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Metronidazole / Nystatin

Flagystatin Ovules

Flagystatin is an FDA-approved medication used to treat vaginal infections caused by a mix of fungi and bacteria. It contains metronidazole and nystatin as an active ingredient, which works by killing bacteria and fungi, respectively. The typical dosage involves inserting one vaginal ovule daily before bedtime for 10 days. If symptoms persist, a further course or additional treatment may be necessary. Users should avoid alcohol and certain medications that may interact with Flagystatin. Common side effects include gastrointestinal discomfort and sensory changes. It’s crucial to follow medical advice precisely and discuss any pre-existing conditions with your primary caregiver before starting treatment.

Flagystatin Ovules Overview

Flagystatin is a combined antifungal and antibacterial treatment specifically formulated for vaginal infections that involve both bacteria and fungi. Each ovule contains 500 mg of metronidazole, which targets bacteria, and 100,000 units of nystatin, which combats fungal infections. The treatment regimen typically requires the insertion of one ovule into the vagina each night at bedtime, continued over a span of 10 consecutive days. If the infection does not resolve, another 10-day course or a switch to oral metronidazole may be advised.

Patients should moisten the ovule under water briefly before insertion to facilitate its disintegration and absorption. It is critical to maintain the medication schedule even during menstruation and not to discontinue the treatment prematurely, even if symptoms appear to improve. Missing a dose should not lead to doubling up; instead, continue with the next scheduled dose.

Significant interactions to note include potential adverse reactions with alcohol, lithium, warfarin, and other medications, which could affect the drug’s efficacy or lead to severe side effects. Patients are advised to disclose all other medications, supplements, and significant health issues to their healthcare provider before starting Flagystatin. Possible side effects range from mild, such as headaches and gastrointestinal disturbances, to severe, including signs of allergic reactions or neurological symptoms. Flagystatin should be stored properly at room temperature, away from light and moisture, and out of reach of children. Any expired or unused medication should be disposed of safely, following guidelines provided by healthcare professionals. Always consult a primary caregiver for tailored advice & treatment adjustments.

Uses of Flagystatin Ovules

Flagystatin is approved to:

  • Treat infections of the vagina (which can be caused by a mixture of certain fungi & bacteria)

Flagystatin Ovules Dosage

It is available in the form of Vaginal ovules and comes in boxes containing 10 ovules which include an applicator for administration. Each vaginal ovule contains:

  • Metronidazole: 500 mg per ovule
  • Nystatin: 100,000 units per ovule

Recommended Dosage for Flagystatin Vaginal Ovules

  • General Dosage: Insert one vaginal ovule deep into the vagina daily, preferably before going to bed, for 10 consecutive days.
  • Preparation Before Use: Before insertion, moisten the vaginal tablet underwater for a second or two to facilitate disintegration.
  • Additional Treatment Course: If a cure is not achieved after the initial 10-day treatment, a second 10-day course may be given.
  • Treatment for Persistent Infections: For cases where Trichomonas vaginalis is not completely eliminated after the vaginal treatment, oral metronidazole at a dose of 250 mg should be administered twice daily for an additional ten days.
  • Usage During Pregnancy: The applicator should not be used after the 7th month of pregnancy to avoid any potential risks.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take Flagystatin Ovules?

  • Insert one vaginal ovule deep into the vagina daily, ideally before bedtime.
  • Continue using this medication for 10 consecutive days.
  • Moisten the ovule underwater for a couple of seconds before insertion to aid dissolution.
  • If the infection is not resolved within 10 days, consult your doctor for potential additional treatment.
  • Inform your doctor if symptoms persist after the treatment period.
  • Dosage can be vary based on some factors like body weight, other medical conditions, and other medications.
  • Follow the dosage recommended explicitly by your doctor; do not alter your regimen without consulting them.
  • Use the medication exactly as prescribed by your primary caregiver.
  • Continue using the medication through the full treatment course, even if you feel better.
  • Continue using the medication during menstruation if it occurs.
  • If you miss a dose, skip it and continue with your regular dosing schedule.
  • Don’t take a second dose to make up for the missed one.
  • Store at room temperature.
  • Keep out of the reach of children. Do not dispose of medication in wastewater (for example, down the toilet or sink) or household garbage.
  • If unsure about what to do after when you miss a dose, contact your pharmacist or doctor for advice. Protect from light and moisture.
  • Consult your pharmacist on proper disposal methods for expired or unneeded medication.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Flagystatin Ovules Work?

Flagystatin is designed to treat vaginal infections that are caused by specific kinds of bacteria & fungi. It includes two active ingredients that work together to combat these infections:

  • Metronidazole: This ingredient targets and kills certain bacteria. It disrupts the DNA of the bacterial cells, inhibiting their ability to replicate and spread, which ultimately leads to their destruction.
  • Nystatin: This ingredient specifically attacks fungi. It binds to sterols in the fungal cell membrane, creating pores that cause the contents of the fungal cells to leak out, which results in the death of the fungal cells.

The combination of these two ingredients in Flagystatin effectively addresses mixed infections, providing a broad spectrum of action against both bacterial and fungal pathogens. However, the medication typically requires several days to fully take effect as it works to eradicate the infection.

Flagystatin Ovules Side Effects

Common side effects of Flagystatin may include:

  • Trouble sleeping
  • Vomiting
  • Other change in taste sensation or metallic taste
  • Hearing loss
  • Granular sensation in the vagina
  • Constipation
  • Headache
  • Heartburn
  • Minor burning, itching, or irritation in the vagina
  • Buzzing, ringing, or whistling in the ears
  • Spinning sensation
  • Diarrhea
  • Darker urine
  • Loss of appetite
  • Nausea
  • Dry mouth

Serious side effects of Flagystatin may include:

  • Signs & symptoms of a serious allergic reaction can include:
    • Difficulty breathing
    • Swelling of the face and throat
    • Abdominal cramps
    • Nausea and vomiting
  • Signs of meningitis may include:
    • Confusion
    • Stiff neck
    • Nausea
    • Vomiting
    • Sudden high fever
    • Headache
  • Signs of a severe skin reaction may consist of: 
    • A rash that spreads quickly
    • Blistering
    • A rash covering a large area of the body
    • Peeling
    • A rash combined with fever or discomfort
  • Thoughts of self-harm or suicide
  • Chest pain
  • Seizures

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Flagystatin Ovules Warnings

Before starting Flagystatin, make sure to inform your doctor about any medical conditions or allergies you have, any medications you are currently taking, whether you are pregnant or breast-feeding, and any other important health information. These factors can influence how you should use this medication.

  • Children: The safety and effectiveness of Flagystatin have not been established for children. Use in pediatric patients should be based on the discretion of a healthcare provider.
  • Dizziness or Confusion: Flagystatin may cause confusion or dizziness. If you experience these effects, avoid driving or engaging in any activities that require alertness.
  • Liver Function: Metronidazole can impact liver function and may lead to liver failure. This risk exists even with the vaginal form of the drug, though it’s more common with oral metronidazole. If you have severe liver disease or previous liver issues related to metronidazole, discuss the potential risks and monitoring with your doctor. Regular liver function tests may be necessary.
  • Effectiveness of Other Products: The use of metronidazole – nystatin vaginal cream or ovules may reduce the effectiveness of condoms and diaphragms. Consider using additional or alternative methods of birth control while on this medication.
  • Mental Health: On rare occasions, users of this medication may experience serious mental health issues such as thoughts of self-harm or suicide, hallucinations, depression, or irrational thoughts. If you or someone you know begins showing these symptoms while using Flagystatin, contact your doctor immediately.
  • Male Partner: If there is evidence of infection in a male sexual partner, he should also be treated with oral metronidazole to prevent re-infection.
  • Neurological Side Effects: Stop using Flagystatin and consult your doctor if you experience muscle seizures, incoordination, or numbness or tingling in the hands or feet.
  • Personal Hygiene: While using Flagystatin, avoid using menstrual tampons and soaps with an acid pH, as these can promote the growth of fungi and complicate treatment. It’s essential to continue using this medication during menstruation to effectively clear up the infection.
  • Overgrowth of Organisms: The use of antifungals & antibiotics like Flagystatin can sometimes lead to the overgrowth of organisms not targeted by the medication, such as other bacteria and fungi. This can result in additional infections. If you develop new symptoms during treatment, notify your doctor.
  • Side Effects: Although less common than with oral administration, side effects associated with oral metronidazole might still occur when using metronidazole vaginally. Be aware of any unusual symptoms and report them to your primary caregiver.
  • Pregnancy: Flagystatin has not been extensively studied in pregnant women. Therefore, it should not be used during pregnancy unless the benefits justify the possible risks. If you become pregnant while taking this medication, inform your doctor immediately. Additionally, the applicator should not be used after the seventh month of pregnancy to avoid risks to the fetus.
  • Underclothing: To aid the treatment and help the infection clear more quickly, wear cotton underwear or pantyhose with cotton gussets instead of synthetic materials, which can create a less breathable environment conducive to fungal growth.
  • Breast-feeding: Metronidazole is known to pass into breast milk, and it is unclear if nystatin does as well. Using metronidazole – nystatin vaginal treatments while breastfeeding could affect the baby. Discuss with your healthcare provider whether you should continue breastfeeding while using this medication.

Flagystatin Ovules Boxed Warning

Severe hepatotoxicity and acute hepatic failure, in some cases resulting in death, have been reported in patients with Cockayne syndrome shortly after the initiation of treatments containing metronidazole for systemic use. Due to these significant risks, Flagystatin should be used in patients with Cockayne syndrome only after a thorough assessment of the benefits & possibility and only if there are no alternative treatment options available. This warning underscores the need for extreme caution and close monitoring in such cases.

Flagystatin Ovules Precautions

  • Your doctor may have prescribed Flagystatin for conditions other than those mentioned in standard drug information sources. If you are unsure why you have been prescribed this medication or have not discussed this with your doctor, it is important to do so. Never stop taking this medication without first consulting your doctor.
  • Do not share Flagystatin with anyone else, even if they exhibit similar symptoms to yours. It can be harmful for others to use this medication without a doctor’s prescription.
  • If you have any of the following medical conditions, you must inform your doctor, as these may affect how you should use Flagystatin:
    • Encephalopathy (History of Brain Disorders): Use with caution. Symptoms may worsen with the use of this medication.
    • Aseptic Meningitis (History of): Use with caution. There may be a risk of worsening this condition.
    • Leukopenia (History of Low White Blood Cells): Use with caution. This condition could potentially worsen.
    • Severe Liver Disease: If you have serious liver disease, use Flagystatin with caution. The effects of the medication may be heightened due to slower drug metabolism and removal from the body.
    • Peripheral Neuropathy (History of Nerve Disease with Pain, Numbness, or Tingling): Use with caution. Symptoms may intensify.
    • Optic Neuropathy (History of Eye Disease with Vision Changes): Use with caution. There is a risk of exacerbating vision problems.
    • Seizures or Epilepsy (History of): Use with extreme caution. There is a risk of triggering seizures or worsening this condition.

Discuss these conditions thoroughly with your healthcare provider to ensure safe and effective use of Flagystatin, tailored to your specific health circumstances.

Flagystatin Contraindications

  • Hypersensitivity: Flagystatin Tablets should not be used by individuals with a known hypersensitivity to metronidazole or other nitroimidazole derivatives. This could lead to severe allergic reactions.
  • Pregnancy and Trichomoniasis: Flagystatin is contraindicated during the first trimester of pregnancy for patients with trichomoniasis due to potential & serious risks to the developing fetus.
  • Psychotic Reaction With Disulfiram: Avoid administering oral metronidazole to patients who have used disulfiram (used to treat alcohol dependence) within the last two weeks. Concurrent use can provoke psychotic reactions in alcoholic patients.
  • Interaction With Alcohol: Oral metronidazole can cause a disulfiram-like reaction when alcohol is consumed. This reaction may include symptoms like abdominal cramps, nausea, vomiting, headaches, and flushing. Patients should avoid alcohol and products containing propylene glycol during & for at least three days following the completion of therapy with metronidazole.
  • Cockayne Syndrome: Flagystatin Tablets are contraindicated for patients with Cockayne syndrome due to the risk of severe irreversible hepatotoxicity or acute liver failure, potentially leading to fatal outcomes after starting treatment with metronidazole.

Flagystatin Ovules Missed Dose

If you miss a dose of Flagystatin, take it as soon as you remember. However, if it’s  time for your next scheduled dose, skip the dose that you missed & continue with your regular dosing schedule. It’s crucial not to double up on doses to compensate for the one missed, as this could increase the risk of potential side effects. Keeping a consistent schedule with your doses will help maintain the effectiveness of the treatment.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Flagystatin Ovules Overdose

In cases of Flagystatin overdose, particularly involving metronidazole, it’s important to be aware of the potential severity and symptoms. Overdose incidents, including those from suicide attempts and accidental cases, have been reported with single oral doses up to 15 grams. Symptoms of such overdoses commonly include nausea, vomiting, and ataxia (a lack of muscle control during voluntary movements).

Metronidazole has also been researched as a radiation sensitizer for treating malignant tumors, and its use in higher doses (6 to 10.4 grams every other day over 5 to 7 days) has been associated with neurotoxic effects. These effects can include seizures and peripheral neuropathy (damage to nerves outside the spinal cord & brain).

There is no specific antidote for an overdose of metronidazole. Therefore, treatment is primarily symptomatic and supportive. This means medical care will focus on treating the symptoms and supporting the patient’s vital functions while the body clears the drug. Immediate medical attention is crucial for managing the effects of an overdose effectively.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Flagystatin Ovules Storage

  • Store Flagystatin in a closed container at room temperature.
  • Protect the medicine from heat, moisture, and direct light.
  • Ensure the medicine is kept from freezing.
  • Keep Flagystatin out of the reach of children to prevent accidental ingestion or misuse.
  • Do not retain outdated medicine or medicine that is no longer needed.
  • Consult your primary caregiver or pharmacist for proper disposal methods for unused medication to ensure it is disposed of safely and responsibly.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Flagystatin Interactions

Flagystatin, which contains metronidazole and nystatin, can interact with several medications. Some of these include:

  • Lithium
  • Busulfan
  • Alcohol
  • Warfarin
  • Cyclosporine
  • 5-fluorouracil
  • Disulfiram
  • Lopinavir
  • Phenytoin
  • Tipranavir
  • Barbiturates (such as phenobarbital)
  • Progesterone (vaginal)

If you are taking any of these medications, it’s important to consult with your doctor or pharmacist. Based on your specific health condition, your doctor might advise you to:

  • Continue with the current regimen without changes,
  • Substitute one of the medications with another,
  • Adjust how you are taking one or both of the medications or
  • Stop taking one of the medications.

Each option will be considered to ensure the best and safest therapeutic outcome for your particular needs. When medications interact, it doesn’t always mean you must stop taking one of them. Discuss with your doctor how these drug interactions are being managed or should be managed. Other medications, not just the ones already listed, may also interact with your current treatment.

 

It’s important to inform your doctor or prescriber about all the medications you are taking, whether they are prescription, over-the-counter, or herbal. Additionally, mention any supplements you use. Substances like caffeine, alcohol, nicotine from cigarettes, and street drugs can affect how many medications work, so it’s crucial to let your prescriber know if you use them. This information helps ensure your treatment is safe and effective.

[Note: This isn’t a complete list, and there could be other drugs that interact with Flagystatin. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Flagystatin Ovules Alternatives

 

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

Frequently Asked Questions Based On Flagystatin Ovules

How many days should I use Flagystatin?

For Flagystatin, it’s generally recommended to use the medication according to the duration prescribed by your healthcare provider, typically not exceeding two courses of treatment each lasting 10 days. If your infection does not improve after these treatment courses, further medical evaluation and cultures might be needed to guide additional treatment options.

Prolonged use of Flagystatin can lead to the overgrowth of bacteria and fungi that are not susceptible to the treatment, which might necessitate discontinuing its use and considering alternative therapies. Always follow the guidance of your primary health care giver for the best results and to manage your condition effectively.

Can you drink alcohol while taking Flagystatin ovules?

While taking Flagystatin ovules, which contain metronidazole, you should avoid consuming alcohol during the treatment and for at least one day after completing it. This precaution is necessary due to the potential for a disulfiram-like reaction. This reaction can occur when alcohol is consumed in conjunction with metronidazole, leading to symptoms such as nausea, vomiting, flushing of the skin, tachycardia (rapid heartbeat), and shortness of breath. To avoid these unpleasant and potentially severe side effects, it’s best to abstain from alcohol while using this medication and for a short period afterwards.

How long does metronidazole take to clear infection?

Metronidazole is one of the active ingredients of Flagystatin which typically begins to work within a few days of starting treatment. Still, the time it takes to see an improvement in symptoms may vary depending on the type & severity of the infection. For serious infections, such as those involving significant swelling or dental infections, it may take longer for symptoms to start improving. In some cases, particularly for certain types of infections, you might only begin to notice symptom improvement after a week of treatment. It’s important to continue taking the medication for the full duration prescribed by your primary caregiver, even if you start to feel better sooner, to ensure the infection is fully cleared.

What foods should you avoid while taking Flagystatin?

While taking Flagystatin, it’s important to avoid certain foods and beverages that contain tyramine, as well as alcohol. This is particularly relevant if you are also taking medications like linezolid (Zyvox) or metronidazole (Flagyl), which are used to treat bacterial infections. Foods and beverages to avoid include:

  • Alcohol: Especially tap beer, sherry, and red wine, as these can interact negatively with your medication.
  • Tyramine-rich foods: Such as avocados, salami, chocolate, and bananas.

These substances can interfere with your medication and potentially cause adverse effects, so it’s best to steer clear of them during your treatment.

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