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.