Nuvessa 1.3% Vag Gel-5g Single Dose
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
Sep 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nuvessa is an antibiotic gel used to treat a common vaginal infection called bacterial vaginosis (BV). It works by stopping the growth of the bacteria that cause the infection. You apply it directly into your vagina using an applicator.
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 may 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
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 may 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
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 alcohol (including alcohol-containing medications) during treatment and for at least 3 days after stopping Nuvessa. Drinking alcohol can cause severe nausea, vomiting, stomach cramps, headaches, and flushing.
- Do not have sexual intercourse during treatment to allow the infection to clear and to prevent re-infection.
- Do not use tampons or douches during treatment.
- Complete the entire 5-day course of treatment, even if your symptoms improve sooner. Stopping early can lead to the infection coming back.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One applicatorful (5g of gel containing 65 mg metronidazole) intravaginally once daily for 5 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to low systemic absorption.
Moderate:
No specific adjustment recommended due to low systemic absorption.
Severe:
Use with caution; systemic exposure is low but accumulation of metabolites may occur in severe renal impairment. Monitor for adverse effects.
Dialysis:
Consider timing application after dialysis if systemic accumulation is a concern, though generally not required for vaginal gel.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to low systemic absorption.
Moderate:
No specific adjustment recommended due to low systemic absorption.
Severe:
Use with caution in patients with severe hepatic impairment (Child-Pugh C) due to potential for reduced metabolism and increased systemic exposure. Monitor for adverse effects.
Pharmacology
Mechanism of Action
Metronidazole is a nitroimidazole antimicrobial. It enters the bacterial cell by passive diffusion. Once inside, the nitro group of metronidazole is reduced by electron transport proteins (e.g., ferredoxin) found in anaerobic and microaerophilic organisms. This reduction forms highly reactive nitro radicals and other cytotoxic byproducts that damage bacterial DNA and other macromolecules, leading to inhibition of nucleic acid synthesis and bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 5% of the systemic exposure achieved with a 500 mg oral dose of metronidazole.
Tmax:
Approximately 6-12 hours (for systemic absorption from vaginal gel).
FoodEffect:
Not applicable for vaginal administration.
Distribution:
Vd:
Not specifically quantified for vaginal gel, but systemically, metronidazole is widely distributed into body tissues and fluids.
ProteinBinding:
<20%
CnssPenetration:
Limited with vaginal administration due to low systemic absorption; however, systemically absorbed metronidazole can penetrate the CNS.
Elimination:
HalfLife:
Approximately 6-11 hours (systemic half-life).
Clearance:
Not specifically quantified for vaginal gel; systemically, renal and fecal clearance.
ExcretionRoute:
Primarily renal (60-80%), with a smaller portion excreted in feces (6-15%).
Unchanged:
Approximately 20% (of systemically absorbed drug) excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically observed within 2-3 days of initiating treatment.
PeakEffect:
Not precisely defined for clinical effect, but symptomatic relief usually occurs within the 5-day treatment course.
DurationOfAction:
Duration of antimicrobial effect lasts for the treatment period; resolution of symptoms should persist after completion of the course.
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
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, contact 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, 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
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, contact 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 stomach upset, nausea, or vomiting (especially if alcohol was consumed)
- New or worsening vaginal itching, burning, or a thick, white discharge (may indicate a yeast infection)
- Dizziness, lightheadedness, or headache
- Numbness, tingling, pain, or weakness in your hands or feet (signs of nerve problems, rare but serious)
- Signs of an allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing
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 symptoms you experienced.
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 (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not 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 symptoms you experienced.
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 (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not 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, consult 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, discuss this with your doctor. Long-term use of metronidazole has been associated with an increased risk of cancer in mice and rats; therefore, it is crucial to talk to your doctor about this potential risk.
This medication has been prescribed to treat a specific health condition. Do not use it to treat other health problems without consulting your doctor. If you are pregnant or planning to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
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 with your doctor.
It is also important to note that this medication may interfere with certain laboratory tests. Ensure that your doctor and laboratory personnel are aware that you are taking this medication to avoid any potential interactions or inaccuracies in test results.
If you are using a product that contains propylene glycol, discuss this with your doctor. Long-term use of metronidazole has been associated with an increased risk of cancer in mice and rats; therefore, it is crucial to talk to your doctor about this potential risk.
This medication has been prescribed to treat a specific health condition. Do not use it to treat other health problems without consulting your doctor. If you are pregnant or planning to become pregnant, inform your doctor to discuss the benefits and risks of using this medication during pregnancy.
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 with your doctor.
It is also important to note that this medication may interfere with certain laboratory tests. Ensure that your doctor and laboratory personnel are aware that you are taking this medication to avoid any potential interactions or inaccuracies in test results.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Ataxia (loss of coordination)
- Peripheral neuropathy (numbness/tingling)
- Seizures (rare)
What to Do:
Overdose with vaginal gel is unlikely due to low systemic absorption. If suspected, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is supportive and symptomatic.
Drug Interactions
Contraindicated Interactions
- Disulfiram (within 14 days of metronidazole use due to psychotic reactions)
Major Interactions
- Alcohol (ethanol) - risk of disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, flushing)
- Warfarin and other oral anticoagulants (increased anticoagulant effect, leading to increased bleeding risk)
- Busulfan (increased busulfan plasma concentrations, leading to increased toxicity)
Moderate Interactions
- Cimetidine (may decrease metronidazole clearance, leading to increased metronidazole levels)
- Phenobarbital, Phenytoin (may decrease metronidazole levels due to increased metabolism)
- Lithium (may increase lithium levels, leading to toxicity)
Minor Interactions
- Oral contraceptives (potential for reduced efficacy, though clinical significance for vaginal gel is low due to minimal systemic absorption)
Monitoring
Baseline Monitoring
Diagnosis of Bacterial Vaginosis (BV)
Rationale: To confirm the appropriate indication for metronidazole vaginal gel.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., vaginal discharge, odor, itching)
Frequency: Daily during treatment, and at follow-up visit if symptoms persist
Target: Complete resolution or significant improvement
Action Threshold: If symptoms worsen or do not improve after completing the course, re-evaluate diagnosis or consider alternative treatment.
Signs of vulvovaginal candidiasis (e.g., new onset itching, thick white discharge)
Frequency: Daily during and after treatment
Target: Absence of new fungal infection symptoms
Action Threshold: If symptoms of candidiasis develop, consider antifungal treatment.
Symptom Monitoring
- Vaginal discharge (color, consistency, odor)
- Vaginal itching or irritation
- Abdominal pain
- Nausea or vomiting (especially if alcohol consumed)
- Dizziness or headache
- Signs of allergic reaction (rash, hives, swelling)
Special Patient Groups
Pregnancy
Metronidazole vaginal gel is generally considered safe for use during the second and third trimesters of pregnancy (Pregnancy Category B). Use in the first trimester should be carefully considered, weighing the potential benefits against any theoretical risks, although studies have not shown an increased risk of birth defects.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided unless clearly needed. Some older studies suggested a possible, but unconfirmed, association with cleft lip/palate, which has largely been refuted by larger studies.
Second Trimester:
Generally considered safe and effective for treating BV.
Third Trimester:
Generally considered safe and effective for treating BV.
Lactation
Metronidazole is excreted into breast milk. However, due to the low systemic absorption of metronidazole from vaginal gel, the amount transferred to breast milk is minimal. The American Academy of Pediatrics considers metronidazole compatible with breastfeeding. If concerns exist, a mother may consider expressing and discarding milk for 12-24 hours after the last dose, but this is often not necessary.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption from vaginal gel. Potential for altered gut flora or mild gastrointestinal upset in the infant, but rarely clinically significant.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
No specific dose adjustments are required for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to low systemic absorption, age-related changes in renal or hepatic function are less likely to significantly impact drug exposure compared to oral formulations.
Clinical Information
Clinical Pearls
- Advise patients to avoid alcohol completely during treatment and for at least 3 days after the last dose to prevent a disulfiram-like reaction.
- Patients should be instructed to complete the full 5-day course of therapy, even if symptoms resolve earlier, to prevent recurrence.
- Metronidazole vaginal gel may cause vulvovaginal candidiasis (yeast infection) as a superinfection; monitor for new onset itching or discharge.
- Inform patients that this medication is for vaginal use only and should not be taken orally.
- Sexual intercourse should be avoided during treatment to allow for healing and prevent re-infection.
- This medication may temporarily interfere with certain laboratory tests (e.g., AST, ALT, LDH, triglycerides, glucose hexokinase method), leading to falsely low values.
Alternative Therapies
- Clindamycin vaginal cream (2%)
- Clindamycin vaginal ovules (100 mg)
- Oral metronidazole (e.g., 500 mg twice daily for 7 days)
- Oral clindamycin (e.g., 300 mg twice daily for 7 days)
- Secnidazole oral granules (single dose)
Cost & Coverage
Average Cost:
Varies widely; check current pharmacy pricing (e.g., $50-$150 for a 5-day course of brand Nuvessa, less for generic) per 5g single dose applicator (5-day supply)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand-name; generic often Tier 1)
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 this 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.