplements:
It makes sense to take 500 mg of calcium per day orally, or to drink a liter of milk. The
milk has the advantage that it supplies not only the calcium but also the daily vitamin
D requirement.
Use tampons (they can introduce new germs into the vagina)
Douche (this can interrupt the normal balance and lead to a vaginal
infection)
Assume that it is a vaginal infection and treat it yourself
References:
Sites :
Online.lexi.com
www.drugs.com
www.safefetus.com
Books :
Drugs during pregnancy and lactation
st
Edition