Vandazole 0.75% Vaginal Gel

What is Metronidazole Gel?

Metronidazole Vaginal Gel (0.75%) is a colorless to yellow gel. It is supplied in a 70g tube and packaged with 5 vaginal applicators. It should be stored at 68° to 77° F (20° to 25°C) and be protected from extreme heat and freezing. Metronidazole is classified as an antiprotozoal and antibacterial agent.

What does Metronidazole Vaginal Gel treat?

Metronidazole Vaginal Gel is used in the treatment of bacterial vaginosis (BV) in non-pregnant women. Bacterial vaginosis is a common condition in which the balance of bacteria inside the vagina gets disrupted and causes unusual vaginal discharge. The vaginal discharge is typically thin or watery, white or grey in color and characterized by a fishy smell.

How does Metronidazole Gel work?

Metronidazole Gel is an antibiotic. It works by killing the bacteria where it is applied. 

How effective is Metronidazole Gel?

Metronidazole gel is one of the most effective treatments for bacterial vaginosis. Approximately 75% of females will be free of bacterial vaginosis after 5 days of treatment with metronidazole gel.

Active ingredients

Metronidazole Vaginal Gel contains the active ingredient metronidazole at a concentration of 7.5 mg/g (0.75%). Each applicator contains 5g of vaginal gel with approximately 37.5mg of metronidazole.

Inactive ingredients

Metronidazole gel also contains the following inactive ingredients: methylparaben, propylparaben, hypromellose, edetate disodium, propylene glycol, purified water, sodium hydroxide.

Which ingredients can cause an allergic reaction?

You should not use this vagina gel if you have a known allergy to metronidazole or any of the inactive ingredients in the gel. The methyl parahydroxybenzoate and propyl parahydroxybenzoate inactive ingredients have been known to cause possibly delayed allergic reaction and propylene glycol can cause skin irritations when used topically. You should do a patch test of the gel before using it fully on the affected area. 

Metronidazole gel dosage

You should always follow your doctor’s instructions when using Metronidazole gel. Generally, for bacterial vaginosis, Metronidazole is used once a day for 5 days. This means that the daily dose would be 1 applicator-full which is 5g of 0.75% metronidazole.

How to use Metronidazole gel

Metronidazole vaginal gel (0.75%) is to be applied intravaginally, which means inside the vagina. It is for vaginal use only, and must not be put into eyes, mouth, or on your skin. If the medicine gets into any of these areas, rinse with water.

Unless your physician advises you otherwise, the recommended dose of metronidazole gel is one applicator full, administered via the vagina once or twice a day for 5 days. Make sure you gently wash your vaginal area before using the medicine and wash your hands before and after vaginal application.

For once-a-day dosing, apply one applicator full of Metronidazole Vaginal Gel at bedtime. After using the applicator, throw it away and use a new applicator for the next day’s dose.

Make sure you read the patient information and medication guide that comes with the medicine. If you have further questions or doubts, ask your physician or pharmacist.

NB: If you experience significant irritation following the use of Metronidazole Vaginal Gel, stop using it and talk to your physician. Keep this medicine out of reach of children and do not use while pregnant unless under the supervision of your physician.

What should I do if I miss a dose?

If you forget a dose, use it as soon as you remember. However, if you remember your dose when it’s almost time to take the next one, proceed as scheduled and do not double the dose to make up for the one you forgot.

Side effects of Metronidazole Gel

Get immediate medical help if you experience signs of an allergic reaction: swelling of your face, lips, tongue, throat; hives; difficulty breathing.

General side effects of Metronidazole Vaginal Gel include:

• Vaginal itching or discharge
• Headache
• Nausea
• Loss of appetite
• Constipation
• Upset stomach
• Vomiting
• Rash
• Infection
• Diarrhea
• Abdominal Pain
• Burning/stinging while applying the medicine
• Pelvic pain/cramps
• Dizziness
• Disturbed sleep (Insomnia)
• Runny nose
• Urinating more than usual
• Acne
• Increased sweating
• Breast discharge

Rare but serious side effects include:

• Seizure (convulsion)
• Numbness/burning/pain/tingling in your hands and/or feet

If you experience any serious side effects, talk to your physician.

Make sure you do not use this medicine if you are allergic to parabens or polyethylene glycol, if you recently drank alcohol, if you took disulfiram (Antabuse) within the past 14 days, or if you use medicine to thin the blood (anticoagulants) such as Warfarin and Coumarin.

For your own safety, make sure you inform your physician of any seizure disorder, any blood cell disorder (anemia, low platelets), or peripheral vascular disease such as Raynaud’s syndrome.

Can I use Metronidazole Vaginal Gel while breastfeeding?

No studies have been conducted yet on levels of metronidazole in human milk after vaginal application. However, it has been established that metronidazole is secreted in human milk, in concentrations similar to those found in plasma following oral intake of metronidazole tablets. Furthermore, metronidazole use in mice and rats has shown a potential for tumorigenicity (ability to grow tumors). Breastfeeding mothers should decide with their physicians whether to stop breastfeeding or stop the medicine, taking into account the importance of the medicine for the mother.

What should I avoid while using Metronidazole Vaginal Gel?

Avoid drinking alcohol or consuming foods or any other substances that contain alcohol or propylene glycol. To be sure, check the ingredient labels of the drinks and foods you consume. Also, avoid having sex until your vaginal infection has completely resolved. Moreover, in order to allow good air circulation, wear loose-fitting clothing made of cotton or other natural fibers until your infection is treated. Avoid tight-fitting and synthetic clothing such as nylon underwear.

Contraindications

You should not use Metronidazole Gel if you are allergic to any of the following:

• Metronidazole
• Nitroimidazole antibiotic
• Parabens 

You should let your doctor know if any of the following apply to you:

• You have ever experienced blood problems or a blood disease 
• You think you have a yeast infection
• You are having your period 
• You are scheduled to have a blood test 
   

Drug interactions

Metronidazole Gel may interact with other medications that are used inside the vagina, along with the following drugs:

• Ciclosporin
• Fluorouracil
• Lithium 
• Warfarin 

You should ensure that the prescribing doctor is aware of any drugs you are taking. 
 

Metronidazole Gel vs Tablets

Metronidazole is available as both tablets and gel. The gel is usually more expensive than the tablets and generally produces fewer side effects. Metronidazole gel is however, more likely to cause thrush compared to the tablets. When making a decision about which form to take, you may also want to consider that the tablets are known to interact more severely with alcohol.  You should not drink alcohol when taking either the tablets or the gel.