How does clindamycin compare to ampicillin in treating otitis media. What are the effectiveness differences for various bacterial strains. Which antibiotic is recommended for Haemophilus influenzae infections. What factors were considered in evaluating treatment outcomes.

Comparing Clindamycin and Ampicillin for Otitis Media Treatment

A comprehensive study was conducted to evaluate the efficacy of clindamycin in comparison to ampicillin sodium for the treatment of otitis media in children. The research involved 271 pediatric patients who were randomly assigned to receive either clindamycin or ampicillin, with both medications provided in identical numbered bottles to ensure a double-blind protocol.

The randomization process resulted in two remarkably similar groups in terms of age, sex, and clinical severity of the disease, providing a solid foundation for comparing the effectiveness of these antibiotics. This careful matching of patient characteristics enhances the reliability of the study’s findings.

Effectiveness of Clindamycin Against Various Bacterial Strains

The study revealed that clindamycin demonstrated effective therapeutic outcomes for otitis media caused by several bacterial strains, including:

• Penicillin-sensitive Staphylococcus aureus
• Penicillin-resistant Staphylococcus aureus
• Staphylococcus epidermidis
• Diplococcus pneumoniae (now known as Streptococcus pneumoniae)

These results suggest that clindamycin could be a viable alternative to ampicillin for treating otitis media caused by these specific pathogens. However, it’s important to note that the effectiveness may vary depending on local resistance patterns and individual patient factors.

Clindamycin’s Limitations in Treating Haemophilus influenzae

Despite its efficacy against several bacterial strains, the study identified a significant limitation of clindamycin. Differences in treatment response were observed when comparing clindamycin and ampicillin for otitis media caused by Haemophilus influenzae. Based on these findings, the researchers explicitly stated that they would not recommend clindamycin for routine treatment of H. influenzae-induced otitis media.

Why is clindamycin not recommended for H. influenzae infections?

Clindamycin’s limited efficacy against H. influenzae can be attributed to its mechanism of action and the natural resistance of this bacterium. Clindamycin primarily targets gram-positive bacteria and anaerobes, while H. influenzae is a gram-negative organism. The cell wall structure of gram-negative bacteria makes them inherently less susceptible to clindamycin’s antibacterial effects.

Factors Considered in Evaluating Treatment Outcomes

The researchers employed a comprehensive approach to assess the efficacy of clindamycin and ampicillin. Key factors considered in the evaluation included:

1. Clinical response to therapy
2. Specific organisms isolated from patients
3. Age of the patients
4. Sex of the patients
5. Clinical severity of the disease at presentation

This multifaceted analysis allowed for a thorough comparison of the two antibiotics across various patient subgroups and bacterial strains, providing a more nuanced understanding of their relative effectiveness.

Implications for Clinical Practice in Otitis Media Treatment

The findings of this study have several important implications for the clinical management of otitis media in pediatric patients:

• Clindamycin can be considered as an effective alternative to ampicillin for treating otitis media caused by susceptible strains of Staphylococcus and Streptococcus pneumoniae.
• For cases of otitis media where H. influenzae is suspected or confirmed, ampicillin or other appropriate antibiotics should be preferred over clindamycin.
• The choice of antibiotic should be guided by local resistance patterns and individual patient factors, including allergy history and previous treatment responses.

When might clindamycin be preferred over ampicillin?

Clindamycin may be preferred in situations where:
1. The patient has a documented penicillin allergy.
2. Local resistance patterns show high rates of penicillin-resistant Staphylococcus aureus.
3. Previous treatment with ampicillin or other beta-lactam antibiotics has failed.
4. The infection is suspected to be caused by anaerobic bacteria, which are more susceptible to clindamycin.

The Role of Antibiotic Stewardship in Otitis Media Management

While this study provides valuable insights into the comparative efficacy of clindamycin and ampicillin, it’s crucial to consider these findings within the broader context of antibiotic stewardship. The judicious use of antibiotics is essential to prevent the development of antibiotic resistance and preserve the effectiveness of these important medications.

How can healthcare providers practice antibiotic stewardship in otitis media treatment?

Healthcare providers can promote antibiotic stewardship by:
1. Accurately diagnosing otitis media and distinguishing it from viral upper respiratory infections.
2. Considering watchful waiting for mild cases in children over 6 months of age.
3. Choosing narrow-spectrum antibiotics when appropriate.
4. Educating patients and caregivers about the importance of completing the full course of antibiotics.
5. Regularly updating treatment protocols based on local resistance patterns and current guidelines.

Advancements in Otitis Media Treatment Since the Study

Since the publication of this study in 1973, there have been significant advancements in the understanding and treatment of otitis media. These developments include:

• Introduction of new antibiotics with broader spectrum coverage
• Development of vaccines against common otitis media pathogens, such as pneumococcal conjugate vaccines
• Improved diagnostic techniques, including tympanometry and acoustic reflectometry
• Greater emphasis on pain management as a component of otitis media treatment
• Refined guidelines for watchful waiting in certain patient populations

These advancements have led to more targeted and effective treatment strategies for otitis media, potentially reducing the need for broad-spectrum antibiotics in some cases.

Future Directions in Otitis Media Research and Treatment

While studies like this one have significantly contributed to our understanding of antibiotic efficacy in otitis media treatment, there are still areas that warrant further investigation:

1. The impact of emerging antibiotic resistance on treatment outcomes
2. The role of biofilms in persistent or recurrent otitis media
3. The potential for personalized medicine approaches based on host genetics and microbiome composition
4. Development of novel non-antibiotic treatments, such as immunomodulators or targeted antimicrobial peptides
5. Long-term effects of different antibiotic regimens on the gut microbiome and overall health

Continued research in these areas may lead to more effective and tailored treatment strategies for otitis media, potentially reducing the reliance on broad-spectrum antibiotics and improving patient outcomes.

How might personalized medicine impact otitis media treatment in the future?

Personalized medicine approaches could revolutionize otitis media treatment by:
1. Using genetic markers to predict antibiotic response and risk of complications.
2. Analyzing the patient’s microbiome to guide antibiotic selection and probiotic supplementation.
3. Employing rapid diagnostic tests to identify specific pathogens and their antibiotic susceptibilities.
4. Tailoring treatment duration based on individual patient characteristics and response.
5. Developing targeted therapies that modulate the host immune response to infection.

The Importance of Comparative Studies in Antibiotic Research

The clindamycin vs. ampicillin study highlights the critical role of comparative research in guiding antibiotic selection for specific infections. Such studies provide valuable insights into the relative efficacy of different antibiotics against various pathogens, helping clinicians make informed decisions about treatment strategies.

Comparative studies are particularly important in the context of evolving antibiotic resistance patterns. As bacteria develop resistance to commonly used antibiotics, it becomes increasingly crucial to understand the effectiveness of alternative treatment options. This knowledge allows healthcare providers to adapt their prescribing practices to ensure optimal patient outcomes while minimizing the risk of contributing to antibiotic resistance.

What are the key components of a well-designed comparative antibiotic study?

A well-designed comparative antibiotic study should include:
1. Randomization of patients to treatment groups to minimize bias.
2. Double-blinding to prevent influence on outcome assessment.
3. Appropriate sample size to ensure statistical power.
4. Clear definition of clinical and microbiological endpoints.
5. Consideration of local resistance patterns and patient demographics.
6. Analysis of adverse events and tolerability.
7. Long-term follow-up to assess relapse rates and long-term outcomes.

By adhering to these principles, researchers can produce high-quality evidence to guide clinical decision-making in antibiotic therapy.

Balancing Efficacy and Safety in Pediatric Antibiotic Use

When treating otitis media in children, it’s crucial to balance the need for effective treatment with considerations of safety and long-term health impacts. While the study focused primarily on efficacy, the choice of antibiotic for pediatric patients must also take into account factors such as:

• Potential side effects and adverse reactions
• Palatability and ease of administration to ensure compliance
• Impact on the developing microbiome
• Risk of promoting antibiotic resistance
• Availability of appropriate pediatric formulations

These considerations underscore the complexity of antibiotic selection in pediatric populations and highlight the need for ongoing research to optimize treatment strategies.

How can healthcare providers minimize the potential negative impacts of antibiotic use in children?

To minimize potential negative impacts, providers can:
1. Use narrow-spectrum antibiotics when possible to reduce disruption of the normal microbiota.
2. Prescribe the shortest effective course of antibiotics to minimize exposure.
3. Consider probiotic supplementation during and after antibiotic treatment.
4. Educate parents about the importance of completing the full course of antibiotics to prevent resistance.
5. Monitor for and promptly address any adverse reactions or side effects.
6. Encourage non-antibiotic measures to support immune function and symptom relief.

By implementing these strategies, healthcare providers can help ensure that the benefits of antibiotic treatment outweigh the potential risks in pediatric patients with otitis media.

Efficacy of Clindamycin Therapy for Otitis Media | JAMA Otolaryngology–Head & Neck Surgery

Efficacy of Clindamycin Therapy for Otitis Media | JAMA Otolaryngology–Head & Neck Surgery | JAMA Network










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Article

July 1973

Ralph D. Feigin, MD^{; Ronald E. Keeney, MD; James Nusrala, MD; et al
Penelope G. Shackelford, MD; Robert D. Lins, MD}

Author Affiliations

St. Louis

From the Edward Mallinckrodt Department of Pediatrics, Washington University School of Medicine and the Division of Infectious Diseases, St. Louis Children’s Hospital, St. Louis.

Arch Otolaryngol. 1973;98(1):27-31. doi:10.1001/archotol.1973.00780020031008

Full Text

Abstract

A pediatric formulation of clindamycin was evaluated in comparison to ampicillin sodium in treatment of otitis media. Ampicillin and clindamycin were provided in identical numbered bottles and dispensed to 271 children.

The randomization procedures employed for assignment of therapeutic regimen yielded two groups which were remarkably similar in relation to age, sex, and clinical severity of disease. No significant differences in clinical response to therapy were observed even when data were evaluated with regard to specific organisms isolated. Clindamycin proved to be effective therapy for otitis media due to penicillin-sensitive and penicillin-resistant Staphylococcus aureus, epidermidis, and Diplococcus pneumoniae. Differences between the two regimens in the response of otitis media caused by Hemophilus influenzae were noted. We would not recommend clindamycin for routine treatment of otitis media caused by H influenzae.

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What is clindamycin used for? Types, dosage, and side effects

Clindamycin is an antibiotic. It works to treat bacterial infections when penicillin is not an option. A doctor may recommend clindamycin for certain respiratory infections, lung infections, blood poisoning, and more.

Clindamycin is an antibiotic drug. Doctors prescribe clindamycin to treat bacterial infections in certain situations.

The drug comes in several different forms. These are:

• oral capsules
• topical creams, lotions, and gels
• intravaginal suppositories
• injections and intravenous drips

Depending on the type of infection and the dosage of clindamycin, the drug can either kill or stop the growth of bacteria.

Topical clindamycin is a common treatment option for acne and bacterial infections in the vagina. Doctors also use clindamycin to treat infections in people with penicillin allergies.

Clindamycin is not suitable for everyone, however, and it can cause a range of serious side effects.

This article looks at some uses, dosages, and symptoms of clindamycin. It also explores types and alternatives.

Doctors use clindamycin to treat a variety of bacterial infections. They prescribe it when they cannot use penicillin and when they have determined the type of bacteria involved in the infection.

This is because the form of clindamycin the doctor prescribes depends on the kind of infection the person has.

A doctor may prescribe clindamycin in the form of oral capsules or dissolvable granules for:

• respiratory infections with streptococci, pneumococci, and staphylococci bacteria
• empyema, anaerobic pneumonitis, or an abscess in the lung
• blood poisoning
• infections from anaerobic bacteria in the gut, resulting in peritonitis or an abscess in the abdomen
• endometriosis, pelvic cellulitis, an abscess in the reproductive system, or a vaginal cuff infection

A doctor may prescribe intravenous or injectible clindamycin for serious infections, such as:

• respiratory infections
• lung infections
• blood poisoning
• infections in the reproductive system
• abdominal infections
• bone and joint infections, and they may sometimes prescribe it alongside other medications during surgery for chronic bone and joint infections
• serious skin infections

A doctor may prescribe clindamycin for children as an oral solution to treat:

• serious respiratory infections
• serious infections of the skin or soft tissue
• blood poisoning
• infections in the abdomen
• infections in the female reproductive tract

A dermatologist may prescribe clindamycin in the form of a gel, solution, or lotion to treat acne.

A doctor may prescribe clindamycin in the form of a transvaginal suppository to treat bacterial vaginal infections. Alternatively, they may prescribe a clindamycin lotion for vaginal infections. Pregnant people in their second and third trimesters can use the lotion.

Some people can also take clindamycin for uses that the Food and Drug Administration (FDA) has not formally approved. Sometimes, for example, doctors use clindamycin to treat anthrax and malaria.

Dentists also use clindamycin as a preventive treatment for endocarditis, which is an infection of the heart’s lining that can occur after a dental procedure in people who are at risk.

Before having surgery, some people receive clindamycin to prevent surgical site infections.

There are four forms of clindamycin: injectable, intravaginal, oral, and topical.

The following table lists the forms of clindamycin along with their dosages in milligrams (mg), milligrams per milliliter (mg/ml), or percentages.

Dosage for capsules

The dosages for clindamycin capsules for adults are:

• for serious infections, 150–300 mg every 6 hours
• for more severe infections, 300–450 mg every 6 hours

The dosages for children who can swallow capsules are:

• for serious infections, 8–16 mg per kilogram (mg/kg) per day, divided into three or four equal doses
• for more severe infections, 16–20 mg/kg per day, divided into three or four equal doses

Dosage for suppositories

One suppository pill contains 100 mg of clindamycin. People can use this form once daily at bedtime for 3 consecutive nights.

Dosage for topical gels and lotions

Doctors prescribe Clindagel 1% to be applied once daily to the affected area.

Dosage for injectable clindamycin

The following table includes the dosages for injectable clindamycin in mg/kg per day and mg per day.

The form and dosage of clindamycin that a doctor prescribes will depend on the infection a person has.

How to take oral capsules and granules

Doctors should only prescribe clindamycin to people who have allergies to penicillin or if they suspect that a different antibiotic would be inappropriate for that person. This is to lower the risk of colitis, which is inflammation of the colon’s inner lining.

If possible, the doctor should take samples from the infection site to determine which bacteria are causing the infection.

Clindamycin capsules may irritate the esophagus, which is the tube that runs from the mouth to the stomach. To prevent this irritation, people may wish to take clindamycin capsules with a full glass of water.

For people who have difficulty swallowing, clindamycin comes in granules that dissolve in water.

How to use vaginal creams and suppositories

Topical clindamycin can help treat bacterial infections in the vagina.

The cream comes with an applicator. A person can insert the amount of one applicator, which is around 100 mg of clindamycin, into the vagina once daily at bedtime for 3 or 7 consecutive nights.

Cleocin vaginal cream is safe for pregnant people to use in the second and third trimesters. A pregnant person requires 7 days of treatment.

Pregnant people should not use clindamycin vaginal suppositories. Researchers have yet to confirm the safety of suppositories during pregnancy.

To use a suppository, a person can insert one suppository pill — which is equivalent to 100 mg of clindamycin — into the vagina once daily at bedtime for 3 consecutive nights.

People with a history of colitis should not use clindamycin creams or suppositories.

How to use lotions, gels, and solutions

Doctors prescribe clindamycin lotions, gels, and solutions to treat acne.

A person with acne can apply a thin layer of Cleocin T 1% lotion or clindamycin 1% solution to the affected area of skin twice per day.

A person can apply Clindagel 1% once daily to the affected area when acne appears.

Topical clindamycin can cause diarrhea. Anyone who has had colitis should avoid using this treatment.

How to take injectable clindamycin

If a person has a very serious infection and cannot take other antibiotics, they may receive injectable clindamycin at the hospital.

One of the most common side effects of many antibiotics is diarrhea. Sometimes, people experience severe diarrhea when taking clindamycin.

Clindamycin can alter the bacterial composition of the colon and cause an overgrowth of the Clostridium difficile bacterium. This bacterium produces toxins that can cause C. difficile-associated diarrhea (CDAD).

CDAD is a severe and life threatening infection. If a person develops CDAD while taking clindamycin, the doctor will immediately stop their treatment with the antibiotic.

Some other possible side effects of oral or injectable clindamycin include:

• abdominal pain
• irritation of the esophagus
• nausea and vomiting
• allergic skin reactions
• severe allergic reactions
• inflammation of the vagina
• fluid buildup under the skin
• impeded liver function
• impeded kidney function
• blood disorders
• disrupted function of the immune system
• arthritis

People using a clindamycin solution or lotion for acne may report skin-related side effects, including:

• dryness
• flushing or discoloration
• a burning or stinging sensation
• peeling
• itchiness
• oiliness

For example, when an individual uses Clindagel for acne, the most common side effects are itchiness and skin peeling.

People rarely experience diarrhea or colitis after using clindamycin topically. However, some people do report abdominal disturbances.

Clindamycin suppositories and vaginal creams may cause the same side effects as the oral or injectable forms.

Rarely, a person may develop colitis from using a vaginal clindamycin product.

Some other side effects of using clindamycin suppositories or vaginal creams include:

• vaginal fungal infections
• inflammation of the vagina and vulva
• disorders of the vagina or vulva
• vaginal pain

People with a history of pseudomembranous or ulcerative colitis should not take clindamycin. These two conditions cause severe inflammation of the lining of the intestine.

The side effects of taking clindamycin can worsen these two conditions.

Doctors should only prescribe clindamycin to people who have bacterial infections. This helps reduce the resistance that bacteria can develop to clindamycin.

Drug interactions may occur when using any form of clindamycin.

Historically, anesthesiologists have worried that clindamycin could delay the effectiveness of neuromuscular blocking agents through surgeries.

More recently, however, researchers have found that the drug may enhance the effect of a blocking agent.

When people take oral forms of clindamycin, the liver enzyme CYP3A4 breaks it down in the body. Stimulating the function of this enzyme can cause a decrease in levels of clindamycin. If something inhibits CYP3A4, clindamycin levels may increase in the blood.

Certain drugs can affect the functioning of CYP3A4. When a person is taking CYP3A4 stimulants along with clindamycin, doctors must follow up and make sure that the antibiotic is working.

If a person is taking an inhibitor of CYP3A4 with clindamycin, the increased levels of the antibiotic may cause side effects. Doctors should monitor any increase in adverse effects.

Clindamycin and lincomycin are the only members of the lincosamide family.

Lincomycin is only available as an injectable solution, and doctors prescribe it for serious infections.

Depending on the infection and the person’s history of allergies and side effects from antibiotics, a doctor may choose another class of antibiotics instead.

Clindamycin is an effective antibiotic for a variety of serious infections. People can also use clindamycin for treating acne.

However, there are many possible side effects of clindamycin. For this reason, doctors should weigh the benefits and risks before prescribing this antibiotic.

People with a history of colitis should avoid taking clindamycin because it could damage their health.

When serious side effects occur, they tend to affect people taking oral or injectable forms of clindamycin. However, they can also arise in people using topical forms.

Read the article in Spanish.

CLINDAMYCIN in the treatment of infectious and inflammatory diseases | Shchotizhnevik PHARMACY

Among all the pathology of ENT organs, infectious and inflammatory diseases occupy a leading position and, accordingly, they account for the majority of all cases of antibiotic therapy [2]. According to the American Academy of Otolaryngology and Head and Neck Surgery, sinusitis of bacterial etiology is the fifth most common disease requiring antibiotics [4]. Therefore, the study of the effectiveness of the use of individual antibiotics in the treatment of infectious and inflammatory diseases of the upper respiratory tract is relevant and of practical importance.

Clindamycin is an antibiotic of the lincosamide group, a semi-synthetic analogue of lincomycin (7-chlorodeoxy derivative of lincomycin), has a bacteriostatic effect due to inhibition of protein synthesis by ribosomes. High concentrations of the drug against highly sensitive microorganisms can have a bactericidal effect.

Clindamycin is resistant to gastric hydrochloric acid. After oral administration, it is rapidly absorbed from the digestive tract, its bioavailability is 90% and does not depend on food intake. When using the drug at a dose of 150 mg, the maximum concentration in blood serum (2. 5 μg / ml) is reached after about 45 minutes, after 3 hours it is 1.5 μg / ml, and after 6 hours – 0.7 μg / ml. Clindamycin is well distributed in most tissues and body fluids, with the exception of cerebrospinal fluid (poorly penetrates the blood-brain barrier). High concentrations of the drug are achieved in bronchopulmonary secretions, bone tissue, and bile. The half-life of clindamycin is 2-3 hours, 10% of the drug is excreted in the urine in the active form, 4% – in the feces, the rest – in the form of inactive metabolites. In renal failure, the pharmacokinetics of clindamycin does not change significantly. In patients with severely impaired liver function, the half-life of the drug may be significantly prolonged.

Most appropriate to prescribe clindamycin for infections caused by Streptococcus anaerobicus ( Peptostreptococcus ), Staphylococcus spp., Clostridium perfringens (in combination with benzylpenicillin), Corynebacterium diphtheria , as well as Bacteroides , intestinal and oropharyngeal anaerobes [1]. The drug is especially indicated for polymicrobial-mixed infections caused by bacteroids and other anaerobes of the oral cavity, the prevalence of which is observed in chronic tonsillitis, deep abscesses of the neck and due to infections of the oral cavity and teeth [3]. Clindamycin is more preferable than penicillins for the eradication of streptococci in tonsillopharyngitis, probably due to the presence of b-lactamase-producing polymicrobial microflora [5], against which unprotected penicillins are ineffective. Clindamycin is moderately active against some protozoa ( Toxoplasma gondii, Plasmodium falciparum) .

Oral administration of clindamycin may cause nausea, vomiting, diarrhea, esophagitis, pseudomembranous colitis (caused by Clostridium dificile) . Rarely, reversible leukopenia, thrombocytopenia, impaired renal function, a transient increase in the level of hepatic transaminases and bilirubin in the blood serum are noted, very rarely – allergic reactions.

We have studied the effectiveness of CLINDAMYCIN manufactured by Balkanfarma (Bulgaria) in the treatment of patients with chronic purulent sinusitis and chronic purulent otitis media in the acute phase, paratonsillitis, paratonsillar abscess.

The choice of ENT pathology, in the treatment of which the effectiveness of CLINDAMYCIN was studied, was due to the pharmacological characteristics of the drug, its antibacterial spectrum, as well as recommendations for use. The microbiological characteristics of individual infectious and inflammatory diseases of the upper respiratory tract were taken into account. For observation, 3 groups (50 people) of patients aged 18 to 65 years were selected.

Group 1 included 18 patients (8 women and 10 men) with chronic purulent sinusitis in the acute phase. The average age of patients was 43.5 ± 7.2 years. Diagnosis was carried out on the basis of anamnesis data, otorhinolaryngological examination, radiography and ultrasound of the paranasal sinuses. The effectiveness of treatment was monitored based on patient complaints, rhinoscopy data, ultrasound of the paranasal sinuses, as well as the results of a general clinical blood test. Treatment of patients of the 1st group lasted for 7–14 days. CLINDAMYCIN was administered orally at a dose of 150-300 mg 4 times a day. The maxillary sinuses were punctured, followed by rinsing with a solution of nitrofural, analgesics, antihistamines (mebhydrolin, loratadine), decongestants for local and systemic use.

Group 2 included 11 patients (6 men and 5 women) with chronic suppurative otitis media in the acute phase. The average age of patients was 54 ± 3.8 years. Treatment effectiveness was monitored based on subjective data, as well as the results of an otorhinolaryngological examination and audiometry, and a general clinical blood test. Antibiotic therapy for patients of the 2nd group was also carried out for 7–14 days. CLINDAMYCIN at a dose of 150-300 mg was administered orally 4 times a day. Additionally, drops were prescribed in the external auditory canal (betamethasone + gentamicin) and vasoconstrictors in the form of nasal drops (naphazoline), antihistamines.

Group 3 included 12 patients (7 men and 5 women) with paratonsillitis and 10 (6 men and 4 women) with peritonsillar abscess. The average age of patients in group 3 was 32 ± 5.6 years. Diagnosis was made on the basis of anamnesis and oropharyngoscopy data. CLINDAMYCIN was prescribed at a dose of 150-300 mg 4 times a day for 5-14 days. Patients with paratonsillitis or paratonsillar abscess were additionally prescribed analgesics (metamisole sodium), rinsing with a solution of nitrofural (1:5000), and the abscess was drained.

In all patients before and after treatment, a microbiological examination of the smear / discharge was performed, the sensitivity of the isolated microflora to CLINDAMYCIN was determined.

The treatment was considered effective in the complete disappearance or significant reduction in the severity of the clinical symptoms of the disease.

The safety of therapy was assessed by the incidence of side effects during the entire observation period.

Microbiological examination revealed a rather high sensitivity of the isolated microflora to CLINDAMYCIN — sensitive strains accounted for 83.3% of the total isolated bacterial microflora. Fungal flora was detected in two patients with chronic purulent sinusitis in the acute phase ( Candida albicans ) and one patient with chronic suppurative otitis media in the acute phase ( Aspergillius niger ).

In tab. 1 shows the results of a study of the sensitivity of the isolated microflora to CLINDAMYCIN.

Table 1

Microflora sensitivity to CLINDAMYCIN

2 summarizes the results of evaluation of the therapeutic efficacy of CLINDAMYCIN.

Table 2

Evaluation of the therapeutic efficacy of CLINDAMYCIN

Recovery and improvement was achieved in 44 (88%) patients out of 50. The highest efficiency of CLINDAMYCIN was observed in patients of the 3rd group: recovery – in 90% with paratonsillitis and 90.9% with paratonsillar abscess. Sufficiently high efficiency of CLINDAMYCIN treatment was noted in chronic sinusitis – clinical remission and improvement were achieved in 88.9% of cases.

If treatment with CLINDAMYCIN was ineffective (according to the results of microbiological examination obtained on the 3-5th day of treatment), it was replaced with another drug. Thus, patients with exacerbation of chronic purulent sinusitis and exacerbation of chronic purulent otitis media, in whom fungal flora was isolated, were prescribed fluconazole orally at a dose of 50 mg 1 time per day for 5–14 days, and a patient with paratonsillar abscess, in whom enterococcus insensitive to CLINDAMYCIN – vancomycin intravenously at a dose of 1 g 2 times a day for 5 days.

When comparing the results of a general clinical blood test before and after complex treatment with the use of CLINDAMYCIN, a significant decrease in the number of leukocytes in peripheral blood and ESR was revealed. The development of leukopenia and thrombocytopenia was not observed.

Treatment with clindamycin caused side effects in 3 cases. One patient with chronic sinusitis and a history of intestinal dysbacteriosis experienced nausea, abdominal pain, and diarrhea on the 4th day of treatment. In this regard, CLINDAMYCIN was canceled, no other antibiotic was prescribed. One patient with paratonsillitis complained of slight nausea and diarrhea on the 5th day of treatment, but CLINDAMYCIN was not discontinued. By the 6th day of treatment, a patient with sinusitis developed a rash similar to urticaria on the skin of the upper limbs and trunk. CLINDAMYCIN was not discontinued, loratadine was administered orally at a dose of 10 mg per day.

The results of the study indicate that oral administration of CLINDAMYCIN at a dose of 150-300 mg 4 times a day for 5-14 days is highly effective in the treatment of patients with paratonsillitis, paratonsillar abscess, as well as chronic purulent sinusitis, purulent otitis media in the acute phase .

A.S. Chemerkin, I.S. Zaritskaya,
N.N. Mogilevskaya
Institute of Otolaryngology
im. A.I. Kolomiychenko Academy of Medical Sciences of Ukraine

The article was provided by the representative office of Balkanpharma in Ukraine

Office address:
01034, Kyiv, st. Yaroslavov Val, 38

Niotite ear drops – instructions for use for otitis media and ear pain

Contents 0483

Contents

What is otitis and how does it manifest

Otitis is an inflammatory process in various parts of the ear. It is classified into external, middle and internal according to the three parts of the organ of hearing. Otitis externa develops during a pathological process in the auricle and auditory canal, up to the tympanic membrane. Otitis media is an inflammation in the tympanic cavity, in which the auditory ossicles are located. Otitis media is an inflammatory process that affects the internal system of canals that are located behind the middle ear cavity.

Otitis externa is more often caused by mechanical, chemical injuries of the ear, through which the infection enters. Its symptoms: throbbing pain, radiating to the neck, jaw. Increases with jaw movement. Outwardly, redness of the skin of the auricle or ear canal is noted. If there is an abscess, then when it breaks, the ear canal can fill with pus, due to which hearing can decrease.

Otitis media can be caused by many pathogens: bacteria, viruses, fungi. It often develops against the background of SARS, influenza. The symptomatology of the disease is different, depending on the pathogen, the severity of the process, the condition of the eardrum. The most common complaint is shooting pain. If there is pus in the cavity, a feeling of fullness is possible. When pus breaks through the eardrum, the pain subsides. If the pus erupted towards the outer ear, note its outflow from the ear.

Otitis media or labyrinthitis – often a complication of the middle ear, with a breakthrough of pus towards the inner ear. The disease is manifested by severe dizziness, which can be combined with nausea and vomiting. Bacteria and viruses can be another reason. Of the diseases, otitis media of the inner ear can provoke meningitis.

Indications for the appointment of ear drops

Drops for inflammation in the ear are prescribed in the following cases:

• otitis media;
• otitis externa;
• acute catarrh of the ear;
• infectious inflammations;
• otitis after pressure drops;
• inflammation after prolonged contact with water;
• pain;
• sulfur plugs.

Anti-inflammatory otics are used for symptomatic treatment. They have a local effect, reducing swelling, but do not destroy the infection.

With internal otitis and eustachitis, drops with anti-inflammatory action are not effective.

This is due to the removal of the focus of inflammation from the external passage. With perichondritis, antibiotics and antiseptics will better cope with the disease.

What are the advantages of drops in otitis media

Means in the form of drops have a local effect, that is, their active components practically do not penetrate into the general blood flow, the percentage of their entry into the systemic circulation depends on the active component. If the drug does not act only in the ear cavity, then the likelihood of developing systemic side effects is extremely small. When using drugs for the treatment of otitis media, which must be taken orally, the components enter the general bloodstream, decompose in the liver.

After instillation, the active substances are immediately absorbed into the ear cavity, showing their therapeutic effect. Drugs for oral administration must first penetrate the mucous membranes and enter the bloodstream, and then act on the focus of inflammation, and this takes time. In addition, the effectiveness of such agents can reduce inflammatory processes in the mucous membrane, due to which the absorption of components may be difficult.

Almost all bottles are equipped with special droppers, which makes them very convenient to use. Most of the drugs in the form of drops are dispensed from pharmacies without a doctor’s prescription. Economic use. Drops are used in small dosages, on average 2-3 per instillation, so one bottle is enough for a long time.

An important plus of drops is the minimum list of side effects, contraindications, which is associated with their local application.

How to properly instill drops in the ears

Wash hands thoroughly with soap and water before instillation. Before instillation, it is necessary to clean the ear cavity if it contains an excess amount of sulfur or liquid discharge. If the ear is not cleaned first, then sulfur or liquid will make it difficult for drops to penetrate into the ear cavity, and their effectiveness decreases accordingly. For cleaning, it is recommended to use children’s ear sticks equipped with a limiter (wide base, thin tip).

Ordinary sticks are intended only for cleaning the skin of the auricle, if they are used to clean the ear canal, earwax can push inward, which can lead to the formation of an ear plug, hearing loss, and inflammation. If sulfur is located deep, it can be removed by dropping a few drops of hydrogen peroxide. It will soften it and bring it out of the cavity. You can not drip peroxide, but moisten a cotton turunda with it and insert it into your ear for 5 minutes.

After instillation, crackling is heard in the ear, which is not a cause for concern – this is how peroxide works.

After 5 minutes, remove the softened wax with a stick or put it on the sore ear so that the peroxide and the wax flow out of the ear. It is forbidden to perform such a procedure if the eardrum is damaged.

See also: Otosclerosis: what it is, what are the signs of the disease and treatment tactics Putting drugs on heating devices is prohibited, most chemicals are destroyed, lose their medicinal properties. To drip drops you need:

• lie down on your healthy side;
• slightly pull the ear shell to the side and up so that the drops penetrate deeper into the ear canal;
• add the required number of drops;
• close the ear canal with dry cotton so that the preparation warms up and does not leak out;
• lie down on your healthy side for about 10 minutes.

If multiple ear drops are prescribed, the minimum interval between drops is 20 minutes.

Niotite Ear Drops Instructions for Use

In case of inflammation of the outer part of the ear or otitis media, first of all it is necessary to undergo an examination by an ENT doctor. Only after his appointment of Niotit ear drops, purchase the drug at a pharmacy. Specify the allowable dosage in advance.

Before injecting medicine into the diseased ear , replace the bottle cap with a plastic one. It combines the drip tip and rubber papilla that come with the product.

After this clean the ear with 3% hydrogen peroxide.

To do this, lay the patient on one side and inject five drops of into the ears. Then the turunda should be placed in the ear canal for fifteen minutes. After the appointed time, wipe the ear canal and outer ear with a clean cotton pad. After completion of these procedures, the use of the drug is allowed.

Immediately before the introduction of “Niotite” into the ears , the bottle of liquid must be warmed up to body temperature . To do this, rub the bottle in your hands or dip it in warm water for a few minutes.

Tilt the patient’s head to the opposite side and carefully insert the drops down the back of the ear canal. To improve the effect, pull the earlobe down. Thus, you will improve the penetration of the agent into the focus of inflammation.

After the insertion into the ears, massage the ear and the tragus. To do this, warm your palms by rubbing them together. Then gently touch the outer ear and move your palms in a clockwise direction. After that, press several times on the tragus.

Repeat this operation for five minutes. After that, rinse the ear with warm water and carefully wipe the outer ear and ear canal with a cotton pad. Keep water out of the ear. It is a favorable environment for the development of bacteria and infections. Product name

Niotite-DF

International non-proprietary name

No

Dosage form

Ear drops, 10 ml 3

Composition

10 ml solution contains

active ingredients: chloramphenicol 0.1 g ,

lidocaine hydrochloride 0. 1 g,

excipients: boric acid 0.1 g, ethyl alcohol 70%.

Description

Clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group

Other preparations for the treatment of otological diseases.

ATC code S02DA30

Pharmacological properties

Pharmacokinetics

When applied topically as ear drops, systemic absorption is low.

Pharmacodynamics

Niotit-DF is a combined topical preparation. It has an antibacterial and local anesthetic effect. Chloramphenicol is a broad-spectrum bacteriostatic antibiotic. Violates the process of protein synthesis in a microbial cell (having good lipophilicity, it penetrates through the bacterial cell membrane and binds back to the 5OS subunit of bacterial ribosomes, in which the movement of amino acids to growing peptide chains is delayed, which leads to a violation of protein synthesis). Active against most strains of gram-positive and gram-negative microorganisms (Staphylococcus spp., Streptococcus spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Serratia spp., Proteus spp., etc.), causing the development of infectious and inflammatory diseases of the external and middle ear resistant to penicillin, tetracyclines, sulfonamides.

Lidocaine hydrochloride, which has a local anesthetic effect, relieves the sharp pain that accompanies most ear diseases. The combination of antibacterial and local anesthetic agents in an alcoholic solution enhances the therapeutic effect of the drug.

Indications for use

Dosage and administration

Before using Niotit-DF, the external auditory canal should be cleaned. To do this, a small piece of sterile cotton wool is wound onto a probe or onto a sulfur-free end of a match. At the same time, at the very end of the probe or match, cotton wool must be fluffed. The patient is pulled back and up the auricle to align the external auditory canal. A probe or a match with cotton wool is slowly and carefully inserted deep into the ear canal to the eardrum (depth 2.0 cm). By gently rotating the probe or match (clockwise) along the walls of the ear canal, pathological content and retrieved back. Change the cotton wool and repeat the toilet until the cotton wool and the external auditory canal are dry and clean.

Then, the drug is instilled along the back upper wall of the ear canal, while tilting the patient’s head in the opposite direction. After instillation, they press the tragus several times with a cotton ball, as if massaging it and the ear. The drug is kept in the ear for 10-15 minutes, then, tilting the head in the opposite direction, it is poured out. The external auditory canal is dried and covered with a sterile cotton swab.

See also: Albucid in the ear – instructions for proper use

Drops should be warm, at body temperature (so as not to irritate the labyrinth). To do this, before instillation, the vial with the drug is placed for several minutes in warm water (35-36 ° C).

If Niotit-DF is used in a vial complete with a plastic dropper, the vial cap must be replaced with a dropper before use.

Instilled into the external auditory canal 3-4 times a day:

– children over 3 years old, 3-5 drops each

– adults and children over 14 years old, 4-5 drops each

Course of treatment: for children – 2-5 days; for adults – 5-10 days.

It is also possible to lay cotton turunda moistened with the preparation. A dense flagellum 2-2.5 cm long is twisted from a piece of sterile cotton. It is moistened with a few drops of a warm preparation and introduced into the ear canal with rotational movements, after pulling the auricle back and up. The tip of the turunda must be left outside so that it can be easily removed. Humidity of the turunda is maintained by instilling warm medicine every 3-5 hours. Turunda is changed once a day. The duration of the drug use with the help of turunda is determined by the doctor.

Side effects

Rarely

– irritation of the skin and mucous membranes

– local allergic reactions in the form of rash, itching, redness and swelling of tissues

Contraindications 9 0407

– perforation of the tympanic membrane of an infectious or traumatic nature

– increased individual sensitivity to any of the components of the drug

– pregnancy and lactation

– children under 3 years of age

– viral and fungal infections of the ears

– eczema of the external auditory canal

– depression of bone marrow hematopoiesis

– acute intermittent porphyria

– deficiency of glucose-6-phosphate dehydrogenase 900 03

Drug interactions

Not recommended for concomitant use ear medications.

When used simultaneously with erythromycin, clindamycin, lincomycin, mutual weakening of the action is noted due to the fact that chloramphenicol can displace these drugs from the bound state or prevent them from binding to the 50S subunit of bacterial ribosomes.

Reduces the antibacterial effect of aminoglycosides, penicillins, polymyxin B, tetracyclines, cephalosporins, erythromycin. It is also incompatible with ascorbic acid, hydrocortisone, B vitamins.

Systematic monitoring of the picture of peripheral blood is necessary during the treatment.

Use with caution in patients who have previously received cytotoxic drugs or radiation therapy.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery

Does not affect.

Overdose

No overdose has been observed with topical application.

Symptoms in case of accidental ingestion: nausea, vomiting, diarrhoea, headache, skin rashes, confusion, decrease in body temperature.

Treatment – symptomatic; it is necessary to ensure sufficient fluid intake in the body.

Release form and packaging

10 ml of the drug in glass bottles with a plastic screw cap that combines a glass dropper and a rubber nipple, or in glass bottles sealed with a plastic screw cap, complete with a plastic dropper. One bottle, together with instructions for medical use in the state and Russian languages, is placed in a cardboard pack or one bottle, together with a plastic dropper and instructions for medical use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store in a place protected from light, at a temperature not exceeding 20 0C.

Keep out of reach of children!

Shelf life

3 years

After opening the vial, the drug is valid for 28 days.

Do not use after the expiry date which is stated on the packaging.

Terms of dispensing from pharmacies

Without a prescription

About the drug, its active ingredients and side effects

Ear diseases cause severe inconvenience, excruciating pain, and complete or partial hearing loss. To get rid of these symptoms, the patient must be given comprehensive treatment. In this case, the patient is prescribed ear drops “Niotit” , the instructions for use of which will be discussed below.

This agent has a local effect in case of inflammation of otitis media, as well as in otitis externa.

It is important to know that these drops are prohibited in case of perforation of the eardrum and with purulent discharge.

“Niotite” is considered to be an effective drug , available in the form of ten milliliter ear drops.

The product contains active ingredients and auxiliary elements:

1. Chloramphenicol.
2. Lidocaine.
3. Boric acid.
4. Ethyl alcohol.

Due to the fact that the drug contains analgesics and anesthetics, the drops eliminate the focus of inflammation in a short time. Thanks to alcohol, the remedy relieves pain, and also significantly improves the overall well-being of the patient.

When purchasing the drug, please note that the color of the drug should be either transparent or slightly yellow . In case of painting in other colors, do not purchase the drug, as there is a possibility of a fake.

Ear drops “Niotit” is considered a combined remedy with an antibacterial effect.

In addition, the agent anesthetizes the affected area immediately after injection into the ears.

Chloramphenicol , which is part of the drug, is considered an antibiotic with a wide spectrum of action.

Read also: How to drip Otipax?

It penetrates into infected cells and binds tightly to them, destroying the infection from the inside. As a result, the virus is quickly eliminated from the body.

The second active ingredient in the drug is lidocaine. It relieves the shooting pains that accompany otitis externa or otitis media. Due to the fact that the drug contains acid and alcohol, the effect of lidocaine is enhanced and has a therapeutic effect.

Specialists prescribe these drops for two types of otitis media , with which it copes equally well:

1. In the case of external otitis, but in the case of a whole eardrum.
2. For otitis media without various discharges.

Remember that self-treatment of ear infections is strictly prohibited. Therefore, before buying “Niotit” consult with your doctor. After purchasing the remedy, carefully study the side effects of the medication.

The main unpleasant consequences of its use include the following points:

1. Swelling of the mucous membrane in the ear canal.
2. Severe irritation of the skin of the ear.
3. In some cases, there is itching, burning sensation, and redness of the external ear.

Separately, it is noted that the instillation of “Niotite” is prohibited if there are holes in the eardrum.

Do not use medication with special sensitivity to the components that make up the drug.

During pregnancy, as well as when breastfeeding a baby, instillation of the drug is also prohibited .

In case of illness in children, the use of drops is allowed only from the age of three.

In addition to the listed contraindications, there are several more prohibitions:

1. Do not instill drops in case of viral inflammation in the ears.
2. If there is a white coating or fungus.
3. In case of eczema on the outside of the ear.
4. For acute inflammations.

During the treatment of otitis, it is important to take complex therapy, however, instillation of Niotit drops simultaneously with other drops is not desirable. Since most topical preparations contain erythromycins, clindamycins and lincomycins.

The active substance of the described drops is chloramphenicol, which can displace the listed medicines. In this regard, an overdose and deterioration of the patient’s condition may occur.

In addition, in the process of treating otitis media , it is important to strictly follow the dosage of prescribed by the attending physician.

If the dosage of is increased independently, adverse reactions may occur , as well as severe dizziness, fatigue, drowsiness or nervous excitement.

In special cases, the appearance of tachycardia and hypertension is noted.

In more serious cases, convulsions, memory loss, confusion, nausea, vomiting, severe pain in the ears and head occur.

For the same reason, doctors do not recommend the use of “Niotit” for prevention.

It is important to know that after a course of treatment with this drug, the state of the peripheral blood should be checked.

In case of accidental ingestion of , nausea, vomiting, shooting pains in the head, rashes on the skin, a strong decrease in body temperature are noted. Therefore, store the drug in a dark place out of the reach of children.

If you did not follow and the child still drank the drops, it is necessary to cleanse the body. In addition, the child should drink plenty of water.

Contraindications

– perforation of the tympanic membrane of an infectious or traumatic nature

– increased individual sensitivity to any of the components of the drug

– pregnancy and lactation

– children under 3 years of age

– viral or fungal diseases of the ear

– eczema of the external auditory canal

– oppression of bone marrow hematopoiesis

– acute intermittent porphyria

– deficiency of glucose-6-phosphate dehydrogenase

Medication dosing

9 0479 In each case of ear inflammation, the dosage is selected by the attending physician. Usually, for otitis externa, is injected into the diseased ear three or four drops three times a day. This dosage is suitable for the treatment of from 14 years of age.

Proper insertion of drops into the ears.

In the case of treatment of children older than three years, it is recommended to instill two drops twice a day.

The course of treatment in this case is from two to five days. For adults, therapy is increased to one week.

Overdose

No overdose has been observed with topical application.

Symptoms in case of accidental ingestion: nausea, vomiting, diarrhoea, headache, skin rashes, confusion, decrease in body temperature.

Treatment: symptomatic, it is necessary to ensure sufficient fluid intake in the body.

Storage conditions

Pharmacy dispensing conditions

Without a prescription

Release form

Niotit-DF – ear drops. 10 ml of the drug in glass bottles with a plastic screw cap that combines a glass dropper and a rubber nipple, or in glass bottles sealed with a plastic screw cap, complete with a plastic dropper.

Conclusion

Otitis is a dangerous inflammation that has a lot of unpleasant consequences. Therefore, at the first sign of an ear disease, you should consult a qualified doctor.