AVOCIN VAGINAL CREAM Avalon Pharma

Transcription

AVOCIN VAGINAL CREAM Avalon Pharma
12-14
AVOCIN VAGINAL CREAM
Avalon Pharma
Composition
Avocin vaginal cream contains the following per
gram
Clindamycin phosphate equivalent to clindamycin
base 20 mg, benzyl alchol 1% m/m
neisseria gonorrhea and herpes simplex should be
ruled out by appropriate methods.
Contraindications
Avocin vc is contraindicated to patients who are
hyper sensitive to clindamycin or lincomycin.
Properties
Pregnancy and lactation
Pharmacological action
Safety has not been demonstrated
Clindamycin phosphate is a synthetic antibiotic proSide effects
duced from lincomycin.
Vaginal irritation, itching, increase white discharge, dizMechanism of action
ziness, nausea, vomiting, diarrhea, skin rash, urticaria
Clindamycin phosphate is hydrolysed in vivo to clindamycin which inhibit the bacterial protein synthesis. Incompatibilities
It binds to 50 S subunit of the bacterial ribosomes Avocin vc contain mineral oil which may weaken the
condoms or vaginal contraceptive diaphragms and
and so it prevent the peptide bond formation.
make them less effective as a barrier method for conMicrobiology
traception or as a protection from sexually transmitted
Clindamycin is an antimicrobial agent which has disease, the use of such product within 72 hrs follobeen shown to have in vitro activity against the fol- wing treatment with avocin vc is not recommended.
lowing organisms:
Warnings and precautions
Gardenella vaginalis
The use of Clindamycin phosphate can lead to overBacteroides spp
growth of non susceptible organisms especially
Mycoplasma hominis
yeast e.g candida albicans, clindamycin has been
Peptostreptococcus spp
associated with diarrhea and in some cases pseuMobiluncus spp
domembranous colitis. Minimum absorption occurs
Pharmacokinetic
following the use of clindamycin phosphate cream
Following once a day 100 mg of vaginally
intra vaginally, if prolonged or significant diarrhea
Clindamycin phosphate at a conc equivalent to
occurs, the drug should be discontinued and a diag20 mg of Clindamycin per gram of cream, peak
nostic and treatment should be used. Safety in pregserum Clindamycin level average is 20 ng/ml, in nornancy and lactation has not been established.
mal volunteers about 3% of the dose is absorbed
systemically. In women with bacterial vaginosis the Drug interaction
amount of clindamycin absorbed following vaginal Cross resistance has been noticed between clinadministrated 5 gm of avocin is 4% which is approxi- damycin and lincomycin. Antagonism has been
mately same like the healthy volunteers.
demonstrated between clindamycin and erythromycin in vitro.
Indications
Avocin vc is indicated in the treatment of symptom- Storage
atic bacterial vaginosis in non pregnant women, Store at room temperature 15-30ºC
other common pathogens associated with vulvovagi- Protect from freezing
nitis e.g candida albicans Chlamydia trachomatis, Keep out from reach of children
AVALON-AVOCIN VAGINAL CREAM - p.1/2
AVALON-AVOCIN VAGINAL CREAM - p.2/2
Dosage and administration
The recommended dose is one applicator full 5 gm
intra vaginally to used at bed time, for 3-7 days.
Concomitant use with other intra vaginally products
are not recommended.
Packaging
Cream containing 2% cvlindamycin base as phosphate for use intra vaginally avocin vc is packed in
40 gm tube accompanied with 7 applicators disposable ones, each applicator full with cream is 5 gram.