metronidazole vaginal

Action and Spectrum

Actions and Spectrum: 

Actions: 

When used to treat vaginal infections including trichomoniasis and bacterial vaginosis (BV), metronidazole vaginal acts in multiple ways to eradicate the causing germs and reduce symptoms. 

Spectrum: 

When metronidazole is administered vaginally, its range of action is mostly directed against specific pathogens, such as bacteria and protozoa like Trichomonas vaginalis, Helicobacter pylori, Entamoeba histolytica, and bacterial vaginosis (BV). 

Drug Interaction

Adverse Reaction

Frequency defined 

>10% 

Bacterial infection (12%)  

1-10% 

Metrorrhagia (1%) 

Headache (7%) 

Breast pain (1%) 

Rash (1%) 

Pruritis (6%) 

Nausea (3%) 

Pharyngitis (2%) 

Diarrhea (1%) 

Abdominal pain (5%) 

Dysmenorrhea (3%) 

Black Box Warning

Black Box Warning: 

If you experience diarrhea, burning or irritation in the vagina, or excessive vaginal discharge, get in touch with your doctor. Additionally, get in touch with your doctor if you have recurring yeast infections, your symptoms persist longer than seven days, or your condition does not improve in three days. 

The medication can irritate your eyes, so avoid getting any in them. Rinse your eyes well with cold water if the medication gets in them. Reinfection can occur after sexual activity. This medication may harm a condom’s, cervical cap’s, or diaphragm’s latex. It might be better to refrain from sexual activity while taking this medication. Discuss this with your healthcare physician. 

For the entire prescribed duration, including when you are menstruating, take this medication as directed. Tampons should not be worn whilst taking this medication. 

For at least three days following the end of your medication’s treatment, avoid drinking alcohol and do not take any medications that include alcohol, such as cough and cold remedies. Drinking alcohol while taking this medication may result in undesirable side effects. Unless your healthcare practitioner gives the okay, avoid using any other medications in the vagina. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 
• Cockayne syndrome 
• 2 weeks of disulfiram administration 
• Alcohol consumption after 3 days 

Cautions 

• Allergies 
• Seizures 
• Blood dyscrasias 
• Alcohol addiction 
• Peripheral neuropathy 
• HIV/AIDS 
• Immunocompromised patients 
• Hepatic impairment 
• Drug interactions 
• Pregnancy  
• Breastfeeding 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

It is an antibacterial agent. It is effective against the majority of strains of organisms linked to bacterial vaginosis in vitro, such as Mobiluncus species, Gardnerella vaginalis, Bacteroides species, and Peptostreptococcus species.  

Pharmacodynamics: 

Metronidazole has antibacterial and antiprotozoal properties that help treat trichomoniasis, giardiasis, and amebiasis. Some anaerobic bacterial infections respond well to metronidazole treatment. While metronidazole has demonstrated antibacterial activity against most obligate anaerobes, it does not show any discernible effect against facultative anaerobes or obligate aerobes in in vitro experiments. The antimicrobial cytotoxic actions of metronidazole, which cause damage to microorganisms’ DNA strands, are probably caused by the nitro group reduction of the antibiotic by anaerobic organisms. 

Pharmacokinetics: 

Absorption 

A mean maximum blood metronidazole concentration of 237 ng/mL (range: 152 to 368 ng/mL) was recorded in 12 normal volunteers after they received a single intravaginal 5 gram dose of metronidazole vaginal gel, which is equivalent to 37.5 mg of metronidazole. With the same participants receiving a single oral 500 mg dosage of metronidazole, this represents around 2% of the mean maximum serum metronidazole concentration recorded (mean Cmax = 12,785 ng/mL, range: 10,013 to 17,400 ng/mL). These peak concentrations were achieved 1–3 hours after oral metronidazole dosage and 6–12 hours after metronidazole vaginal gel dosage. 

Distribution 

Metronidazole is present in many bodily fluids and is broadly dispersed throughout the body. These consist of the placenta, bile, saliva, breastfeeding, and cerebrospinal fluid.sixteen Adults’ steady-state metronidazole volume distribution ranges from 0.51 to 1.1 L/kg. It is not detected in significant amounts in the placental tissue, but it reaches 60–100% of plasma concentrations in a number of tissues, including the central nervous system. Less than 20% of metronidazole is bound to plasma proteins. 

Metabolism 

A significant amount of the absorbed dose of metronidazole is eliminated as metabolites when it is metabolized in the liver via side chain oxidation and glucuronide production. 

Elimination and Excretion 

60–80% of metronidazole and its metabolites are excreted in the urine, while the remaining 6–15% are expelled in the feces. 

In healthy subjects, the half-life of metronidazole elimination is 7.3 ± 1.0 following a single 500mg intravenous dose. According to another source, metronidazole has an elimination half-life of six to ten hours. 

Adminstartion

Administration: 

Utilize this medication precisely as prescribed by your physician. Don’t use it for longer than your doctor prescribed, don’t use it more frequently, and don’t use it in excess. This medication should only be applied vaginally. Unless your doctor instructs you otherwise, take it before bed. 

Avoid getting it in your mouth, nose, eyes, or skin. Should this medication find its way into your eyes, immediately rinse them thoroughly with copious amounts of cool tap water. See your doctor if the burning or pain in your eyes persists. 

A patient information sheet and instructions are included with this medication. Carefully read and adhere to the directions. Should you have any questions, ask your doctor. Both before and after taking this medication, wash your hands with soap and water.  

Nuvessa comes in an applicator that is already filled. The applicator features a pink cap on one end where the medication is released and an open end where the plunger is inserted.  

There is a tube of Vandazole. The gel will be applied to your vagina using an applicator. The applicator consists of a barrel-shaped plastic tube with an opening at one end and a moveable plunger (an additional piece of plastic) at the other. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: metronidazole vaginal 

Pronounced: meh-troh-NY-duh-zohl vuh-JY-nuhl 

Why do we use metronidazole vaginal? 

Bacterial vaginosis is a common vaginal infection that is often treated with metronidazole vaginal. An imbalance in the natural bacterial flora of the vagina, with an overgrowth of pathogenic germs, causes bacterial vaginosis.