AdultPediatricDosage 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 yearsUse before menarche is not indicatedInteraction CheckerEnter a drug name and lactic acid/citric acid/potassium bitartrate vaginalNo Results No Interactions Found Interactions FoundContraindicatedSerious - Use AlternativeSignificant - Monitor CloselyMinorAll Interactions Sort By: SeverityName Contraindicated (0)Serious - Use Alternative (0)Monitor Closely (0)Minor (0) >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%) 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 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 productionPregnancy 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. Mechanism of Action Vaginal pH range is 3.5-4.5 and semen pH range is 7.2-8 Introduction of semen into the vagina causes increased pH (>6) owing to ejaculate alkalinity; the alkaline pH neutralizes the normally acidic vaginal environment allowing spermatozoa survival Vaginal pH lowering effect of lactic acid/citric acid/potassium bitartrate causes reduced sperm motility and contributes to intravaginal contraceptive activity 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 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) No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. 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