Dosing & Uses
Dosage 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 years
Use before menarche is not indicated
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
Adverse Effects
>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%)
Warnings
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 & Lactation
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 production
Pregnancy 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.Pharmacology
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
Administration
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)
Images
Formulary
Adding 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.
Adding 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.
