Nonoxynol-9 is a nonionic detergent that is used as a barrier spermicidal contraceptive agent. Nonoxynol-9 may be used alone or in conjunction with a cervical cap, diaphragm, or condom. Barrier methods for pregnancy prevention might not be appropriate for those who cannot use them consistently and correctly because of the relatively higher typical-use failure rates of these methods. Nonoxynol-9 products, when used alone, generally result in an estimated 28 pregnancies per 100 women in a year. Spermicide use does not protect against the transmission of any sexually transmitted disease (STD), including the human immunodeficiency virus (HIV). Spermicides are available in many formulations for nonprescription purchase.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Intravaginal Administration
-For vaginal use only. No product is to be inserted into the rectum or the urethra.
-Instruct patient to carefully read the product instructions before use.
-In general, instruct patient not to douche within 6 hours of intercourse to ensure maximum efficacy of the spermicide to prevent pregnancy.
Vaginal pre-filled gel single-dose applicators:
-Insert 1 applicatorful into the vagina prior to intercourse. Each applicatorful is effective immediately and up to 1 hour after application.
-May be applied used along with condoms or with a cervical cap or diaphragm.
-An additional applicatorful is required prior to each act of intercourse, regardless of time since last application.
Vaginal film:
-Be sure fingers are dry before touching the film.
-Insert 1 film and place as far into the vagina as possible, against the cervix.
-Insert not less than 15 minutes, and not more than 3 hours, before intercourse.
-An additional film is required prior to each act of intercourse, regardless of time since last application.
Vaginal contraceptive sponge (e.g., Today sponge):
-Moisten sponge with clean water as directed in package labeling and compress to activate contraceptive foam.
-Insert 1 sponge intravaginally, against the cervix, up to, but not exceeding, 24 hours prior to intercourse. The sponge maintains activity, regardless of number of acts of intercourse, for up to 24 hours, as long as it remains in place.
-Leave sponge in place for at least 6 hours after the last act of intercourse. Do not leave sponge in vagina for longer than 30 hours. Do not reuse the sponge. A new sponge should be prepared and inserted prior to the next act.
Potential adverse reactions reported in the literature with nonoxynol-9 products include contact dermatitis, irritations, and allergic reactions. Local tissue/skin irritation/burning sensations, rash, vaginal irritation, or penile irritation occurs infrequently in treated patients or their exposed partners. Counsel patients to discontinue use if burning, itching, a rash, or other irritation of the vagina or penis occurs. Unpleasant taste (dysgeusia) may potentially occur when a person is exposed to small amounts of nonoxynol-9 orally during usual use as intended, and may be due to the formulation ingredients or the medication. Urethral or urinary tract and rectal irritation have also rarely been reported when vaginal nonoxynol-9 products have been inadvertently administered into the urethra or rectum, respectively. Remind patients to use the vaginal route only for these products. Spermicidal contraceptive sponges have been linked to cases of toxic-shock syndrome (TSS). To avoid risks for infection, a contraceptive sponge formulation should not be left in place in the vagina beyond the labeled duration of use per each device.
In general, there are no absolute contraindications to the use of nonoxynol-9 spermicides. Allergic reactions are rare. There may be cross-sensitivity with other spermicides (e.g., octoxynol) due to chemical similarities. If contact irritation or allergy occurs in the user or the sexual partner, discontinue use.
The use of nonoxynol-9 products does not confer protection against the transmission of sexually transmitted disease (STD), including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). Use of these products may increase the risk of getting HIV from an infected partner. If the patient or their partner(s) are HIV infected or has AIDs, or it is not known if they or their sex partner(s) are infected with HIV, it is advisable to have them choose another form of contraception. Advise patients to use a latex condom without nonoxynol-9 if they or their sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors. The use of female or male condoms are encouraged to help reduce the potential for STD transmission, including reducing the risk for HIV transmission.
There is a risk of infection (i.e., toxic-shock syndrome, TSS) in the users of the spermicidal contraceptive foam sponge; risk is increased in persons who keep the contraceptive sponge in place intravaginally beyond the recommended duration of use.
The use of nonoxynol-9, or other nonprescription spermicides, does not appear to cause harmful fetal effects from unintentional exposure during early pregnancy. After several epidemiologic studies, there is not increased risk of spontaneous abortion or birth defects from the use of spermicidal products.
Use of vaginal spermicides, including nonoxynol-9, in appropriately selected patents is generally considered compatible with breast-feeding in expert guidelines for contraception. No adverse effects have been reported in breastfed infants or on lactation during clinical use. It is not known if vaginal spermicides pass into breast milk in humans. However, rat studies indicated low excretion in milk at approximately 0.3% of an intravaginal dosage.
For contraception:
Vaginal dosage (gel, 4%):
Adults: 1 applicator of gel PV just prior to intercourse. Each applicatorful is effective immediately and up to 1 hour after application. Insert an additional applicatorful prior to each act of intercourse, regardless of time since last application.
Vaginal dosage (film, soluble 28%):
Adults: 1 film PV inserted as far as possible into the vagina and against the cervix, not less than 15 minutes and not more than 3 hours before intercourse. Insert an additional film prior to each act of intercourse, regardless of time since last application.
Vaginal dosage (vaginal contraceptive sponge, e.g., Today sponge):
Adults: Insert 1 sponge PV after activation as directed, against the cervix, not longer than 24 hours prior to intercourse. Regardless of number of acts of intercourse, activity is maintained for up to 24 hours. Leave in place for 6 hours after the last act, but do not leave in place past 30 hours of use. Do not reuse sponge after removal; a new sponge should be inserted.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available; use as directed for the specific product chosen.
-Geriatric
No maximum dosage information is available; use as directed for the specific product chosen.
-Adolescents
No maximum dosage information is available; use as directed for the specific product chosen.
-Children
Safety and efficacy have not established before menarche and not indicated for children prior to puberty.
-Infants
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments required.
Patients with Renal Impairment Dosing
No dosage adjustments required.
*non-FDA-approved indication
There are no drug interactions associated with Nonoxynol-9 products.
Nonoxynol-9 interacts causes lysis of the cell membrane causing a rapid loss of function and motility of the spermatozoa, and resulting in sperm death. In addition, the inactive vehicle in some product formulations may act as a mechanical barrier by inhibiting the passage of sperm to the cervical os. When used by itself, a spermicide is considered one of the least effective methods of contraception, and results in an estimated 28 pregnancies per 100 women in a year. Clinical results from controlled studies have demonstrated that nonoxynol 9 is not an effective vaginal microbicide, and it does not protect against the transmission of any sexually transmitted disease. A Phase III efficacy trial reported that nonoxynol-9 enhanced the likelihood of HIV-1 transmission and that there was an increased risk in women who administered the gel more than 3.5 times/day.
Nonoxynol-9 is administered intravaginally. Direct human data for nonoxynol-9 (N-9) absorption via the vaginal wall and other pharmacokinetic characteristics are not available. Animal studies have shown that radiolabeled N-9 is rapidly and extensively absorbed into the systemic circulation from the vaginal mucosa of rats and rabbits. The rate of absorption was dependent upon the vehicle used in the formulation. Once in the systemic circulation, N-9 was efficiently removed by the liver and by the kidney. Most of the intravaginally administered aqueous N-9 is excreted within 3 to 4 days. There were no definitive data regarding the metabolism of N-9, but the researchers noted that other studies have indicated that a small amount of radioactivity (1.2%) is exhaled via the lungs as CO2 within 7 days. The excretion pattern of N-9 showed differences between species in the animal studies. In the rabbit, the major excretory pathway was via the kidney while in the rat it was in the feces. Excretion into the milk of lactating rats, at approximately 0.3% of an intravaginally administered dose, was noted. The applicability of these findings to humans is not completely certain.