Flagystatin (Metronidazole and Nystatin) - Uses, Dose, MOA, Brands

Flagystatin (Metronidazole and Nystatin) is used as a topical intravaginal ovule for the treatment of mixed vaginal infections.

Metronidazole and nystatin Uses:

  • Mixed vaginal infection:
    • It is indicated for the treatment of mixed vaginal infections caused by Trichomonas vaginalis and Candida albicans.

Metronidazole and Nystatin Dose in Adults:

Flagystatin (Metronidazole and Nystatin) Dose in the treatment of mixed vaginal infection:

  • Form: It comes as a vaginal tablet (ovule).
  • How to Use: At bedtime, put one tablet into your vagina every day for 10 days in a row.
  • If Needed: If your infection doesn't go away after the first 10 days, you can do another 10 days of treatment.

Important Note: If you're pregnant, don't use the applicator (the tool to put the tablet in) after the seventh month of pregnancy. If the infection caused by a specific parasite called Trichomonas (T. vaginalis) isn't completely gone, you might need to take metronidazole as a pill that you swallow.


Use in Children:

Not indicated.


Pregnancy Risk Category: C/ D

  • Metronidazole can reach the baby in the womb, but we don't know about nystatin, though it probably doesn't since it doesn't go into the bloodstream easily.
  • The company making these drugs says don't use metronidazole in the first three months of pregnancy and don't use the applicator to insert it after the seventh month.
  • This medicine might make condoms or diaphragms work less well, so use different birth control while taking it.
  • Always check details for each drug separately.

Use of nystatin and metronidazole during breastfeeding

  • Metronidazole can get into breast milk, but we're unsure about nystatin.
  • However, it's likely nystatin doesn't enter the bloodstream much.
  • The company that makes these drugs suggests that breastfeeding women shouldn't use them.
  • Always check details for each drug on its own.

Metronidazole and Nystatin Dose in Kidney Disease:

  • The company that makes the drug doesn't give specific instructions on adjusting the dosage for people with kidney problems.

Metronidazole and Nystatin Dose in Liver disease:

  • The company that makes the drug doesn't give clear instructions about changing the dosage for people with liver problems.
  • But, they do suggest a smaller dose for those with serious liver issues.

Side effects of Flagystatin (Metronidazole and Nystatin):

  • Central nervous system:
    • Bitter taste
    • Fatigue
    • Headache
  • Dermatologic:
    • Pruritus
    • Skin rash (located around the knee)
    • Urticaria
  • Gastrointestinal:
    • Coated tongue
    • Nausea
    • Vomiting
  • Genitourinary:
    • Vaginal discomfort (granular sensation)
    • Vulvovaginal burning
  • Neuromuscular & skeletal:
    • Arthralgia (including ankles, wrists)
    • Joint swelling (including ankles, wrists)

Contraindication to Flagystatin (Metronidazole and Nystatin):

  • Don't use this medicine if you're allergic to metronidazole, nystatin, imidazoles, or any part of the drug.
  • If you have active brain problems, a history of blood disorders, or issues with your thyroid or adrenal glands, you shouldn't mix this with oral metronidazole.
  • For more details on metronidazole, check its main information guide.

Caution and Alert

Carcinogenic:

  • Metronidazole might cause cancer based on tests done on animals.

CNS effects

  • Metronidazole can affect the nervous system, possibly causing nerve problems.
  • If someone taking it starts to feel unsteady or shows other brain-related symptoms, they should be watched closely.
  • It might be best to stop the medication.
  • Be extra careful using it in people with brain diseases.

Hematologic effects

  • While long-term blood issues haven't been seen in studies, it's still important to check white blood cell counts before and after using metronidazole, especially if a person needs a second round of the medication.

Hypersensitivity

  • Allergic reactions to the medicine can happen.
  • Serious skin reactions like AGEP, SJS, and TEN have been reported.
  • There might also be local irritation or sensitivity where the medicine is applied.
  • If someone shows signs of an allergy or irritation, stop the medicine and treat the reaction properly.

Superinfection

  • Using this medicine for a long time can lead to other infections, including dangerous diarrhea from C.
  • difficile or an inflamed colon.
  • These problems can even appear more than 2 months after stopping the antibiotic.
  • If the infection doesn't get better after 20 days (two rounds of 10-day treatments), doctors should test to find out what's causing it.

Systemic effects

  • Even if metronidazole is given in the vagina, some of it might enter the body's system.
  • This means side effects usually seen when taking metronidazole by mouth or injection might also happen with vaginal use.

Urine discoloration:

  • Patients should know that this medicine might make their urine a darker color.

Cockayne syndrome:

  • Be very careful when using metronidazole in patients with Cockayne syndrome.
  • These patients can experience serious liver damage, which can happen quickly after starting the medicine, and can even be deadly.
  • If a patient shows signs of liver problems, stop the medicine immediately.

Hepatic impairment

  • For people with serious liver problems, be cautious when using this medicine as it might build up in their system.
  • It's advised to adjust the dose for them.
  • Also, be careful in patients with brain issues related to liver problems and those who had liver issues from metronidazole in the past.

Metronidazole and Nystatin (United States: Not available): Drug Interaction

Risk Factor C (Monitor therapy)

Lopinavir

The harmful or unpleasant effects of lopinavir may be increased by metroNIDAZOLE (Topical). In particular, lopinavir/ritonavir solution (which includes 42% alcohol) and topical metronidazole may cause a disulfiram-like response.

Tipranavir

The toxic/unfavorable effects of Tipranavir may be exacerbated by MetroNIDAZOLE (Topical).

Risk Factor D (Consider therapy modification)

Alcohol (Ethyl)

Alcohol's negative or toxic effects may be exacerbated by MetroNIDAZOLE (Topical) (Ethyl). There might be a response like disulfiram. Management: If patients drink while using topical metronidazole, warn them and keep an eye out for any signs and symptoms of a disulfiram-like response. Alcohol usage between 24 to 72 hours of using vaginal metronidazole is prohibited by several manufacturers of the medication.

Disulfiram

MetroNIDAZOLE (Topical) may intensify Disulfiram's harmful or hazardous effects. In particular, there may be an elevated risk for CNS toxicities including psychosis. Management: If topical metronidazole is administered in a patient on disulfiram, alert patients and keep an eye out for the emergence of significant CNS effects. Disulfiram usage within two weeks is prohibited by several manufacturers of vaginal metronidazole products.

Risk Factor X (Avoid combination)

Progesterone

Vaginal antifungal agents may reduce progesterone's therapeutic efficacy.

Monitoring Parameters:

None mentioned. Monitor the response to treatment.


How to administer Flagystatin (Metronidazole and Nystatin)?

Using the Medicine in the Vagina

  • For Vaginal Use Only: This medicine is meant to be used inside the vagina.
  • How to Use the Applicator:
    • Use only the applicator given with the medicine.
    • Pull the applicator's plunger back about an inch.
    • Put a tablet into the cup at the end of the tube.
    • Fill the applicator with one tablet.
  • How to Insert:
    • Lie down on your back, bending your knees.
    • Gently push the applicator into the vagina as far as you can without it hurting.
    • Once it's in the right place, push the plunger.
    • Pull out the applicator.
  • After Using:
    • Clean the applicator with warm water.
  • Note: Don't use other products in the vagina, like tampons or douches, while you're on this treatment.

Mechanism of action of Flagystatin (Metronidazole and Nystatin):

See individual agents (Nystatin and Metronidazole)


International Brand Names of Metronidazole and nystatin:

  • Flagystatin
  • Amrizole N
  • Bio-Vagin
  • Colpatrin
  • Etron nistatina
  • Farm-X Duo
  • Fladystin
  • Flagyl Comp
  • Flagyl Nistatina
  • Flagystatin
  • Flagystatin V
  • Flagystatine
  • Linfol
  • Metanis
  • Metrocaps N
  • Metrozin Nistatina
  • Neo Gynoxa
  • Nistatina Metronidazol L.C.H.
  • Nystazole
  • Provagin
  • Tratomax
  • Vagistin
  • Vanestrin
  • Vaxi

Metronidazole and Nystatin Brand Names in Pakistan:

Update soon.

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