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Lactic acid, citric acid, and potassium bitartrate: Drug information

Lactic acid, citric acid, and potassium bitartrate: Drug information
(For additional information see "Lactic acid, citric acid, and potassium bitartrate: Patient drug information" and see "Lactic acid, citric acid, and potassium bitartrate: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Phexxi
Pharmacologic Category
  • Contraceptive
Dosing: Adult
Contraception

Contraception: Intravaginal: Insert the contents of 1 prefilled applicator vaginally immediately before or up to 1 hour before each act of vaginal intercourse. An additional dose is needed if vaginal intercourse does not occur within 1 hour of insertion. One application is needed for each act of vaginal intercourse; if more than 1 act of vaginal intercourse occurs within 1 hour, additional doses must be applied.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely (not systemically absorbed).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely (not systemically absorbed).

Dosing: Older Adult

For use in patients of reproductive potential; not for use post menopause.

Dosing: Pediatric

(For additional information see "Lactic acid, citric acid, and potassium bitartrate: Pediatric drug information")

Contraception

Contraception: Postmenarche patients: Intravaginal: 1 prefilled applicator (5 g) immediately before or up to 1 hour before each act of vaginal intercourse; repeat dose if vaginal intercourse does not occur within 1 hour of administration; an additional dose is needed if >1 act of vaginal intercourse occurs within 1 hour. Note: Not effective for the prevention of pregnancy when administered after vaginal intercourse.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

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

>10%: Genitourinary: Vulvovaginal burning (18%), vulvovaginal pruritus (15%)

1% to 10%:

Genitourinary: Bacterial vaginosis (8%), dysuria (3%), urinary tract infection (9%), vaginal discharge (6%), vaginal discomfort (9%), vaginal pain (2%), vulvar pain (genital discomfort: 4%), vulvovaginal candidiasis (9%)

Nervous system: Local discomfort (male partners: 10%; burning, itching, pain [mild: 75%, moderate: 20%, severe: 4%])

<1%:

Genitourinary: Cystitis

Hypersensitivity: Hypersensitivity reaction

Renal: Pyelonephritis

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Genitourinary effects: Avoid use in patients with a history of recurrent urinary tract infections (UTIs) or urinary tract abnormalities. Cystitis, upper UTIs, and pyelonephritis (requiring hospitalization in one case) have been reported.

• Vulvovaginal effects: Burning and pruritus may occur; effects are usually mild but may require discontinuation in some cases.

Other warnings/precautions:

• HIV infection protection: Use of this product does not protect against HIV infection or other sexually transmitted diseases.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, Vaginal:

Phexxi: Lactic acid 1.8%, citric acid 1%, and potassium bitartrate 0.4% (5 g) [contains benzoic acid]

Generic Equivalent Available: US

No

Pricing: US

Gel (Phexxi Vaginal)

1.8-1-0.4% (per gram): $6.96

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 administration only. May be used at any time during the menstrual cycle. May be used following childbirth, abortion, or miscarriage once vaginal intercourse is safe to resume. Avoid use with vaginal rings. May be used concomitantly with hormonal contraceptives, condoms (latex, polyurethane, and polyisoprene), and vaginal diaphragms. May be used concomitantly with intravaginal products for vaginal infections (including miconazole, metronidazole, or tioconazole).

Administration: Pediatric

Vaginal: Use within 1 hour prior to vaginal intercourse. Wash hands before using. Remove pink cap prior to use. Hold the prefilled applicator at the grooved area and gently insert prefilled applicator of gel into vagina; press the plunger to release the medication. Discard used prefilled applicators and pink cap after use.

Note: Administer an additional dose if vaginal intercourse does not occur within 1 hour of administration.

Use: Labeled Indications

Contraception: Prevention of pregnancy as an on-demand method of contraception.

Limitations of use: For use in patients who may become pregnant; not for use prior to menarche or post menopause. Not effective for the prevention of pregnancy when administered after intercourse.

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.

Ethinyl Estradiol: May diminish the therapeutic effect of Lactic Acid, Citric Acid, and Potassium Bitartrate. Risk X: Avoid combination

Reproductive Considerations

This product is a nonhormonal contraceptive, intended to prevent pregnancy when used immediately prior to or up to 1 hour prior to vaginal intercourse. It may be used at any time during the menstrual cycle, and after childbirth, abortion, or miscarriage once it is safe to resume vaginal intercourse. It is not effective for contraception after vaginal intercourse.

Avoid use with vaginal rings. May be used concomitantly with hormonal contraceptives, condoms (latex, polyurethane, and polyisoprene), and vaginal diaphragms.

In a premarketing study, the cumulative pregnancy rate was 13.7% (95% CI: 10% to 17.5%) over 7 cycles of typical use.

Male partners may experience local discomfort (eg, burning, itching, pain); symptoms are most commonly mild to moderate in severity.

In general, all available forms of contraception can be considered for patients on gender-affirming testosterone therapy after evaluating patient preferences and medical conditions (Bonnington 2020; Krempasky 2020).

Pregnancy Considerations

This product is intended to prevent pregnancy; it should not be used if pregnancy has been confirmed.

Breastfeeding Considerations

Following vaginal application, lactic acid, citric acid, and potassium bitartrate are not systemically absorbed (Nelson 2018).

Monitoring Parameters

Local hypersensitivity reactions; signs of urinary tract infection.

Mechanism of Action

Following vaginal application, the combination of lactic acid, citric acid, and potassium bitartrate maintains vaginal pH in an acidic range and decreases sperm motility. In addition to providing rapidly reversible contraception, this product has also been evaluated for lubricant and antimicrobial properties (Nelson 2018).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Not systemically absorbed (Nelson 2018).

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

  • (PR) Puerto Rico: Phexxi
  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. Krempasky C, Harris M, Abern L, Grimstad F. Contraception across the transmasculine spectrum. Am J Obstet Gynecol. 2020;222(2):134-143. doi:10.1016/j.ajog.2019.07.043 [PubMed 31394072]
  3. Nelson AL. An overview of properties of Amphora (acidform) contraceptive vaginal gel. Expert Opin Drug Saf. 2018;17(9):935-943. doi:10.1080/14740338.2018.1515197 [PubMed 30136907]
  4. Phexxi (lactic acid, citric acid, and potassium bitartrate) [prescribing information]. San Diego, CA: Evofem Inc; February 2022.
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