Raja Super Condom

Approved Indications:

• Contraception:
  Latex Condom [Raja Super] is indicated for the prevention of pregnancy. It functions as a physical barrier to prevent sperm from entering the uterus during vaginal intercourse.
• Prevention of Sexually Transmitted Infections (STIs):
  Reduces the risk of transmission of various STIs by preventing contact with infected bodily fluids and mucous membranes, including:
• HIV (Human Immunodeficiency Virus)
• Chlamydia
• Gonorrhea
• Syphilis
• Genital Herpes (HSV)
• Human Papillomavirus (HPV)
• Hepatitis B and C

Clinically Accepted Uses:

• Educational Settings:
  Used in sexual health education and public health campaigns to teach correct condom use.
• Postpartum and Postabortion Barrier Method:
  Recommended as a non-hormonal method of contraception when hormonal options are not immediately advisable.

Dosage:

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

Route of Administration:

• External use on an erect penis before any genital contact.

Instructions for Use:

1.        Carefully open the package without using sharp objects.

2.        Pinch the tip to leave room for semen collection.

3.        Roll the condom down to the base of the penis while it is erect.

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

5.        Dispose of the condom in a waste bin. Do not reuse or flush.

Special Populations:

• Adolescents and adults: Appropriate and safe.
• No systemic dose adjustments are needed for elderly or individuals with renal/hepatic impairment.
• Latex-sensitive individuals: Should use non-latex alternatives such as polyisoprene or polyurethane condoms.

Latex Condom [Raja Super] operates by forming a physical barrier that blocks semen, vaginal fluids, and blood from passing between sexual partners. This prevents sperm from entering the female reproductive tract, thereby preventing fertilization and pregnancy. Additionally, the condom reduces skin-to-skin and mucosal contact, helping prevent the transmission of STIs including viruses and bacteria.

Not applicable.
Latex condoms are external, non-systemic devices. They do not undergo absorption, distribution, metabolism, or excretion, and therefore possess no pharmacokinetic properties.

Pregnancy:

• Category N (Not classified): As a non-systemic medical barrier, condoms do not affect pregnancy or fetal development. Safe throughout all trimesters.

Lactation:

• Safe during breastfeeding. No drug enters the bloodstream or breast milk. No risk to nursing infants.

• Primary Therapeutic Class: Mechanical Barrier Contraceptive
• Subcategory: Male Latex Condom
• Function: Dual protection for contraception and STI prevention

• Known hypersensitivity to natural rubber latex
• Previous latex-induced allergic reaction or anaphylaxis
• Do not use if the condom is damaged, discolored, expired, or improperly stored

• Latex Allergy Risk: May cause rash, itching, burning, or anaphylactic reactions in latex-sensitive individuals.
• Lubricant Use: Only compatible with water-based or silicone-based lubricants. Do not use oil-based products (e.g., Vaseline, baby oil) as they degrade latex.
• Breakage or Slippage Risk: Ensure proper use and fit; incorrect application may lead to condom failure.
• Single-Use Only: Never reuse condoms.
• Storage-Sensitive: Exposure to heat, light, or moisture may reduce effectiveness.

Common (Localized):

• Mild irritation or itching of the genital area
• Slight discomfort due to friction

Less Common:

• Allergic contact dermatitis (rash, redness)

Rare but Serious:

• Anaphylaxis in individuals with severe latex allergy

Timing & Severity:

• Side effects occur immediately after use in sensitive users and are localized. Most are mild and resolve quickly after discontinuation.

Not applicable.
As a medical barrier, Latex Condom [Raja Super] does not interact with systemic medications, foods, or alcohol.

Important Material Interactions:

• Avoid oil-based substances: These can weaken latex and increase breakage risk.
• Compatible with: Water-based and silicone-based lubricants.

• WHO, CDC, and UNFPA: Reinforce that latex condoms are the most accessible and effective dual-protection strategy for preventing both STIs and unintended pregnancy.
• ISO & FDA Standards: Condoms must comply with ISO 4074 for strength, elasticity, and integrity.
• Public Health Programs: Continued focus on correct and consistent condom use to reduce STI prevalence, especially among youth and high-risk populations.

• Temperature Range: Store between 20°C and 30°C
• Protection from Environment: Avoid sunlight, humidity, and heat exposure
• Handling Instructions:
• Do not use if the packaging is torn, damaged, or the condom is expired
• Avoid long-term storage in wallets or cars due to heat and friction
• Shelf Life: Typically 3 to 5 years, depending on manufacturer and storage conditions