2. Missed pills
50% of pill users missed 3 pills/pack by the 3rd cycle of
oral contraceptive use
(Potter et al.,2001)
Aboubakr Elnashar
3. Contents
•Advantages
•Formulations
Description of the Patch
Instruction for use
Patch adhesion
Pharmakokinetics
Side effects
Contraindication
Patient satisfaction
Compliance
Efficacy
Conclusion
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4. Advantages
(Burkman, 2007)
Continuous, sustained release:
avoids peak& low drug levels
Longer dosing interval:
improves patient compliance
Avoids first-pass:
met& enzymatic degradation by GIT
induction of hepatic protein synthesis e.g. extrinsic clotting
factors.
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5. TD:
Can be given when oral route is not suitable
Unaffected by vomiting or diarrhea.
Drug administration stops with patch removal
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6. Formulations
ORTHO EVRA: FDA 2001
0.75 mg EE
6.0 mg norelgestromin: active metabolite of
norgestimate:
(Cilest: EE, 30ug, Norgestimate, 250 Ug)
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8. Mode of action
•Suppress
ovulation similar to OCs.
follicular development.
•Reduce cervical mucus scores, more hostile to
sperm penetration.
•Induce progestational endometrium and reduce
endometrial thickness.
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9. Description of the Patch
3 separate layers:
Lower: packing, light brown,
flexible 4.5 x 4.5 cm
Middle: adhesive, contains the
active hormones
Top: protecting the adhesive layer
& removed prior to application
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10. Instruction for use
4 sites:
Upper Torso
(excluding the breasts)
Upper outer arm
Lower abdomen
Buttock
Two consecutive patches should not be placed over
the exact same area.
Hormonal absorption from the lower abdomen is 20%
lower than that from the other 3 sites
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11. Regimen:
• One patch/w for 3ws, followed by a patch-free w.
• The first patch should be placed on 1st day of the
menstrual cycle
• If a patch change is missed for 2 d:
clinical efficacy is maintained: backup contraception
is not needed.
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12. When initiating:
• After childbirth and no-breast feeding:
Wait 4 w
Backup contraception for 7 days.
• After a first-trimester miscarriage:
immediately (the same day).
Backup contraception is not necessary if the patch is
started within 5 days.
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13. Patch adhesion
Patch to the abdomen
(Zacur et al, 2002)
Showers, sunbathing, strenuous exercise, sauna,
whirlpool, treadmill, swimming:
Adhesive reliability was maintained for 7 d
1.8%: replaced {fell off}
2.9%: replaced {partial detachment }
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14. Pharmakokinetics
ORTHO EVRA patch Vs OCs (FDA)
1. Higher EE steady concentrations:
AUC & average concentration at steady state for EE
are 60% higher
2. lower EE peak concentrations.
25%
Increased estrogen exposure: increase the risk of
adverse events, including VTE.
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16. 3. Coagulation factors
(antithrombin III, tProtS and fProtS):
No significant differences
(Johnson et al, 2006).
Higher EE levels seen with the patch
might not have any greater hepatic impact than lower
EE levels seen with the pill.
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17. Side effects
1. VTE
Jick et al, 2006, 2007, 2010
Risk is similar to that for users of OCs
Cole et al, 2007:
increased risk of with the patch Vs OCs
VTE /100,000 women years:
Patch: 40.8
OCs: 18.3
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18. little or no increasedVTE
Contraindicated: in high risk forVTE:
Safe
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20. 3. Breast symptoms:
(discomfort, engorgement, pain)
more with patch than OCs during cycles 1& 2 only
with continued use, decreased to none during cycle
13
(Sibai et al, 2002)
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21. 4. Dysmenorrhea
greater in patch than in OC users
(13.3% Vs 9.6%)
(Sibai et al, 2002)
5. BTB:
Low& similar to those with OCs
(Zieman et al, 2002).
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22. 6. Application site reactions
Mild or moderate
20%
Discontinuation: 2.6%
(Sibai et al, 2002)
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23. 7. Changes in wt.
Minimal
Use for 13 cycles:
2.2%: wt gain of 10%
1.4%: wt loss of 10%.
Comparable to OCs
(Sibai et al, 2002)
With the exception of application site reactions,
patch is well tolerated
adverse events are similar to that of OCs.
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25. Contraindications
• Identical to those for OCs
• Exceptions.
1. Active skin conditions: which could alter the rate
of hormonal absorption
2. Dermatologic conditions that would be worsened
by patch application.
• On the other hand
patches are used when pills can not be used e.g. GIT
absorption problems
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26. Patient satisfaction
Emotional
Physical well-being
Improvements in premenstrual symptoms
Higher than OCs
(Urdl et al, 2005).
: Significantly better compliance: fewer unintended
pregnancies
European multinational study (2011)
High levels of women's satisfaction and
compliance with TD contraception
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27. Compliance
Consistent & correct use
(89% Vs. 79%).
Compliance was higher for the patch
(Cochrane systematic review, Gallo et al, 2003; Audet et al, 2001)
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28. Efficacy
Overall& method failure:
Method failure: 0.4 %
User failure: 0.1%
Efficacy:
Higher {higher rates of correct& consistent use of
patch}
Similar
(Cochrane systematic review, Gallo et al, 2003)
less effective
Wt >90 kg
(Zieman et al, 2002)
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29. Conclusion
TD C patch compared to COs:
Similar efficacy& adverse effects
Higher satisfaction & compliance
Easier to use
More suitable for today’s active lifestyles
Aboubakr Elnashar
30. Benha University Hospital, Egypt
Email: elnashar53@hotmail.com
Prof. Aboubakr Elnashar
Aboubakr Elnashar