FEM Ph Gel 50gm
It is used to treat certain vaginal problems.
Drug Class
Vaginal antiseptic, acidifier
Pharmacologic Class
Antiseptic (Oxyquinoline), Acidifier (Acetic Acid)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
FEM Ph Gel is a vaginal gel containing acetic acid and oxyquinoline. It helps restore the natural acidic balance of the vagina and acts as an antiseptic to fight off certain germs that can cause vaginal discomfort, odor, or discharge.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Use the applicator provided to insert the medication into your vagina. After use, wash the applicator and replace the cap.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.
This medication is for vaginal use only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Use the applicator provided to insert the medication into your vagina. After use, wash the applicator and replace the cap.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Use as directed by your healthcare provider or package instructions.
- Wash hands thoroughly before and after application.
- Insert the gel deep into the vagina, preferably at bedtime.
- Avoid douching or using other vaginal products unless advised by your doctor.
- Wear a panty liner to protect clothing from leakage.
- Continue treatment for the full prescribed duration, even if symptoms improve.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply 1 applicatorful (approx. 5g) vaginally, usually once or twice daily, or as directed by a healthcare professional.
Condition-Specific Dosing:
vaginitis:
Typically once daily at bedtime for 7-14 days, or as prescribed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (use in post-menarcheal adolescents should be under medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Acetic acid lowers the vaginal pH, creating an acidic environment unfavorable for the growth of many pathogenic bacteria and fungi, while promoting the growth of beneficial lactobacilli. Oxyquinoline acts as a broad-spectrum antiseptic by denaturing proteins and disrupting microbial cell membranes, inhibiting the growth of bacteria and fungi.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption for both active ingredients when applied topically to the vagina.
Tmax:
Not clinically significant for topical application.
FoodEffect:
Not applicable for topical vaginal gel.
Distribution:
Vd:
Not clinically significant for topical application.
ProteinBinding:
Not clinically significant for topical application.
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not clinically significant for topical application.
Clearance:
Not clinically significant for topical application.
ExcretionRoute:
Primarily local elimination/wash-off.
Unchanged:
Not clinically significant for topical application.
Pharmacodynamics
OnsetOfAction:
Local effect is immediate upon application.
PeakEffect:
Local effect sustained as long as the gel is present.
DurationOfAction:
Several hours, until the gel is absorbed or expelled.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for guidance:
Burning or stinging
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for guidance:
Burning or stinging
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased vaginal irritation, burning, or itching after application.
- Development of a rash or hives.
- No improvement in symptoms after several days of use.
- Worsening of vaginal discharge or odor.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor. This conversation will help you and your doctor weigh the benefits and risks of taking this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely with topical vaginal application due to minimal absorption.
- Local symptoms might include severe irritation, burning, or discomfort.
What to Do:
Discontinue use immediately. Wash the affected area with water. If irritation persists or is severe, seek medical attention. For accidental ingestion, call a Poison Control Center (1-800-222-1222) or emergency services.
Drug Interactions
Monitoring
Routine Monitoring
Resolution of vaginal symptoms (e.g., discharge, odor, itching)
Frequency: Daily during treatment
Target: Symptom improvement/resolution
Action Threshold: Lack of improvement or worsening of symptoms after several days of use; onset of new or severe irritation.
Local irritation or allergic reaction (e.g., burning, itching, redness)
Frequency: Daily during treatment
Target: Absence of irritation
Action Threshold: Any significant or persistent irritation; discontinue use and consult healthcare provider.
Symptom Monitoring
- Vaginal discharge characteristics (color, consistency, odor)
- Vaginal itching or irritation
- Vaginal burning or discomfort
- Redness or swelling of vulvovaginal area
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if clearly needed and after consulting a healthcare provider. While systemic absorption is minimal, limited data exist for the combination. Acetic acid is generally considered safe. Oxyquinoline's safety in pregnancy is less established, leading to a Category C classification.
Trimester-Specific Risks:
First Trimester:
Potential risk cannot be ruled out; use with caution.
Second Trimester:
Potential risk cannot be ruled out; use with caution.
Third Trimester:
Potential risk cannot be ruled out; use with caution.
Lactation
Considered low risk during lactation due to minimal systemic absorption. It is unlikely to be excreted in breast milk in clinically significant amounts.
Infant Risk:
Low risk of adverse effects to the breastfed infant.
Pediatric Use
Not recommended for use in pre-menarcheal children. Use in post-menarcheal adolescents should be under medical supervision.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Use with caution if there is significant vaginal atrophy or thinning of the vaginal mucosa, which might increase local irritation.
Clinical Information
Clinical Pearls
- This product is often used to help restore normal vaginal pH after menstruation, intercourse, or antibiotic use, which can disrupt the natural balance.
- It can be helpful for non-specific vaginitis or to alleviate symptoms like odor and discharge associated with pH imbalance.
- Patients should be advised that this product is not a cure for sexually transmitted infections (STIs) or severe vaginal infections requiring specific antimicrobial treatment.
- Advise patients to avoid using tampons during treatment to ensure optimal contact of the gel with the vaginal mucosa.
Alternative Therapies
- Metronidazole (for bacterial vaginosis)
- Clotrimazole or Miconazole (for candidiasis)
- Topical estrogen (for atrophic vaginitis)
- Probiotic vaginal suppositories (for restoring flora)
Cost & Coverage
Average Cost:
Not available per 50gm tube
Generic Available:
Yes
Insurance Coverage:
Often Over-The-Counter (OTC), may not be covered by insurance unless prescribed.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.