Metronidazole 0.75% Vaginal Gel 70g
It is used to treat vaginal infections. If this drug has been given for some other reason, talk with the doctor for more information.
Drug Class
Anti-infective
Pharmacologic Class
Nitroimidazole antibiotic
Pregnancy Category
Category B
FDA Approved
Feb 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Metronidazole vaginal gel is an antibiotic medication used to treat bacterial vaginosis, a common vaginal infection caused by an overgrowth of certain bacteria. It works by stopping the growth of these bacteria.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the medication. Continue using the medication as directed, even if your symptoms improve.
Important Administration Instructions
Do not take this medication by mouth. It is for vaginal use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
* Some products are designed to be used at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best time to use your specific product.
Duration of Use
Do not use this medication for longer than prescribed, as this can increase the risk of a second infection.
Storage and Disposal
Store the medication at room temperature, protecting it from heat and cold. Do not freeze the medication.
Missed Dose Instructions
If you miss a dose, use 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 correctly, follow your doctor's instructions and read all the information provided. Wash your hands before and after handling the medication. Continue using the medication as directed, even if your symptoms improve.
Important Administration Instructions
Do not take this medication by mouth. It is for vaginal use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
* Some products are designed to be used at bedtime, while others can be used at any time. Consult with your pharmacist to determine the best time to use your specific product.
Duration of Use
Do not use this medication for longer than prescribed, as this can increase the risk of a second infection.
Storage and Disposal
Store the medication at room temperature, protecting it from heat and cold. Do not freeze the medication.
Missed Dose Instructions
If you miss a dose, use 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
- Avoid consuming alcohol during treatment and for at least 3 days after stopping the gel, as it can cause severe nausea, vomiting, flushing, and headache (disulfiram-like reaction).
- Avoid sexual intercourse during treatment to allow the infection to clear and prevent re-infection.
- Complete the entire course of medication, even if symptoms improve, to prevent the infection from returning.
- Do not douche or use other vaginal products during treatment unless directed by your doctor.
Available Forms & Alternatives
Available Strengths:
- Metronidazole 0.75% Topical Crm 45g
- Metronidazole 250mg Tablets
- Metronidazole 0.75% Topical Lotion
- Metron/nacl 500mg Pb Inj, 100ml
- Metronidazole 0.75% Vaginal Gel 70g
- Metronidazole 500mg Tablets
- Metronidazole 0.75% Topical Crm 45g
- Metronidazole 0.75% Topical Gel 45g
- Metronidazole 375mg Capsules
- Metronidazole 500mg Tablets
- Metronidazole 250mg Tablets
- Metronidazole 1% Topical Gel Pump
- Metronidazole 1% Topical Gel Tube
- Metronidazole 500mg/100ml Inj,100ml
- Metronidazole 0.75% Vaginal Gel 70g
Dosing & Administration
Adult Dosing
Standard Dose:
One applicator full (5g containing 37.5mg metronidazole) intravaginally once daily at bedtime for 5 days.
Dose Range:
37.5 - 37.5 mg
Condition-Specific Dosing:
bacterialVaginosis:
One applicator full (5g containing 37.5mg metronidazole) intravaginally once daily at bedtime for 5 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment necessary due to minimal systemic absorption.
Moderate:
No adjustment necessary due to minimal systemic absorption.
Severe:
No adjustment necessary due to minimal systemic absorption.
Dialysis:
No specific considerations for vaginal gel due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment necessary due to minimal systemic absorption.
Moderate:
No adjustment necessary due to minimal systemic absorption.
Severe:
No adjustment necessary due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Metronidazole is a nitroimidazole that enters the bacterial cell, where its nitro group is reduced by electron transport proteins. This reduction forms reactive cytotoxic compounds that bind to DNA, proteins, and membranes, leading to cell death. It is active against anaerobic bacteria and certain protozoa.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 5% of the absorbed dose of oral metronidazole (systemic exposure)
Tmax:
6-12 hours (vaginal application)
FoodEffect:
Not applicable for vaginal gel.
Distribution:
Vd:
Not specifically quantified for vaginal gel due to low systemic absorption (systemic Vd is 0.51-1.1 L/kg)
ProteinBinding:
<20%
CnssPenetration:
Limited (due to low systemic absorption from vaginal route)
Elimination:
HalfLife:
6-11 hours (systemic, if absorbed)
Clearance:
Not specifically quantified for vaginal gel (systemic clearance is 10 mL/min/kg)
ExcretionRoute:
Renal (60-80% of absorbed dose), Fecal (6-15% of absorbed dose)
Unchanged:
Approximately 20% (of absorbed dose) in urine
Pharmacodynamics
OnsetOfAction:
Within 24-48 hours (symptomatic relief)
PeakEffect:
Within 2-3 days of treatment initiation
DurationOfAction:
Duration of treatment is 5 days; effects persist after completion.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Irritation at the site where the medication was applied
Nervous system problems, including:
+ Burning, numbness, or tingling sensations that are not normal
+ Changes in balance or eyesight
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mood changes, such as:
+ Confusion
+ Depression
+ Irritability
+ Fatigue
+ Weakness
Vaginal discharge
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 symptoms that bother you or do not go away, contact your doctor:
Headache
* Stomach pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
Irritation at the site where the medication was applied
Nervous system problems, including:
+ Burning, numbness, or tingling sensations that are not normal
+ Changes in balance or eyesight
+ Dizziness or fainting
+ Headache
+ Insomnia
+ Seizures
+ Speech difficulties
Mood changes, such as:
+ Confusion
+ Depression
+ Irritability
+ Fatigue
+ Weakness
Vaginal discharge
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 symptoms that bother you or do not go away, contact your doctor:
Headache
* Stomach pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also 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:
- Severe vaginal irritation, burning, or itching that worsens during treatment.
- New vaginal discharge that is thick, white, and clumpy, which could indicate a yeast infection.
- Rash or hives.
- Signs of a severe allergic reaction (e.g., difficulty breathing, swelling of face/throat).
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. Be sure to describe the allergic reaction and its symptoms.
If you have taken disulfiram in the past 2 weeks.
* If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with 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. Be sure to describe the allergic reaction and its symptoms.
If you have taken disulfiram in the past 2 weeks.
* If you are breastfeeding or plan to breastfeed, as you may need to avoid breastfeeding while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with 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 your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before consuming alcohol or using products containing alcohol, discuss this with your doctor, as you may need to avoid them during treatment and for a period after your last dose.
If you are using a product that contains propylene glycol, consult your doctor to discuss potential interactions. Long-term use of metronidazole has been associated with an increased risk of cancer in animal studies, so it is crucial to discuss this with your doctor.
This medication has been prescribed for a specific health condition, and you should not use it to treat other health problems without consulting your doctor. If you are pregnant or planning to become pregnant, you will need to discuss the benefits and risks of using this medication with your doctor.
While using this medication, refrain from having vaginal sex. Additionally, avoid douching or using other vaginal products, such as tampons, during treatment and for a period after your last dose. If you have questions or concerns, consult your doctor.
It is also important to note that this medication may affect the results of certain laboratory tests. Be sure to inform your doctor and laboratory personnel that you are taking this medication to ensure accurate test results.
If you are using a product that contains propylene glycol, consult your doctor to discuss potential interactions. Long-term use of metronidazole has been associated with an increased risk of cancer in animal studies, so it is crucial to discuss this with your doctor.
This medication has been prescribed for a specific health condition, and you should not use it to treat other health problems without consulting your doctor. If you are pregnant or planning to become pregnant, you will need to discuss the benefits and risks of using this medication with your doctor.
While using this medication, refrain from having vaginal sex. Additionally, avoid douching or using other vaginal products, such as tampons, during treatment and for a period after your last dose. If you have questions or concerns, consult your doctor.
It is also important to note that this medication may affect the results of certain laboratory tests. Be sure to inform your doctor and laboratory personnel that you are taking this medication to ensure accurate test results.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Ataxia (loss of coordination)
- Seizures
- Peripheral neuropathy (numbness, tingling in hands/feet)
What to Do:
Overdose with vaginal gel is unlikely due to low systemic absorption. In case of accidental ingestion or excessive use, seek immediate medical attention. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Alcohol (during treatment and for at least 3 days after)
- Disulfiram (within 14 days of metronidazole use)
Major Interactions
- Warfarin (potentiates anticoagulant effect, monitor INR)
- Lithium (increased serum lithium levels, monitor)
- Busulfan (increased busulfan exposure)
Moderate Interactions
- Phenytoin (decreased metronidazole levels, increased phenytoin levels)
- Phenobarbital (decreased metronidazole levels)
- Cimetidine (increased metronidazole levels)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Diagnosis of Bacterial Vaginosis
Rationale: Confirm appropriate indication for treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of vaginal symptoms (discharge, odor, irritation)
Frequency: Daily during treatment, and post-treatment
Target: Absence of symptoms
Action Threshold: Persistent or worsening symptoms may indicate treatment failure or alternative diagnosis.
Symptom Monitoring
- Vaginal discharge (amount, color, odor)
- Vaginal irritation or itching
- Abdominal discomfort
- Metallic taste in mouth
- Signs of new yeast infection (e.g., thick, white discharge, severe itching)
Special Patient Groups
Pregnancy
Metronidazole vaginal gel is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Due to minimal systemic absorption, the risk is considered lower than with oral metronidazole. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Generally considered safer than oral metronidazole due to lower systemic exposure, but caution is still advised.
Second Trimester:
Generally considered safe for use.
Third Trimester:
Generally considered safe for use.
Lactation
Metronidazole is excreted into breast milk. While systemic absorption from vaginal gel is low, some drug will be transferred to the infant. The American Academy of Pediatrics considers metronidazole compatible with breastfeeding. However, some sources recommend considering temporary interruption of breastfeeding for 12-24 hours after a single dose or during treatment, or using an alternative drug, especially with higher doses or prolonged use. Monitor infant for gastrointestinal upset (e.g., diarrhea).
Infant Risk:
Low to moderate risk, potential for gastrointestinal upset in infant.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not recommended for use in pre-pubertal girls.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. Systemic exposure is minimal, and age-related changes in renal or hepatic function are unlikely to significantly impact drug levels from vaginal application.
Clinical Information
Clinical Pearls
- Instruct patients to use the gel at bedtime to minimize leakage.
- Advise patients that a metallic taste may occur, even with vaginal application, due to some systemic absorption.
- Metronidazole can sometimes lead to a secondary vaginal yeast infection; advise patients to report new or worsening itching/discharge.
- Emphasize the importance of avoiding alcohol during and for at least 3 days after treatment due to the disulfiram-like reaction.
- This formulation is for vaginal use only and should not be taken orally.
Alternative Therapies
- Oral Metronidazole (e.g., 500mg twice daily for 7 days)
- Oral Clindamycin (e.g., 300mg twice daily for 7 days)
- Secnidazole (oral single dose)
Cost & Coverage
Average Cost:
Varies, typically $20-$100 per 70g tube with applicators
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.