lactic acid/citric acid/potassium bitartrate
lak-tik as-id/sit-rik as-id/poe-tas-ee-um bye-tar-trate
Rep: Prevention of pregnancy in women of reproductive potential as an on-demand form of contraception.
Lowers the pH in the vagina which subsequently reduces sperm motility.
Prevention of pregnancy.
Absorption: Systemic absorption not expected following vaginal administration.
Distribution: Systemic absorption not expected following vaginal administration.
Metabolism and Excretion: Unknown.
- OB: Pregnancy;
- Rep: History of recurrent UTI or urinary tract abnormalities.
Use Cautiously in:
Lactation: Safety not established in breast feeding.
Adverse Reactions/Side Effects
GU: vulvovaginal burning, vulvovaginal pruritus, bacterial vaginosis, cystitis, dysuria, genital discomfort, pyelonephritis, urinary tract infection, vagina discharge, vulvovaginal candidiasis, vulvovaginal pain
Misc: hypersensitivity reactions
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
Avoid use with vaginal rings.
Vag (Adults and Children [females of reproductive potential]): One prefilled applicator (5 g) immediately before or up to 1 hr before each act of vaginal intercourse. If ≥1 act of vaginal intercourse occurs within 1 hr, must insert another prefilled applicator.
Vaginal gel: lactic acid 90 mg/citric acid 50 mg/potassium bitartrate 20 mg in each 5–g prefilled applicator
- Assess patient for history of recurrent urinary tract infections or urinary tract abnormalities. May cause cystitis and pyelonephritis.
- Vag Administer one pre-filled applicator vaginally immediately before or up to 1 hr before each act of vaginal intercourse. If >1 act of vaginal intercourse occurs within 1 hr, apply an additional dose.
- Instruct patient in correct timing and technique for vaginal administration before vaginal sex. May be used during any part of menstrual cycle and as soon as it is safe to resume vaginal intercourse after childbirth, abortion, or miscarriage. Advise patient to read Patient Information before starting and with each Rx refill in case of changes.
- Advise patient that Phexxi is not effective at preventing pregnancy when used after vaginal sex.
- Inform patient that Phexxi may be used with hormonal contraceptives; latex, polyurethane, and polyisoprene condoms; and vaginal diaphragms. Avoid use with vaginal rings. May also be used concomitantly with other products for vaginal infections (miconazole, metronidazole, tioconazole).
- Advise patient to notify health care professional if severe or prolonged genital irritation or symptoms of urinary tract infection (burning feeling when passing urine, cloudy urine, pain in the pelvis, back pain) occur. May also cause burning, itching, and pain in male partner.
- Inform patient that Phexxi does not protect against HIV or other sexually transmitted infections.
- Advise parents to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breast feeding. There is no use for Phexxi in pregnancy; discontinue use.
Prevention of pregnancy.