Sterilin (Suppositories) Instructions for Use

Marketing Authorization Holder

Four Ventures Enterprises Inc. (USA)

Manufactured By

Vetro Inc (DBA Rose Laboratories) (USA)

ATC Code

G02BB (Intravaginal contraceptives)

Active Substance

Nonoxinol (Rec.INN registered by WHO)

Dosage Form

Sterilin

Vaginal suppositories 100 mg: 5 pcs.

Dosage Form, Packaging, and Composition

5 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Vaginal contraceptive with spermicidal action

Pharmacotherapeutic Group

Contraceptive agent for topical application

Pharmacological Action

Contraceptive agent. It has a pronounced spermicidal effect.

It causes fragmentation, reduced motility, and death of spermatozoa.

It also has antimicrobial, antifungal, antiviral, and antiparasitic effects against a number of pathogens that cause sexually transmitted diseases.

Indications

• Local contraception for women of reproductive age.
• Use in the presence of contraindications to hormonal or intrauterine contraception.
• Employ with irregular sexual contacts.
• Utilize when taking medications that reduce the effectiveness of hormonal contraception.
• Apply when missing or being late in taking regularly used oral contraceptives.

ICD codes

Dosage Regimen

Administer one 100 mg suppository intravaginally 5 to 15 minutes before each sexual intercourse.

Ensure the suppository is inserted high into the vagina near the cervix. For repeated intercourse, insert a new suppository each time.

The protective effect lasts for approximately one hour after insertion. Do not douche for at least 6 hours after the last intercourse.

Adverse Reactions

Local reactions may occur, including increased vaginal discharge, itching, burning in the vagina or on the partner’s penis, and vaginal dryness.

Allergic reactions and painful urination are also possible. Discontinue use if severe irritation develops.

Drug Interactions

Any other intravaginally administered medication may reduce the spermicidal effect.

Avoid concurrent intravaginal use of soaps and solutions, as they can inactivate the spermicide and compromise contraceptive efficacy.

Contraindications

• Hypersensitivity to nonoxinol or any component of the suppository.
• Presence of genital anomalies, vaginitis, or ulceration and irritation of the vaginal mucosa.
• Diagnoses of cervical erosion, cervicitis, or endometritis.
• Unexplained vaginal bleeding.

Overdose

No specific antidote exists. Overdose is unlikely with correct vaginal use.

Accidental ingestion may cause gastrointestinal irritation. In case of ingestion, administer symptomatic and supportive treatment.

Use in Pregnancy and Lactation

Nonoxinol is a contraceptive and is not used during pregnancy. During breastfeeding, it can be used as indicated in cases where the expected benefit to the mother outweighs the potential risk to the infant.

Geriatric Use

Not intended for use in the elderly.

Special Precautions

The product can be used for a long time.

The product can be used in combination with a condom.

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.