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Nonoxynol-9: Drug information

Nonoxynol-9: Drug information
(For additional information see "Nonoxynol-9: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Options Conceptrol [OTC] [DSC];
  • Options Gynol II Contraceptive [OTC];
  • Today Sponge [OTC];
  • VCF Vaginal Contraceptive [OTC]
Pharmacologic Category
  • Contraceptive;
  • Spermicide
Dosing: Adult
Contraception

Contraception: Note: If repeated intercourse takes place, additional application may be necessary. Prior to use, refer to specific product labeling for complete instructions.

Options Gynol II gel 3%: Intravaginal: Insert 1 applicatorful (150 mg) vaginally immediately prior to intercourse; effective for 1 hour. If used with a diaphragm, apply 1 applicatorful (~1 teaspoonful) of gel onto dome of diaphragm and spread around the edge using fingertip prior to inserting. If intercourse occurs >6 hours after insertion, or if repeated intercourse occurs, additional application of gel is needed. Do not remove diaphragm to reapply; use applicator to apply gel, taking care not to dislodge the diaphragm.

Today Sponge: Intravaginal: Insert 1 sponge (1 g) vaginally prior to intercourse; allow to remain in place for 6 hours after intercourse before removing; effective for use up to 24 continuous hours. Do not leave in place for >30 hours.

VCF:

Film 28%: Intravaginal: Insert 1 film vaginally at least 15 minutes, but no more than 3 hours, prior to intercourse. Insert new film for each act of intercourse or if >3 hours have elapsed.

Gel 4%: Intravaginal: Insert 1 applicatorful vaginally immediately prior to intercourse; effective for 1 hour. If repeated intercourse occurs, additional application of gel is needed regardless of time since last application.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Barrier contraceptives may not be appropriate for use in patients in which the risk of becoming pregnant is unacceptable due to other health conditions, because of their relatively higher failure rate if not use correctly (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Barrier contraceptives may not be appropriate for use in patients in which the risk of becoming pregnant is unacceptable due to other health conditions, because of their relatively higher failure rate if not use correctly (Ref).

Dosing: Older Adult

For use in patients who may become pregnant; not for use post menopause.

Dosing: Pediatric
Contraception

Contraception: Adolescents: Females: Intravaginal: Refer to adult dosing; not for use prior to menarche.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined: Local: Application-site reaction (including application-site burning, application-site irritation, application-site pruritus, and application-site rash)

Postmarketing: Dermatologic: Allergic contact dermatitis (Fisher 1994)

Contraindications

OTC labeling: When used for self-medication, do not use if you or your sex partner has HIV/AIDS.

Today Sponge only: Do not use if allergic to nonoxynol 9 or any component of the formulation; if allergic to sulfites; within 6 weeks after giving birth; history of toxic shock syndrome; during menstrual period.

Warnings/Precautions

Concerns related to adverse effects:

• Toxic shock syndrome: Has been reported with barrier contraceptive use.

• Vaginal irritation: May cause vaginal irritation (eg, burning, itching or rash); irritation may also be present without symptoms. Irritation may be associated with an increased risk of getting HIV from an infected partner. Nonoxynol-9 may adversely affect lactobacillus disrupting the vaginal lining, leading to sloughing that may cause ulceration (Bonnington 2020).

Dosage form specific issues:

• Today Sponge: Prior to use, patients should consult healthcare provider following recent miscarriage or abortion, or with vaginal or uterine conditions which may make the product ineffective (eg, vaginal septum, uterine prolapse) or if told to not become pregnant.

Other warnings/precautions:

• Appropriate use: Patients should consult with health care provider concerning the best form of birth control. For use in persons with only 1 partner and when neither partner is infected with HIV or has HIV risk factors; most products may be used with or without a diaphragm or condom. The CDC does not recommend the use of condoms lubricated with spermicides due to their association with urinary tract infections in young females. In addition, condoms with nonoxynol-9 are no more effective than condoms without nonoxynol-9 in preventing HIV or sexually transmitted infection (CDC [Workowski 2021]). Use is not recommended for patients with recurrent or chronic bacterial vaginosis (Bonnington 2020)

• HIV infection protection: Nonoxynol 9 does not protect against HIV infection or other sexually transmitted diseases and use may increase the risk of getting HIV from an infected sex partner. Not for use in persons with HIV or those who have a sexual partner with HIV; another form of birth control should be used. Proper use of a latex condom will help reduce the risk of infection from HIV. If HIV status is unknown, a different form of birth control should be used.

• Rectal use: Not for use as a microbicide or lubricant during anal intercourse. Rectal use may cause irritation, which may increase the risk of getting HIV from an infected sexual partner.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Film, Vaginal:

VCF Vaginal Contraceptive: 28% (9 ea) [contains glycerin, polyvinyl alcohol]

Gel, Vaginal:

Options Conceptrol: 4% (2.55 g [DSC]) [hormone free; contains methylparaben, propylene glycol]

Options Gynol II Contraceptive: 3% (81 g) [hormone free; contains methylparaben, propylene glycol]

VCF Vaginal Contraceptive: 4% (2.55 g) [hormone free; contains edetate (edta) trisodium, methylparaben, propylene glycol, sodium benzoate]

Miscellaneous, Vaginal:

Today Sponge: 1000 mg (3 ea) [contains benzoic acid, sodium metabisulfite]

Generic Equivalent Available: US

No

Pricing: US

Film (VCF Vaginal Contraceptive Vaginal)

28% (per each): $1.73

Gel (Options Gynol II Contraceptive Vaginal)

3% (per gram): $3.33

Gel (VCF Vaginal Contraceptive Vaginal)

4% (per gram): $0.61

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Intravaginal: For vaginal use only; not for rectal use. Note: If repeated intercourse takes place, additional application may be necessary. Prior to use, refer to specific product labeling for complete instructions.

Options Gynol II gel 3%: Insert using diaphragm or enclosed applicator; see product labeling for details.

Today Sponge: Prior to use, wet sponge with clean water and squeeze gently until sudsy in order to activate spermicide. Fold sponge in half with dimple side inside and string loop on bottom end, then insert into vagina. May be inserted up to 24 hours prior to intercourse. Sponge should not be reinserted if it accidentally falls out (insert new sponge). Do not reuse sponge.

VCF film: Fingers should be dry before touching film. Remove film from pouch and fold in half; insert vaginally using finger. Place as far in vagina as possible against the cervix.

VCF gel: Insert applicatorful vaginally immediately prior to intercourse.

Administration: Pediatric

Intravaginal: For vaginal use only; not for rectal use. Note: If repeated intercourse takes place, additional application may be necessary. Prior to use, refer to specific product labeling for complete instructions.

Options Gynol II gel 3%: Insert using diaphragm or enclosed applicator; see product labeling for details.

Today Sponge: Prior to use, wet sponge with clean water and squeeze gently until sudsy in order to activate spermicide. Fold sponge in half with dimple side inside and string loop on bottom end, then insert into vagina. May be inserted up to 24 hours prior to intercourse. Sponge should not be reinserted if it accidentally falls out (insert new sponge). Wait at least 6 hours after last intercourse before removing sponge. Do not leave sponge inserted >30 hours; increases risk of vaginal irritation and serious infection. Do not reuse sponge.

VCF:

Film: Fingers should be dry before touching film. Remove film from pouch and fold in half; insert vaginally using finger. Place as far in vagina as possible against the cervix.

Gel: Insert applicatorful vaginally immediately prior to intercourse.

Use: Labeled Indications

Contraception: Prevention of pregnancy

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Rates for unintended pregnancies associated with use are highly variable and may be influenced by the behavior of users, personal characteristics, or dose of nonoxynol-9 (products with higher strengths may be more effective) (Grimes 2013; Raymond 2004). The percentage of unintended pregnancies following use of these products is generally higher than with other methods of contraception; many can be used with a diaphragm and/or external (male) condom. Consistent and correct use of the external (male) latex condom is recommended to reduce the risk for sexually transmitted disease and HIV transmission and provides an additional method of contraception. Barrier contraceptives may not be appropriate for use in patients in which the risk of becoming pregnant is unacceptable due to other health conditions, because of their relatively higher failure rate if not used correctly (CDC [Curtis 2016]).

Pregnancy Considerations

Use of spermicides has not been associated with birth defects (FDA 1986).

Mechanism of Action

Nonoxynol 9 is a nonionic surfactant which prevents pregnancy by damaging the cell membrane of sperm; some product formulations may also provide a physical barrier

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Gynol;
  • (BR) Brazil: Preserv nonoxinol-9;
  • (CN) China: Advantage L. A.;
  • (DE) Germany: Patentex;
  • (EE) Estonia: C-film lucchini;
  • (GB) United Kingdom: Duragel | Gynol ii | Staycept | Today;
  • (IE) Ireland: Duragel | Gygel | Ortho gynol 11;
  • (JP) Japan: C c c;
  • (NZ) New Zealand: Gynol 11 | Nonoxynol;
  • (PR) Puerto Rico: Advantage-s;
  • (SE) Sweden: Gynol plus;
  • (ZA) South Africa: Delfen
  1. Bonnington A, Dianat S, Kerns J, et al. Society of Family Planning clinical recommendations: contraceptive counseling for transgender and gender diverse people who were female sex assigned at birth. Contraception. 2020;102(2):70-82. doi:10.1016/j.contraception.2020.04.001 [PubMed 32304766]
  2. Curtis KM, Tepper NK, Jatlaoui TC, et al. US medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep. 2016;65(3):1‐103. doi: 10.15585/mmwr.rr6503a1. [PubMed 27467196]
  3. "Data Do Not Support Association Between Spermicides, Birth Defects," FDA Drug Bull, 1986, 16(2):21. [PubMed 3817349]
  4. Fisher AA. Allergic contact dermatitis to nonoxynol-9 in a condom. Cutis. 1994;53(3):110-111. [PubMed 8187536]
  5. Food and Drug Administration, US Department of Health and Human Services. Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule. Fed Regist. 2007;72(243):71769-71785. [PubMed 18159651]
  6. Gynol II (nonoxynol 9) [prescribing information]. Madison, NJ: Revive Personal Products Company; received April 2021.
  7. Grimes DA, Lopez LM, Raymond EG, Halpern V, Nanda K, Schulz KF. Spermicide used alone for contraception. Cochrane Database Syst Rev. 2013;(12):CD005218. doi:10.1002/14651858.CD005218.pub4 [PubMed 24307556]
  8. Options Gynol II (nonoxynol 9) [prescribing information]. Madison, NJ: Revive Personal Products Company; 2013.
  9. Raymond EG, Chen PL, Luoto J; Spermicide Trial Group. Contraceptive effectiveness and safety of five nonoxynol-9 spermicides: a randomized trial. Obstet Gynecol. 2004;103(3):430-439. [PubMed 14990402]
  10. Today Sponge (nonoxynol 9) [prescribing information]. Berkeley, CA: Mayer Laboratories Inc; received April 2021.
  11. VCF Vaginal Contraceptive (nonoxynol 9) [prescribing information]. Ronkonkoma, NY: Apothecus Pharmaceutical Corp; received April 2021.
  12. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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