Description
Release form
vaginal cream
packaging
tube 72g
Pharmacological action
Pharmatex – vaginal contraceptive.
Benzalkonium chloride is both a spermicide and antiseptic. The active substance destroys sperm membranes. The destruction of sperm occurs in two stages: first, the destruction of the flagellum, then rupture of the head, which makes impossibility of fertilization.
The use of Pharmatex significantly reduces the risk of pregnancy, but does not completely eliminate it.
Clinical efficacy is determined by the adjusted Pearl Index, which is less than 1 if the drug is used correctly.
In vitro, the drug is active against many sexually transmitted pathogens, especially Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Staphylococcus aureus, Herpes simplex type 2, HIV.
The drug is not active against Mycoplasma spp. and weakly active against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.
In vivo, the components of the drug show some activity in the prevention of sexually transmitted diseases, but there is no evidence for this.
The drug does not affect saprophytic vaginal microflora, incl. on the Doderlein wand.
Pharmacokinetics
Benzalkonium chloride is not absorbed by the vaginal mucosa. It is absorbed only on the surface of the walls of the vagina and then excreted with normal physiological secretions or eliminated by simple washing with water.
Contraindications
– the inability to use Pharmatex properly in people with mental disorders or those who do not allow any interventions on the genitals, and which prevent the use of
contraceptive – to anyone who is unable to understand or agree with this type of contraception
– colpitis
and irritation of the mucous membrane of the vagina and uterus
– increased sensitivity to the components of the drug.
Use during pregnancy and lactation
No harmful effects associated with the use of the drug during pregnancy were found. An examination of the teratogenic properties of the final product gave negative results, as did an examination of the teratogenic properties of the active substance itself. In addition, studies have shown that benzalkonium chloride is not absorbed into the blood.
Since it has been proven that the active substance has not penetrated into the blood and breast milk, the use of this spermicide during lactation is not dangerous.
Special instructions
The effectiveness of contraception is connected exclusively with strict observance of the rules for its use: – apply
systematically before each sexual intercourse – enter a capsule (tablet, suppository, tampon, cream) so that the selected dosage form penetrates the vagina as deep as possible, preferably in the supine position
– wait until the capsule or tablet is completely dissolved in the vagina for at least 10 minutes, the suppository – at least 5 minutes, so that the active substance is completely released
– byazatelno introducing a new capsule (tablet dose lotions, suppository) before each repeated sexual intercourse
– it is forbidden to use soap for the toilet of the genitals 2 hours before intercourse and within 2 hours after intercourse, because soap, even in residual amounts, destroys the active substance of Pharmatex
– immediately after sexual intercourse only the external toilet of the genitals is possible only with clean water or with the help of foaming agent Pharmatex that does not contain soap, which includes benzalkonium chloride. Before doing vaginal irrigation, you should wait for 2 hours after
sexual intercourse – with Pharmatex inserted into the vagina, you should not take baths, swim in the sea, pool or water because of the danger of reducing the subsequent contraceptive effect of
– since Pharmatex contains benzalkonium chloride , it is necessary to interrupt its use in case of any vaginal diseases or their exacerbation
– if there is a need to treat vaginal diseases and / or prescribe any other medicine vaginally, it is necessary to wait until the treatment is completed before resuming (starting) contraception with using Pharmatex.
Composition
100 g of cream contains benzalkonium chloride 1.2 g
excipients: citric acid macrogol 300 and 1500 ethylene glycol stearate (Tefoz 63) lavender essence purified water qs up to 100 g
Dosage and administration
Before administration of vaginal cream, a dosing device should be installed at the end of the tube. Fill it completely (to the annular mark or to the stop of the piston) so that no air bubbles form. Disconnect the dosing device from the tube. Before intercourse, inject the cream deep into the vagina using a dosing device, slowly pressing the plunger. Remove the metering device. The introduction is easier to do lying down. The protective effect begins immediately and lasts at least 10 hours. Be sure to introduce a new portion of the cream before each repeated sexual intercourse.
1 serving of cream is designed for one sexual intercourse.
The frequency of use of the drug is limited by the individual tolerance of the active substance and the frequency of sexual intercourse.
Pharmatex may be used in conjunction with the vaginal diaphragm or IUD.
Side effects
Allergic reactions: burning, itching, contact dermatitis (if they occur, stop using Pharmatex).
Drug Interactions
Concomitant use with vaginal drugs is not recommended. Any drug introduced into the vagina can inactivate the local spermicidal effect of Pharmatex.
Farmateks is destroyed by soap. Do not do vaginal irrigation before and after sexual contact, because soap, even its traces, destroys the active substance.
Storage conditions
Keep out of the reach and sight of children at temperatures not exceeding 25 ° C.
Expiration
3 years.
active substance
Benzalkonium chloride
Conditions of release from
pharmacies Without prescription
Dosage form
Cream
Prescription
For women of childbearing age
