lactic acid/citric acid/potassium bitartrate vaginal (Rx)

Brand and Other Names:Phexxi
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lactic acid/citric acid/potassium bitartrate vaginal

gel, vaginal

  • 18mg/10mg/4mg per gram
  • 5g/prefilled single-dose vaginal applicator

Contraception

Indicated for prevention of pregnancy in females of reproductive potential for use as an on-demand contraceptive method

Apply 1 prefilled applicator (5 grams) vaginally immediately before or up to 1 hr before each act of vaginal intercourse

If >1 act of vaginal intercourse occurs within 1 hr, an additional dose must be applied

5 grams contains 90 mg of lactic acid, 50 mg of citric acid, and 20 mg of potassium bitartrate

Dosing Considerations

Concomitant use with other contraceptive methods

  • May be used concomitantly with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms
  • Avoid use with vaginal rings

Concomitant use with other vaginal products

  • May be used concomitantly with other products for vaginal infections, including miconazole, metronidazole, and tioconazole

Limitations of use

  • Not effective for prevention of pregnancy when administered after intercourse

Safety and efficacy not established

Similar efficacy is expected for postmenarchal females aged <17 years as for users >17 years

Use before menarche is not indicated

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Interactions

Interaction Checker

and lactic acid/citric acid/potassium bitartrate vaginal

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (0)

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                  Minor (0)

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                    Adverse Effects

                    >10%

                    • Vulvovaginal burning sensation (18%)
                    • Vulvovaginal pruritus (14.5%)

                    1-10%

                    • Local discomfort in male partners (9.8%)
                    • Vulvovaginal mycotic infection (9.1%)
                    • Urinary tract infection (UTI) (9%)
                    • Vulvovaginal discomfort (9%)
                    • Bacterial vaginosis (8.4%)
                    • Vaginal discharge (5.5%)
                    • Genital discomfort (4.1%)
                    • Dysuria (3.1%)
                    • Vulvovaginal pain (2.1%)
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                    Warnings

                    Contraindications

                    None

                    Cautions

                    Discontinue if hypersensitivity reactions develops

                    Cystitis and pyelonephritis

                    • Cystitis, pyelonephritis, or other upper UTI may occur
                    • Avoid use of in females of reproductive potential with a history of recurrent UTI or urinary tract abnormalities
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                    Pregnancy & Lactation

                    Pregnancy

                    Do not use during pregnancy

                    Discontinue during pregnancy

                    No data available with the use in pregnant females or animals

                    Lactation

                    No data available on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, or effects on breastfeeding or milk production

                    Pregnancy Categories

                    A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                    B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                    C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                    D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                    X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                    NA: Information not available.

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                    Pharmacology

                    Mechanism of Action

                    Vaginal pH range is 3.5-4.5 and semen pH range is 7.2-8

                    Introduction of semen into the vagina causes increased pH (>6) owing to ejaculate alkalinity; the alkaline pH neutralizes the normally acidic vaginal environment allowing spermatozoa survival

                    Vaginal pH lowering effect of lactic acid/citric acid/potassium bitartrate causes reduced sperm motility and contributes to intravaginal contraceptive activity

                    Pharmacokinetics

                    Pharmacokinetic studies in humans have not been performed

                    Systemic exposures of lactic acid, citric acid, and potassium bitartrate following vaginal administration are not expected to lead to safety concerns

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                    Administration

                    Intravaginal Administration

                    May use during any part of the menstrual cycle

                    May use as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage

                    Storage

                    Store in the original foil pack at room temperature 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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                    Images

                    No images available for this drug.
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

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                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
                    Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                    ST Step Therapy
                    Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                    OR Other Restrictions
                    Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.