Lactic Acid-Citric acid-Potassium Bitartrate Vaginal

Lactic Acid-Citric acid-Potassium Bitartrate Vaginal is a combination medication indicated  for the prevention of pregnancy in females of reproductive potential for use as an on-demand contraceptive method.

• Lactic Acid-Citric acid-Potassium Bitartrate Vaginal is available under the following different brand names: Phexxi

Common side effects of Lactic Acid-Citric acid-Potassium Bitartrate Vaginal include:

• vulvovaginal burning sensation
• vulvovaginal itching
• vulvovaginal yeast infection
• urinary tract infection (UTI) 
• vulvovaginal discomfort
• bacterial vaginosis
• vaginal discharge
• genital discomfort
• pain or discomfort when urinating
• vulvovaginal pain

Serious side effects of Lactic Acid-Citric acid-Potassium Bitartrate Vaginal include:

• cystitis
• pyelonephritis
• urinary tract infection

Rare side effects of Lactic Acid-Citric acid-Potassium Bitartrate Vaginal include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Gel, vaginal

• 18 mg/10 mg/4 mg per gram
• 5 g/prefilled single-dose vaginal applicator

Contraception

Adult dosage

• Apply 1 prefilled applicator (5 grams) vaginally immediately before or up to 1 hr before each act of vaginal intercourse
• If more than1 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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Lactic Acid-Citric acid-Potassium Bitartrate Vaginal has severe interactions with no other drugs
• Lactic Acid-Citric acid-Potassium Bitartrate Vaginal has serious interactions with no other drugs
• Lactic Acid-Citric acid-Potassium Bitartrate Vaginal has moderate interactions with no other drugs
• Lactic Acid-Citric acid-Potassium Bitartrate Vaginal has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lactic Acid-Citric acid-Potassium Bitartrate Vaginal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lactic Acid-Citric acid-Potassium Bitartrate Vaginal?”

Cautions

Discontinue if hypersensitivity reactions develop

• Cystitis and pyelonephritis
• Cystitis, pyelonephritis, or other upper UTI may occur
• Avoid the use of Lactic Acid-Citric acid-Potassium Bitartrate Vaginal in females of reproductive potential with a history of recurrent UTI or urinary tract abnormalities

Pregnancy and Lactation

• 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.