Benzalkonium chloride (Suppositories) Instructions for Use

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Amcapharm Pharmaceutical, GmbH (Germany)

ATC Code

G02BB (Intravaginal contraceptives)

Active Substance

Benzalkonium chloride (Rec.INN registered by WHO)

Dosage Form

Benzalkonium chloride

Vaginal suppositories 18.9 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories white in color, cylindrical in shape with a conical tip, odorless.

Excipients: suppository base witepsol S51.

5 pcs. – contour cell packs (2) – cardboard packages.

Clinical-Pharmacological Group

Vaginal contraceptive with spermicidal action

Pharmacotherapeutic Group

Contraceptive agent for topical application

Pharmacological Action

Antiseptic with spermicidal action. It is a quaternary ammonium compound, belongs to cationic surfactants.

Spermicidal action is due to the ability of the active substance to destroy sperm membranes (first the flagella, then the heads), which makes it impossible for the egg to be fertilized by a damaged sperm.

The effect develops within 5-10 minutes after insertion into the vagina.

Does not affect the normal vaginal microflora and the menstrual cycle.

In vitro Benzalkonium chloride is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus. It has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum. It is not active against Mycoplasma spp.

Pharmacokinetics

Benzalkonium chloride is not absorbed into the vaginal mucosa, it is removed by simple washing with water and with normal physiological secretions. When applied topically, it is practically not absorbed.

Indications

Local contraception.

ICD codes

Dosage Regimen

Administer one suppository intravaginally 5-10 minutes before each sexual intercourse.

Ensure the suppository is inserted deep into the vagina.

The contraceptive effect develops within the specified 5-10 minutes and lasts for several hours.

For repeated intercourse, insert a new suppository each time.

Do not use soap for genital hygiene 2 hours before and 2 hours after application, as it inactivates the active substance.

Avoid concurrent use of other intravaginal medications, as they may reduce spermicidal efficacy.

This method does not protect against sexually transmitted infections.

Discontinue use and consult a physician if vaginitis, ulceration, or mucosal irritation is present.

Adverse Reactions

Possible allergic reactions, contact dermatitis, burning, itching in the vagina and/or partner’s penis, painful urination.

Contraindications

Hypersensitivity to benzalkonium chloride; vaginitis, ulceration and irritation of the vaginal and cervical mucosa.

Use in Pregnancy and Lactation

Not used during pregnancy. Does not have a negative effect on the course of pregnancy. It is not excreted in breast milk, can be used during breastfeeding.

Special Precautions

The effectiveness of contraception depends on the correct use of the drug containing Benzalkonium chloride.

In case of vaginal diseases, the use of benzalkonium chloride should be temporarily discontinued until the end of treatment with vaginal medications.

This method of contraception does not protect against sexually transmitted infections or those caused by HIV.

The use of soap for genital hygiene is prohibited 2 hours before and 2 hours after sexual intercourse, because soap destroys Benzalkonium chloride. Vaginal douching should be applied 2 hours after sexual intercourse.

Drug Interactions

Any medication used intravaginally may reduce the spermicidal effect of benzalkonium chloride.

Benzalkonium chloride is destroyed by soap.

Iodine solutions (including 0.1% iodonate solution) inactivate Benzalkonium chloride.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.