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Boric acid vaginal suppository: Drug information

Boric acid vaginal suppository: Drug information
(For additional information see "Boric acid vaginal suppository: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • AZO Boric Acid [OTC]
Pharmacologic Category
  • Anti-infective Agent, Vaginal
Dosing: Adult

Note: Use for the treatment of bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis is based on studies utilizing boric acid powder compounded in a gelatin capsule for intravaginal use; commercially available boric acid suppositories have not been evaluated for these indications (Ref).

Bacterial vaginosis, recurrent infection

Bacterial vaginosis, recurrent infection (off-label use):

Note: Treatment is generally not warranted for patients who are asymptomatic (Ref).

Intravaginal: 600 mg once daily at bedtime for 3 to 4 weeks, in combination with or after 7 days of an oral nitroimidazole, followed by suppressive topical antibacterial therapy (Ref).

Candidiasis, vulvovaginal, caused by C. glabrata

Candidiasis, vulvovaginal, caused by C. glabrata (off-label use): Intravaginal: 600 mg once daily at bedtime for 14 days (Ref). Note: Reserve for patients with no other clear cause of symptoms (Ref).

Trichomoniasis, refractory or resistant infection

Trichomoniasis, refractory or resistant infection (off-label use):

Note: For patients with infection refractory to multiple prior regimens (Ref).

Intravaginal: 600 mg twice daily for 28 days in combination with oral tinidazole for 14 days (Ref).

Vaginal pH balance

Vaginal pH balance (OTC labeling): Intravaginal: 1 suppository (600 mg) once daily at bedtime for 7 days; if symptoms persist, may repeat for another week. May be used twice daily if needed.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Postmarketing:

Dermatologic: Erythema of skin (Prutting 1998), skin irritation (sexual partner) (Prutting 1998)

Genitourinary: Vaginal discharge (watery) (Mittelstaedt 2021; Prutting 1998)

Local: Local irritation (Mittelstaedt 2021; Prutting 1998)

Nervous system: Burning sensation (Prutting 1998)

Warnings/Precautions

Other warnings/precautions:

• Appropriate use: Do not take orally; suppositories and compounded capsules are for vaginal use only. Acute toxicity (sometimes fatal) may occur if boric acid is ingested orally (ACOG 2020; Hadrup 2021). Do not use on broken or irritated vaginal mucosa. Discontinue use and contact a health care provider if symptoms persist or worsen or if irritation or burning develop.

Dosage Forms Considerations

Note: Not all available formulations may be represented in Dosage Forms. Additional boric acid suppository products may be available from other manufacturers/suppliers.

Dosage Forms: US

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

Suppository, Vaginal:

AZO Boric Acid: 600 mg (30s)

Administration: Adult

Intravaginal: For intravaginal use only; do not administer orally. Use at bedtime as there may be watery leakage; if used during the day, use with a panty liner.

Use: Labeled Indications

Vaginal pH balance: Balance vaginal pH and control odor.

Use: Off-Label: Adult

Bacterial vaginosis, recurrent infection; Candidiasis, vulvovaginal, caused by Candida glabrata; Trichomoniasis, refractory or resistant infection

Medication Safety Issues
Sound-alike/look-alike issues:

Baricitinib.

Administration issues:

Do not take orally; suppositories and compounded capsules are for vaginal use only. Acute toxicity (sometimes fatal) may occur if boric acid is ingested orally (ACOG 2020; Hadrup 2021).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Reproductive Considerations

Patients should use reliable contraception during treatment with boric acid vaginal suppositories (ACOG 2020).

Pregnancy Considerations

Outcome data following maternal use of boric acid vaginal suppositories during pregnancy are limited (Acs 2006; Heinonen 1977).

Due to limited human data and lack of animal reproduction studies (Mittelstaedt 2021), vaginal boric acid is only recommended for patients who are not pregnant (ACOG 2020). Agents other than boric acid are recommended for the treatment of bacterial vaginosis or vulvovaginal candidiasis in patients who are pregnant (CDC [Workowski 2021]; IDSA [Pappas 2016]).

Breastfeeding Considerations

Boric acid is present in breast milk (Manakova 2008; Wiley 1907).

Boric acid concentrations in breast milk may vary based on route of exposure (Manakova 2008; Wiley 1907).

Mechanism of Action

Boric acid has weak bacteriostatic and fungistatic properties when used vaginally (Prutting 1998).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Oral: ~100%, vaginal: limited (up to 6% in uninfected volunteers) (Mittelstaedt 2021).

Excretion: Renal (Mittelstaedt 2021).

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

  • (QA) Qatar: Greenwood Healthcare Boric Acid
  1. Acs N, Bánhidy F, Puhó E, Czeizel AE. Teratogenic effects of vaginal boric acid treatment during pregnancy. Int J Gynaecol Obstet. 2006;93(1):55-56. doi:10.1016/j.ijgo.2005.12.031 [PubMed 16530197]
  2. American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 215: vaginitis in nonpregnant patients. Obstet Gynecol. 2020;135(1):e1-e17. doi:10.1097/AOG.0000000000003604 [PubMed 31856123]
  3. AZO Boric Acid (boric acid) topical [prescribing information]. Cromwell, CT: I-Health Inc; received January 2022.
  4. Hadrup N, Frederiksen M, Sharma AK. Toxicity of boric acid, borax and other boron containing compounds: a review. Regul Toxicol Pharmacol. 2021;121:104873. doi:10.1016/j.yrtph.2021.104873 [PubMed 33485927]
  5. Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Publishing Sciences Group Inc; 1977.
  6. Manakova E, Hubickova-Heringova L, Novakova L. Drugs during lactation accenting boron exposure. Neuro Endocrinol Lett. 2008;29(5):631-634. [PubMed 18987605]
  7. Mittelstaedt R, Kretz A, Levine M, et al. Data on safety of intravaginal boric acid use in pregnant and nonpregnant women: a narrative review. Sex Transm Dis. 2021;48(12):e241-e247. doi:10.1097/OLQ.0000000000001562 [PubMed 34561373]
  8. Muzny C, Barnes A, Mena L. Symptomatic Trichomonas vaginalis infection in the setting of severe nitroimidazole allergy: successful treatment with boric acid. Sex Health. 2012;9(4):389-391. doi:10.1071/SH11114 [PubMed 22877600]
  9. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62(4):e1-e50. doi:10.1093/cid/civ933 [PubMed 26679628]
  10. Prutting SM, Cerveny JD. Boric acid vaginal suppositories: a brief review. Infect Dis Obstet Gynecol. 1998;6(4):191-194. doi:10.1002/(SICI)1098-0997(1998)6:4<191::AID-IDOG10>3.0.CO;2-6 [PubMed 9812253]
  11. Reichman O, Akins R, Sobel JD. Boric acid addition to suppressive antimicrobial therapy for recurrent bacterial vaginosis. Sex Transm Dis. 2009;36(11):732-734. doi:10.1097/OLQ.0b013e3181b08456 [PubMed 19704395]
  12. Salas A, Hamill MM, Tuddenham S. Nitroimidazole resistance in Trichomonas vaginalis infection: a teachable moment. JAMA Intern Med. 2019;179(2):247-248. doi:10.1001/jamainternmed.2018.7241 [PubMed 30575848]
  13. Sobel JD. Bacterial vaginosis: Initial treatment. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 30, 2022a.
  14. Sobel JD. Candida vulvovaginitis: treatment. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 30, 2022b.
  15. Sobel JD, Chaim W, Nagappan V, Leaman D. Treatment of vaginitis caused by Candida glabrata: use of topical boric acid and flucytosine. Am J Obstet Gynecol. 2003;189(5):1297-1300. doi:10.1067/s0002-9378(03)00726-9 [PubMed 14634557]
  16. Van Slyke KK, Michel VP, Rein MF. Treatment of vulvovaginal candidiasis with boric acid powder. Am J Obstet Gynecol. 1981;141(2):145-148. doi:10.1016/s0002-9378(16)32581-9 [PubMed 7282789]
  17. Wiley HW. The excretion of boric acid from the human body. J Biol Chem. 1907;3:11-19. http://www.jbc.org/content/3/1/11.full.pdf.
  18. 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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