Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate
Generic Name: lactic acid, l-, citric acid monohydrate, and potassium bitartrate
Brand Names:
Phexx
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS AND USAGE PHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PHEXX is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. ( 1 ) Limitations of Use: PHEXX is not effective for the prevention of pregnancy when administered after intercourse. Limitations of Use PHEXX is not effective for the prevention of pregnancy when administered after intercourse [ see Dosage and Administration (2.1) ].
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Side Effects
6 ADVERSE REACTIONS 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.
Warnings
5 WARNINGS AND PRECAUTIONS 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.
Pregnancy
8.1 Pregnancy Risk Summary There is no use for PHEXX in pregnancy; therefore, discontinue PHEXX during pregnancy. There are no data with the use of PHEXX in pregnant women or animals. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Storage
Store in the original foil pack at room temperature 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [ see USP Controlled Room Temperature ].
Frequently Asked Questions
What is Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate used for?▼
1 INDICATIONS AND USAGE PHEXX is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. PHEXX is a combination of lactic acid, citric acid, and potassium bitartrate indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. ( 1 ) Limitations of Use: PHEXX is not effective for the prevention of pregnancy when administered after intercourse. Limitations of Use PHEXX is not effective for the prevention of pregnancy when administered after intercourse [ see Dosage and Administration (2.1) ].
What are the side effects of Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate?▼
6 ADVERSE REACTIONS 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.
Can I take Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate during pregnancy?▼
8.1 Pregnancy Risk Summary There is no use for PHEXX in pregnancy; therefore, discontinue PHEXX during pregnancy. There are no data with the use of PHEXX in pregnant women or animals. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
What are the important warnings for Lactic Acid, L-, Citric Acid Monohydrate, And Potassium Bitartrate?▼
5 WARNINGS AND PRECAUTIONS 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.