1. New standard in Vaginitis treatment

2. VAGINAL INFECTIONS Worldwide problem
Affect 75% of women at least once in their lives
Recur in at least 40 % of these women.
Not easily treated
Productivity and quality of life is highly affected
No satisfactory single product previously available
Ref: Scott, E.: The Management of Candida Infections. Practitioner, 1990; 234: 2

3. General Symptoms of Vaginitis
Vaginal and vulvar itching
Increase in vaginal discharge, change in color and consistency
Unpleasant odour
Pain on urination / coitus 3

4. Three Major Types of Vaginal Infections
Candidal vulvo-vaginitis 4

5. Three Major Types of Vaginal Infections
Trichomonal Vaginitis 5

6. Three Major Types of Vaginal Infections
Bacterial Vaginosis 6

7. CANDIDAL VULVO-VAGINITIS
Clinical findings:
Itching
White,“Cottage cheese-like” discharge
Cause: Candida ssp.
Standard Treatment:
Miconazole nitrate 7

8. CANDIDAL VULVO-VAGINITIS
Local preparations are preferred
Pessaries, creams
Vaginal tablets may cause irritation of the vaginal mucosa !
*Isoconazole *Nystatine *Fluconazole
*Clotrimazole *Miconazole
Ref: Sexually Transmitted Diseases, Treatment Guideline, 2006 8

9. TRICHOMONAL VAGINITIS
Clinical findings:
Profuse discharge
yellow-green or brown
Unpleasant odour
Strawberry cervix
Dyspareunia
Cause:
Trichomonas vaginalis
Standard Treatment:
Metronidazole 9

10. Alternative Treatments
Ornidazole
Tinidazole
Treatment of the Partner:
(Metronidazole 2 g single dose) 10

11. BACTERIAL VAGINOSIS Metronidazole Clinical Findings: Causes:
Profuse, white/gray discharge
Fishy smell
Itching
Dysuria
50% asymptomatic
Causes:
G. vaginalis, anaerobes
Standard Treatment:
Metronidazole 11

12. Differential Diagnosis
Fishy smell on 10% KOH application
pH > 4.5
“Clue” cells
“Clue” cell 12

13. Alternative Treatments (Systemic or Local)
Ornidazole
Tinidazole
Clindamycin 13

14. Basis of laboratory diagnosis Bacterial vaginosis
Vulvovaginal candidiasis
Trichomoniasis
Vaginal pH (normal = <4.5)
Elevated (>4.5)
Normal
Microscopic examination of wet-mount and KOH preparations of vaginal discharge
"Clue cells" (vaginal epithelial cells coated with coccobacilli) Few lactobacilli Mobiluncus species
Pseudohyphae, budding yeast cells
Motile trichomonads
"Whiff" test (normal = no odor)
Positive
Negative
Can be positive
Additional tests
Amsel's criteria (three of four criteria must be met). Criteria of Nugent for Gram stain.
KOH microscopy Gram stain Culture
DNA probe tests: sensitivity 90%, specificity 99.8% Culture:
sensitivity 98% , specificity 100% 14

15. Taifa Leo, April 26, 2006

16. New standard in Vaginitis treatment

17. QUESTION:
Is there an efficient single medication for vaginitis and mixed infections ? 17

18. Product Rationale - 1
40-50 % of patients with candidal vaginitis may have coexisting bacterial vaginosis and/or trichomoniasis mixed infections
mixed infections require more than one medication 18

19. MIXED VAGINITIS
40-50 % of Patients have CVV together with BV or TV 19

20. Product Rationale - 2
Diagnosis is usually made on the basis of clinical findings
Microbiological tests take some time to obtain or may not be available at all 20

21. Diagnosis of Vaginal Infections
90% of physicians never measure pH
or check odour 21

22. Limitations of Direct Microscopy
Availability of a quality microscope
Training of the observer
Mixed pathogens
Poor reproducibility 22

23. Trichomonas vaginalis
Vaginal cultures for detection of
require up to 5 days of incubation 23

24. Bacterial vaginosis
Amsel Criteria: abnormal vaginal discharge, amine odour, pH >4.5, clue cells on microscopy.
Nugent Criteria: Specialized Gram stain evaluation for BV is frequently not available.
Routine cultures are not useful for diagnosis because more than 50 % of women are asymptomatic. 24

25. Candidiasis culture positivity does not mean candidiasis.
Yeast is part of normal vaginal flora
culture positivity does not mean candidiasis. 25

26. Product Rationale - 3
Metronidazole may cause development of vaginal candidiasis
Metronidazole should be combined with an antifungal (e.g. miconazole) 26

27. Product Rationale - 4 Combining two standard treatments
greatly increases patient compliance
Higher compliance à Higher Cure Rates
à Economical treatment 27

28. Product Rationale - 5 Local treatment is preferred to oral therapy
Systemic therapy
does not increase cure rates
does not eliminate candidal reservoirs in the bowel
may cause systemic side effects
more expensive 28

29. QUESTION:
Is there an efficient single medication for vaginitis and mixed infections ? 29

30. NEO-PENOTRAN® FORTE VAGINAL PESSARY
Yes !
NEO-PENOTRAN® FORTE VAGINAL PESSARY 30

31. NEO-PENOTRAN® FORTE VAGINAL PESSARY
Metronidazole mg
Miconazole nitrate mg 31

32. Indication: Bacterial vaginosis Trichomonal vaginitis
antifungal
antibacterial
Bacterial vaginosis
Trichomonal vaginitis
Vaginal candidiasis
Mixed infections
antiprotozoal

34. POSOLOGY
Special ovule shape (Spade form) providing large contact area with vaginal mucosa (2.5 grams) – guarantees complete release of all active ingredients.
7 Pessaries / box (1 for 7 days).
7 Disposable Finger stalls for ease of application. 34

35. Why Do Doctors Choose NeoPenotran®Forte
Why Do Doctors Choose NeoPenotran®Forte? They have the availablity of treating mixed vaginal infections with only ‘1’ ovule !!! Other benefits…
Unique combination
Ovula formulation
Excellent patient compliance
Broad spectrum with a single product (BV, TV, VC, MixIn.)
Economic treatment
No need for laboratory testing
Impressive track and safety record worldwide
7 day therapy duration 35 35

36. Patient Safety is important to us!
Pharmacovigilance (Patient Safety) is important to Bayer.
We are committed to the National and International obligations for Pharmacovigilance
Any suspected Adverse Drug Reaction (sADR) to a Bayer medicine should be reported to:
Suggested presenter’s notes:
As Bayer, we are committed to patient safety.
If you have any reports to our medicines, you can contact us directly using these contact details.
Pharmacovigilance Department
Phone:
Emergency phone:
(outside working hours)
proSMS: Report to "22937"
Pharmacovigilance• July 2013

37. Pharmacovigilance• July 2013
Medical Enquiries
proSMS
Any medical enquiries?
Please contact:
Medical Affairs Department
Phone:
Suggested presenter’s notes:
If you have any medical related enquiries, do write to us on these details…
You can also sms to us using the number “22937” (which spells “BAYER”) and we will promptly respond to your enquiry.
This is a free sms service provided by Bayer. In order to use this, you need to subscribe using this form and we will have you connected at the earliest… etc
Pharmacovigilance• July 2013

38. Thanks