Download Over-the-counter vaginal preparations

Review
Over-the-counter vaginal preparations
Johnston L, BPharm
Amayeza Info Centre
The vagina is typically acidic (pH
around 3.5-4.5) in healthy women
during their fertile years. The acidic
environment is established by the
presence of Lactobacillus species which
have an essential role in preventing
the proliferation of pathogenic
microorganisms.
The vagina offers a good drug delivery site
thanks to its large surface area, rich blood
supply, and reduced enzymatic breakdown
as compared with the gastrointestinal tract.
However, there are some limitations to the
intravaginal route, such as variability in
drug absorption related to the menstrual
cycle, pregnancy and menopause.
Symptoms include:
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Itching, discomfort and/or burning in
the vagina;
A white curd-like discharge;
A red rash affecting the inner and
outer parts of the vulva.
Azole antifungals such as clotrimazole
and miconazole are the drugs of choice
for the local treatment of vulvovaginal
candidiasis (vaginal thrush). There is
no clear evidence that one intravaginal
azole is more effective than another.
Intravaginal nystatin may also be used
in the treatment of uncomplicated
vulvovaginal candidiasis. However,
it is generally less effective than the
intravaginal azole antifungals.
vaginalis and Mycoplasma hominis
and a decrease in the levels of
lactobacilli. Bacterial vaginosis is
often asymptomatic and may resolve
spontaneously. However, treatment
is indicated in symptomatic women.
Symptoms may include an abnormal
white or grey vaginal discharge with an
unpleasant odour (sometimes reported
as a fish-like odour, especially after
intercourse). The patient may also
report burning during urination and
or itching around the outside of the
vagina.
Low sugar/yeast and high yoghurt diets
have not been shown to be effective, nor
has inserting yoghurt into the vagina.
Intravaginal metronidazole is
as effective as a seven-day oral
metronidazole regimen. The dosage
is one applicatorful (37.5 mg/5 g
dose) administered intravaginally,
once daily, preferably at bedtime, for
five consecutive days. An available
formulation is Metrogel V®.
Approximately 20% of non-pregnant
women aged 15-55 years harbour Candida
albicans, a type of yeast, in the vagina.
Candidial infection is more prevalent in this
age group due to the presence of oestrogen,
which causes the lining to mature and
produce glycogen on which Candida
albicans thrives. Most individuals have
no symptoms of infection, unless there is
overgrowth of the organism.
Who should be referred?
Other vaginal infections
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Povidone iodine is a broad-spectrum
antiseptic with bactericidal and fungicidal
properties. It is indicated in the treatment
of trichomonal, candidial and nonspecific vaginal infections. Available
preparations include Betadine® Douche
and Betadine® Vaginal Gel.
Overgrowth of Candida albicans may be
precipitated by:
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Several types of intravaginal formulations
are available. These include tablets,
ovules, gels, creams, and douches.
Vaginal candidiasis (thrush)
Vaginal candidiasis is not usually acquired
through sexual contact and treatment of
the sexual partner is not recommended,
but may be considered in women who
have recurrent infections.
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Table I lists a number of OTC vaginal
formulations for the treatment of vaginal
candidiasis.
Bacterial vaginosis
Bacterial vaginosis is not caused by a
single organism. It is a complex change
in the vaginal flora characterised by
an increase in the levels of Gardnerella
Povidone iodine vaginal preparations
should not be used by pregnant or
breastfeeding women.
Atrophic vaginitis
Atrophic vaginitis is inflammation of the
vagina due to reduced lubrication and
thinning tissue. It is caused by reduced
levels of oestrogen, generally following
menopause. Oestrogen assists in keeping
the vagina lubricated and healthy.
However, when oestrogen levels drop,
vaginal tissue may become thin, dry and
inflamed. Atrophic vaginitis can also
occur in younger women who have had
their ovaries removed, or immediately
after childbirth, or during lactation when
oestrogen levels are lower.
SA Pharmacist’s Assistant [ Autumn 2011 ]
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Pregnancy;
Broad-spectrum antibiotics;
Diabetes mellitus;
Immunosuppression [e.g. human
immunodeficiency virus (HIV)
infection or chemotherapy];
Combined oral contraceptives
or oestrogen-based hormone
replacement therapy.
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Pregnant patients.
Patients whose infections do not
improve within three days, or that
persist beyond seven days of having
started treatment.
Patients who have symptoms of
vulvovaginal candidiasis that recurs
within two months of using vaginal
cream self-medication.
Patients who are experiencing vaginal
itching or discomfort for the first
time.
Patients experiencing malodorous
vaginal discharge, or abdominal pain
and fever.
Girls under the age of 12 years.
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Review
Table I: Available over-the-counter (OTC) vaginal formulations
Topical antifungal
Available formulations
Dose and administration
Clotrimazole
Vaginal creams:
A-Por®, Canalba®, Candaspor®, Candizole V®,
Canestan®, Canex®, Closcript®, Covospor®, Fungispor
V®, Innospor®, Medaspor®, Normospor®
One applicatorful (about 5 g) of the 1% cream
inserted into the vagina daily (preferably at night)
for six to seven consecutive days. Cream may also be
applied to the external genitalia two to three times a
day for one to two weeks.
Nystatin
Vaginal tablets:
Canstat® tablets (100 000 units of nystatin per tablet)
Insert one to two tablets (100 000 to 200 000 units)
daily. Two weeks of the therapy is usually sufficient,
but prolonged treatment may be necessary. It is
important for the treatment to be continued during
menstruation.
Miconazole nitrate
Vaginal cream:
Gyno Daktarin®
Insert one applicatorful (5 g) into the vagina at night,
for seven days.
Vaginal capsules:
Gyno Daktarin® single-dose (1 200 mg) vaginal
capsules.
Vaginal cream and capsules:
Gyno Daktarin Combipak®
Insert the capsule into the vagina at night.
Vaginal cream:
Gyno-Pevaryl® cream
Vaginal ovules:
Gyno-Pevaryl® ovules
One applicatorful at night for two weeks.
Vaginal depot-ovule:
Gyno-Pevaryl® depot-ovule
One depot-ovule (150 mg) in the vagina before
retiring for the night.
Econazole
Symptoms of atrophic vaginitis may
include:
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Burning on urination;
Painful intercourse;
Vaginal pain, including itching or
burning;
Slight vaginal discharge.
Treatments
SA Pharmacist’s Assistant [ Autumn 2011 ]
Vaginal lubricants and moisturisers
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Mild symptoms during intercourse may
be relieved by water-soluble vaginal
lubricants such as KY® jelly or Durex®
water-soluble lubricants .
An OTC, water-based moisturising
gel (Replens®) is available as a vaginal
moisturiser. Replens® is an aqueous gel
containing 78.82% purified water in a
hydrophilic polymer base. The vaginal
gel offers long lasting moisture and
should be used every three days for best
results, although it is safe to use daily if
necessary.
KY® jelly, Durex® lubricants and Replens®
are compatible with condom use.
Insert one capsule into the vagina at night for three
consecutive nights, and apply the cream around the
entrance to the vagina mornings and evenings.
One ovule (150 mg) nightly for three consecutive
nights.
Vaginal oestrogen preparations
Bibliography
Vaginal oestrogen therapy is indicated for
short-term treatment of symptoms related
to vaginal atrophy in postmenopausal
women. Available formulations include
Synapause® and Premarin® creams and
Vagifem® vaginal tablets.
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Instructions for use of vaginal
formulations
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Wash your hands with soap and
water.
Open/prepare the vaginal applicators.
Lie on your back with the knees
drawn up, or squat, or stand with one
leg up on a chair.
Hold open the folds of the skin
around the vagina in one hand.
Place the tip of the applicator into the
vagina, then, using the index finger,
gently push the applicator into vagina
until there is some resistance.
Depress the plunger expelling the
preparation (tablet/cream/ovule/
capsule).
Remove the applicator.
Wash your hands and the applicator
with warm soapy water.
3.
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Gad SC. Pharmaceutical manufacturing
handbook: production and processes, Volume
10. Wiley-Interscience. New Jersey: John Wiley
and Sons; 2008.
Oakley A. New Zealand Dermatological
Society. Vulvovaginal candidiasis [homepage
on the Internet]. c2010. Available from: http://
dermnetnz.org/fungal/vaginal-candidiasis.html
American Hospital Formulary Service (AHFS)
Drug Information, 2009.
Canstat® vaginal tablets package insert, 1993.
Gyno Daktarin® VC vaginal cream package
insert, 2009.
Gyno Daktarin Combipak® package insert, 2009.
Gyno-Pevaryl® vaginal cream package insert,
2005.
Gyno-Pevaryl® ovule package insert, 2005.
Amayeza Drug Information Centre. MetroGel
V: a metronidazole vaginal preparation. SA Fam
Pract. 2007:49(4) [homepage on the Internet].
Available at: http://www.safpj.co.za/index.php/
safpj/article/viewFile/831/725
MetroGel V® vaginal gel package insert, 2000.
Centres for Disease Control and Prevention.
Bacterial vaginosis fact sheet. [homepage on the
Internet]. c2011. Available from: http://www.
cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
Betadine® douche package insert, 1993.
Betadine® vaginal gel package insert, 1987.
MedlinePlus. Atrophic vaginitis [homepage on
the Internet]. c2011. Available from: http://www.
nlm.nih.gov/medlineplus/ency/article/000892.
htm
Replens ® vaginal moisturising gel package insert,
1994.
Synapause® vaginal cream package insert, 2005.
Premarin® cream package insert, 1974.
Vagifem® vaginal tablets package insert, 1992.