Amore Gold

Approved Indications:

• Contraception: Indicated for the prevention of pregnancy by acting as a physical barrier that prevents sperm from entering the uterus.
• Prevention of Sexually Transmitted Infections (STIs): Provides effective protection against a broad range of STIs, including:
• Human Immunodeficiency Virus (HIV)
• Chlamydia
• Gonorrhea
• Syphilis
• Herpes Simplex Virus (HSV)
• Human Papillomavirus (HPV)
• Hepatitis B and C

Clinically Accepted Uses:

• Sexual Health Education: Commonly used in sexual education programs for teaching safe sex practices.
• Postpartum and Postabortion Contraception: Suitable for use after childbirth or abortion when non-hormonal methods are preferred.

Recommended Usage:

• Use one condom for each act of sexual intercourse (vaginal, anal, or oral).
• Instructions for Use:

1.        Open the package carefully, avoiding sharp objects or fingernails.

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

3.        Pinch the tip to leave space for semen and unroll it down to the base of the penis.

4.        After ejaculation, withdraw while holding the base of the condom to prevent slippage.

5.        Discard the condom in a waste bin—do not flush.

Special Populations:

• No age restrictions. Suitable for all sexually active individuals.
• Not suitable for individuals with latex allergy. In such cases, use non-latex alternatives (e.g., polyurethane or polyisoprene condoms).

Latex condoms act as a physical barrier that prevents the exchange of semen, vaginal secretions, and blood during sexual contact. By blocking the passage of sperm, they prevent fertilization and thus pregnancy. Additionally, they reduce the risk of STI transmission by minimizing contact with infected bodily fluids and mucosal surfaces.

Not applicable.
As a non-systemic physical barrier, latex condoms do not undergo absorption, distribution, metabolism, or excretion. No pharmacokinetic properties apply.

Pregnancy:

• Category N (Not classified): Latex condoms are medical devices and do not enter systemic circulation. Safe for use during pregnancy to prevent STIs and reinfection.

Lactation:

• Completely safe during breastfeeding. Latex condoms have no effect on milk production or infant exposure.

• Primary Class: Mechanical Barrier Contraceptive
• Subclass: Male External Condom (Latex)
• Function: Dual protection—contraceptive and STI prevention

• Known hypersensitivity or allergy to natural rubber latex
• Presence of latex-induced dermatitis or anaphylaxis history
• Do not use if the condom is torn, expired, or improperly stored

• Allergic Reactions: Latex may cause allergic skin reactions or, rarely, anaphylaxis.
• Material Integrity: Oil-based lubricants (e.g., petroleum jelly, baby oil) can degrade latex. Only water-based or silicone-based lubricants should be used.
• Breakage Risk: Increased with improper use, insufficient lubrication, or expired products.
• Single Use Only: Never reuse condoms.
• Storage Sensitivity: Degraded condoms due to heat or sunlight exposure can lose effectiveness.

Common Side Effects (Non-systemic):

• Mild genital irritation or discomfort
• Redness or itching due to friction

Less Common:

• Allergic contact dermatitis
• Burning sensation or localized swelling

Rare but Serious:

• Anaphylactic reactions in individuals with severe latex allergy

Onset & Severity:

• Usually mild and immediate
• Severity depends on individual sensitivity

Not applicable.
Latex condoms are not pharmaceutical products and do not interact with medications, alcohol, or food.

Important Compatibility Warning:

• Do not use oil-based lubricants with latex condoms—they weaken the material.
• Compatible with water-based and silicone-based lubricants only.

• World Health Organization (WHO) and CDC: Continue to recommend latex condoms as first-line protection against unintended pregnancy and STIs, including HIV.
• FDA & UNFPA Standards: Latex condoms must comply with ISO 4074 quality standards for strength, elasticity, and leak prevention.
• Public Health Policy Updates: Programs emphasize consistent and correct condom use as a key component of sexual and reproductive health services worldwide.

• Temperature: Store at 20°C to 30°C (room temperature)
• Light & Humidity: Protect from direct sunlight, high humidity, and heat
• Handling:
• Do not use if the packaging is torn or if the product is expired
• Avoid prolonged storage in wallets or cars where heat may degrade latex
• Shelf Life: Typically 3 to 5 years, depending on the manufacturer and storage conditions