How should Flagyl be taken with food. What are the proper usage instructions for oral metronidazole. When is the best time to take Flagyl in relation to meals. What precautions should be taken when using metronidazole orally.

Understanding Flagyl S: Uses and Active Ingredients

Flagyl S is a medication containing the active ingredient metronidazole benzoate in liquid form. This powerful antibiotic is prescribed for various purposes:

• Treatment of certain bacterial and protozoal infections in different body parts
• Prevention or treatment of specific infections that may occur during surgical procedures

Metronidazole belongs to a class of drugs known as nitroimidazole antimicrobials. Its effectiveness lies in its ability to penetrate bacterial cell walls and disrupt DNA synthesis, ultimately leading to cell death in susceptible organisms.

Common Infections Treated with Flagyl S

Flagyl S is effective against a wide range of infections, including:

• Bacterial vaginosis
• Trichomoniasis
• Giardiasis
• Amoebiasis
• Certain anaerobic bacterial infections

Is Flagyl S effective against all types of infections. No, Flagyl S is specifically targeted towards anaerobic bacteria and certain protozoal infections. It is not effective against viral infections or infections caused by aerobic bacteria.

Proper Usage and Dosage Instructions for Flagyl S

To ensure maximum effectiveness and minimize potential side effects, it’s crucial to follow the prescribed dosage and administration instructions for Flagyl S:

1. Take Flagyl S exactly as directed by your healthcare provider
2. Complete the full course of treatment, even if symptoms improve before completion
3. Use the measuring device provided to ensure accurate dosing of the liquid suspension
4. Shake the bottle well before each use to ensure proper mixing of the medication

Can Flagyl S be taken with or without food. Flagyl S can be taken with or without food. However, taking it with food may help reduce stomach upset. If you experience nausea or stomach discomfort, try taking the medication with a meal or snack.

Timing of Doses

Consistency in timing is key when taking Flagyl S. Try to space your doses evenly throughout the day. For example, if prescribed three times daily, aim to take it every 8 hours. This helps maintain a steady level of the medication in your system for optimal effectiveness.

Precautions and Considerations Before Using Flagyl S

Before starting treatment with Flagyl S, it’s essential to inform your healthcare provider about certain factors that may affect its use:

• Any known allergies, especially to metronidazole or other nitroimidazole antibiotics
• Existing medical conditions, particularly liver disease or nervous system disorders
• Pregnancy or breastfeeding status
• All medications currently being taken, including over-the-counter drugs and supplements

Are there any specific conditions that may contraindicate the use of Flagyl S. Yes, Flagyl S should not be used in patients with a history of blood disorders, active neurological disorders, or during the first trimester of pregnancy unless absolutely necessary and under close medical supervision.

Potential Interactions with Other Medications

Flagyl S can interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. Some notable interactions include:

• Warfarin and other blood thinners: May increase the risk of bleeding
• Alcohol-containing medications: Can cause severe nausea, vomiting, and abdominal cramps
• Lithium: May increase lithium levels in the blood
• Busulfan: Can increase the risk of severe toxicity

How long should alcohol be avoided when taking Flagyl S. It’s crucial to avoid alcohol consumption while taking Flagyl S and for at least 24 hours after completing the course of treatment. Alcohol interaction can lead to severe side effects, including flushing, headache, nausea, vomiting, and rapid heart rate.

Managing Side Effects and Monitoring Treatment Progress

While Flagyl S is generally well-tolerated, some patients may experience side effects. Common side effects include:

• Nausea and vomiting
• Metallic taste in the mouth
• Diarrhea
• Headache
• Loss of appetite

Most side effects are mild and resolve on their own. However, it’s important to monitor for any severe or persistent side effects and report them to your healthcare provider immediately.

Signs of Improvement and When to Seek Medical Attention

During treatment with Flagyl S, pay attention to your symptoms and overall health. If you notice any of the following, contact your healthcare provider:

• Symptoms worsen or fail to improve after a few days of treatment
• Development of new or unexpected symptoms
• Signs of an allergic reaction, such as rash, itching, or difficulty breathing
• Severe abdominal pain or persistent diarrhea

How quickly should improvement be noticed when taking Flagyl S. While individual responses may vary, most patients begin to notice improvement in their symptoms within 2-3 days of starting treatment. However, it’s crucial to complete the entire prescribed course, even if you feel better, to ensure complete eradication of the infection.

Special Considerations for Prolonged Flagyl S Therapy

In some cases, Flagyl S may be prescribed for extended periods. Patients on long-term therapy should be aware of potential risks and additional monitoring requirements:

• Regular liver function tests may be necessary
• Increased risk of peripheral neuropathy (numbness or tingling in hands and feet)
• Potential for candidiasis (yeast infection) due to disruption of normal flora

What precautions should be taken during prolonged Flagyl S therapy. During extended treatment, maintain open communication with your healthcare provider, report any new or worsening symptoms promptly, and attend all scheduled follow-up appointments for proper monitoring and assessment of treatment efficacy.

Nutritional Considerations During Treatment

While taking Flagyl S, particularly for extended periods, it’s important to maintain a balanced diet and stay well-hydrated. Some patients may benefit from probiotic supplementation to help maintain healthy gut flora. However, always consult with your healthcare provider before starting any new supplements during treatment.

Proper Storage and Handling of Flagyl S Suspension

To maintain the effectiveness and safety of Flagyl S suspension, follow these storage guidelines:

• Keep the medication in its original container
• Store at room temperature, below 25°C (77°F)
• Protect from light and excessive heat
• Keep out of reach of children
• Do not use after the expiration date printed on the bottle

How long can Flagyl S suspension be used after opening. Once opened, Flagyl S suspension typically remains stable for 14 days when stored properly. However, always check the package insert or consult your pharmacist for specific storage instructions, as recommendations may vary by manufacturer.

Disposal of Unused Medication

Proper disposal of unused or expired Flagyl S is important to prevent accidental ingestion and environmental contamination. Do not flush the medication down the toilet or pour it down the drain. Instead, check with your local pharmacy about medication take-back programs or follow FDA guidelines for safe disposal of unused medications.

Flagyl S in Pregnancy and Breastfeeding

The use of Flagyl S during pregnancy and breastfeeding requires careful consideration and should only be done under the close supervision of a healthcare provider:

• Pregnancy: Flagyl S is generally avoided during the first trimester unless the potential benefits outweigh the risks
• Breastfeeding: Metronidazole is excreted in breast milk and may affect the infant. Temporary discontinuation of breastfeeding may be recommended during treatment

Can Flagyl S be safely used during any stage of pregnancy. While Flagyl S is generally considered safe during the second and third trimesters, its use should always be evaluated on a case-by-case basis. The potential benefits of treating the infection must be weighed against any possible risks to the developing fetus.

Alternative Treatments for Pregnant or Breastfeeding Women

In some cases, alternative antibiotics or treatment approaches may be considered for pregnant or breastfeeding women. These might include:

• Clindamycin for bacterial vaginosis
• Ampicillin for certain anaerobic infections
• Probiotics for maintaining vaginal health

The choice of treatment will depend on the specific infection, its severity, and the stage of pregnancy or breastfeeding. Always consult with your healthcare provider to determine the most appropriate and safe treatment option for your individual situation.

Flagyl S Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.

Why am I using Flagyl S?

Flagyl S contains the active ingredient metronidazole benzoate (liquid). Flagyl S
is used to treat certain infections caused by bacteria and other organisms in different
parts of the body. It is also used to prevent or treat certain infections that may
occur during surgery.

For more information, see Section 1. Why am I using Flagyl S? in the full CMI.

What should I know before I use Flagyl S?

Do not use if you have ever had an allergic reaction to Flagyl S or any of the ingredients
listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Flagyl S? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with Flagyl S and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I use Flagyl S?

Follow the instructions provided and use Flagyl S until your doctor tells you to stop.

More instructions can be found in Section 4. How do I use Flagyl S? in the full CMI.

What should I know while using Flagyl S?

For more information, see Section 5. What should I know while using Flagyl S? in the full CMI.

Are there any side effects?

Serious side effects: Allergic reaction: Some symptoms of an allergic reaction include skin rash, itching,
shortness of breath or swelling of the face, lips or tongue, which may cause difficulty
in swallowing or breathing. If you have been on prolonged Flagyl S therapy, you may
experience unusual numbness of the feet or hands.

Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.

For more information, including what to do if you have any side effects, see Section
in the full CMI.

Active ingredients:
Metronidazole benzoate (met-ro(h)-nide-ah-zole benz-o(h)-ate) 200 mg/5 mL oral suspension

Consumer Medicine Information (CMI)

This leaflet provides important information about using Flagyl S. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Flagyl S.

Where to find information in this leaflet:

1. Why am I using Flagyl S?

2. What should I know before I use Flagyl S?

3. What if I am taking other medicines?

4. How do I use Flagyl S?

5. What should I know while using Flagyl S?

6. Are there any side effects?

7. Product details

Why am I using Flagyl S?

Flagyl S contains the active ingredient metronidazole benzoate (liquid). Flagyl S is an antibiotic that belongs to a group of medicines called nitroimidazoles.

Flagyl S is used to treat certain infections caused by bacteria and other organisms
in different parts of the body.

It is also used to prevent or treat certain infections that may occur during surgery.

This medicine works by killing or stopping the growth of bacteria and other organisms
causing these infections.

Your doctor may have prescribed Flagyl S for another reason.

Ask your doctor if you have any questions about why Flagyl S has been prescribed for
you.

This medicine is available only with a doctor’s prescription.

There is no evidence that this medicine is addictive.

What should I know before I use Flagyl S?

Warnings

Do not use Flagyl S if:

you are allergic to metronidazole or any other nitroimidazoles, or any of the ingredients
listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

you have evidence of, or have a history of, a blood disorder.

you have, or have ever had, a disease of the brain, spinal cord or nerves.

the expiry date on the pack has passed. If you use this medicine after the expiry
date has passed it may have no effect at all, or worse, an entirely different effect.

the packaging is torn or shows signs of tampering.

Check with your doctor if you:

have any allergies to any other medicines or any other substances such as foods, preservatives
or dyes.

have or have ever had any health problems/ medical conditions including:

a blood disorder

disease of the brain, spinal cord or nerves

liver or kidney disease

an inflammatory disease of the small intestine (e.g., Crohn’s disease)

Cockayne syndrome

drink alcohol. Do not drink alcohol during (and for 24 hours after stopping) treatment
with Flagyl S.

If you have not told your doctor or pharmacist about any of the above, tell them before
you start using Flagyl S.

During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.

Some medicines may interfere with Flagyl S and affect how well it works. These include:

any medication that may cause ECG disturbances (certain anti-arrhythmics (medicines
for heart rhythm disorders), certain antibiotics, psychotropic medicines)

warfarin or other medicines used to prevent blood clots

Antabuse® (disulfiram), a medicine used to treat chronic alcohol dependence

Medications containing alcohol (ethanol), e.g., some cough syrups

some anticancer drugs, such as carmustine, cyclophosphamide monohydrate, 5-fluorouracil
or busulfan

phenytoin, a drug used to treat convulsions

phenobarbital (phenobarbitone), a medicine for convulsions or sedation

cimetidine, a medicine used to treat gastric reflux and ulcers

lithium, a medicine used to treat manic depressive illness and some other types of
depression

cyclosporin, a medicine used to prevent organ transplant rejection or to treat immune
responses

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Flagyl S.

You may need different amounts of your medicine or you may need to take different
medicines. Your doctor will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while taking Flagyl S.

How do I use Flagyl S?

Follow all directions given to you by your doctor and pharmacist carefully. They may
differ from the information contained in this CMI.

If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.

How much to use

The dose will vary from patient to patient. Your doctor will decide the right dose
for you.

Follow the instructions provided when Flagyl S was prescribed, including the number
of days it should be taken.

How long to use

For treating infection, Flagyl S suspension is usually taken for 7 days, however,
your doctor may decide to reduce or extend your treatment. Your doctor will tell you
how much Flagyl S to take.

How to take Flagyl S suspension

Flagyl S suspension should be taken at least one hour before a meal or food.

This medicine works better if taken on an empty stomach.

If you forget to use Flagyl S

If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, then go back
to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering to take/use Flagyl S, ask your pharmacist for some
hints.

If you use too much Flagyl S

If you think that you have used too much Flagyl S, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling
Australia 13 11 26)

contact your doctor, or

go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much suspension you may experience vomiting and a feeling of disorientation.

What should I know while using Flagyl S?

Things you should do

Call your doctor straight away if:

the symptoms of your infection do not improve or become worse

you become pregnant

you are about to start taking any new medicines

Some people being treated with metronidazole can experience mental health problems
such as irrational thoughts, hallucinations, feeling confused or feeling depressed,
including thoughts of self-harm or suicide.

These symptoms can occur even in people who have never had similar problems before.
If you or others around you notice any of these side effects stop taking this medicine
and seek medical advice straight away.

If you get a sore, white mouth or tongue while taking or soon after stopping Flagyl
S treatment, tell your doctor. Also tell your doctor if you get vaginal itching or
discharge.

This may mean you have a fungal/yeast infection called thrush. Sometimes the use of
Flagyl S allows fungi/yeast to grow and the above symptoms to occur. Flagyl S does
not work against fungi/yeast.

If you are using Flagyl S for 10 days or longer, make sure you have any tests of your
blood and nervous system that your doctor may request.

If you need to have a blood test while using Flagyl S, tell your doctor as Flagyl
S may affect the results of some laboratory tests.

Remind any doctor, dentist or pharmacist you visit that you are using Flagyl S.

Things you should not do

Do not give Flagyl S to anyone else, even if they have the same condition as you.

Do not use Flagyl S to treat any other medical complaints unless your doctor tells
you to.

Do not stop taking your suspension if you feel better.

If you do not complete the full course prescribed by your doctor, all of the bacteria/organisms
causing your infection may not be killed. These bacteria/organisms may continue to
grow and multiply so that your infection may not clear completely or may return.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Flagyl
S affects you.

While using Flagyl S you may feel dizzy or experience vertigo (spinning sensation),
confused, hallucinations (see or hear things that are not there), convulsions (have
fits) or temporary eyesight problems (such as blurred or double vision). If this happens,
do not drive or use any machinery or tools.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may make you feel very sick, vomit, have stomach cramps, headaches and flushing.

Do not drink alcohol during (and for 24 hours after stopping) treatment with Flagyl
S.

Looking after your medicine

Keep Flagyl S suspension in a cool dry place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store in a cool dry place away from moisture, heat or sunlight; for example, do not
store it:

in the bathroom or near a sink, or

in the car or on window sills

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.

Do not use this medicine after the expiry date.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effect you experience, you can
report side effects as follows:

Australia: Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems 

By reporting side effects, you can help provide more information on the safety of
this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.

Product details

This medicine is only available with a doctor’s prescription.

What Flagyl S contains

Do not take this medicine if you are allergic to any of these ingredients.

What Flagyl S looks like

There are three forms of Flagyl: Flagyl tablets, Flagyl S suspension and Flagyl suppositories.
Flagyl tablets and suppositories are covered by a separate CMI.

Flagyl S suspension (Aust R 27501) is a creamy white to yellow liquid with an orange/lemon
odour in a 100 mL bottle.

Who distributes Flagyl S

Flagyl S is supplied in Australia by:

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Australia

Freecall No: 1800 818 806

This leaflet was prepared in March 2022.

flagyl S-ccdsv17-cmiv12-31mar22

How to Avoid Bad Medication and Food Combinations

When taking medications, it’s important to check the labels for any potentially toxic interactions that can be caused by food. Several medication and food combinations could make the medication ineffective or even impact your body in severe, negative ways.

Read about some of the drug and food interactions you should be aware of:

Grapefruit juice

Do not mix grapefruit juice with antihistamines, blood pressure drugs, thyroid replacement drugs, birth control, stomach acid-blocking drugs and the cough suppressant dextromethorphan.

Grapefruit can increase or decrease the absorption of certain drugs. It causes the body to metabolize drugs abnormally, resulting in lower or higher than normal blood levels of the drug. It’s best to avoid or significantly reduce intake of grapefruit juice when taking these medications.

Unlike other citrus juices, grapefruit juice contains a class of compounds called furanocoumarins, which act in the body to alter the characteristics of these medications.

Orange juice and other citrus juices do not contain these compounds. There is some concern for Seville oranges and the pomelo, which are relatives of the grapefruit.

Bananas, green leafy vegetables, oranges, salt substitutes

Do not mix these items with ACE inhibitors such as captopril (Capoten), enalapril (Vasotec), and lisinopril (Prinivil, Zestril), used to lower blood pressure or treat heart failure. And avoid mixing with some diuretics, such as triamterene (Dyrenium), used to reduce fluid retention and treat high blood pressure.

These foods are all high in potassium, which helps provide electrical signals to heart-muscle cells and other cells. Consuming them with these medications could increase the amount of potassium in your body and may lead to an irregular heartbeat or heart palpitations—which could be deadly.

Broccoli, Brussels sprouts, cabbage, kale, spinach

Do not mix these items with blood thinners such as warfarin (Coumadin).

Foods that contain a lot of vitamin K, such as these greens, can reduce the drugs’ ability to thin the blood. In some people with heart disease, that could trigger a heart attack or a stroke. Once you begin taking warfarin, maintain a consistent diet and don’t suddenly overload on leafy greens.

Real black licorice (or supplements with licorice extract)

Do not mix these items with digoxin (Lanoxin), used to treat heart failure and abnormal heart rhythms. It’s also best not to consume real black licorice with most blood pressure drugs, blood thinners, and birth-control pills.

Real black licorice (and products with licorice extract, as opposed to licorice-flavored candy) contain glycyrrhizin, which can cause an irregular heartbeat, or even death, when combined with digoxin. Glycyrrhizin may reduce the effectiveness of most blood pressure drugs, intensify the side effects of blood thinners, and raise blood pressure and lower potassium levels when consumed with birth-control pills.

Cheese, yogurt, milk, calcium supplements, antacids with calcium

Do not mix these items with tetracycline.

The calcium in these foods and products can interfere with the body’s ability to absorb the antibiotic fully.

Alcohol, avocados, bananas, chocolate, salami

Do not mix these items with drugs such as metronidazole (Flagyl) and linezolid (Zyvox), used to treat bacterial infections.

These foods, along with tap beer, red wine, and sherry, contain tyramine, an amino acid that can cause blood pressure to spike if taken with linezolid. Tyramine is also found in foods that are aged, pickled, fermented, or smoked, such as processed cheeses, anchovies, and dry sausage. Alcohol and metronidazole together could cause nausea, stomach cramping, and vomiting.

Soybean flour, walnuts

Do not mix these items with thyroid drugs such as levothyroxine (Levothroid, Levoxyl, Synthroid).

These high-fiber foods can prevent your body from absorbing these medications. If you eat a high-fiber diet, try taking your medications later in the evening.

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Photo credit: margouillatphotos

Flagyl film-coated tablets 250mg No.

20 at a low price in Omsk, instructions for use, composition, analogues 0

International non-proprietary name

Metronidazole

Medicinal form

film-coated tablets.

Composition

One tablet contains:

tablet core:

active ingredient: metronidazole – 250 mg,

excipients: wheat starch – 82.15 mg, povidone – 17.5 mg, magnesium stearate – 0.35 mg;

tablet shell: hypromellose 2.1 mg, macrogol 20000 0.7 mg.

Description

Film-coated tablets, round, white to light yellow, debossed with “F 250” on one side. Cross-sectional view: from white to light yellow.

Pharmacotherapeutic group

Antimicrobial and antiprotozoal agent

ATC code

P01AB01

Pharmacological properties

Pharmacodynamics

Me Tronidazole is a derivative of 5-nitroimidazole. The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.

Active against Trichomonas vaginalis, Entamoeba histolytica , as well as Gram-negative anaerobes Bacteroides spp. (including B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp. , and some gram-positive anaerobes (sensitive strains Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp .). The MIC for these strains is 0.125–6.25 µg/mL. In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin inhibits the development of resistance to metronidazole).

Metronidazole is insensitive Aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against normal aerobes.

Pharmacokinetics

When administered orally, metronidazole is rapidly and almost completely absorbed (approximately 80% in 1 hour). Eating does not affect the absorption of metronidazole. Bioavailability not less than 80%. After oral administration of 500 mg of metronidazole, the plasma concentration is 10 μg / ml after 1 hour, and 13.5 μg / ml after 3 hours. The half-life is 8-10 hours, the connection with blood proteins is insignificant and does not exceed 10-20%. Metronidazole quickly penetrates into tissues (lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, seminal fluid, vaginal secretions), into breast milk and passes through the placental barrier.

About 30-60% of metronidazole is metabolized by hydroxylation, oxidation and glucuronidation. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects.

Excretion of metronidazole is carried out by 40-70% through the kidneys (in unchanged form – about 35% of the accepted dose). In patients with impaired renal function, a course of taking metronidazole may increase its concentration in the blood serum.

Readings

Protozoal infections: extraintestinal amoebiasis, including amoebic liver abscess, intestinal amoebiasis (amebic dysentery), trichomoniasis (including).

Infections due to Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B; thetaiotaomicron, B. vulgatus) , infections of bones and joints, infections of the central nervous system (CNS), including meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema and lung abscess, sepsis.

Species 9 infections0025 Clostridium spp., Peptococcus niger and Peptostreptococcus spp.: infections of the abdominal cavity (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infections of the vaginal fornix).

Pseudomembranous colitis (associated with antibiotic use).

Gastritis or duodenal ulcer associated with Helicobacter pylori (complex therapy).

Prevention of postoperative complications (especially interventions on the colon, pararectal area, appendectomy, gynecological operations).

Contraindications

• Hypersensitivity to imidazoles and nitroimidazole derivatives.
• Organic disorders of the central nervous system (including epilepsy).
• Leukopenia (including history).
• Liver failure (in case of high doses).
• Pregnancy.
• lactation.
• Children under 10 years of age.

Precautions

• Hepatic encephalopathy.
• Acute and chronic diseases of the peripheral and central nervous system (risk of worsening neurological symptoms).
• Renal failure.

Dosage and Administration

Metronidazole is intended for oral administration before or after meals. Drink plenty of water.

For intestinal amoebiasis Flagyl ^® is used for 7 days at 1500 mg per day in three divided doses. In acute amoebic dysentery – the daily dose is 2250 mg, divided into three doses. Children from 10 to 15 years old – 500 mg per day, divided into 2 doses.

For liver abscess and other extraintestinal forms of amoebiasis The maximum daily dose is 2,500 mg divided into 3 doses for 3-5 days, in combination with tetracycline antibiotics and other therapies. Children from 10 to 15 years old – 500 mg per day, divided into 2 doses.

For trichomoniasis in women (urethritis and vaginitis) Flagyl ^® is prescribed as a single dose of 2 g or as a course of treatment for 10 days: 1 tab. (250 mg) 2 times a day.

For trichomoniasis in men (urethritis) Flagyl ^® is prescribed as a single dose of 2 g or as a course of treatment for 10 days, 1 tab. (250 mg) 2 times a day.

Treatment of anaerobic infections is usually started with intravenous infusions, followed by the transition to tablets. For adults, the dose of Flagyl ^® is 500 mg 3 times a day. The duration of treatment is up to 7 days.

For the treatment of pseudomembranous colitis , 500 mg of Flagyl ^® (2 tablets) are prescribed 3-4 times a day. The duration of treatment is determined by the doctor.

For the eradication of Helicobacter pylori , 500 mg of Flagyl ^® is prescribed 3 times a day as part of combination therapy (for example, with amoxicillin).

To prevent postoperative complications 750-1500 mg per day in 3 divided doses 3-4 days before surgery. 1-2 days after the operation (when ingestion is already allowed) – 750 mg of Flagyl ^® per day for 7 days.

Side effects

Gastrointestinal disorders

Epigastric pain, nausea, vomiting, diarrhea.

Inflammation of the oral mucosa (glossitis, stomatitis), taste disturbances (“metallic” taste in the mouth), loss of appetite, anorexia, dryness of the oral mucosa, constipation.

Pancreatitis (reversible cases).

Discoloration of the tongue / “coated tongue” (due to the growth of fungal microflora).

Immune system disorders

Angioedema, anaphylactic shock.

Nervous system disorders

Peripheral sensory neuropathy.

Headache, convulsions, dizziness.

Encephalopathy (eg, confusion) and subacute cerebellar syndrome (impaired coordination and synergism of movements, ataxia, dysarthria, gait disturbances, nystagmus and tremor) have been reported, which regress after metronidazole is discontinued.

Aseptic meningitis.

Mental disorders

Psychotic disorders, including confusion, hallucinations.

Depression, insomnia, irritability, irritability.

Visual disturbances

Transient visual disturbances such as diplopia, myopia, blurring of the contours of objects, decreased visual acuity, impaired color perception.

Neuropathy/optic neuritis.

Blood and lymphatic disorders

Agranulocytosis, leukopenia, neutropenia and thrombocytopenia.

Liver and biliary tract disorders

Increased activity of “liver” enzymes (aspartate aminotransferase (ACT) and alanine aminotransferase (ALT), alkaline phosphatase), development of cholestatic or mixed hepatitis and hepatocellular liver damage, sometimes accompanied by jaundice.

Patients treated with metronidazole in combination with other antibiotics have experienced liver failure requiring liver transplantation.

Skin and subcutaneous tissue disorders

Rash, itching, skin flushing, urticaria.

Pustular skin rash.

Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal and urinary tract disorders

Brown-reddish urine may be stained due to the presence of a water-soluble metabolite of metronidazole in the urine.

Dysuria, polyuria, cystitis, urinary incontinence, candidiasis.

General disorders and administration site disorders

Fever, nasal congestion, arthralgia, weakness.

Laboratory and instrumental data

Flattening of the T wave on the ECG.

Interaction with other medicinal products

With disulfiram

Psychotic reactions have been reported in patients receiving both metronidazole and disulfiram (the interval between the administration of these metronidazoles must be at least 2 weeks).

With ethanol

Difulfiram-like reactions may occur (skin hyperemia, vomiting, tachycardia).

With indirect anticoagulants (warfarin)

Increased anticoagulant effect and increased hemorrhagic risk associated with a slowdown in their hepatic metabolism, which may lead to an increase in prothrombin time. In the case of simultaneous use, more frequent monitoring of prothrombin time is required and, if necessary, dose adjustment of anticoagulants.

With lithium preparations

Simultaneous administration of metronidazole with lithium preparations may increase the concentration of the latter in the blood plasma. With simultaneous use, plasma concentrations of lithium, creatinine and electrolytes should be monitored.

With cyclosporine

Simultaneous administration of metronidazole with cyclosporine may increase the serum concentration of cyclosporine. If necessary, the simultaneous use of these two metronidazoles requires monitoring of serum concentrations of cyclosporine and creatinine.

With cimetidine

Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increase in the risk of side effects.

With drugs that induce liver microsomal oxidation enzymes (phenobarbital, phenytoin)

Simultaneous administration of metronidazole with drugs that stimulate hepatic microsomal oxidation enzymes (phenobarbital, phenytoin) may accelerate the elimination of metronidazole, resulting in a decrease in its plasma concentration .

With fluorouracil

Metronidazole reduces the clearance of fluorouracil, leading to an increase in its toxicity.

With busulfan

Metronidazole increases the plasma concentration of busulfan, which can lead to the development of a severe toxic effect of busulfan.

With non-depolarizing muscle relaxants (vecuronium bromide)

Not recommended in combination with non-depolarizing muscle relaxants (vecuronium bromide).

Sulfonamides enhance the antimicrobial effect of metronidazole.

Warnings

Since concomitant use of metronidazole with alcohol may have an effect similar to that of disulfiram (fever, vomiting, tachycardia), patients should be warned that during treatment with Flagyl ^® , alcoholic beverages or drugs should not be consumed containing alcohol.

The indications for long-term use of the drug should be carefully weighed and long-term use should be avoided without strong indications. If, in the presence of strict indications, the drug is used for a longer time than is usually recommended, then treatment should be carried out under the control of hematological parameters and adverse reactions, such as peripheral or central neuropathy (paresthesia, ataxia, dizziness, convulsions), in the event of which treatment should be discontinued .

In the treatment of trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to abstain from sexual intercourse. Mandatory simultaneous treatment of sexual partners.

Treatment does not stop during menses. After therapy for trichomoniasis, control tests should be carried out for 3 regular cycles before and after menstruation.

Be aware that metronidazole can immobilize treponemes resulting in a false positive Nelson test.

Influence on the ability to drive vehicles, mechanisms

Taking into account the profile of side effects (dizziness, visual impairment, etc.), it is recommended to refrain from driving during treatment, from engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions .

Formulation

Film-coated tablets, 250 mg.

10 tablets in a PVC/aluminum foil blister.

2 blisters with instructions for use in a cardboard box.

Storage

Store in a place protected from light, at a temperature not exceeding 30 °C.

Keep out of reach of children.

Shelf life

3 years.

Do not use after the expiry date.

Terms of dispensing from pharmacies

Dispensed by prescription.

Flagyl – instructions for use

Flagyl ^®

Instruction:

• Dosage form
• Composition
• Description
• Pharmacological action
• Readings
• Contraindications
• With care
• Dosage and Administration
• Side effects
• Interaction
• Special instructions
• Transport management
• Release form
• Storage
• Expiry date
• Terms of dispensing from pharmacies
• Classification

Dosage form

film-coated tablets.

Composition

One tablet contains:

tablet core:

active substance: metronidazole – 250 mg,

excipients: wheat starch – 82.15 mg, povidone – 17.5 mg, magnesium stearate – 0 .35 mg;

tablet shell: hypromellose 2.1 mg, macrogol 20000 0.7 mg.

Description

Film-coated tablets, round, white to light yellow, debossed with “F 250” on one side. Cross-sectional view: from white to light yellow.

Pharmacological action

Pharmacodynamics

Metronidazole is a derivative of 5-nitroimidazole. The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.

Active against Trichomonas vaginalis, Entamoeba histolytica and Gram-negative anaerobes Bacteroides spp. (including B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp. , and some gram-positive anaerobes (sensitive strains Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp .). The MIC for these strains is 0.125–6.25 µg/mL. In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin inhibits the development of resistance to metronidazole).

Metronidazole is insensitive aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against normal aerobes.

Pharmacokinetics

When administered orally, metronidazole is rapidly and almost completely absorbed (approximately 80% in 1 hour). Eating does not affect the absorption of metronidazole. Bioavailability not less than 80%. After oral administration of 500 mg of metronidazole, the plasma concentration is 10 μg / ml after 1 hour, and 13.5 μg / ml after 3 hours. The half-life is 8-10 hours, the connection with blood proteins is insignificant and does not exceed 10-20%. Metronidazole quickly penetrates into tissues (lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, seminal fluid, vaginal secretions), into breast milk and passes through the placental barrier.

About 30-60% of metronidazole is metabolized by hydroxylation, oxidation and glucuronidation. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects.

Excretion of metronidazole is carried out by 40-70% through the kidneys (in unchanged form – about 35% of the accepted dose). In patients with impaired renal function, a course of taking metronidazole may increase its concentration in the blood serum.

Indications

Protozoal infections: extraintestinal amoebiasis, including amoebic liver abscess, intestinal amoebiasis (amebic dysentery), trichomoniasis (including).

Infections due to Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B; thetaiotaomicron, B. vulgatus) , infections of bones and joints, infections of the central nervous system (CNS), including meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema and lung abscess, sepsis.

Infections caused by Clostridium spp., Peptococcus niger and Peptostreptococcus spp.

Pseudomembranous colitis (associated with antibiotic use).

Gastritis or duodenal ulcer associated with Helicobacter pylori (complex therapy).

Prevention of postoperative complications (especially interventions on the colon, pararectal area, appendectomy, gynecological operations).

Contraindications

• Hypersensitivity to imidazoles and nitroimidazole derivatives.
• Organic disorders of the central nervous system (including epilepsy).
• Leukopenia (including history).
• Liver failure (in case of high doses).
• Pregnancy.
• lactation.
• Children under 10 years of age.

Precautions

• Hepatic encephalopathy.
• Acute and chronic diseases of the peripheral and central nervous system (risk of worsening neurological symptoms).
• Renal failure.

Dosage and Administration

Metronidazole is intended for oral administration before or after meals. Drink plenty of water.

For intestinal amoebiasis Flagyl ^® is used for 7 days at 1,500 mg per day in three divided doses. In acute amoebic dysentery – the daily dose is 2250 mg, divided into three doses. Children from 10 to 15 years old – 500 mg per day, divided into 2 doses.

For liver abscess and other extraintestinal forms of amoebiasis the maximum daily dose is 2500 mg divided into 3 doses for 3-5 days, in combination with tetracycline antibiotics and other methods of therapy. Children from 10 to 15 years old – 500 mg per day, divided into 2 doses.

For trichomoniasis in women (urethritis and vaginitis) Flagyl ^® is prescribed as a single dose of 2 g or as a course of treatment for 10 days: 1 tab. (250 mg) 2 times a day.

For trichomoniasis in men (urethritis) Flagyl ^® is prescribed as a single dose of 2 g or as a course of treatment for 10 days, 1 tab. (250 mg) 2 times a day.

Treatment of anaerobic infections is usually started with intravenous infusions, followed by the transition to tablets. For adults, the dose of Flagyl ^® is 500 mg 3 times a day. The duration of treatment is up to 7 days.

For the treatment of pseudomembranous colitis , 500 mg of Flagyl ^® (2 tablets) is prescribed 3-4 times a day. The duration of treatment is determined by the doctor.

For the eradication of Helicobacter pylori , 500 mg of Flagyl ^® is prescribed 3 times a day as part of a combination therapy (for example, with amoxicillin).

To prevent postoperative complications 750-1500 mg per day in 3 divided doses 3-4 days before surgery. 1-2 days after the operation (when ingestion is already allowed) – 750 mg of Flagyl ^® per day for 7 days.

Side effects

Gastrointestinal disorders

Epigastric pain, nausea, vomiting, diarrhea.

Inflammation of the oral mucosa (glossitis, stomatitis), taste disturbances (“metallic” taste in the mouth), loss of appetite, anorexia, dryness of the oral mucosa, constipation.

Pancreatitis (reversible cases).

Discoloration of the tongue / “coated tongue” (due to the growth of fungal microflora).

Immune system disorders

Angioedema, anaphylactic shock.

Nervous system disorders

Peripheral sensory neuropathy.

Headache, convulsions, dizziness.

Encephalopathy (eg, confusion) and subacute cerebellar syndrome (impaired coordination and synergism of movements, ataxia, dysarthria, gait disturbances, nystagmus and tremor) have been reported, which regress after metronidazole is discontinued.

Aseptic meningitis.

Mental disorders

Psychotic disorders, including confusion, hallucinations.

Depression, insomnia, irritability, irritability.

Visual disturbances

Transient visual disturbances such as diplopia, myopia, blurring of the contours of objects, decreased visual acuity, impaired color perception.

Neuropathy/optic neuritis.

Blood and lymphatic disorders

Agranulocytosis, leukopenia, neutropenia and thrombocytopenia.

Liver and biliary tract disorders

Increased activity of “liver” enzymes (aspartate aminotransferase (ACT) and alanine aminotransferase (ALT), alkaline phosphatase), development of cholestatic or mixed hepatitis and hepatocellular liver damage, sometimes accompanied by jaundice.

Patients treated with metronidazole in combination with other antibiotics have experienced liver failure requiring liver transplantation.

Skin and subcutaneous tissue disorders

Rash, itching, skin flushing, urticaria.

Pustular skin rash.

Stevens-Johnson syndrome, toxic epidermal necrolysis.

Renal and urinary tract disorders

Brown-reddish urine may be stained due to the presence of a water-soluble metabolite of metronidazole in the urine.

Dysuria, polyuria, cystitis, urinary incontinence, candidiasis.

General disorders and administration site disorders

Fever, nasal congestion, arthralgia, weakness.

Laboratory and instrumental data

Flattening of the T wave on the ECG.

Interactions

With disulfiram

Psychotic reactions have been reported in patients treated concomitantly with metronidazole and disulfiram (the interval between administration of these metronidazoles must be at least 2 weeks).

With ethanol

Difulfiram-like reactions may occur (skin hyperemia, vomiting, tachycardia).

With indirect anticoagulants (warfarin)

Increased anticoagulant effect and increased hemorrhagic risk associated with a slowdown in their hepatic metabolism, which may lead to an increase in prothrombin time. In the case of simultaneous use, more frequent monitoring of prothrombin time is required and, if necessary, dose adjustment of anticoagulants.

With lithium preparations

Simultaneous administration of metronidazole with lithium preparations may increase the concentration of the latter in the blood plasma. With simultaneous use, plasma concentrations of lithium, creatinine and electrolytes should be monitored.

With cyclosporine

Simultaneous administration of metronidazole with cyclosporine may increase the serum concentration of cyclosporine. If necessary, the simultaneous use of these two metronidazoles requires monitoring of serum concentrations of cyclosporine and creatinine.

With cimetidine

Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increase in the risk of side effects.

With drugs that induce liver microsomal oxidation enzymes (phenobarbital, phenytoin)

Simultaneous administration of metronidazole with drugs that stimulate hepatic microsomal oxidation enzymes (phenobarbital, phenytoin) may accelerate the elimination of metronidazole, resulting in a decrease in its plasma concentration .

With fluorouracil

Metronidazole reduces the clearance of fluorouracil, leading to an increase in its toxicity.

With busulfan

Metronidazole increases the plasma concentration of busulfan, which can lead to the development of a severe toxic effect of busulfan.

With non-depolarizing muscle relaxants (vecuronium bromide)

Not recommended in combination with non-depolarizing muscle relaxants (vecuronium bromide).

Sulfonamides enhance the antimicrobial effect of metronidazole.

Precautions

Since concomitant use of metronidazole with alcohol may have an effect similar to that of disulfiram (fever, vomiting, tachycardia), patients should be warned that during treatment with Flagyl ^® , alcoholic beverages or drugs should not be consumed, containing alcohol.

The indications for long-term use of the drug should be carefully weighed and long-term use should be avoided without strong indications. If, in the presence of strict indications, the drug is used for a longer time than is usually recommended, then treatment should be carried out under the control of hematological parameters and adverse reactions, such as peripheral or central neuropathy (paresthesia, ataxia, dizziness, convulsions), in the event of which treatment should be discontinued .

In the treatment of trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to abstain from sexual intercourse. Mandatory simultaneous treatment of sexual partners.

Treatment does not stop during menses. After therapy for trichomoniasis, control tests should be carried out for 3 regular cycles before and after menstruation.

Be aware that metronidazole can immobilize treponemes resulting in a false positive Nelson test.

Influence on the ability to drive vehicles or work with mechanisms reactions.

Form

Film-coated tablets, 250 mg.