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|Gynol II Original Formula Contraceptive Jelly Vaginal

SPERMICIDES (Vaginal)

Some commonly used brand names are:

In the U.S.—

• Advantage 24 ²
• Because ²
• Conceptrol Contraceptive Inserts ²
• Conceptrol Gel ²
• Delfen ²
• Emko ²
• Emko Pre-Fil ²
• Encare ²
• Gynol II Extra Strength Contraceptive Jelly ²
• Gynol II Original Formula Contraceptive Jelly ²
• Koromex Cream ³
• Koromex Crystal Clear Gel ²
• Koromex Foam ²
• Koromex Jelly ²
• K-Y Plus ²
• Ortho-Creme ²
• Ortho-Gynol ³
• Ramses Crystal Clear Gel ²
• Semicid ²
• Shur-Seal ²
• VCF ²

In Canada—

• Advantage 24 ²
• Delfen ²
• Emko ²
• Encare ²
• Ortho-Gynol ³
• Pharmatex ¹
• Ramses Contraceptive Foam ²

Category

• Contraceptive, vaginal—Benzalkonium Chloride; Nonoxynol 9; Octoxynol 9

Description

Vaginal spermicides are a type of contraceptive (birth control). These products are inserted into the vagina before any genital contact occurs or sexual intercourse begins. They work by damaging and killing sperm in the vagina. Therefore, the sperm are not able to travel from the vagina into the uterus and fallopian tubes, where fertilization usually takes place.

Vaginal spermicides when used alone are much less effective in preventing pregnancy than birth control pills or the IUD or spermicides used with another form of birth control, such as cervical caps, condoms, or diaphragms. Studies have shown that when spermicides are used alone, pregnancy usually occurs in 21 of each 100 women during the first year of spermicide use . The number of pregnancies is reduced when spermicides are used with another method, especially the condom. Discuss with a doctor what your options are for birth control and the risks and benefits of each method.

Laboratory studies have shown that nonoxynol 9 kills or stops the growth of the AIDS virus (HIV) and herpes simplex I and II viruses. It was also shown to be effective against other types of organisms that cause gonorrhea, chlamydia, syphilis, trichomoniasis, and other sexually transmitted diseases (venereal disease, VD, STDs). Benzalkonium chloride also killed the AIDS virus in laboratory studies. Although this has not been proven in human studies, some scientists believe that if spermicides are put into the vagina or on the inside and outside of a latex (rubber) condom, they may kill these germs before they are able to come in contact with the vagina or rectum (lower bowel).

The most effective way to protect yourself against STDs (such as AIDS) is by abstinence (not having sexual intercourse) or by having one partner who you can be sure is not already infected or is not going to get an STD. However, if either of these methods is not likely or possible, using latex (rubber) condoms with a spermicide is the best way of protecting yourself.

The use of a spermicide is recommended even when you are using nonbarrier methods of birth control such as birth control pills (the Pill) or intrauterine devices (IUDs), since these do not offer any protection from STDs.

The safety of using spermicides in the rectum (lower bowel), anus, or rectal area is not known. However, no side effects or problems have been reported that are different from those reported for use in the vagina.

Vaginal spermicides are available without a prescription, in the following dosage forms:

• Vaginal
• Benzalkonium chloride
  • Suppositories (Canada)
• Nonoxynol 9
  • Cream (U.S. and Canada)
  • Film (U.S.)
  • Foam (U.S. and Canada)
  • Gel (U.S. and Canada)
  • Jelly (U.S.)
  • Suppositories (U.S. and Canada)
• Octoxynol 9
  • Cream (U.S.)
  • Jelly (U.S. and Canada)

Before Using This Medicine

In deciding to use vaginal spermicides, the risks of using them must be weighed against the good they will do. This is a decision you and possibly your doctor will make. The following information may help you in making your decision:

Allergies—If you have ever had any unusual or allergic reaction to benzalkonium chloride, nonoxynol 9, or octoxynol 9, it is best to check with your doctor before using vaginal spermicides.

Pregnancy—Many studies have shown that the use of vaginal spermicides does not increase the risk of birth defects or miscarriage.

Breast-feeding—It is not known if vaginal spermicides pass into breast milk in humans. However, their use has not been reported to cause problems in nursing babies.

Children—These products have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. However, some younger users may need extra counseling and information on the importance of using spermicides exactly as they are supposed to be used so they will work properly.

Other medicines—If you are using this medicine without a prescription, carefully read and follow any precautions on the label. For spermicides, the following should be considered:

• Salicylates used on the skin (e.g., some types of ointments for muscle aches) or
• Sulfonamides (sulfa medicine) for use in the vagina or
• Chemicals or substances such as aluminum, citrate, cotton dressings, hydrogen peroxide, iodides, lanolin, nitrates, permanganates, some forms of silver, soaps, detergents, or tartrates—Benzalkonium chloride may not work if it comes in direct contact with these as well as many other chemicals

• Vaginal douches and rectal or vaginal cleansing products—For spermicides to work properly to prevent pregnancy, they must stay in contact with the sperm in the vagina for at least 6 or 8 hours (depending upon which brand of spermicide you use) after sexual intercourse. Vaginal douching is not necessary after use of these medicines . Douching too soon (even with just water) may stop the spermicide from working. Also, washing or rinsing the vaginal or rectal area may also make the spermicide ineffective in helping to prevent sexually transmitted diseases

Other medical problems—The presence of certain medical problems may affect the use of vaginal spermicides. Since in some cases spermicides should not be used, check with your doctor if you have any of the following:

• Allergies, irritations, or infections of the genitals—Using vaginal spermicides may cause moderate to severe irritation in these conditions. Also, benzalkonium suppositories may be less effective in women with vaginal infections

• Conditions or medical problems where it is important that pregnancy does not occur—Vaginal spermicides when used alone are much less effective than birth control pills or the IUD or spermicides used with another form of birth control such as cervical caps, condoms, or diaphragms. Discuss with your doctor what your options are for birth control and the risks and benefits of each method

• Recent childbirth or abortion or
• Toxic shock syndrome (history of)—Cervical caps or diaphragms should not be used in these cases because there is an increased chance of developing toxic shock syndrome

• Sores on the genitals (sex organs) or
• Irritation of the vagina—It is not known whether spermicides can cause breaks in the skin that could increase the chances of getting a sexually transmitted disease, especially AIDS. Discuss this with a doctor if you have any questions

If you develop any medical problem or begin using any new medicine (prescription or nonprescription) while you are using this medicine, you may want to check with your doctor.

Proper Use of This Medicine

Make sure you carefully read and follow the directions that come with each spermicide product. Each product may have different directions for using the product. The directions tell you how much to use, how long you must wait before having intercourse, and how long you must leave it in the vagina after intercourse.

Vaginal douching is not needed or advised after using these medicines . When using a spermicide, douching within 6 to 8 hours after the last sexual intercourse (even with just water) may stop the spermicide from working properly. Also, washing or rinsing the vaginal or rectal area may wash the spermicide away before it has had time to work properly.

Cervical caps and diaphragms are not recommended for use during your menstrual period because of an increased chance of developing toxic shock syndrome. Your doctor may advise you to use condoms with a spermicide instead during your menstrual periods when protection is needed.

For proper use of spermicide when used alone :

• Follow directions carefully to make sure the spermicide is properly placed in the vagina. The spermicide should be inserted deep into the vagina, directly on the cervix (opening to the uterus).
• Use the correct amount, according to the product directions.
• Use another dose for each act of intercourse.
• After you have applied or inserted the spermicide, wait the correct amount of time before having intercourse so that the spermicide can begin to work.
• If you do not have intercourse within half an hour, read the product directions to see if you need to apply more spermicide.

For proper use of spermicide with cervical caps, condoms, or diaphragms :

• Make sure the directions for the spermicide you choose state that it is safe for use with latex cervical caps, condoms, or diaphragms. If the directions do not say the spermicide is safe to use with latex products, the spermicide may cause cervical caps, condoms, or diaphragms to weaken and leak or cause condoms to break during intercourse.
• If there is a leak or break during intercourse, it may be a good idea for the female partner to immediately place more spermicide in the vagina.
• If you need an extra lubricant, make sure it is a water-based product safe for use with cervical caps, condoms, or diaphragms . Spermicides, especially gels and jellies, provide some lubrication during sexual intercourse.
• Oil-based products such as hand, face, or body cream; petroleum jelly; cooking oils or shortenings; or baby oil should not be used because they weaken the latex rubber. (Even some products that easily rinse away with water are oil-based and should not be used.) Use of oil-based products increases the chances of the condom breaking during sexual intercourse. These products can also cause the rubber in cervical caps or diaphragms to break down faster and wear out sooner.

For patients using spermicides with a cervical cap :

• To be most effective at preventing pregnancy, the cervical cap must always be used with a spermicide . Both must be used every time you have sexual intercourse.
• Before inserting the cervical cap, inspect it for holes, tears, or cracks. If there are holes or defects, the cervical cap will not work effectively, even with a spermicide. It must be replaced.
• Before you put the cervical cap over the cervix (opening to the uterus), a spermicide cream, foam, gel, or jelly should be put into the cup of the cervical cap. Follow the manufacturer"s directions on how long before sexual intercourse you may apply the spermicide. Fill the cervical cap one-third full with spermicide.
• To insert the cervical cap, squeeze the rim between your thumb and forefinger so that it is narrow enough to fit into the vagina. While in a comfortable position, push the cervical cap as deeply into the vagina as it will go. Release the rim and press it into place around the cervix with your finger. The rim should be round again and be directly on the cervix. The cervical cap is held onto the cervix by suction.
• Some doctors may recommend that you put more spermicide into the vagina each time you repeat sexual intercourse using a cervical cap. You should also check to make sure the cervical cap is in the proper position on the cervix before and after each time you have intercourse. You may wear the cervical cap for up to 48 hours (2 days).
• Do not remove the cervical cap if it has been less than 8 hours since the last time you had sexual intercourse . For the cervical cap to be most effective at preventing pregnancy, it must remain in the vagina for at least 8 hours after sexual intercourse.
• To remove the cervical cap, use 1 or 2 fingers to push the rim away from the cervix. This will break the suction seal with the cervix. Then gently pull the cervical cap out of the vagina. Call your doctor if you have trouble removing the cervical cap .

For patients using spermicides with condoms :

• Condoms do not have to be used with spermicides, but the spermicide may provide a back-up birth control method in case the condom breaks or leaks.
• Spread some spermicide on the outside of the condom, after it is unrolled over the penis. It is even more important that the female partner also use a spermicide inside the vagina.
• Each time you repeat intercourse, a new condom must be used. Condoms should never be reused . Spermicide should also be applied to the outside of the new condom. The female partner must also put more spermicide in the vagina each time she has intercourse.

For patients using spermicides with a diaphragm :

• To be most effective at preventing pregnancy, diaphragms must always be used with a spermicide . Some women may choose to insert a diaphragm every night, to avoid the chance of unprotected sexual intercourse and unplanned pregnancy happening.
• Inspect the diaphragm for holes by holding it up to a light. If there are holes or defects, the diaphragm will not work effectively, even with a spermicide. It must be replaced.
• Before you put the diaphragm over the cervix (opening to the uterus), a spermicide cream, foam, gel, or jelly should be put into the cup of the diaphragm. Follow the manufacturer"s directions on how much spermicide to use and how long before sexual intercourse you may apply the spermicide. Also, spread some spermicide all around the rim of the diaphragm that will be touching the cervix. Some doctors also advise spreading more spermicide on the outside of the cup of the diaphragm.
• To insert the diaphragm, squeeze the rim between your thumb and forefinger so that it is narrow enough to fit into the vagina. While in a comfortable position, push the diaphragm as deeply into the vagina as it will go. (Some women use a special applicator that makes it easier to insert the diaphragm.) Release the rim. The diaphragm rim should be round again and be directly on the cervix.
• Each time you repeat sexual intercourse, you should put more spermicide into the vagina. Do not remove the diaphragm if it has been less than 6 or 8 hours (depending upon which brand of spermicide you use) since the last sexual intercourse . For the diaphragm to be most effective at preventing pregnancy, it must remain in the vagina for at least 6 or 8 hours (depending upon which brand of spermicide you use) after sexual intercourse. Be careful not to move the diaphragm out of place while you are applying more spermicide.
• Do not wear the diaphragm for more than 24 hours, since doing so increases the risk of getting toxic shock syndrome or a urinary tract (bladder) infection.
• To remove the diaphragm, hook one finger over the rim nearest the front. Pull the diaphragm downward and out of the vagina. Call your doctor if you have trouble removing the diaphragm .

Dosing—Follow your doctor"s orders or the directions on the label . The following information includes the usual way that spermicides are used.

• For benzalkonium chloride
• For preventing pregnancy:
  • For vaginal suppositories dosage form:
    • Adults and teenagers:
      • For use alone: One suppository inserted into the vagina at least ten minutes but not longer than four hours before each time you have sexual intercourse.
      • For use with a diaphragm: After the diaphragm with spermicide has been placed into the vagina, insert one suppository at least ten minutes, but not longer than four hours, before each time you have sexual intercourse. Also, insert another suppository before sexual intercourse if six hours have passed since you inserted the diaphragm.

• For nonoxynol 9
• For preventing pregnancy:
  • For vaginal cream dosage form:
    • Adults and teenagers:
      • For use alone: One applicatorful of a 5% cream inserted into the vagina just before each time you have sexual intercourse.
      • For use with a diaphragm: One applicatorful of a 2 or 5% cream inserted into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert one applicatorful just before each time you have intercourse or if six hours have passed since you inserted the diaphragm.
  • For vaginal film dosage form:
    • Adults and teenagers—One film inserted into the vagina from five to fifteen minutes (but not longer than one and one-half hours) before each time you have sexual intercourse.
  • For vaginal foam dosage form:
    • Adults and teenagers:
      • For use alone: One applicatorful inserted into the vagina just before, but not longer than one hour before, each time you have sexual intercourse.
      • For use with a diaphragm: One applicatorful inserted into either the vagina or into the cup of the diaphragm, depending on the product. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than one hour before, sexual intercourse. Also, insert another applicatorful into the vagina just before, but not longer than one hour before, each time you have sexual intercourse.
  • For vaginal gel dosage form:
    • Adults and teenagers:
      • For use alone: One applicatorful of a 3.5, 4, or 5% gel inserted into the vagina before each time you have sexual intercourse. The 3.5% gel may be used up to twenty-four hours before each act of intercourse. The 4% gel may be used up to one hour before each act of intercourse. The 5% gel must used just before intercourse.
      • For use with a diaphragm: One or two teaspoonfuls (depending on the product) or the contents of one packet of gel is placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, or up to six hours before, sexual intercourse. Also, insert another applicatorful or the contents of one packet into the vagina before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm.
  • For vaginal jelly dosage form:
    • Adults and teenagers:
      • For use alone: One applicatorful of 2.2 or 3% jelly inserted into the vagina just before each time you have sexual intercourse. The contraceptive effect of the 2.2 or 3% jelly will last one hour.
      • For use with a diaphragm: One applicatorful or two teaspoonfuls of jelly (depending on the product) placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert another applicatorful before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm.
  • For vaginal suppositories dosage form:
    • Adults and teenagers:
      • For use alone: One suppository inserted into the vagina from ten to fifteen minutes (depending on the product) before, but not longer than one hour before, each time you have sexual intercourse.
    • Adults and teenagers:
      • For use with a diaphragm: After the diaphragm with spermicide has been placed into the vagina, insert one suppository into the vagina from ten to fifteen minutes (depending on the product) before, but not longer than one hour before, sexual intercourse. Also, insert another suppository before each time you have sexual intercourse or if six hours have passed since you have inserted the diaphragm.

• For octoxynol 9
• For preventing pregnancy:
  • For vaginal cream dosage form:
    • Adults and teenagers:
      • For use with a diaphragm: Two teaspoonfuls placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert one applicatorful of the vaginal cream just before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm.
  • For vaginal jelly dosage form:
    • Adults and teenagers:
      • For use with a diaphragm: One applicatorful placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert another applicatorful just before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not refrigerate.
• Do not keep outdated products or products no longer needed. Be sure that any discarded products are out of the reach of children.

Precautions While Using This Medicine

During use of spermicides, either partner may feel burning, stinging, warmth, itching, or other irritation of the skin, sex organs, anus, or rectum. Using a weaker strength of vaginal spermicide or one with different ingredients may be necessary. If you are using benzalkonium chloride suppositories, it may help to wet them before they are inserted into the vagina. If any of these effects continue after you have changed products, you may have an allergy to these products or an infection, and should contact a doctor as soon as possible.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. However, check with a doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some people. If you notice any other effects, check with your doctor.

Revised: 08/16/1997

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