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

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            Regulates vaginal pH within the normal range of 3.5-4.5, even in the presence of semen, which normally raises the vaginal pH to 7-8

            Maintains an acidic environment that is inhospitable to sperm, as well as certain viral and bacterial pathogens associated with sexually transmitted infections, but is integral to the survival of healthy bacteria in the vagina

            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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            Formulary

            FormularyPatient Discounts

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            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.
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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.