FDA approved a new vaginal gel for the prevention of pregnancy in women

 FDA Approved New Vaginal Gel for the Prevention of Pregnancy in Women
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 FDA Approved New Vaginal Gel for the Prevention of Pregnancy in Women

U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm.

How well does PHEXXI work?

Your chance of getting pregnant depends on how well you follow the directions for using PHEXXI. The better you follow the directions, the less chance you have of getting pregnant. It is very important that you follow the directions carefully each time you have vaginal sex. PHEXXI does not protect against HIV infection or other sexually transmitted infections (STIs)

Indication and Uses:- 

PHEXXI 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.

Limitations of Use: PHEXXI is not effective for the prevention of pregnancy when administered after intercourse.

Dosage and Administration 

• Administer one (1) pre-filled single-dose applicator of PHEXXI (5 grams) vaginally immediately before (or up to one hour before) each episode of vaginal intercourse.
• May use during any part of the menstrual cycle.

Dosage forms and Strengths 

Each pre-filled single-dose vaginal applicator delivers 5 grams of gel containing lactic acid (1.8%), citric acid (1%), and potassium bitartrate (0.4%).

Warning and Precautions 

• Cystitis and Pyelonephritis: Avoid use in women with a history of recurrent UTI or urinary tract abnormalities

Adverse Effects 

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.

For more detail visit: https://go.usa.gov/xw326

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