U&ME Long Love

Approved Indications:

• Contraception:
  Latex Condom [U & ME] is indicated for the prevention of pregnancy during vaginal intercourse by creating a physical barrier that prevents sperm from entering the female reproductive tract.
• Prevention of Sexually Transmitted Infections (STIs):
  Provides protection against a wide range of STIs including:
• HIV (Human Immunodeficiency Virus)
• Gonorrhea
• Chlamydia
• Syphilis
• Human Papillomavirus (HPV)
• Herpes Simplex Virus (HSV)
• Trichomoniasis
• Hepatitis B and C (to a certain degree)

Clinically Accepted (Off-label) Uses:

• Postpartum or Post-abortion Use:
  Recommended as a temporary contraceptive option when hormonal or intrauterine methods are not advised.
• Sex Education & Public Health Campaigns:
  Commonly used in educational and outreach settings for demonstrating safe sex practices.

Dosage:

• One condom per act of sexual intercourse. Do not reuse.

Route of Administration:

• Topical external application to an erect penis.

Instructions for Use:

1.        Tear open the foil packet carefully to avoid damaging the condom.

2.        Place the condom on the tip of the erect penis, ensuring the rolled side is facing outward.

3.        Pinch the reservoir tip to leave space for semen and unroll the condom completely to the base.

4.        After ejaculation, withdraw while the penis is still erect, holding the condom at the base to prevent leakage.

5.        Remove and dispose of the condom properly in a trash bin. Do not flush.

Special Populations:

• Safe for use by all sexually active individuals.
• No dose adjustments required for patients with hepatic or renal impairment.
• Individuals with latex allergy should use non-latex alternatives such as polyurethane or polyisoprene condoms.

Latex Condom [U & ME] acts as a mechanical barrier, physically preventing sperm from entering the female reproductive tract, thereby avoiding fertilization. Additionally, the condom prevents direct contact with genital secretions, lesions, and mucosal membranes, thereby reducing the transmission of sexually transmitted infections (STIs). Its dual function for both contraception and STI protection makes it a key component of safe sex practices. Effectiveness relies on correct and consistent use.

Not applicable.
As a non-systemic, external-use product, Latex Condom [U & ME] has no pharmacokinetic properties. It does not undergo absorption, distribution, metabolism, or excretion.

Pregnancy:

• FDA Category N (Not Assigned): Not applicable to non-drug barrier methods. Latex condoms are safe for use during all stages of pregnancy.

Lactation:

• Safe to use while breastfeeding. There is no systemic absorption; therefore, it does not affect milk composition or pose a risk to the infant.

• Primary Class: Mechanical Barrier Contraceptive
• Subclass: Male Latex Condom
• Purpose: Contraception and prevention of STI transmission

• Known hypersensitivity to natural rubber latex
• Severe latex allergy (e.g., anaphylaxis, urticaria)
• Do not use if:
• The condom is expired, damaged, or stored improperly
• Oil-based lubricants are being used (which can degrade latex)

• Latex Allergy: May cause allergic reactions in sensitive individuals, including rash, irritation, or anaphylaxis. Use non-latex condoms if allergy is known.
• Lubricant Compatibility: Only use water-based or silicone-based lubricants. Avoid oil-based substances like baby oil or petroleum jelly as they weaken latex.
• Single Use Only: Reuse significantly increases the risk of breakage and failure.
• Proper Application Required: Improper use increases the risk of slippage, leakage, or condom breakage.
• Check Packaging and Expiry Date: Do not use if packaging is torn or product is expired.

Common:

• Mild genital irritation
• Dryness or discomfort due to friction

Uncommon:

• Localized rash or itching
• Latex sensitivity symptoms (e.g., erythema, burning sensation)

Rare but Serious:

• Severe allergic reaction or anaphylaxis

Timing and Severity:
Adverse reactions are typically immediate and localized. Severe allergic responses are rare but require urgent medical attention.

Drug-Drug, Drug-Food, Drug-Alcohol Interactions:

• Not applicable. No systemic absorption or drug interactions occur.

Material Interactions:

• Avoid oil-based lubricants (e.g., lotions, petroleum jelly, coconut oil), as they weaken latex and increase risk of breakage.
• Compatible lubricants: Water-based and silicone-based products only.

• WHO, CDC, and UNAIDS continue to promote latex condoms as a primary strategy for preventing HIV and STI transmission.
• ISO 4074:2015 Compliance: Latex Condom [U & ME] must meet international quality standards for tensile strength, bursting volume, and absence of holes.
• Increased focus on accessibility and education in underserved populations for condom use to reduce rates of unintended pregnancy and STIs.

• Temperature: Store between 20°C to 30°C
• Humidity & Light: Protect from direct sunlight, excessive heat, and moisture
• Handling:
• Avoid carrying condoms in wallets or pockets for long periods due to friction and heat exposure
• Do not use if the packaging is torn or the condom appears brittle or sticky
• Shelf Life: Usually 3 to 5 years depending on the manufacturer
• Disposal: Wrap in paper or tissue and discard in trash. Do not flush.