What is clindamycin used for. How should clindamycin be taken. What are the potential side effects of clindamycin. Who should avoid taking clindamycin. How does clindamycin work against bacterial infections.

Understanding Clindamycin: A Powerful Antibiotic

Clindamycin is a potent antibiotic belonging to the lincomycin class of medications. It’s primarily used to combat various bacterial infections, offering a robust solution when other antibiotics may not suffice. However, its usage comes with important considerations and potential risks that both healthcare providers and patients should be aware of.

What is Clindamycin?

Clindamycin is an antibiotic that works by inhibiting bacterial protein synthesis, effectively slowing or stopping the growth of bacteria. It’s available in multiple forms, including capsules and oral solutions, providing flexibility in administration based on patient needs and the specific infection being treated.

Indications for Clindamycin Use

Clindamycin is prescribed for a variety of bacterial infections. Its broad spectrum of activity makes it valuable in treating:

• Lung infections
• Skin infections
• Blood infections
• Infections of the female reproductive organs
• Internal organ infections

Additionally, clindamycin finds application in less common scenarios:

• Acne treatment
• Management of anthrax exposure
• Treatment of malaria in combination with other medications
• Ear infections resistant to other antibiotics
• Tonsillitis and pharyngitis in specific cases
• Toxoplasmosis in immunocompromised individuals
• Bacterial vaginosis
• Prevention of endocarditis in high-risk dental procedures

Proper Administration of Clindamycin

Correct usage of clindamycin is crucial for its effectiveness and to minimize potential side effects. Here are the key points to remember:

• Typically taken three to four times daily
• Duration of treatment varies based on the infection type and response
• Should be taken at consistent times each day
• Liquid form should be well-shaken before each use
• Capsules should be taken with a full glass of water to prevent throat irritation

Is it necessary to complete the entire course of clindamycin? Yes, it’s crucial to finish the prescribed course, even if symptoms improve. Stopping early may lead to incomplete treatment and contribute to antibiotic resistance.

Potential Side Effects and Risks of Clindamycin

While clindamycin is effective against many bacterial infections, it’s not without risks. One of the most significant concerns is its potential to cause overgrowth of harmful bacteria in the large intestine, leading to conditions ranging from mild diarrhea to severe colitis.

Warning Signs to Watch For

Patients should be vigilant for the following symptoms during and after treatment:

• Watery or bloody stools
• Diarrhea
• Stomach cramps
• Fever

These symptoms may indicate a serious intestinal condition and require immediate medical attention.

Precautions and Contraindications

Before starting clindamycin treatment, it’s essential to consider several factors:

Allergies and Sensitivities

Patients should inform their healthcare provider about any allergies, especially to:

• Clindamycin
• Lincomycin
• Aspirin (for those taking clindamycin capsules)
• Tartrazine (a yellow dye found in some medications)

Medical History

Certain medical conditions may affect the suitability of clindamycin treatment. These include:

• History of colitis or other gastrointestinal conditions
• Liver disease
• Kidney disease

Clindamycin in Special Populations

The use of clindamycin requires special consideration in certain groups:

Pregnancy and Breastfeeding

Can pregnant or breastfeeding women safely use clindamycin? While clindamycin can cross the placenta and is present in breast milk, its use may be necessary in some cases. The potential benefits must be weighed against the risks, and this decision should be made in consultation with a healthcare provider.

Pediatric Use

Clindamycin can be used in children, but dosing is typically based on weight and the specific condition being treated. Careful monitoring is essential to ensure safety and efficacy.

Geriatric Use

Older adults may be more sensitive to the effects of clindamycin, particularly its impact on the gastrointestinal system. Dose adjustments may be necessary, and close monitoring is advised.

Drug Interactions and Considerations

Clindamycin can interact with various medications and substances, potentially affecting its efficacy or increasing the risk of side effects. Some important interactions to be aware of include:

• Erythromycin: May reduce the effectiveness of clindamycin
• Muscle relaxants: Clindamycin may enhance their effects
• Warfarin: Clindamycin may increase the risk of bleeding
• Live bacterial vaccines: Clindamycin may reduce their effectiveness

How can patients ensure they’re avoiding problematic drug interactions? It’s crucial to provide a complete list of all medications, supplements, and herbal products to the healthcare provider before starting clindamycin treatment.

Monitoring and Follow-up During Clindamycin Treatment

Proper monitoring during clindamycin treatment is essential for ensuring its effectiveness and catching any potential issues early. Here are some key aspects of monitoring:

Symptom Improvement

Patients should typically begin to feel better within the first few days of treatment. If symptoms persist or worsen, it’s important to contact the healthcare provider promptly.

Gastrointestinal Health

Given the potential for intestinal complications, patients should be vigilant about any changes in bowel habits or abdominal discomfort, even after completing the course of antibiotics.

Liver Function

In some cases, particularly with prolonged use, healthcare providers may recommend periodic liver function tests to ensure the medication isn’t causing any adverse effects on the liver.

How frequently should patients follow up with their healthcare provider during clindamycin treatment? This can vary based on the specific condition being treated and individual patient factors, but generally, at least one follow-up appointment is recommended to assess progress and address any concerns.

Alternative Treatments and Considerations

While clindamycin is an effective antibiotic for many conditions, it’s not always the first-line choice due to its potential for side effects, particularly gastrointestinal issues. In some cases, alternative antibiotics or treatment approaches may be considered:

Alternative Antibiotics

Depending on the specific infection and its sensitivity, other antibiotics that may be considered include:

• Penicillins
• Cephalosporins
• Macrolides
• Fluoroquinolones

Non-Antibiotic Approaches

In some cases, particularly for conditions like acne or bacterial vaginosis, non-antibiotic treatments may be explored:

• Topical treatments
• Probiotics
• Lifestyle modifications

How do healthcare providers determine the most appropriate treatment approach? This decision is based on various factors, including the specific infection, its severity, the patient’s medical history, potential drug interactions, and local antibiotic resistance patterns.

Patient Education and Antibiotic Stewardship

Proper use of antibiotics like clindamycin is crucial not only for individual patient outcomes but also for broader public health concerns, particularly the growing issue of antibiotic resistance. Here are some key points for patient education:

Importance of Completing the Full Course

Patients should understand why it’s crucial to complete the entire prescribed course of antibiotics, even if they start feeling better. Stopping early can lead to incomplete eradication of the infection and contribute to antibiotic resistance.

Recognizing Appropriate Use

Educating patients about when antibiotics are and aren’t appropriate is essential. Clindamycin and other antibiotics are ineffective against viral infections like colds and flu, and their unnecessary use can increase the risk of developing antibiotic-resistant infections.

Proper Disposal

Patients should be instructed on how to properly dispose of unused antibiotics to prevent environmental contamination and reduce the risk of misuse.

How can healthcare providers effectively communicate the importance of antibiotic stewardship to patients? Clear, concise explanations of the risks of antibiotic misuse, combined with practical advice on proper usage and disposal, can help patients understand their role in combating antibiotic resistance.

Future Directions in Antibiotic Development and Use

As antibiotic resistance continues to be a global health concern, research into new antibiotics and alternative approaches to treating bacterial infections is ongoing. Some areas of focus include:

Novel Antibiotic Classes

Researchers are working to develop new classes of antibiotics that can overcome existing resistance mechanisms.

Combination Therapies

Using multiple antibiotics in combination may help prevent the development of resistance and improve efficacy against certain infections.

Targeted Delivery Systems

Developing methods to deliver antibiotics more precisely to the site of infection could improve efficacy while reducing side effects and the risk of resistance.

Alternatives to Traditional Antibiotics

Exploring options like bacteriophage therapy, immunomodulators, and probiotics as alternatives or adjuncts to traditional antibiotic treatment.

What role might clindamycin and similar antibiotics play in future treatment strategies? While newer approaches are being developed, antibiotics like clindamycin are likely to remain important tools in the fight against bacterial infections. However, their use may become more targeted and precise as diagnostic technologies improve and our understanding of bacterial resistance mechanisms evolves.

In conclusion, clindamycin remains a valuable antibiotic in the treatment of various bacterial infections. Its proper use, guided by healthcare professionals and informed by patient education, can contribute to effective treatment outcomes while minimizing the risks of side effects and antibiotic resistance. As research continues, the role of clindamycin and other antibiotics will likely evolve, but their importance in combating bacterial infections is likely to persist for the foreseeable future.

Clindamycin: MedlinePlus Drug Information

pronounced as (klin” da mye’ sin)

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Many antibiotics, including clindamycin, may cause overgrowth of dangerous bacteria in the large intestine. This may cause mild diarrhea or may cause a life-threatening condition called colitis (inflammation of the large intestine). Clindamycin is more likely to cause this type of infection than many other antibiotics, so it should only be used to treat serious infections that cannot be treated by other antibiotics. Tell your doctor if you have or have ever had colitis or other conditions that affect your stomach or intestines.

You may develop these problems during your treatment or up to several months after your treatment has ended. Call your doctor if you experience any of the following symptoms during your treatment with clindamycin or during the first several months after your treatment has finished: watery or bloody stools, diarrhea, stomach cramps, or fever.

Talk to your doctor about the risks of taking clindamycin.

Clindamycin is used to treat certain types of bacterial infections, including infections of the lungs, skin, blood, female reproductive organs, and internal organs. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria.

Antibiotics such as clindamycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Clindamycin comes as a capsule and a solution (liquid) to take by mouth. It is usually taken three to four times a day. The length of your treatment depends on the type of infection you have and how well you respond to the medication. Take clindamycin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take clindamycin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

Take the capsules with a full glass of water so that the medication will not irritate your throat.

You should begin to feel better during the first few days of treatment with clindamycin. If your symptoms do not improve or if they get worse, call your doctor.

Take clindamycin until you finish the prescription, even if you feel better. If you stop taking clindamycin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Clindamycin is also sometimes used to treat acne and is used along with other medications to treat anthrax (a serious infection that may be deliberately spread as part of a terror attack) and malaria (a serious infection that is spread by mosquitoes in certain parts of the world). Clindamycin is also sometimes used to treat ear infections, tonsillitis (infection that causes swelling of the tonsils), pharyngitis (infection that causes swelling in the back of the throat), and toxoplasmosis (an infection that may cause serious problems in people who do not have healthy immune systems or in unborn babies whose mothers are infected) when these conditions cannot be treated with other medications. Clindamycin is also sometimes used to treat bacterial vaginosis (an infection caused from too much of certain bacteria in the vagina). Clindamycin is also sometimes used to prevent endocarditis (infection of the heart valves) in certain people who are at risk of developing this infection as a result of a dental procedure. Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking clindamycin,

• tell your doctor and pharmacist if you are allergic to clindamycin, lincomycin (Lincocin), any other medications, or any of the ingredients in clindamycin capsules or solution. Ask your pharmacist for a list of the ingredients. If you will be taking clindamycin capsules, tell your doctor if you are allergic to aspirin or tartrazine (a yellow dye found in some medications).
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention clarithromycin (Biaxin, in PrevPac), erythromycin (E.E.S, E-Mycin, Erythrocin, others), indinavir (Crixivan), itraconazole (Sporanox), ketoconazole (Nizoral), nefazodone, nelfinavir (Viracept), rifampin (Rifadin, in Rifamate, in Rifater, Rimactane), and ritonavir (Norvir, in Kaletra). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with clindamycin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had asthma, allergies, eczema (sensitive skin that often becomes itchy or irritated) or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking clindamycin, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking clindamycin.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Clindamycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• unpleasant or metallic taste in the mouth
• joint pain
• pain when swallowing
• heartburn
• white patches in the mouth
• thick, white vaginal discharge
• burning, itching, and swelling of the vagina

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• peeling or blistering skin
• rash
• hives
• itching
• difficulty breathing or swallowing
• hoarseness
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• yellowing of the skin or eyes
• decreased urination

Clindamycin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate clindamycin liquid because it may thicken and become hard to pour. Dispose of any unused clindamycin liquid after 2 weeks.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

• Cleocin^®

Last Revised – 05/15/2018

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E-Mycin (erythromycin) Drug / Medicine Information

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

erythromycin (as ethyl succinate)

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about E-Mycin tablets and mixtures.

It does not contain all the available information. It does not take the place of talking
to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking
E-Mycin against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What E-Mycin is used for

E-Mycin is used to:

treat certain bacterial infections

control acne, in addition to other acne treatments

prevent infections in people with a history of rheumatic disease, congenital heart
disease or other acquired valvular heart disease and who are allergic to penicillin
antibiotics.

E-Mycin is an antibiotic that belongs to a group of medicines called macrolides. These
medicines work by killing or stopping the growth of bacteria, which cause infections
or make acne worse.

E-Mycin will not work against infections caused by viruses, such as colds or flu.

Ask your doctor if you have any questions about why E-Mycin has been prescribed for
you.

Your doctor may have prescribed E-Mycin for another reason.

E-Mycin is available only with a doctor’s prescription.

There is no evidence that E-Mycin is addictive.

Before you take E-Mycin

When you must not take it

Do not take E-Mycin if you are allergic to:

medicines containing erythromycin (e.g. EES) or any other antibiotic from the macrolide
group (e.g. clarithromycin, roxithromycin)

any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

Skin rash, itching or hives;

Swelling of the face, lips, tongue or other parts of the body;

Shortness of breath, wheezing or troubled breathing.

Do not take E-Mycin if you are taking any of the following medicines:

terfenadine or astemizole

cisapride, pimozide or domperidone

class IA and III antiarrhythmics e.g. quinidine, disopyramide, procainamide, amiodarone
and sotalol

certain neuroleptics and tri- and tetracyclic antidepressants

arsenic trioxide, methadone, budipine, certain fluoroquinolones, imidazole anti-mycotics
and anti-malarials e.g. petamidine i.v.

simvastatin, lovastatin or atorvastatin

ergotamine or dihydroergotamine

Taking E-Mycin with any of the above medicines may cause serious side effects.

Ask your doctor or pharmacist if you are not sure if you are taking one of the above
medicines.

Do not take E-Mycin if you have:

severe liver disease

heart rhythm disorders from birth of have developed it

irregular heartbeat or severe chronic heart failure

deficiency of potassium and magnesium in blood

Do not take E-Mycin if the packaging shows signs of tampering or the tablets or mixtures
do not look quite right.

Do not take E-Mycin if the expiry date (EXP) printed on the label has passed.

If you take this medicine after the expiry date, it may not work as well.

Do not use any E-Mycin mixture left in the bottle after 10 days.

If you are not sure whether you should start taking E-Mycin, talk to your doctor.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.

Your doctor will discuss the risks and benefits of taking E-Mycin during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed.

Your doctor will discuss the risks and benefits of taking E-Mycin when breastfeeding.

Tell your doctor if you have any medical conditions including:

liver problems

heart problems

myasthenia gravis, a condition in which the muscles become weak and tire easily

eye disorder

pneumonia

If you have not told your doctor about any of the above, tell them before you start
taking E-Mycin.

Taking other medicines

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

Some medicines may interfere with EES. These include:

medicines used to prevent blood clotting, such as warfarin, acenocoumarol

some medicines used for epilepsy such as phenytoin, carbamazepine, hexobarbital, phenobarbital
(phenobarbitone) and valproate

theophylline, a medicine used to treat asthma

diltiazem, verapamil, felodipine and mibefradil, medicines used to treat high blood
pressure and certain heart conditions

digoxin, a medicine used to treat heart failure

omeprazole and cimetidine, used to prevent ulcers by reducing amount of acid produced
in stomach

ciclosporin, used to prevent organ transplant rejection or to treat certain problems
with the immune system

tacrolimus, used as an adjunct to kidney transplantation

triazolam, zopiclone and midazolam, used to treat sleeplessness

nefazodone and St. John’s wort, medicines used to treat depression

alprazolam used to treat anxiety disorders

methylprednisolone, a corticosteroid

vinblastine, a medicine used to treat Hodgkin’s Disease

sildenafil, used to treat erectile dysfunction in adult males

mizolastine and ebastine medicines used to treat allergies such as hay fever

ritonavir, used to treat infections in patients with advanced HIV infection

medicines used to treat fungal infections such as ketoconazole, itraconazole, fluconazole

rifabutin, rifampicin, clindamycin, lincomycin, chloramphenicol, streptomycin, colistin
and bactericidal betalactam antibiotics (e.g. penicillin, cephalosporin)

bromocriptine, used to treat various conditions including Parkinson’s Disease

colchicine, used for pain relief in gout

alfentanil, a medicine used for pain relief during anaesthesia

cilostazol, a medicine used in the treatment of painful calves, due to poor blood
flow to the muscles

diphenoxylate with atropine used to treat diarrhoea

opiates used as analgesics.

Your doctor can tell you what to do if you are taking any of these medicines. You
may need different amounts of yours medicines, or you may need to take different medicines.

If you are not sure whether you are taking any of these medicines, check with your
doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking E-Mycin.

How to take E-Mycin

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

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

How much to take

The usual adult dose is one E-Mycin tablet (400 mg) every six hours but this may vary
from person to person.

Your doctor will tell you how many tablets you will need to take. This depends on
the infection being treated and how severe it is.

For children, their doctor will work out the dose according to their age, body weight
and how severe the infection is.

Your doctor will adjust the amount or frequency of your doses according to the infection
being treated and the severity of the condition.

How to take it

Tablets: Swallow whole with a glass of water.

Mixture: Always shake the bottle well before using a metric measure to measure the
correct dose.

Shaking the bottle and using a medicine measure will make sure that you get the correct
dose. You can buy a medicine measure from your pharmacist.

When to take it

Space the doses of E-Mycin evenly apart and take them at about the same time each
day.

This will allow E-Mycin to have its best effect and also help you to remember when
to take it.

E-Mycin can be taken with or without food. However, taking E-Mycin with food may help
reduce the chance of a stomach upset occurring.

How long to take it for

Keep taking E-Mycin until you finish the tablets or mixture, or for as long as your
doctor recommends.

If you are being treated for an infection, E-Mycin is usually taken for one to two
weeks. Your infection may not clear completely if you stop taking your medicine too
soon.

For controlling acne, E-Mycin is normally taken for a few months.

Check with your doctor if you are not sure how long you should be taking E-Mycin.

If you forget to take it

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 the missed dose as soon as you remember, and then go back to taking
your medicine as you would normally.

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

If you have any questions or are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13
11 26), or go to Accident and Emergency at the nearest hospital, if you think you
or anyone else may have taken too much E-Mycin.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much E-Mycin, you may have nausea, vomiting or problems with your
hearing.

While you are taking E-Mycin

Things you must do

If you are taking E-Mycin for an infection and your symptoms do not improve within
a few days, or if they become worse, tell your doctor.

If your baby develops irritability with feeding or has severe vomiting during treatment
with E-Mycin, tell your doctor immediately. This may be a sign of a stomach disorder
in the infant.

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking E-Mycin.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given this medicine.

It may affect other medicines used during surgery.

If you become pregnant while taking E-Mycin, tell your doctor.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even
if it occurs several weeks after you have stopped taking E-Mycin.

Do not take any diarrhoea medicine without checking with your doctor.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care.

If you have to have any urine tests, tell your doctor you are taking E-Mycin.

E-Mycin may affect the results of some tests.

If you develop itching with swelling or skin rash or difficulty breathing while you
are taking E-Mycin, do not take any more and contact your doctor immediately.

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

This may mean you have a fungal infection called thrush. Sometimes, the use of E-Mycin
allows fungi to grow and the above symptoms to occur. E-Mycin does not work against
fungi.

Things you must not do

Do not use E-Mycin to treat any other conditions unless your doctor tells you to.

Do not give E-Mycin to anyone else, even if they have the same condition as you.

Do not stop taking E-Mycin, even if you feel better after a few days, unless advised
by your doctor.

If you stop taking E-Mycin too soon, the infection may not clear completely or your
symptoms may return.

If possible, your doctor will gradually reduce the amount you take each day before
stopping the medicine completely.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking E-Mycin.

E-Mycin treats infections and controls acne in most people, but it may have unwanted
side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

If any of the following happen, stop taking E-Mycin and tell your doctor immediately
or go to Accident and Emergency at the nearest hospital:

signs of an allergic reaction such as any type of skin rash, itching, or hives; swelling
of the face, lips, tongue or other parts of the body; shortness of breath, wheezing,
troubled breathing

watery and severe diarrhoea, which may also be bloody.

The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital
if you notice any of the following:

yellowing of the eyes or skin (jaundice)

severe stomach cramps

feeling generally unwell and having poor appetite

loss of hearing

ringing or buzzing in the ears

fast, irregular or pounding heart beat, palpitations

chest pain

muscle pain, weakness and joint swelling

dizziness, drowsiness, confusion, hallucinations, fits

any type of skin rash, itching, hives, serious scaly red rash with bumps under skin
and blisters

severe diarrhoea especially if bloody

any vision problems.

in infants, irritability with feeding or severe vomiting.

The above list includes serious side effects which may require medical attention.

Tell your doctor if you notice any of the following and they worry you:

stomach cramps and pains

feeling sick, vomiting, accumulation of gas and severe diarrhoea

oral thrush (white, furry sore tongue and mouth)

vaginal thrush (sore and itchy vagina, vaginal discharge).

Weight loss

Fever, headache

The above list includes the more common and mild side effects of E-Mycin.

Tell your doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After you have finished taking E-Mycin

Tell your doctor immediately if you notice any of the following side effects, particularly
if they occur several weeks after stopping treatment with E-Mycin:

severe abdominal cramps or stomach cramps

watery and severe diarrhoea, which may also be bloody

fever, in combination with one or both of the above.

You may have a serious condition affecting your bowel. These are rare but serious
side effects. Therefore, you may need urgent medical attention.

Do not take any medicine for diarrhoea without first checking with your doctor.

After taking E-Mycin

Storage

Keep E-Mycin where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Keep E-Mycin tablets in a cool, dry place where the temperature stays below 30°C.

Keep E-Mycin mixture in the refrigerator but not in the freezer.

Do not use any mixture left in the bottle after 10 days.

Do not store E-Mycin or any other medicine in the bathroom or near a sink.

Do not leave E-Mycin in the car or on window sills.

Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking E-Mycin, or your medicine has passed its expiry
date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

E-Mycin is available as a tablet and mixture.

Tablets are flesh pink in colour, oval-shaped, film-coated and marked “E-N” on one
side and a Greek alpha symbol on the other. Each pack contains 25 tablets.

Mixtures are available as two strengths:

E-Mycin 200

E-Mycin 400.

Both mixtures are pink, cherry flavoured and sugar-free. Each bottle contains 100
mL of mixture.

Ingredients

The active ingredient in E-Mycin tablets and mixtures is erythromycin (as erythromycin
ethyl succinate).

E-Mycin tablets

E-Mycin tablets contain 400 mg of erythromycin (as erythromycin ethyl succinate).

The E-Mycin tablets also contain the following inactive ingredients:

calcium hydrogen phosphate anhydrous

maize starch

sorbic acid

povidone

purified talc

sodium starch glycollate

magnesium stearate

Opadry Pink OY-B-34901 (contains colours titanium dioxide CI 77891[171]), iron oxide
red CI 77491 [172]).

E-Mycin tablets do not contain lactose, sucrose, gluten, tartrazine or any other azo
dyes.

E-Mycin mixtures

E-Mycin 200 – each 5 mL contains 200 mg of erythromycin (as erythromycin ethyl succinate).

E-Mycin 400 – each 5 mL contains 400 mg of erythromycin (as erythromycin ethyl succinate).

The mixtures also contain the following inactive ingredients:

sorbitol

propylene glycol alginate

sodium citrate

colloidal anhydrous silica

aspartame (951)

sodium benzoate (211)

erythrosine CI45430 (127)

Trusil Nature Identical Cherry Flavour (contains preservative 320).

E-mycin mixtures contain benzoates, aspartame, phenylalanine and sorbitol.

Products containing sorbitol may have a laxative effect or cause diarrhoea.

Phenylketonurics are warned that this product contains phenylalanine.

E-Mycin mixtures do not contain lactose, sucrose, gluten, tartrazine or any other
azo dyes.

Manufacturer

E-Mycin is made in Australia by:

Alphapharm Pty Ltd

Level 1, 30 The Bond

 30-34 Hickson Road

Millers Point NSW 2000

www.mylan.com.au

Australian Registration Numbers:

Tablet:

E-Mycin – AUST R 71310

Mixtures:

E-Mycin 200 – AUST R 48286

E-Mycin 400 – AUST R 48287

This leaflet was prepared in August 2021..

e-mycin_cmi/Aug21

Azithromycin: instruction, price, analogues | Compendium – drug guide

The year is 1980. Dr. Slobodan Rokeach and his research team at Pliva (a pharmaceutical company in Croatia) have discovered Azithromycin. A patent for it was obtained a year later. And then, using the Pliva license, Pfizer brings the drug to the pharmaceutical markets and already under a completely different trade name. And this happens in 10 years. A few more years passed. And they approved a new formulation of azithromycin for the treatment of eye infections.

Azithromycin is practically insoluble in water and freely soluble in anhydrous ethanol and methylene chloride. Azithromycin is a macrolide antibiotic. It is a semi-synthetic derivative of erythromycin. Azithromycin differs from erythromycin by the addition of a methyl-substituted nitrogen atom to the lactone ring. This structural modification increased the acid resistance of the compound and improved the penetration of the drug molecule into tissues, expanding its spectrum of action. Macrolides are generally distinguished by their activity, covering a wide range of Gram-positive and Gram-negative bacterial species, including intracellular pathogens such as Chlamydia and Legionella. They exhibit their antibiotic activity by binding to the 50S ribosome (its subunit) and inhibiting protein synthesis. Modern antibacterial drugs are intended not only for inpatient treatment, but also for outpatient use. But at the same time, patients often do not comply with the drug regimen or the total duration of the course of treatment. In turn, this can lead to chronic bacterial inflammation or to the development of antibiotic resistance in bacteria. That is why preference is given to drugs with a simple regimen (1 r / day) with a long T _½ , which reduces the duration of the course of treatment. Such drugs make it possible to achieve the complete elimination of the bacterial pathogen and are even able to prevent the exacerbation of chronic diseases. Azithromycin meets all these requirements.

Compared with other macrolide drugs, azithromycin has a number of advantages in terms of pharmacokinetics, pharmacodynamics, as well as safety and tolerability in both adult and pediatric practice. It demonstrates time-dependent bacteriostatic or bactericidal activity, and at the same time shows concentration-dependent bactericidal activity and a pronounced post-antibacterial effect (Matzneller P., 2013). After oral administration, the drug is distributed throughout the body, with C _max is achieved in 2–3 hours, and the tissue concentration exceeds the serum concentration by 50 times (instruction of the Ministry of Health of Ukraine). At the same time, azithromycin accumulates mainly in the extracellular space of muscle tissue and subcutaneous adipose tissue, as well as in fibroblasts and tissue phagocytes. The concentration of azithromycin in the lung tissue can be characterized as high or very high, which ensures the effectiveness of the drug against most respiratory bacterial infections (Leophonte P., 1995). The post-antibacterial effect of azithromycin lies in the fact that its molecules strongly bind to tissue proteins and T _½ is 5 days after the completion of the course of treatment, and in some patients it reached 10 days (Matzneller P., 2013).

The spectrum of antibacterial activity of azithromycin covers methicillin-susceptible strains of staphylococcus, penicillin-susceptible strains of streptococcus, hemophilic infection, moraxella and pasteurella, as well as intracellular pathogens such as chlamydia and legionella (Neu H.C., 1991). In addition, azithromycin is active against anaerobic bacteria such as clostridia and fusobacteria.

The group of bacteria resistant to azithromycin is represented by penicillin-resistant streptococci, methicillin-resistant Staphylococcus aureus, bacteroids and the overwhelming majority of gram-negative bacteria. Cross-resistance to azithromycin is observed in pathogens resistant to erythromycin, other macrolides and lincosamides (instruction of the Ministry of Health of Ukraine).

Azithromycin pharmacology and therapy

Azithromycin has been found to be less active than erythromycin against Gram-positive bacteria, but more effective against some Gram-negative organisms such as Haemophilus influenzae, Moraxella catarrhalis, and also has activity against some enterobacteria such as Escherichia coli and Salmonella and Shigella species, as well as against Legionella pneumophila, B. burgdorferi, Mycoplasma pneumoniae. He (azithromycin) has increased activity against Mycobacterium avium-intracellulare, as well as some protozoa (eg Cryptosporidium and Plasmodium species), excellent action against Toxoplasma gondii, kills cysts. It is more active than erythromycin against Chlamydia trachomatis and Ureaplasma urealyticum.

Mechanism of action. It is a bacteriostatic agent that inhibits protein synthesis by reversibly binding to the 50S ribosomal subunits of susceptible microorganisms. The cells of the body are much more permeable to the dosage form of the drug, which is likely to exhibit increased antimicrobial activity at an alkaline pH.

Macrolide resistance. Generally, resistance to macrolides is mediated by the following mechanisms:

• ribosomal protection through inducible or constitutive production of methylase enzymes mediated by the expression of (ermA), (ermB), and (ermC), which modify the ribosomal target and reduce drug binding;
• hydrolysis by esterases produced by Enterobacteriaceae;
• chromosomal mutations that alter the 50S ribosome subunit protein (noted in B. subtilis, Campylobacter species, mycobacteria, and Gram-positive cocci).

Action other than antimicrobial effects. Studies have indicated the activity of Azithromycin as a promising drug for the treatment of gastroparesis and gastrointestinal motility disorders.

• One study showed that azithromycin may be effective against asthma (late onset).
• Information has been obtained on the effectiveness of azithromycin against malaria when used in combination with artemisinin or quinine sulfate. Azithromycin-artemisinin, even if taken only once a day (3 days), and azithromycin-quinine sulfate – 3 times a day. These drug combinations have been relatively safe and effective in uncomplicated malaria and deserve further study in specific patient populations.
• Ischemic heart disease: macrolide antibacterial agents, including Azithromycin.

Clarithromycin, roxithromycin, azithromycin have been investigated for the prevention of coronary artery disease based on the proposed association between atherosclerosis and Chlamydophila pneumoniae (Chlamydia) infection. Although the preliminary results of some experimental studies have been promising, long-term studies in a large number of patients have been disappointing, and none of the three macrolides reduced ischemic outcomes or provided a clinical benefit. In one study, an unexpected increase in cardiovascular mortality was observed with clarithromycin.

• Gingival hyperplasia: azithromycin has a positive effect on the treatment of gingival hyperplasia, which was caused by the use of cyclosporine, especially when it (azithromycin) is introduced early in the inflammation process.
• Cystic fibrosis: Azithromycin is widely used in cystic fibrosis, with evidence demonstrating decreased lung function and exacerbation rates. This immunomodulatory therapy likely interferes with Pseudomonas aeruginosa biofilm growth.

ADME (absorption, distribution, metabolism, and excretion) profile. Orally administered azithromycin is rapidly absorbed and widely distributed throughout the body except the brain and cerebrospinal fluid. Peak plasma concentrations are reached 2-3 hours after oral administration. A loading dose of 500 mg will give a peak plasma drug concentration of 0.4 g/mL. When the loading dose is 250 mg 1 time per day for 4 days, then in a stationary state, the peak concentration of the drug is 0. 24 g / ml. Azithromycin can also be administered intravenously, producing plasma concentrations of 3–4 g/mL following a 1-hour infusion of 500 mg. Absorption from capsules decreases with food. The unique pharmacokinetic properties of the drug are extensive redistribution in tissues and high concentrations of the drug in cells (including phagocytes). This leads to an increase in the concentration of the drug in the tissues, when compared with simultaneous concentrations in the blood serum. Tissue fibroblasts act as a natural drug reservoir in vivo.

Animal data show that azithromycin crosses the placenta. At very low plasma concentrations, this represents 50% of the amount of protein. Azithromycin undergoes demethylation in the liver to an inactive metabolite, but excretion is carried out by the biliary tract – the main route. Only 12% of the drug is excreted unchanged in the urine. Half-life (T _½ ) – 40-68 hours

Adverse reactions. Anorexia, dyspepsia, flatulence, dizziness, headache, drowsiness, convulsions, arthralgia and taste and smell disorders; rarely – constipation, hepatitis, liver failure, syncope, insomnia, agitation, restlessness, asthenia, paresthesia, hyperactivity, thrombocytopenia, hemolytic anemia, interstitial nephritis, acute renal failure, photosensitivity, discoloration of the lips and tongue.

Drug interactions. It is not recommended to use Azithromycin in combination with antacids containing aluminum or magnesium. Salts can reduce the rate, but not the extent of its absorption;

Azithromycin should be given at least 1 hour before or 2 hours after an antacid.

• Serum concentrations of azithromycin are markedly increased when given with nelfinavir.
• Azithromycin capsules should not be administered with food because this reduces the availability of the drug itself.
• Azithromycin possibly enhances the anticoagulant effect of coumarins.
• Azithromycin possibly increases the concentration of theophylline in blood plasma (Bakheit A.H., 2014).

Clinical experience with azithromycin

Clinical use and dosing (see instructions of the Ministry of Health of Ukraine).

1. respiratory infections;

2. skin and soft tissue infections;

3. chlamydial infections;

4. mild or moderate non-gonococcal urethritis;

5. otitis media;

6. typhoid fever due to multiple antibacterial resistant organisms;

7. prophylaxis of group A streptococcal infection;

8. as a prophylactic treatment for bacterial endocarditis in patients undergoing dental procedures at high risk of developing endocarditis;

whooping cough;

10. mycobacterial infections.

• Treatment or prophylaxis of Mycobacterium avium intracellular infection in AIDS patients requiring higher doses: 600 mg per day in combination with one or more other drugs for treatment or 1200 mg once a week for primary prevention.
• Azithromycin is prescribed for the treatment of sexually transmitted diseases, especially during pregnancy, when tetracyclines are contraindicated. Treatment for uncomplicated nongonococcal urethritis suspected to be C. trachomatis is a single dose (1 g) of azithromycin. This dose is also effective in chancroid.
• Azithromycin (1 g/week for 3 weeks) is an alternative regimen for the treatment of inguinal or venous lymphogranuloma.
• Uncomplicated genital chlamydial infections and non-gonococcal urethritis, 1 g as a single dose.
• Typhoid fever, 500 mg once a day (total number of days of taking the drug – 7).

Systematic reviews contain a wealth of information on the use and safety of Azithromycin in various therapeutic areas.

Here is information on several studies that, in our opinion, may be of interest.

Long-term therapy with azithromycin has been shown to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and is indicated according to the latest recommendations for patients with COPD who are at risk of recurrent exacerbations. However, concerns about adverse effects limit its widespread use. Physicians deciding whether to use long-term azithromycin therapy should evaluate each patient’s individual risk of cardiovascular events and the individual and population impact of macrolide resistance versus expected benefit. This review will summarize data on the efficacy and safety of chronic azithromycin for the prevention of COPD exacerbations (Taylor S. P., 2015).

The FDA updated the package labeling of azithromycin to include the risk of prolonged cardiac repolarization and prolongation of the QT interval, which increases the risk of cardiac dysrhythmias, especially in the elderly. The update was initiated by a study that found an increased risk of death in patients taking azithromycin compared to patients taking amoxicillin. However, the cardiovascular results of other studies of azithromycin have been inconsistent, so more research is needed. At the same time, specialists should recognize that azithromycin plays a role in the treatment of bacterial infections, and should prescribe an antibiotic if necessary (Sutton S.S., 2017).

Azithromycin is widely used as a first-line drug for the treatment of children with mycoplasmal pneumonia, although children often vomit in the pediatric ward as a result of oral administration. It is believed that drugs that are administered rectally enter the circulatory system without first passing through the liver. Therefore, 5 healthy volunteers were included in the study. All participants gave written informed consent to participate in the study. Either oral administration of a 500 mg Azithromycin tablet or rectal administration of a suppository of the same preparation 125 was randomly assigned; 250 or 500 mg. Blood samples for serum preparation were taken before and after 1; 2; 3; 4; 6; 12 and 24 hours after the first rectal dose. Serum azithromycin concentrations were determined by high performance liquid chromatography (HPLC) with electrochemical detection.

Thus, the bioavailability of the suppository when administered rectally was 20.3% compared to oral administration. It is assumed that the surface area where the active substance is absorbed also affects the absorption when administered rectally. Although further research is needed to improve rectal absorption and child safety, azithromycin suppositories may already be effective in cases where oral administration is not allowed (Maeda M. et al., 2016).

Antibacterial therapy with azithromycin is widely used in modern medical practice: the drug is effective for middle ear infections, tonsillitis, pneumonia, typhoid, bronchitis and sinusitis. In addition, it is effective against some STDs – it is included in the treatment regimens for non-gonococcal urethritis, cervicitis and chlamydia (Bakheit A., 2014). Azithromycin is successfully used for the treatment of chlamydial cervicitis and urethritis, and its single dose is comparable in its effectiveness to a 7-day course of doxycycline treatment (Katanani M.S., 1994).

According to a prospective study, it was found that a 5-day course of azithromycin can be considered quite sufficient for the treatment of erythema migrans in tick-borne borreliosis (Arnez M., 2015).

Interestingly, azithromycin has been shown to be effective against typhus in 5 clinical trials, with activity comparable to that of other anti-rickettsial drugs. Azithromycin is an effective alternative to doxycycline, which is contraindicated, for example, in pregnant women or young children (Lee S. C., 2017).

Azithromycin is recommended for the treatment of obstructive bronchiolitis, obstructive airway injury associated with lung or allogeneic stem cell transplantation. Meta-analysis data suggest that when it is included in the treatment regimen, there is a small but statistically significant increase in such an indicator as forced expiratory volume in the first second. The therapeutic effect is associated with the fact that under the influence of azithromycin, the secretion of interleukin-8 by alveolar macrophages decreases, the activity of fibroblast matrix metalloproteases decreases, the survival of neutrophils and the general microbial contamination of the lungs decrease (Yadav H., 2016). In addition, studies of in vitro and in animals it was found that azithromycin acts like an inhibitor of nuclear factor κβ and inhibits the maturation of dendritic cells, thereby reducing the severity of the graft versus host reaction (Iwamoto S., 2013).

In a randomized, double-blind, placebo-controlled trial (3 years), it was found that the use of azithromycin as an antibiotic prophylaxis helps to reduce the number of chronic lung infections in patients with primary antibody deficiency (Milito C. , 2019).

Azithromycin is also recommended for the prevention of exacerbations in patients with fibrous bronchiectasis – its systematic use improves the quality of life in patients who have experienced at least one exacerbation per year without therapy (Wong C., 2012).

The effectiveness of azithromycin for the treatment and prevention of whooping cough has been proven (Devasia R., 2009) – it is recommended as an alternative first-line drug. The high efficacy of azithromycin in the treatment of legionella pneumonia has also been established – it has been proven not only in animal models, but also in clinical studies (Plouffe J.F., 2003).

According to a systematic review, it was found that azithromycin can be prescribed to premature babies – the antibiotic significantly reduces the risk of developing bronchopulmonary dysplasia in them (Smith C., 2015). The ability of azithromycin to prevent the development of chronic pulmonary pathology during intrauterine infection with ureaplasma has been proven (Turner M. A., 2012). Azithromycin is also used in pediatric practice for the treatment of mycoplasmal pneumonia (Wang J., 2018). It is very important that azithromycin therapy is well combined with probiotic preparations based on Saccharomyces boulardii – with this combination, the cure for mycoplasmal pneumonia is accelerated and the frequency of intestinal dysbacteriosis is reduced (Chen Q.F., 2018).

Azithromycin has proven itself in dermatological practice. For the treatment of chronic furunculosis – recurrent staphylococcal abscesses of hair follicles – it is recommended to use the drug for a 12-week course at a dosage of 500 mg / week. This treatment regimen makes it possible to achieve stable remission after 3 months in 79 patients..2% of patients (Amynzadeh A., 2007).

The literature describes the successful treatment of cutaneous leishmaniasis with azithromycin. At the same time, the drug was prescribed in the regimen of 500 mg/day for 10 days (Minodier P. , 2008).

Data from a meta-analysis suggest the possibility of including azithromycin in a triple therapy regimen for peptic ulcer disease. Azithromycin after a single dose accumulates in the gastric mucosa, is secreted with gastric juice and reaches a sufficient concentration for eradication Helicobacter pylori (Dong J., 2009).

.

Lincomycin: instruction, price, analogues | capsules Kievmedpreparat

• Pharmacological properties
• Indications Lincomycin
• Application Lincomycin
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

pharmacodynamics

Sensitivity. Depending on the sensitivity of the pathogen and the concentration of the antibiotic, lincomycin can have both bactericidal and bacteriostatic effects.

The table below shows the MIC values ​​obtained from the literature. The spread of resistance may change over time and by region.

*Lincomycin is inactive against H. influenzae , enterococci and species of the genus Neisseria (see INDICATIONS).

In vitro observed the phenomenon of cross-resistance in a dissociated type between clindamycin and lincomycin on the one hand and antibiotics of the macrolide group (erythromycin, clarithromycin, azithromycin) on the other. There is absolute cross-resistance between lincomycin and clindamycin. In studies in vitro and in vivo did not show rapid development of resistance. In staphylococci, resistance to lincomycin or clindamycin in vitro develops gradually. Studies indicate the absence of common antigenic properties of lincomycin and penicillins.

Pharmacokinetics

Suction . When taken orally on an empty stomach, 20-30% of the drug is absorbed. With oral administration of 500 mg of lincomycin, C _max in serum is about 3 μg / ml and is reached 2-4 hours after application. If lincomycin is taken with food, this figure is reduced by about 50%. After oral administration, the therapeutic concentration of the drug in the blood is maintained for 6-8 hours for the most sensitive gram-positive pathogens.

Distribution . Based on published studies, it has been established that the binding of the drug to plasma proteins has a saturation pattern, that is, the percentage of bound drug decreases with increasing serum concentration of the drug.

The concentration of the drug in the blood of the fetus, in the peritoneal and pleural fluid can reach 25-50% of the concentration in the blood, in breast milk – 50-100%, in bone tissue – about 40%, and in soft tissues – 75% of the concentration in blood.

However, lincomycin slowly penetrates into the cerebrospinal fluid (1-18% of the concentration in the blood). With meningitis, an increase in the level of the drug to about 40% of the concentration in the blood was observed.

Removal. Much of the drug’s metabolism occurs predominantly in the liver. Normally, T _½ from blood serum is 5.4 ± 1 hour. In case of impaired liver and / or kidney function, this time may increase, so patients with impaired liver and / or kidney function should consider the possibility of reducing the frequency of lincomycin.

After a single oral dose of 500 mg of the drug, the excretion of the microbiologically active form in the urine is 1-31% (mean – 4%), and in the feces – up to 33%.

Given that the concentration of the drug in the bile can be 10 times the level of the drug in the blood, excretion in the bile is undoubtedly an important route of excretion of the drug from the body when taken orally.

Residues of the drug are excreted as microbiologically inactive metabolites. Hemodialysis and peritoneal dialysis procedures do not affect the elimination of lincomycin from the blood.

Lincomycin is indicated for the treatment of infections caused by strains of gram-positive aerobic microorganisms susceptible to lincomycin, such as streptococci, pneumococci and staphylococci, or by susceptible anaerobic bacteria:

1. Upper respiratory tract infections: chronic sinusitis caused by anaerobic strains. Lincomycin can be used in selected cases of suppurative otitis media or as adjunctive therapy along with an antibiotic that is effective against aerobic gram-negative pathogens. Infections caused by H.influenzae are not an indication for the use of the drug (see pharmacodynamics ).

2. Infections of the lower respiratory tract, including infectious exacerbations of chronic bronchitis and infectious pneumonia.

3. Infections of the skin and soft tissues caused by susceptible microorganisms, in cases where the administration of antibiotics of the penicillin group is not indicated.

4. Bone and joint infections, including osteomyelitis and septic arthritis.

5. Septicemia and endocarditis. In some cases of septicemia and / or endocarditis due to the sensitivity of pathogens to lincomycin, a pronounced response to treatment with lincomycin was observed. However, in the treatment of such infections, the use of bactericidal drugs has an advantage.

dose and route of administration should be determined taking into account the severity of the infection, the condition of the patient and the sensitivity of the bacterial pathogen. The duration of treatment is determined individually by the doctor.

The drug is preferably taken 1-2 hours before or 1-2 hours after a meal. Hard capsules should be taken with plenty of water.

Adults. 500 mg 3-4 times daily.

Children (age 6+) . 30-60 mg / kg / day, which are divided into 3-4 equal doses.

Patients with impaired renal and/or hepatic function . If necessary, the use of lincomycin for the treatment of patients with severely impaired renal and / or liver function, the appropriate dose is 25-30% of the dose recommended for patients with unchanged kidney / liver function.

Children . Do not prescribe the drug in this dosage form (capsules) to children under the age of 6 years.

hypersensitivity to the active substance or to any other component of the preparation, or to clindamycin. Meningitis.

from the gastrointestinal tract : abdominal pain, nausea, vomiting and antibiotic-associated diarrhea (see SPECIAL INSTRUCTIONS), esophagitis, glossitis, stomatitis, anal itching. Almost all antibiotics, including penicillins, cephalosporins and lincosamides, can lead to the development of severe diarrhea (sometimes the onset of diarrhea is preceded by a latent period), colitis, including pseudomembranous, caused by the action of toxins C.difficile . If diarrhea occurs during treatment, the drug should be discontinued gradually. Colitis may also develop 2-3 weeks after completion of therapy. The use of drugs that inhibit intestinal motility should be avoided.

From the side of the hematopoietic system : Cases of neutropenia, leukopenia, agranulocytosis and thrombocytopenic purpura have been reported. Rare cases of aplastic anemia and pancytopenia have also been described in which the role of lincomycin as a causative factor cannot be ruled out.

From the side of the immune system : hypersensitivity reactions, including angioedema, serum sickness, anaphylaxis; some of these reactions were observed in patients with hypersensitivity to penicillin. Rare cases of erythema multiforme, sometimes similar to Stevens-Johnson syndrome, have been associated with the use of lincomycin.

Serious anaphylactoid reactions require urgent intensive treatment with epinephrine, oxygen therapy and intravenous corticosteroids. If indicated, the airway should also be restored, if necessary by intubation.

Skin and mucosal disorders : Cases of pruritus, skin rash, urticaria, vaginitis and rare cases of exfoliative and vesicular bullous dermatitis have been reported.

From the side of the liver : during therapy with lincomycin, the occurrence of jaundice and changes in liver function parameters (in particular, an increase in serum transaminase levels) were observed.

From the side of the kidneys : although a direct relationship between lincomycin and kidney damage has not been established, in some cases, impaired renal function was observed, as evidenced by azotemia, oliguria and / or proteinuria.

From the side of the organ of hearing and balance : in some cases, tinnitus and vertigo have been reported.

The use of lincomycin may cause overgrowth of non-susceptible organisms, in particular yeasts.

it is necessary to conduct microbiological studies in order to determine pathogens and their sensitivity to lincomycin.

Lincomycin has been shown to be effective in the treatment of staphylococcal infections resistant to other antibiotics and susceptible to lincomycin. Strains of staphylococci resistant to lincomycin have been identified, therefore, during therapy with Lincomycin, it is necessary to carry out bacteriological cultures and sensitivity studies of pathogens. In the case of the use of macrolides, partial, but not complete, cross-resistance is possible. If indicated, the drug can be used simultaneously with other antibacterial drugs.

To reduce the rate of emergence of drug-resistant bacteria and maintain the efficacy of lincomycin and other antibacterial drugs, Lincomycin should only be used to treat or prevent infections that are proven or very likely to be caused by susceptible bacteria. Where culture and susceptibility information is available, it should be taken into account when selecting or changing antibiotic therapy. In the absence of such data, local epidemiological data and susceptibility characteristics may influence the empirical choice of treatment.

Lincomycin is not indicated for the treatment of minor bacterial infections and viral infections. The administration of Lincomycin in the absence of a confirmed or highly suspected bacterial infection is unlikely to be of benefit to the patient and increases the risk of developing drug-resistant bacteria.

Because of the risk of developing pseudomembranous colitis, the physician should evaluate the nature of the infection and evaluate the suitability of less toxic alternatives (eg, erythromycin) before deciding to use lincomycin.

Diarrhea associated with Clostridium difficile has been reported with almost all antibacterial agents, including lincomycin.

The severity of the manifestation can be from mild diarrhea to fatal colitis. C. difficile , which produce toxins A and B. C. difficile associated diarrhea may be mild with watery, liquid stools, but may also progress to severe persistent diarrhea, leukocytosis, fever, severe abdominal cramps, mucus or blood in stools.

For mild pseudomembranous colitis, discontinuation of the drug is usually sufficient. Moderate to severe cases should be treated with fluids, electrolytes, proteins, and antibacterial agents effective against C. difficile in colitis.

As soon as the initial diagnosis of pseudomembranous colitis is established, treatment should be started. Diagnosis is usually based on clinical symptoms, but endoscopy or definitions can also be used to confirm the diagnosis C.difficile and its toxins in the stool of a patient.

If left untreated, the patient may develop potentially fatal peritonitis, shock, and toxic megacolon.

C.difficile associated diarrhea is more common and more severe in debilitated and elderly patients. The cause of increased morbidity and mortality can also be strains C. difficile , which are capable of increased production of toxins.

The possibility of diarrhea associated with C. difficile should be considered in patients with diarrhea associated with antibiotic use. It is necessary to conduct a thorough analysis of the anamnesis, since the development of diarrhea associated with C. difficile was described even 2 months after the completion of antibiotic therapy.

Lincomycin should be used with caution in patients with a history of gastrointestinal disease, especially colitis.

Lincomycin should not be used to treat patients with meningitis because levels of the drug in the cerebrospinal fluid are insufficient.

During long-term treatment, liver and kidney function should be monitored and blood tests performed.

The use of lincomycin may lead to overgrowth of non-susceptible organisms, in particular yeasts. In the event of superinfection, appropriate measures should be taken according to the clinical situation. If patients with pre-existing fungal infections need treatment with Lincomycin, antifungal therapy should be carried out simultaneously.

Lincomycin should be used with caution in patients with a history of asthma burden or severe allergy.

Assigned surgical procedures should be carried out in conjunction with antibiotic therapy.

Lincomycin has been shown to be able to block neuromuscular impulse transmission, and therefore may potentiate the effects of other neuromuscular blockers. Thus, lincomycin should be used with caution in patients taking drugs of this class.

Lincomycin should be used with caution in atopic patients.

Lincomycin should be used with caution in patients with severe renal and/or hepatic impairment associated with severe metabolic disorders. For such patients, the dose of the drug should be changed (see APPLICATION). During treatment with high doses in such patients, it is necessary to control the level of lincomycin in the blood serum, since T _½ of the drug in these categories of patients can be extended by 2-3 times.

Use during pregnancy or lactation . In humans, lincomycin is able to cross the hematoplacental barrier. At the same time, the levels of the drug in the cord blood serum reach 25% of the levels of the drug in the mother’s blood serum. Significant accumulation of the drug in the amniotic fluid does not occur. Controlled studies on the use of the drug in pregnant women have not been conducted. In 302 children of patients treated with lincomycin in different trimesters of pregnancy, there was no increase in the frequency of congenital anomalies or developmental delay compared with the control group during the first 7 years of life.

Lincomycin should not be used during pregnancy unless there is a clearly defined need for treatment. Lincomycin has been detected in breast milk at a concentration of 0.5–2.4 µg/mL. Due to the possibility of severe reactions to lincomycin in breastfed infants, a decision should be made to stop breastfeeding or stop treatment with the drug, depending on the need for the drug for the mother.

Ability to influence the reaction rate when driving vehicles or operating other mechanisms . There was no particular effect on the reaction rate when driving vehicles or working with other mechanisms, but isolated cases of dizziness were reported.

may increase the effect of drugs of the neuromuscular blocker class (see SPECIAL INSTRUCTIONS).

Simultaneous oral administration of kaolin-pectin mixtures slows down the absorption of lincomycin by 90%. Therefore, in order to avoid such an interaction, these mixtures should be taken at least 2 hours before or 3-4 hours after taking lincomycin.

In vitro antagonistic interactions have been observed between lincomycin and erythromycin, as well as macrolide compounds that have a chemical structure similar to erythromycin. Because of the possible clinical significance of the described interaction, these two drugs should not be administered simultaneously.

Lincomycin may interfere with blood ALP levels.