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Phexxi Gel
  • Professionals
  • FDA PI

Phexxi Gel

Generic name: lactic acid, citric acid, and potassium bitartrate
Drug class:Miscellaneous vaginal agents

Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.

Indications and Usage for Phexxi Gel

PHEXXI is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Limitations of Use

PHEXXI is not effective for the prevention of pregnancy when administered after intercourse [see Dosage and Administration (2.1)].

Phexxi Gel Dosage and Administration

Recommended Dosage

Administer one pre-filled applicator of PHEXXI (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 PHEXXI contains 90 mg of lactic acid, 50 mg of citric acid, and 20 mg of potassium bitartrate.

Timing of PHEXXI Use

May use PHEXXI during any part of the menstrual cycle. May use PHEXXI as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage.

Use of PHEXXI with Other Contraceptive Methods

PHEXXI may be used concomitantly with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid PHEXXI use with vaginal rings.

Use of PHEXXI with Other Vaginal Products

PHEXXI may be used concomitantly with other products for vaginal infections including miconazole, metronidazole, and tioconazole.

Dosage Forms and Strengths

Vaginal gel: 18 mg of lactic acid, 10 mg of citric acid, and 4 mg of potassium bitartrate in each gram (1.8%, 1%, and 0.4%, respectively) of off-white to tan color gel supplied in a pre-filled single-dose (5 grams) vaginal applicator

Warnings and Precautions

Cystitis and Pyelonephritis

Among 2804 subjects who received PHEXXI in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or oth...