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Lactic Acid, Citric Acid, and Potassium Bitartrate

Medically reviewed by Drugs.com. Last updated on Aug 31, 2020.

Pronunciation

(LAK tik AS id, SIT rik AS id & poe TAS ee um bye TAR trate)

Index Terms

  • Acidform
  • Amphora
  • Citric Acid, Lactic Acid, and Potassium Bitartrate
  • Citric Acid, Potassium Bitartrate, and Lactic Acid
  • Lactic Acid, Potassium Bitartrate, and Citric Acid
  • Phexxi
  • Potassium Bitartrate, Citric Acid, and Lactic Acid
  • Potassium Bitartrate, Lactic Acid, and Citric Acid

Dosage Forms

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]

Brand Names: U.S.

  • Phexxi

Pharmacologic Category

  • Contraceptive

Pharmacology

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).

Absorption

Not systemically absorbed (Nelson 2018).

Use: Labeled Indications

Contraception: Prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Limitations of use: Not effective for the prevention of pregnancy when administered after intercourse.

Contraindications

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

Dosing: Adult

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: Geriatric

For use in women of reproductive potential; not for use in postmenopausal women.

Dosing: Pediatric

Contraception: Postmenarche females: 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.

Administration

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 products for vaginal infections (including miconazole, metronidazole, or tioconazole).

Storage

Store in original foil pack at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Drug Interactions

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

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

Warnings/Precautions

Concerns related to adverse effects:

• Genitourinary effects: Avoid use in females 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.

Special populations:

• Pediatric: Not for use prior to menarche.

• Postmenopausal women: Not indicated for use in postmenopausal women.

Other warnings/precautions:

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

Monitoring Parameters

Local hypersensitivity reactions; signs of urinary tract infection.

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.

Pregnancy Considerations

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

Patient Education

What is this drug used for?

• It is used to prevent pregnancy.

• This drug must be used before you have sex. It will not work if used after you have sex.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Vaginal burning, discomfort, or itching

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Urinary tract infection like blood in your urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain

• Back pain

• Vaginal discharge

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.