Latex condom [Sensation]

Approved Indications:

• Contraception:
  Latex Condom [Sensation] is indicated for prevention of pregnancy. It functions as a physical barrier to block sperm from entering the female reproductive tract during vaginal intercourse.
• Sexually Transmitted Infection (STI) Prevention:
  Used to reduce the risk of transmission of sexually transmitted infections by limiting exposure to infectious genital secretions and mucosal contact. These include:
• HIV (Human Immunodeficiency Virus)
• Gonorrhea
• Syphilis
• Chlamydia
• Herpes Simplex Virus (HSV)
• Human Papillomavirus (HPV)
• Hepatitis B and C

Clinically Accepted Uses:

• Sexual Education and Health Promotion:
  Employed in health education programs to promote safe sex practices.
• Barrier method after childbirth or abortion:
  Suitable as a temporary, non-hormonal contraception post-delivery or post-abortion.

Dosage:

• One condom per act of intercourse (vaginal, oral, or anal). Do not reuse.

Route of Administration:

• External use on erect penis.

Instructions for Use:

1.        Carefully open the foil packet to avoid tearing the condom.

2.        Pinch the tip to leave room for semen and roll it down the erect penis.

3.        After ejaculation, withdraw while holding the base of the condom.

4.        Dispose of in a waste bin (do not flush). Use a new condom for each act.

Special Populations:

• Adolescents, adults, and elderly: No special adjustments required.
• Renal/hepatic impairment: Not applicable as there is no systemic absorption.
• Latex allergy: Contraindicated; recommend non-latex alternatives (polyurethane/polyisoprene).

Latex Condom [Sensation] acts as a physical barrier that prevents sperm from entering the vagina and fertilizing an ovum, thereby preventing pregnancy. It also blocks the exchange of genital fluids and direct mucosal contact during intercourse, significantly lowering the risk of transmission of sexually transmitted pathogens. It provides dual protection without systemic absorption or hormonal interaction.

Not applicable.
Latex condoms are non-pharmacologic, external barrier devices and do not undergo absorption, metabolism, or excretion. There are no ADME properties.

Pregnancy:

• FDA Category N (Not Classified): Latex condom use is considered safe during pregnancy, with no systemic exposure or risk to the fetus.

Lactation:

• Safe for use while breastfeeding. No components are absorbed systemically or excreted in breast milk. There is no effect on milk production or infant health.

• Primary Therapeutic Class: Barrier Contraceptive Device
• Subclass: Male Latex Condom
• Function: Dual-purpose (Contraception + STI prevention)

• Known hypersensitivity to natural rubber latex
• History of anaphylaxis or severe allergic reaction to latex products
• Use of damaged, expired, or improperly stored condoms

• Latex Allergy Risk: May cause mild to severe hypersensitivity reactions including itching, rash, or anaphylaxis.
• Use Compatible Lubricants Only:
• Safe: Water-based or silicone-based lubricants
• Unsafe: Oil-based products (e.g., petroleum jelly, baby oil, cooking oil) degrade latex and increase the risk of breakage.
• Proper Storage Required: Excessive heat or humidity can damage the material.
• Single-Use Only: Reuse significantly increases the chance of failure.
• Check Expiration Date: Expired condoms may lose strength and integrity.

Common:

• Mild irritation or itching of the genital area
• Temporary discomfort during use (due to friction)

Less Common:

• Contact dermatitis due to latex sensitivity
• Genital rash or redness

Rare but Serious:

• Anaphylaxis (severe allergic reaction in latex-sensitive individuals)

Severity & Onset:

• Symptoms are typically immediate and resolve upon discontinuation. Severe allergic reactions require emergency intervention.

Not applicable.
There are no interactions with medications, foods, or alcohol due to the condom’s non-systemic nature.

Material Interactions:

• Avoid oil-based substances: They weaken latex and increase failure rates.
• Compatible only with water-based or silicone-based lubricants.

• WHO, CDC, and FDA guidelines continue to support condoms as a core component of global STI and pregnancy prevention strategies.
• Emphasis has increased on:
• Correct and consistent use
• Education on proper application
• Access for at-risk populations (youth, MSM, HIV-prevention groups)
• Regulatory Standards: Must comply with ISO 4074 and FDA medical device regulations ensuring tensile strength, leak resistance, and safety.

• Temperature: Store between 20°C and 30°C
• Light & Humidity: Keep away from direct sunlight and moisture
• Handling:
• Do not store in wallets or cars where heat can degrade material
• Avoid puncturing or tearing the packaging
• Shelf Life: Usually 3–5 years depending on packaging and storage
• Disposal: Wrap in tissue and dispose of in a trash bin. Do not flush.