Latex condom [Hero]

Approved Indications:

• Contraception:
  Latex condom [Hero] is indicated for the prevention of pregnancy by serving as a barrier to sperm entry into the uterus during sexual intercourse.
• Sexually Transmitted Infection (STI) Prevention:
  Provides a physical barrier to reduce the risk of acquiring or transmitting STIs, including:
• Human Immunodeficiency Virus (HIV)
• Chlamydia trachomatis
• Neisseria gonorrhoeae
• Treponema pallidum (Syphilis)
• Herpes Simplex Virus (HSV)
• Human Papillomavirus (HPV)
• Hepatitis B and C

Other Clinically Accepted Uses:

• Sexual Health Education Programs: Frequently used as a teaching tool for proper condom use and safe sex practices.
• Barrier Method in Postpartum or Postabortion Periods: Preferred in settings where hormonal contraception is temporarily contraindicated.

Standard Use:

• Use one new condom per sexual act (vaginal, anal, or oral).
• Route of Administration: External application to the erect penis.

Instructions for Proper Use:

1.        Open the wrapper carefully to avoid damage.

2.        Place the condom on the tip of the erect penis before any genital contact.

3.        Pinch the tip to remove air and allow space for semen.

4.        Roll down the condom completely to the base of the penis.

5.        After ejaculation, withdraw while holding the base to prevent slippage.

6.        Dispose of the condom in the trash—do not flush.

Special Populations:

• Adolescents and Adults: Safe for all sexually active individuals.
• Latex-Allergic Individuals: Should use non-latex alternatives.
• No renal, hepatic, or systemic dose adjustments are required, as this is a non-pharmaceutical device.

Latex Condom [Hero] acts as a mechanical barrier that physically blocks the exchange of semen, vaginal secretions, and other genital fluids between sexual partners. This prevents sperm from entering the female reproductive tract, thereby preventing fertilization and pregnancy. It also significantly reduces skin-to-skin and mucosal contact, minimizing the transmission of pathogens responsible for sexually transmitted infections, including HIV and HPV.

Not applicable.
Latex condoms are non-systemic barrier devices and do not undergo absorption, distribution, metabolism, or excretion. No pharmacokinetic profile is involved.

Pregnancy:

• Category N (Not classified): Latex condoms do not affect maternal physiology or fetal development. Safe to use throughout pregnancy for STI prevention and contraception.

Lactation:

• Completely safe for breastfeeding mothers. No systemic absorption occurs, and there is no effect on milk production or infant health.

• Primary Class: Mechanical Barrier Contraceptive
• Subcategory: Male Latex Condom
• Functional Role: Dual-purpose device for contraception and STI prevention

• Known hypersensitivity to natural rubber latex
• History of latex-induced contact dermatitis or anaphylaxis
• Visibly damaged, expired, or improperly stored condoms

• Allergic Reactions: Latex may cause irritation, rash, or rarely, anaphylactic reactions in sensitive individuals.
• Lubricant Compatibility: Use only water-based or silicone-based lubricants. Oil-based products (e.g., baby oil, petroleum jelly) weaken latex and may cause breakage.
• Proper Storage Required: Degraded latex due to improper storage (heat/sunlight) may compromise effectiveness.
• Single-Use Only: Never reuse a condom.
• Breakage or Slippage Risk: May occur if improperly applied or if the condom is too loose or too tight.

Common (non-systemic, localized):

• Mild genital discomfort or irritation
• Redness or itching in the genital area

Less Common:

• Contact dermatitis
• Burning sensation during or after use

Rare (Severe):

• Anaphylactic reaction due to latex allergy

Timing & Severity:

• Symptoms are typically immediate and depend on individual sensitivity
• Reactions are local and non-systemic

Not applicable.
Latex Condom [Hero] is a medical device and has no pharmacological action. It does not interact with drugs, foods, or alcohol.

Material Interactions:

• Incompatible with oil-based lubricants: They weaken latex, increasing breakage risk.
• Compatible with: Water-based and silicone-based lubricants.

• WHO, CDC, and UNFPA: Continue to list latex condoms as a first-line, cost-effective, and accessible method for dual protection (STI prevention and contraception).
• FDA & ISO Certification: Latex condoms must comply with ISO 4074 and FDA regulations for quality, elasticity, and leakage standards.
• Public Health Initiatives: Programs emphasize correct and consistent use as a core component of reproductive health services.

• Temperature Range: Store between 20°C and 30°C (room temperature)
• Light & Humidity Protection: Keep away from direct sunlight, high humidity, and excessive heat
• Handling Precautions:
• Do not use if the package is torn or expired
• Avoid carrying condoms in wallets for long durations (due to friction and heat)
• Shelf Life: Usually 3 to 5 years depending on manufacturer and storage