phexxi
Phexxi is a combination medicine containing Citric Acid, Lactic Acid, and Potassium Bitartrate.
Citric Acid and Lactic Acid and Potassium Bitartrate · by Evofem Inc
Key facts
- Active ingredient
- Citric Acid and Lactic Acid and Potassium Bitartrate
- Form
- Topical
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Evofem Inc
- FDA application
- NDA208352
What is Phexxi?
From the FDA label:PHEXX (lactic acid, citric acid, and potassium bitartrate) is a vaginal gel. PHEXX is an off-white to tan in color gel of uniform consistency, containing three active ingredients: lactic acid, citric acid, and potassium bitartrate. The structural formula for lactic acid is: Lactic acid is designated chemically as 2-hydroxypropanoic acid with an empirical formula of C 3 H 6 O 3 and a molecular weight of 90.08 g/mol. The structural formula for citric acid is: Citric acid is designated chemically as 2-hydroxypropane-1,2,3-tricarboxylic acid with an empirical formula of C 6 H 8 O 7 and a molecular weight of 192.124 g/mol. The structural formula for potassium bitartrate is: Potassium bitartrate is designated chemically as potassium; (2 R , 3 R )-2,3,4-trihydroxy-4-oxobutanoate with an empirical formula of KC 4 H 5 O 6 and a molecular weight of 188.177 g/mol. Each 5 gram dose is provided in a pre-filled single-dose applicator containing lactic acid USP (1.8% w/w), citric acid USP (1% w/w), and potassium bitartrate USP (0.4% w/w). Inactive ingredients present in the gel are: glycerin, alginic acid, xanthan gum, sodium hydroxide, benzoic acid, and purified water. Chemical Structure Chemical Structure Chemical Structure
How to use
Administer one ( 1 ) pre-filled single-dose applicator of PHEXX (5 grams) vaginally immediately before (or up to one hour before) each episode of vaginal intercourse ( 2.1 ) May use during any part of the menstrual cycle ( 2.2 ) 2.1 Recommended Dosage Administer one pre-filled applicator of PHEXX (5 grams) vaginally immediately before or up to one hour before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, an additional dose must be applied. Five grams of PHEXX contains 90 mg of lactic acid, 50 mg of citric acid, and 20 mg of potassium bitartrate. 2.2 Timing of PHEXX Use May use PHEXX during any part of the menstrual cycle. May use PHEXX as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage. 2.3 Use of PHEXX with Other Contraceptive Methods PHEXX may be used concomitantly with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid PHEXX use with vaginal rings. 2.4 Use of PHEXX with Other Vaginal Products PHEXX may be used concomitantly with other products for vaginal infections including miconazole, metronidazole, and tioconazole.
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [ see Warnings and Precautions (5.1) ] Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PHEXX (pre-filled applicator with 5-gram dose) has been evaluated in two clinical trials (Study 1 and Study 2) in 2804 subjects (over 19,000 cycles of exposure). The racial/ethnic distribution was 66% White, 27% Black or African American, 2% Asian, 1% American Indian or Alaska Native, 0.3% Native Hawaiian or Pacific Islander, and 5% other; 32% of the study population was Hispanic. Study 1 included a one-year extension phase where 342 U.S. subjects were exposed to PHEXX for 13 cycles. Hypersensitivity…
Warnings
Important safety information
Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities ( 5.1 ) 5.1 Cystitis and Pyelonephritis Among 2804 subjects who received PHEXX in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or other upper urinary tract infection (UTI). Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of PHEXX in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities.
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Use copay cards
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Frequently asked questions
- Is there a coupon or discount for Phexxi?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Phexxi. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Phexxi?
- Phexxi is marketed by Evofem Inc. You can see Evofem Inc's full profile, rating, and other products on pharmaranks.
- Is Phexxi a brand-name or generic drug?
- Phexxi is a brand-name product with the active ingredient Citric Acid and Lactic Acid and Potassium Bitartrate.
- Is Phexxi available over the counter?
- No. Phexxi is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Phexxi come in?
- Phexxi is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Phexxi FDA-registered?
- Phexxi is on record with the U.S. FDA under application number NDA208352. You can verify this on its official FDA label.
- Is Phexxi safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Phexxi. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Phexxi?
- Phexxi's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Cystitis and Pyelonephritis [ see Warnings and Precautions (5.1) ] Most common adverse reactions (≥2%) were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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