BREAKTHROUGH TREATMENT of NAUSEA VOMITING of PREGNANCY Dr Sharda Jain / Dr Jyoti Agarwal / Dr. Dipti Nabh

1. BREAKTHROUGH TREATMENT of
NAUSEA VOMITING of PREGNANCY
Dr Sharda Jain / Dr Jyoti Agarwal / Dr. Dipti Nabh

2. Over 350 ppts are available on
slideshare.net ***for use of public/Doctors
www.slideshare.net / Lifecarecentre

3. Pregnancy
oyful & efreshing Gift!!!

4. Nausea & Vomiting during pregnancy (NVP)
also called “Morning Sickness”
is a major challenge in pregnancy!!!
Let’s understand more…….

5. Incidence of Nausea & Vomiting
during pregnancy (NVP)
• NVP occurs in approximately 75-80% of
pregnant women
• Whereas 50% of all pregnant women
experience both nausea and vomiting, 25%
experience only nausea, and vomiting alone is
quite rare

6. When does NVP begin to appear
• Symptoms generally begin around week 5 of
gestation and typically cease by week 12; the
nausea lasts a mean of 34.6 days
• However, up to 15% of pregnant women
experience persistent symptoms until delivery

7. Etiology & Pathophysiology of NVP
• Psychological predisposition – Depression,
anxiety, relationship issues
• Evolutionary adaptation – natural phenomenon
protecting the mother & embryo
• Hormonal stimuli – hCG, estradiol and
progesterone levels during pregnancy
• H.pylori infection – may cause NVP

8. hCG & hyperemesis in pregnancy

9. Risk factors for NVP
• Women with multiple gestation
• Women who failed to take multivitamins during
per-conceptional period
• Women with heartburn & acid reflux
• Genetic factors

10. Treatment options for NVP
1. Non-pharmacologic – Lifestyle and dietary changes
2. Pharmacologic therapy
a. Multivitamin supplementation
b. Antihistamines – Doxylamine, Pyridoxine
c. Dopamine antagonists – Metoclopramide, Promethazine
d. Corticosteroids
3. Home Remedy
a. Ginger
b. Acupressure

11. Goals of treatment for NVP
1. Reduce symptoms through changes in
diet/environment and by medication
2. Correct complications of nausea and vomiting
(fluid depletion, hypokalemia & metabolic
acidosis)
3. Minimize the fetal effects of maternal nausea
and vomiting

12. Pharmacological treatment of NVP
 “Category A Drug In
Pregnancy”
Doxylamine & Pyridoxine – highly effective in
treatment of NVP
1st Line of treatment

13. Doxylamine + Pyridoxine

14. Mode of action of Doxylamine & P5P
• Primary mechanism is direct inhibition of
histamine at the H1 receptor and anticholinergic
effect
• Secondary mechanism is an indirect effect on the
vestibular system by decreasing stimulation of the
vomiting centre

15. Pharmacokinetics of
Doxylamine & P5P
• Absorption: Doxylamine and pyridoxine are absorbed
in the gastrointestinal tract, mainly in the jejunum. The
Cmax of doxylamine and pyridoxine are achieved
within 7.5 and 5.5 hours, respectively
• Distribution: Pyridoxine main active metabolite,
pyridoxal 5’-phosphate, is released into the circulation
(accounting for at least 60% of circulating vitamin B6)
and is highly protein bound, primarily to albumin.

16. Pharmacokinetics of
Doxylamine & P5P
• Metabolism: Doxylamine is bio-transformed in the liver by
N-dealkylation to its principle metabolites N-desmethyl
doxylamine and N,N-didesmethyl doxylamine.
• Excretion: The principle metabolites of doxylamine, N-
desmethyl-doxylamine and N, N-didesmethyldoxylamine,
are excreted by the kidney.
• The major metabolite of pyridoxine, 4-pyridoxic acid, is
inactive and is excreted in urine.
• Half-life of doxylamine is 12.5 hours

17. Adverse effects of
Doxylamine & P5P
• Drowsiness
• Dry mouth
• Light headedness

18. ejunal elease
Technology

19. Features of JR Technology
Site specific
Ensures pH dependent
(6.0-7.0) drug release at jejunum
Gastro Resistant (coated polymer)
Prevents dissolution
of drug in gastric environment
Drug Bioavailability Enhancer
Enhances drug absorption, ensures
high bioavailability & higher peak
plasma concentration

20. Advantages of JR Technology
Better therapeutic efficacy
Better targeted delivery of drug
Better patient compliance

21. Pyridoxal 5 Phosphate (P5P)
Active metabolite of Vit B6Bypasses biological conversion
Directly utilized by the body

22. Better efficacy & effective control of symptoms of NVP

23. Clinical Study - 1
Conclusion: Diclegis/Diclectin is the only safe and effective
treatment for a pregnancy-related condition suffered by
many millions of women.

24. Clinical Study - 2
Conclusion: Doxylamine succinate–pyridoxine hydrochloride delayed
release combination is safe and well tolerated by pregnant women when
used in the recommended dose of up to 4 tablets daily in treating nausea
and vomiting of pregnancy.

25. Clinical Study - 3
Conclusion: The combination of immediate release with a delayed action
is unique to the dual release combination of doxylamine and pyridoxine as
it allows for the bedtime dose to be effective immediately and also provide
with sustained control of NVP symptoms throughout the day.

26. Each Gastro Resistant tablet contains
Doxylamine Succinate USP 10mg
Pyridoxal 5-Phosphate 10mg

27. Each strip contains
30 Tablets (30s)
Each box contains
10 Strips (10*30s)

29. Morning Sickness gone!!!
Morning Happiness on!!!

30. Take Home Message
• Jejunal Release Technology: Better absorption &
bioavailability
• Pyridoxal 5 Phosphate: Active metabolite of Vit B6
for rapid absorption & efficacy
• Effective—90%., SAFE, USFDA approved

31. OUR USP
*Star Training Centre of D.G.F. for Gynaecologist
*Home for all Advanced SURGERIES / All Office
Procedures *IVF

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