Klacid dose for adults. Instructions for use of the Klacid suspension

Klacid is an antibiotic with a fairly wide range of applications. It is relatively safe and rarely causes side effects, so it is used often. It is prescribed for various diseases: from purulent inflammatory processes to acne on the skin.

The active ingredient of the drug is the antibiotic clarithromycin. This is an antibiotic from the macrolide group - quite effective and safe. The product is available in tablets containing 250 or 500 mg active component. Film-coated tablets yellow, are available in blisters of 7, 10 and 14 tablets. Blisters are packed in cardboard packs of 1, 2 or 3 pieces.

What is it used for?

Klacid is an antibiotic, so it is prescribed for bacterial infections. inflammatory processes. It is most effective for the following diseases:

• bacterial inflammation respiratory tract(angina, laryngitis, bronchitis, pneumonia);
• purulent lesions of the skin and subcutaneous fat (acne, erysipelas, boils);
• mycobacterial infections;
• eradication Helicobacter pylori, prevention of ulcer recurrence.

In order to determine whether the pathogen is sensitive to the drug, a test is performed. To do this, the discharge from the affected area is placed in a nutrient medium, and after a colony of bacteria has formed there, it is exposed to an antibiotic. Growth inhibition means sensitivity is present, which means the drug is effective. This method takes time, so when severe conditions Clarithromycin may be prescribed before an antibiogram is obtained.

Pharmacological action

The drug has a bactericidal effect due to disruption of bacterial protein synthesis. The spectrum of action of clarithromycin includes streptococci, staphylococci, pneumococci, chlamydia and mycoplasma, the causative agents of a number of sexually transmitted infections.

Peculiarities dosage form ensure gradual absorption of the drug in the intestine. This allows you to maintain the desired concentration of the active ingredient in the blood, which means that you need to take the drug more rarely.

Clarithromycin is excreted from the body through the kidneys, so in case of kidney disease, the rate of excretion decreases. Liver disease does not affect the metabolism of the drug.

Instructions for use

Klacid tablets are taken orally regardless of meals. Dosage for adults is 250 mg twice a day, in severe cases take 500 mg twice a day. Maximum daily dose drug - 2000 mg (for adults). The course of treatment lasts from 5 to 14 days. The drug is taken as prescribed by a doctor.

It is very important to take your pills at the same time every day. The interval between doses is 12 hours; it should not be shortened or extended.

Patients with kidney disease and the elderly are recommended to take lower doses - 125 mg (half a tablet) twice a day. In some cases, it is acceptable to take the medicine once instead of twice.

The tablets should be taken with water or warm tea. They should not be mixed with milk, juices or coffee, as this may interfere with the absorption of the drug. The duration of treatment cannot be less than five days to avoid the development of bacterial resistance to clarithromycin.

Klacid SR

This form of medication is a long-acting drug. The tablets contain 500 mg of clarithromycin, which enters the body gradually as the drug passes through the gastrointestinal tract. This feature allows you to use one tablet per day during treatment instead of the usual two.

Contraindications and side effects

Clarithromycin is contraindicated in case of porphyria, hypersensitivity to macrolide antibiotics, as well as during pregnancy and breastfeeding. It is unacceptable to use it for children under three years of age. There are also restrictions on simultaneous administration with a number of drugs (indicated in the instructions).

The list of side effects of the drug is extremely extensive. Most often, nausea, vomiting, abdominal pain, changes in taste perception, and headaches occur. Indicators may change biochemical analysis blood, in this case there is increased activity of liver enzymes.

Rarer side effects include:

• candidiasis of the oral cavity or genital organs;
• intestinal dysbiosis;
• hypoglycemia;
• insomnia, hallucinations;
• hematopoietic disorder;
• cramps, muscle pain, loss of coordination;
• hearing loss (reversible);
• ventricular tachycardia.

The incidence of these effects is relatively small, but the possibility of their development should be taken into account. Such reactions are dangerous to health, so if they occur, you should consult a doctor so that a specialist can decide whether it makes sense to complete the course of treatment or whether clarithromycin should be replaced with another drug.

Suspension for children

Klacid is intended for children over 3 years of age. There is a suspension especially for babies. This is a thick liquid containing 125 or 250 mg active substance per teaspoon. The suspension must be shaken before use and diluted with water or milk. Take 5 ml (a teaspoon) of undiluted suspension twice a day.

The suspension, unlike tablets, can be taken with milk, regardless of meals. The medicine is given to the child twice a day, the interval between doses of the suspension should be 12 hours, as in adults. Exact dosage determined by the doctor. In adolescents over 12 years of age, tablets can be used; after 15 years, “adult” doses are acceptable.

Special instructions

The medicine should be used with extreme caution for liver diseases. Clarithromycin may interfere with the metabolism of other drugs and increase the activity of liver enzymes. At chronic diseases the liver may experience an exacerbation caused by taking Klacid.

Among the additional substances, the drug contains sucrose, so patients diabetes mellitus You should check with your endocrinologist on how to adjust your diet and insulin administration during treatment.

Patients with heart disease, especially conduction disorders and heart rate, you should take the medicine with caution. Symptoms of myasthenia gravis may worsen in those who suffer from this disease. Driving a car or doing work that requires precision and concentration should be done with caution - slower reactions and deceptive perceptions may occur.

Drug interactions

The drug actively interacts with many other drugs. The instructions describe these points in detail. You should not use Klacid and medications that affect electrical activity heart, in this case the side effects of the drugs are significantly increased, and severe arrhythmia may develop.

Ergotamines and ergot alkaloids are better absorbed when taken together with Klacid, which can lead to acute poisoning. There are a number of drugs that increase the metabolism of clarithromycin, resulting in a decrease in its effectiveness.

The use of clarithromycin and related drugs together with other drugs provokes an overdose. Joint appointment with some antiviral drugs enhances the effectiveness of both, but care must be taken not to cause an overdose.

Drug price

The price of Klacid tablets ranges from 500 to 800 rubles per package, depending on the number of tablets. A bottle of suspension costs less - from 300 to 400 rubles. The medicine is sold in pharmacies with a prescription; it must be stored at room temperature out of the reach of children and pets.

The shelf life of tablets with an intact blister and suspension with an unopened bottle is 3 years. After opening the bottle, the contents should be consumed within a month. If an individual tablet cell is damaged, it remains usable for 24 hours.

For a number of “childhood” diseases, as well as many infectious lesions of the respiratory tract, the doctor prescribes antibacterial agent called Klacid. In what form is the drug available? What substances are included in its composition? How does the product work? Are there certain rules for its use? Who should not take Klacid? How to properly give an antibiotic to a child? Is it possible to choose an analogue medicine if taking Klacid for some reason becomes impossible? Let's find out in this article.

Antibacterial agent Klacid

Release form and composition of the medicinal product

Klacid is a medicine from the group of semi-synthetic antibacterial drugs - macrolides. His pharmacological effects provided by active active ingredient– clarithromycin. Available in the form:

• oval bilayer tablets consisting of a white core and a yellow outer layer, each containing 125 or 250 mg of clarithromycin;
• powder for preparing a suspension for children – 250 mg / 5 ml.

The medicine is sold in pharmacies. It can only be purchased with a prescription. The shelf life of the tablets is 2 years from the date of issue, ready suspension– 2 weeks from the date of preparation. Klacid should be stored at room temperature out of the reach of small children (but not in the refrigerator).

The main disadvantages of the drug include relatively high price, side effects that most often develop from gastrointestinal tract(however, drugs such as Linex help solve this problem - the doctor usually prescribes them along with an antibiotic) and the presence of a set of contraindications. That is, in fact, all the disadvantages of Klacid are inherent in almost all antibacterial drugs.

Antibiotic Klacid SR in tablet form

At the same time, the antibiotic in question has a number of advantages, including:

• anti-inflammatory effect;
• immunomodulatory effect;
• Compared to other antibiotics, Klacid is well tolerated by young patients (side effects when taking the drug by a child occur less frequently and are much less pronounced);
• convenient release forms that take into account the physiology of patients of different ages;
• the effect manifests itself very quickly - patient reviews indicate that a noticeable improvement in the condition is observed already on the second or third day of taking the medicine;
• wide spectrum of action, including infections of mycobacterial origin.

Pharmacological action of the drug Klacid

The use of antibacterial drugs has made possible treatment diseases that just a hundred years ago were guaranteed to lead to death. You can drink antibiotics (as well as buy them at pharmacies) only as prescribed by a doctor, since we're talking about O strong drugs, uncontrolled reception which may pose a danger. For this reason, it is important to have an idea not only of the purpose, but also of the characteristics of the action of the antibiotic.

The drug helps suppress the process of bacterial protein synthesis. Thanks to the two-layer structure of the tablets, the active component is gradually released while the medicine passes through the patient's gastrointestinal tract. Gram-negative bacteria are insensitive to the effects of the drug, which should be taken into account when prescribing therapy. The pharmacokinetic characteristics of the main active component do not depend on the age of the patient who is being treated with Klacid.

Indications for use

An antibiotic may be prescribed within preventive measures aimed at preventing pathological processes caused by mycobacterial complexes. It also helps reduce the frequency of relapses peptic ulcer duodenum. For therapeutic purposes, taking the drug Klacid is indicated in the following cases:

• mycobacterial infections;
• diseases skin and soft tissues of infectious origin;
• pathological processes in the upper and lower respiratory tract caused by infection.

Klacid is used for infectious diseases of the respiratory tract

Contraindications for use

Since Klacid is an antibacterial drug, its use is contraindicated in certain groups of patients:

1. Taking the suspension is prohibited in childhood up to 6 months. Clarithromycin 250 mg tablets should not be given to children under 12 years of age.
2. Contraindications also include pregnancy and breastfeeding.
3. It is prohibited to use the medicine in the treatment of patients suffering from hypersensitivity to the components of the drug, as well as patients with porphyria.
4. For renal and liver failure medicine Use with caution.
5. It is forbidden to take the medicine in parallel with drugs such as Terfenadine, Cisapride, Dihydroergotamine, Pimozide, Ergotamine, Astemizole.

Directions for use and dosage selection for a child

Klacid is prescribed to children in the form of a suspension. You can purchase granules for its preparation at most pharmacies in the country. For ease of dosing, the package contains a measuring syringe or a special spoon with marks.

How to make a suspension from powder?

The method for preparing the syrup is indicated in the instructions for the drug. Preparing the suspension is very simple - you need to open a plastic bottle with granules, pour warm (but not hot) boiled water into it up to the mark and shake thoroughly until the suspension becomes almost homogeneous. The result should be an opaque whitish liquid containing a small amount of undissolved whitish particles and having a light fruity aroma.

The finished composition can be stored for 14 days at temperatures up to +30 degrees in a dark place. Before taking, the bottle of suspension should be shaken vigorously.

How long does the treatment last?

The therapeutic course of taking Klacid suspension for children is from five to ten days - the duration is determined by the attending physician based on individual characteristics the patient, his medical history, the diagnosed disease and the severity of the latter. You can take the medicine regardless of food intake. Infants can take the medicine with milk or an adapted mixture.

How to calculate the dosage?

Dosage antibacterial drug for children is selected depending on the patient’s body weight. For this reason, before starting calculations, it is recommended to weigh the child. Babies whose body weight is less than 8 kilograms (mostly infants under one year of age) take the medicine twice a day at the rate of 7.5 mg per kilogram. That is, if the baby weighs 6 kg, then the one-time volume of Klacid will be 45 mg. For small children who weigh more than 8 kg, the dosage is determined according to the table below.

The dosage of Klacida is calculated taking into account body weight

Special instructions for use

During the period of treatment with Klacid, it is recommended to refrain from performing any activities that require concentration, including managing any types of vehicles. Upon appointment medicinal product Patients with diagnosed diabetes mellitus should take into account that the suspension contains sucrose.

Also, when treating with this antibacterial agent, the following special instructions should be taken into account:

• in patients suffering from myasthenia gravis, when exposed to a substance such as clarithromycin, symptoms may increase, including pathological fatigue;
• patients suffering from heart failure in severe forms, can receive treatment with Klacid only with constant ECG monitoring;
• in case of chronic liver failure, Klacid can be used with caution, and it is necessary to regularly monitor blood serum enzymes;
• if the patient is simultaneously taking other medications that are metabolized by the liver, Klacid is prescribed with caution;
• therapy with this antibacterial agent can lead to changes in intestinal microflora and the development of pseudomembranous colitis;
• long-term use of the drug leads to the formation of large colonies of bacteria and fungi that are not sensitive to a substance such as clarithromycin;
• the drug is incompatible with alcohol, since the latter increases the level of toxicity of clarithromycin, significantly increasing the risk of side effects.

Long-term use Klacida can cause disruption of intestinal microflora

Possible side effects

Side effects can occur when using Klacid in any form, including in the case of intravenous administration drug in a hospital setting. If, after taking tablets or a suspension, or administering an antibiotic injection, the patient notes that he has a headache and/or stomach pain, taste sensations change, he feels nauseous, dyspepsia, diarrhea or vomiting is noted, inflammation appears at the injection site, and pain is felt when pressed, he should See a doctor immediately.

The specialist may recommend stopping treatment with Klacid and recommend another antibacterial agent. The conditions listed above represent the most common side effects from the use of the drug in question. Much less commonly, antibiotics cause the following phenomena:

There are also isolated reports of the development of colchicine toxicity - mainly in elderly patients suffering from chronic renal failure and taking drugs containing colchicine in parallel with Klacid. In several cases, the development of this toxicity led to death.

Signs of drug overdose

Overdose medicine manifests itself through disruption of the functioning of the gastrointestinal tract. At the first signs of an overdose, measures should be taken to remove the drug from the patient’s body, after which symptomatic therapy until the patient's condition is completely normalized. The hemodialysis procedure is practically not prescribed, since in this case it shows low efficiency.

Cost and analogues of antibiotics

Clarithromycin is the main analogue of Klacid

The average cost of a Klacid package containing 10 tablets with a concentration of the active component of 250 mg is about 800 rubles. For a 125 ml bottle of suspension in pharmacies across the country you will have to pay about 380-400 rubles. If for some reason it is not possible to take this antibiotic (contraindications, unavailable in pharmacies), the doctor may recommend replacing it with one of its analogues. It should be borne in mind that some antibiotic analogues are cheaper, while others are more expensive.

Drug name: KLACID®

International name: clarithromycin (clarithromycin)
KFG: Macrolide antibiotic
Owner reg. credentials: ABBOTT S.P.A. (Italy)

DOSAGE FORM, COMPOSITION AND PACKAGING:

Yellow, oval, film-coated tablets.

1 tab. clarithromycin 250 mg

Excipients: croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, silicon dioxide, povidone, stearic acid, magnesium stearate, talc, quinoline yellow (E104).

Shell composition: hypromellose, hyprolose, propylene glycol, sorbitan monooleate, titanium dioxide, sorbic acid, vanillin, quinoline yellow (E104).

7 pcs. - blisters (1) - cardboard packs.

PHARMACOLOGICAL ACTION

Semi-synthetic antibiotic of the macrolide group. It has an antibacterial effect by interacting with the 50S ribosomal subunit of bacteria and inhibiting protein synthesis in the microbial cell.

Clarithromycin has demonstrated high activity in vitro against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro studies confirm high efficiency clarithromycin against Legionella pneumophila, Mycoplasma pneumoniae and Helicobacter (Campylobacter) pylori.

The drug is also active against aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Legionella pneumophila; others microorganisms: Mycoplasma pneumoniae Chlamydia pneumoniae(TWAR), Chlamydia trachomatis, mycobacteria Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC): Mycobacterium avium, Mycobacterium intracellulare.

To clarithromycin insensitive Enterobacteriaceae, Pseudomonas spp., as well as other non-lactose-degrading gram-negative bacteria.

The production of β-lactamases does not affect the activity of clarithromycin. Most strains of staphylococci resistant to methicillin and oxacillin are also resistant to clarithromycin.

The sensitivity of Helicobacter pylori to clarithromycin was studied on Helicobacter pylori isolates isolated from 104 patients before starting drug therapy. In 4 patients, clarithromycin-resistant Helicobacter pylori strains were isolated, in 2 patients, intermediate-resistant strains were isolated, and in the remaining 98 patients, Helicobacter pylori isolates were sensitive to clarithromycin.

Clarithromycin is effective in vitro and against most strains of the following microorganisms (however, the safety and effectiveness of the use of clarithromycin in clinical practice has not been confirmed by clinical studies and the practical significance remains unclear): aerobic gram-positive microorganisms: Streptococcus agalactiae, streptococci (groups C, F, G), streptococci of the Viridans group; aerobic gram-negative microorganisms: Bordetella pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms:Сlostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni.

The main metabolite of clarithromycin in the human body is the microbiologically active metabolite 14-hydroxyclarithromycin. The microbiological activity of the metabolite is the same as that of the parent substance, or 1-2 times weaker against most microorganisms. The exception is Naemophilus influenzae, for which the effectiveness of the metabolite is 2 times higher. The parent substance and its main metabolite have either an additive or synergistic effect against Haemophilus influenzae in vitro and in vivo, depending on the bacterial culture.

Sensitivity studies

Quantitative methods that require measuring the diameter of the growth inhibition zone of microorganisms provide the most accurate estimates of the sensitivity of bacteria to antimicrobial agents. One recommended susceptibility testing procedure uses discs soaked in 15 μg of clarithromycin (Kirby-Bauer diffusion test); the test results are interpreted depending on the diameter of the zone of growth inhibition of the microorganism and the value of the minimum inhibitory concentration (MIC) of clarithromycin. The MIC value is determined by diluting the medium or diffusion into agar. Laboratory tests give one of three results: 1) “resistant” - it can be considered that the infection cannot be treated with this drug; 2) "medium sensitive" - therapeutic effect controversial, and it is possible that increasing dosage may lead to sensitivity; 3) “sensitive” - we can assume that the infection can be treated with clarithromycin.

PHARMACOKINETICS

The first data on pharmacokinetics were obtained from the study of clarithromycin tablets.

The bioavailability and pharmacokinetics of clarithromycin suspension were studied in healthy adults and children.

Healthy

Suction and distribution

With a single dose in adults, the bioavailability of the suspension was equivalent to the bioavailability of tablets (at the same doses) or slightly higher. Eating slightly delayed the absorption of clarithromycin suspension, but did not affect the overall bioavailability of the drug.

When taking the pediatric suspension (after meals), the Cmax and AUC of clarithromycin were 0.95 µg/ml, 6.5 µg×h/ml, respectively.

When clarithromycin suspension was administered at a dose of 250 mg every 12 hours in adults, steady-state blood levels were practically achieved by the fifth dose. In this case, the pharmacokinetic parameters were as follows: Cmax 1.98 μg/ml, AUC 11.5 μg×h/ml and Tmax 2.8 h for clarithromycin and, respectively, 0.67, 5.33, 2.9 for 14-hydroxyclarithromycin.

U healthy people Serum concentrations peaked within 2 hours after oral administration. C ss max of 14-hydroxyclarithromycin is about 0.6 μg/ml. When clarithromycin is prescribed at a dose of 500 mg every 12 hours, the C ss max of 14-hydroxyclarithromycin is slightly higher (up to 1 μg/ml). When using both doses, C ss max metabolite is usually achieved within 2-3 days.

In in vitro studies, the binding of clarithromycin to plasma proteins averaged about 70% at clinically relevant concentrations from 0.45 to 4.5 μg/ml.

Metabolism and excretion

Clarithromycin is metabolized in the liver under the action of the CYP3A isoenzyme to form the microbiologically active metabolite 14-hydroxyclarithromycin.

T1/2 of clarithromycin when taking a children's suspension (after meals) was 3.7 hours. When using a clarithromycin suspension at a dose of 250 mg every 12 hours in adults, T1/2 was 3.2 hours for clarithromycin and 4.9 for 14-hydroxyclarithromycin.

In healthy people when using clarithromycin: at a dose of 250 mg every 12 hours T1/2 of 14-hydroxyclarithromycin is 12 hours; at a dose of 500 mg every 12 hours T1/2 of 14-hydroxyclarithromycin is about 7 hours.

When clarithromycin is used at a dose of 250 mg every 12 hours, approximately 20% of the dose is excreted unchanged in the urine. When clarithromycin is used at a dose of 500 mg every 12 hours, approximately 30% of the dose is excreted unchanged in the urine. The renal clearance of clarithromycin is not significantly dose-dependent and approaches the normal glomerular filtration rate. The main metabolite found in urine is 14-hydroxyclarithromycin, which accounts for 10-15% of the dose (250 mg or 500 mg every 12 hours).

Sick

Clarithromycin and its metabolite are well distributed in tissues and body fluids. Tissue concentrations are usually several times higher than serum concentrations.

Examples of tissue and serum concentrations after oral administration of the drug at a dose of 250 mg every 12 hours are given in the table:

U children who require oral antibiotic treatment, clarithromycin is characterized by high bioavailability. Moreover, its pharmacokinetic profile was similar to that of adults taking the same suspension. The drug is quickly and well absorbed from the gastrointestinal tract. Food slightly delays the absorption of clarithromycin without significantly affecting its bioavailability or pharmacokinetic properties.

The equilibrium parameters of the pharmacokinetics of clarithromycin, achieved after 5 days (dose 9) were as follows: Cmax - 4.6 μg/ml, AUC - 15.7 μg×h/ml and Tmax - 2.8 h; the corresponding values ​​for 14-hydroxyclarithromycin were 1.64 μg/ml, 6.69 μg×h/ml and 2.7 h, respectively. The calculated T1/2 of clarithromycin and its metabolite are 2.2 and 4.3 hours, respectively.

Pharmacokinetics in special clinical situations

In elderly patients receiving clarithromycin repeated at a dose of 500 mg, a comparative study revealed increased plasma levels of the drug and slower elimination compared with those in young healthy people. However, there was no difference between the two groups when adjustment was made for creatinine clearance. Changes in the pharmacokinetics of clarithromycin reflect renal function and not the age of the patient.

In patients with otitis media, 2.5 hours after taking the fifth dose (7.5 mg/kg 2 times/day), the average concentrations of clarithromycin and 14-hydroxyclarithromycin in the middle ear were 2.53 and 1.27 mcg/g. Concentrations of the drug and its metabolite were 2 times higher than their serum levels.

In patients with impaired liver function, C ss of clarithromycin did not differ from those in healthy people, while the level of the metabolite was lower. The decrease in the formation of 14-hydroxyclarithromycin was partially offset by an increase in the renal clearance of clarithromycin compared with that in healthy subjects.

In patients with impaired renal function who received the drug orally at a dose of 500 mg repeatedly, plasma levels, T1/2, Cmax, Cmin and AUC of clarithromycin and the metabolite were higher than in healthy people. Deviations in these parameters correlated with the degree of renal failure: with more severe renal dysfunction, the differences were more significant.

In adult patients with HIV infection receiving the drug in usual doses, C ss of clarithromycin and its metabolite were similar to those in healthy people. However, when clarithromycin is used in higher doses, which may be required in the treatment of mycobacterial infections, antibiotic concentrations may be significantly higher than usual.

In children with HIV infection taking clarithromycin at a dose of 15-30 mg/kg/day in 2 divided doses, steady-state Cmax values ​​usually ranged from 8 to 20 mcg/ml. However, in children with HIV infection who received a clarithromycin suspension at a dose of 30 mcg/kg/day in 2 doses, C max reached 23 mcg/ml. When using the drug in higher doses, a prolongation of T1/2 was observed compared with that in healthy people receiving clarithromycin in usual doses. The increase in plasma concentration and T1/2 duration when clarithromycin is prescribed in higher doses is consistent with the known nonlinearity of the pharmacokinetics of the drug.

INDICATIONS

- lower respiratory tract infections (bronchitis, pneumonia);

- infections upper sections respiratory tract (pharyngitis, sinusitis);

- infections of the skin and soft tissues (folliculitis, cellulitis, erysipelas);

- common mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare ;

- localized mycobacterial infections caused by Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii;

— eradication of Helicobacter pylori and reduction in the frequency of relapses of duodenal ulcers;

- prevention of the spread of infection caused by the Mycobacterium avium complex (MAC) in HIV-infected patients with a content of CD4 lymphocytes (T-helper lymphocytes) of no more than 100 per 1 mm 3;

- odontogenic infections.

DOSING REGIME

Pills

The drug is taken orally regardless of food intake.

Usually adults Prescribe 250 mg 2 times/day. IN more severe cases the dose is increased to 500 mg 2 times/day. Usually the duration of treatment is from 5-6 to 14 days.

Patients with CC less than 30 ml/min Prescribe half the usual dose of clarithromycin, i.e. 250 mg 1 time/day or, if more severe infections- 250 mg 2 times/day. Treatment of such patients continues for no more than 14 days.

At mycobacterial infections Prescribe 500 mg 2 times/day.

At common infections caused by MAC in patients with AIDS Treatment should be continued as long as there is clinical and microbiological evidence of its benefit. Clarithromycin should be prescribed in combination with other antimicrobial drugs.

At infectious diseases caused by mycobacteria, except tuberculosis, The duration of treatment is determined by the doctor.

For prevention of infections caused by MAC, recommended dose of clarithromycin for adults- 500 mg 2 times/day.

At odontogenic infections The dose of clarithromycin is 250 mg 2 times a day for 5 days.

For eradication of Helicobacter pylori

Combination treatment with three drugs

— clarithromycin 500 mg 2 times/day + lansoprazole 30 mg 2 times/day + amoxicillin 1000 mg 2 times/day for 10 days;

— clarithromycin 500 mg 2 times/day + omeprazole 20 mg/day + amoxicillin 1000 mg 2 times/day for 7-10 days.

Combination treatment with two drugs

— clarithromycin 500 mg 3 times/day + omeprazole 40 mg/day for 14 days with the prescription of omeprazole at a dose of 20-40 mg/day over the next 14 days;

— clarithromycin 500 mg 3 times/day + lansoprazole 60 mg/day for 14 days. For complete healing of the ulcer, additional reduction in the acidity of gastric juice may be required.

Powder for suspension for oral administration

The prepared suspension should be taken orally regardless of food intake (with milk).

To prepare the suspension, water is gradually added to the bottle with granules up to the mark, then the bottle is shaken. The prepared suspension can be stored for 14 days at room temperature.

Suspension 60 ml: 5 ml - 125 mg of clarithromycin; suspension 100 ml: 5 ml - 250 mg of clarithromycin.

Recommended daily dose of clarithromycin suspension for non-mycobacterial infections at children is 7.5 mg/kg 2 times/day. The maximum dose is 500 mg 2 times/day. The usual duration of treatment is 5-7 days, depending on the pathogen and the severity of the patient's condition. Before each use, shake the bottle of the drug well.

U children with CC<30 мл/мин the dose of clarithromycin should be halved: to 250 mg 1 time / day or 250 mg 2 times / day for more severe infections. In such cases, the course of treatment should not exceed 14 days.

U children With disseminated or local mycobacterial infections The recommended dose of clarithromycin is 15-30 mg/kg/day in 2 divided doses. Treatment with clarithromycin should be continued as long as the clinical effect persists. The addition of other antimycobacterial drugs may be useful.

SIDE EFFECTS

The most common adverse events occurred from the digestive system: diarrhea, vomiting, abdominal pain, nausea. Pseudomembranous enterocolitis has been observed extremely rarely. Other adverse reactions included headache, taste disturbances, and transient increases in liver enzymes. As with the use of other macrolide antibiotics, the development of microbial resistance may occur.

Klacid suspension is comparable in safety to Klacid 250 mg tablets in adults.

Post-marketing experience

From the digestive system: glossitis, stomatitis, oral thrush, tongue discoloration, tooth discoloration (these changes are usually reversible and can be corrected by a dentist); uncommon - impaired liver function, increased activity of liver enzymes, hepatocellular and/or cholestatic hepatitis with/without jaundice; rarely - pancreatitis. Liver dysfunction can be severe but is usually reversible. In very rare cases, deaths from liver failure have been reported, which usually occur in the presence of serious concomitant diseases and/or simultaneous use of other drugs.

From the central nervous system and peripheral nervous system: dizziness, anxiety, insomnia, nightmares, tinnitus, confusion, disorientation, hallucinations, psychosis, depersonalization. Side effects are temporary; a cause-and-effect relationship with the use of the drug has not been established. Rare cases of seizures have been described.

From the cardiovascular system: rarely - prolongation of the QT interval, ventricular tachycardia, ventricular tachycardia of the "pirouette" type.

From the senses: hearing loss (after cessation of treatment, hearing was usually restored), impaired sense of smell, usually combined with a perversion of taste.

From the hematopoietic system: isolated cases of leukopenia, thrombocytopenia.

From the side of metabolism: rarely - cases of hypoglycemia, some of which were observed in patients receiving oral hypoglycemic agents or insulin; isolated cases of increased serum creatinine levels (no connection with the use of clarithromycin has been established).

Allergic reactions: urticaria, rash, anaphylaxis, Stevens-Johnson syndrome, Lyell's syndrome.

Others: cases interstitial nephritis and the toxicity of colchicine when used concomitantly with clarithromycin (especially in the elderly). Some of them were observed in patients with renal failure; Several deaths have been reported in similar patients.

Children with suppressed immune systems

In patients with acquired immunodeficiency syndrome and other immunodeficiency conditions receiving clarithromycin in higher doses over a long period of time for the treatment of mycobacterial infections, it is often difficult to differentiate unwanted effects medicine for symptoms of HIV infection or intercurrent illnesses.

The main adverse events in patients taking clarithromycin orally at a dose of 1 g were nausea, vomiting, taste disturbance, abdominal pain, diarrhea, rash, bloating, headache, hearing loss, constipation, increased AST and ALT levels. Dyspnea, insomnia, and dry mouth were also reported less frequently.

In this group of immunosuppressed patients, significant deviations in laboratory parameters from standard values in specific tests (sharp increase or decrease). Based on this, approximately 2-3% of patients taking clarithromycin orally at a dose of 1 g/day had significant laboratory abnormalities, such as increased levels of AST, ALT and decreased white blood cell and platelet counts. Fewer patients also experienced elevated blood urea nitrogen levels.

In a limited number of pediatric patients with AIDS, clarithromycin suspension has been used to treat mycobacterial infections. The main adverse events not related to the underlying disease were tinnitus, deafness, vomiting, nausea, abdominal pain, purpura, pancreatitis and increased amylase activity. In this study, significant deviations of laboratory parameters from normative values ​​(sharp increase or decrease) were recorded. Based on these criteria, one child with AIDS who received clarithromycin at a dose of<15 мг/кг/сут, отмечено значительное повышение уровня общего билирубина; среди пациентов, принимавших кларитромицин в дозе 15-25 мг/кг/сут, было зарегистрировано по одному случаю значительного повышения уровней АЛТ, остаточного азота мочевины и снижения числа тромбоцитов. У пациентов, получавших кларитромицин в максимальной дозе (≥25 мг/кг/сут), значительных изменений указанных лабораторных параметров не выявлено.

CONTRAINDICATIONS

- severe liver dysfunction;

- severe renal dysfunction (KR)<30 мл/мин);

- porphyria;

- simultaneous use with astemizole, cisapride, pimozide, terfenadine, ergotamine, dihydroergotamine;

- pregnancy;

- lactation period (breastfeeding);

- children under 3 years of age (for the dosage form in the form of tablets);

- increased sensitivity to macrolide antibiotics.

WITH caution The drug should be prescribed to patients with impaired liver and kidney function.

PREGNANCY AND LACTATION

The safety of clarithromycin during pregnancy and lactation has not been studied.

Clarithromycin is known to be secreted from breast milk.

Therefore, Klacid ® should be used during pregnancy and lactation only in cases where there is no safer alternative and the risk associated with the disease itself exceeds possible harm for mother and fetus.

SPECIAL INSTRUCTIONS

Clarithromycin is eliminated primarily by the liver. In this regard, caution should be exercised when prescribing Klacid to patients with impaired liver function.

In the presence of chronic liver diseases, it is necessary to regularly monitor serum enzymes.

Caution should be exercised when treating patients with moderate to severe renal failure with clarithromycin.

In clinical practice, cases of toxicity of colchicine when combined with clarithromycin have been described, especially in elderly people. Some of them were observed in patients with renal failure; Several deaths have been reported in similar patients.

The possibility of cross-resistance between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin, must be taken into account.

Prescribe with caution against drugs metabolized by the liver.

In case of co-administration with warfarin or other indirect anticoagulants, it is necessary to monitor the prothrombin time.

OVERDOSE

Taking a large dose of clarithromycin causes gastrointestinal symptoms. In one patient with a history of bipolar disorder, changes in mental status, paranoid behavior, hypokalemia, and hypoxemia were described after taking 8 g of clarithromycin.

Treatment: The unabsorbed drug should be removed from the gastrointestinal tract and symptomatic therapy should be carried out. Hemodialysis and peritoneal dialysis do not have a significant effect on the level of clarithromycin in the serum, which is also typical for other macrolide drugs.

DRUG INTERACTIONS

Clarithromycin is metabolized in the liver under the action of the CYP3A isoenzyme. This mechanism determines many interactions with other drugs. Clarithromycin may inhibit the biotransformation of other medicinal substances under the influence of this system, which may lead to an increase in their serum levels.

Metabolized by the same isoenzyme CYP3A: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergotamine alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (warfarin), pimozide, quinidine, rifabutin, denafil, simvastatin, tacrolimus , terfenadine, triazolam and vinblastine. Similar mechanisms interactions that are mediated by other isoenzymes of the cytochrome P450 system are characteristic of phenytoin, theophylline and valproic acid.

IN clinical studies when theophylline or cabramazepine was combined with clarithromycin, there was a small but statistically significant (p<0.05) повышение уровней теофиллина и карбамазепина в сыворотке крови.

In clinical practice, the following cases of interaction mediated by the CYP3A isoenzyme have been reported with the use of erythromycin and/or clarithromycin:

When clarithromycin was used simultaneously with HMG-CoA reductase inhibitors (lovastatin, simvastatin), rhabdomyolysis developed in rare cases.

With simultaneous use of clarithromycin with cisapride, an increase in the levels of the latter was observed. This may lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and polymorphic ventricular tachycardia of the "pirouette" type. Similar effects have been reported in patients receiving clarithromycin with pimozide.

Macrolides cause disruption of the metabolism of terfenadine, which leads to an increase in its plasma levels and is sometimes associated with the development of arrhythmias, incl. prolongation of the QT interval, ventricular tachycardia, ventricular fibrillation and torsade de pointes. In one study of 14 healthy volunteers, the combined use of clarithromycin tablets and terfenadine resulted in a 2- to 3-fold increase in serum levels of the acid metabolite terfenadine and a prolongation of the QT interval, which was not associated with any clinical effects.

In clinical practice, cases of ventricular tachycardia of the “pirouette” type have been reported when clarithromycin is combined with quinidine or disopyramide. Serum levels of these drugs should be monitored during treatment with clarithromycin.

In clinical practice, when clarithromycin was combined with ergotamine or dihydroergotamine, cases of acute toxicity of the latter, which is characterized by vasospasm, ischemia of the limbs and other tissues, including the central nervous system, were recorded.

In patients receiving clarithromycin tablets in combination with digoxin, an increase in serum concentrations of the latter was observed. Monitoring serum digoxin levels is advisable.

Colchicine is a substrate for CYP3A and P-glycoprotein. Clarithromycin and other macrolides are inhibitors of CYP3A and P-glycoprotein. When colchicine and clarithromycin are coadministered, inhibition of P-glycoprotein and/or CYP3A may result in increased effects of colchicine. Patients should be closely monitored for symptoms of colchicine toxicity.

Concomitant use of oral clarithromycin tablets with zidovudine in HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. This interaction was not observed in HIV-infected children taking clarithromycin suspension with zidovudine or dideoxyinosine.

In a pharmacokinetic study, the combined use of ritonavir 200 mg every 8 hours and clarithromycin 500 mg every 12 hours resulted in significant suppression of the metabolism of clarithromycin. C max of clarithromycin when used in combination with ritonavir increased by 31%, C min by 182%, AUC by 77%. Virtually complete inhibition of the formation of 14-hydroxyclarithromycin was observed. Given the high therapeutic index of clarithromycin, dose reduction is not required in patients with normal renal function. However, in patients with impaired renal function, dose adjustment is advisable. In patients with CC = 30-60 ml/min, the dose of clarithromycin is reduced by 50%, and in patients with CC<30 мл/мин - на 75%. В дозах >Clarithromycin 1 g/day should not be used in combination with ritonavir.

STORAGE CONDITIONS AND EXPIRATION DATES

List B. The drug in tablet form should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C. Shelf life - 5 years.

The drug in powder form for the preparation of a suspension for oral administration should be stored out of the reach of children, protected from light at a temperature not exceeding 30°C. Shelf life - 2 years.

The prepared suspension can be stored for 14 days at room temperature.

The antibiotic Klacid belongs to the group of macrolides. It's worth figuring out what this means.

Antibiotics are substances that destroy (or inhibit, prevent reproduction) microbes, that is, bacterial forms of infections. Antibiotics are powerless against viruses. Only some of them are able to influence individual large viruses.

Therefore, it is almost impossible to cure, for example, the flu with antibiotics. Antibiotics are divided into several groups according to their chemical composition and the principle of action on bacteria.

Based on their effect on bacteria, antibiotics are divided into bactericidal and bacteriostatic:

1. Bactericidal antibiotics directly kill bacteria. They are used in acute forms of the disease, when there is no time for a milder effect. Their action is very fast and effective. As a rule, their use is radical in nature and is extremely rarely accompanied by relapses.
2. Bacteriostatic antibiotics (macrolides are one of them) disrupt protein synthesis, which leads to a stop in bacterial division and the gradual death of the population. Such antibiotics are recommended for use in diseases of moderate severity.

The principle of action of macrolides is to inhibit (slow down) the synthesis of RNA (ribonucleic acid, the basis for genetic material) at the level of bacterial ribosomes.

Macrolides are drugs that accumulate well inside cells, which leads to good suppression of infections inside cells. But it can lead to resistance to the action of the antibiotic already during treatment. Although this applies to a greater extent to first-generation drugs. The second and third generations are already more effective in treatment:

• the first generation includes Erythromycin and Oleandomycin;
• second generation - Spiramycin (or Rovamycin), Roxithromycin (or Rulid), Josamycin (or Vilprafen), Clarithromycin (or Klacid), Midekamecin (or Macropen);
• the third generation is so far represented by only one drug: Azithromycin (or Sumamed).

Macrolides are broad-spectrum drugs. But, it should be remembered that it is impossible to independently replace one drug with another, without the consent of the attending physician. Because even drugs from the same group are not always substitutes for each other in the fight against a particular infection. Each of them has its own wide range. Somewhere they intersect, and somewhere they diverge.

For the most part, macrolides are well absorbed into the adenoids, tonsils, ear tissues, lungs, bronchi, skin, and synovial fluid (joint lubrication). In the nervous system their effect is weak.

Drugs are excreted by liver cells through bile.

Macrolides of the second and third generation are characterized by resistance to an acidic environment, which allows them to be taken not intravenously, but through the gastrointestinal tract. The acidic environment of the stomach does not destroy them, which allows use in tablet form or as a suspension.

Macrolides mainly help with the following diseases:

• tonsillitis;
• pneumonia;
• bronchitis;
• diphtheria;
• whooping cough;
• purulent otitis;
• diseases of the liver and biliary tract;
• fight against chlamydia.

Macrolides are low-toxic, but they still create irritation of the gastric mucosa, which in some cases can cause nausea, even vomiting, and diarrhea. Under no circumstances should macrolides be combined with Levomycetin, Penicillin, or Cephalosporin. You should also not combine macrolides with new generation antihistamines. There is a great danger of toxicity and cardiac arrhythmia.

Intramuscular injections are prescribed extremely rarely, in special cases, since they are not only painful, but can also lead to phlebitis.

Klacid for adults

The active ingredient of the drug Klacid is clarithromycin.

Indications for use:

• pneumonia, bronchitis and other diseases of the lower respiratory system;
• pharyngitis, sinusitis and other infectious diseases of the upper respiratory system;
• erysipelas, folliculitis, inflammation and infections of the skin and soft tissues;
• infections caused by Mycobacterium intracellulare, Mycobacterium fortuitum, Mycobacterium chelonae, Mycobacterium kansasii;
• ulcerative manifestations in the stomach and duodenum provoked by the bacterium Helicobacter pylori (as part of the complex);
• in some cases HIV-infected.

Klacid for children

In some cases, the antibiotic Klacid may be prescribed for children:

• childhood infections: whooping cough, scarlet fever;
• acute or chronic respiratory diseases: bronchitis, pneumonia, etc.;
• sore throat, pharyngitis, laryngitis;
• otitis media, sinusitis, sinusitis;
• infections caused by chlamydia;
• as an element of a set of measures for stomach or duodenal ulcers;
• is prescribed for burns, bites, wounds and other infectious skin lesions (including diseases such as erysipelas).

Contraindications for use

The drug Klacid has contraindications for use:

• individual intolerance to components;
• pregnancy and breastfeeding;
• for Porphyria disease (usually a hereditary disease associated with a disorder of pigment metabolism, with the manifestation of pigmentation of the skin, internal organs, and mental illness);
• children under 3 years old;
• together with the following medications: Terfenadine, Cisapride, Dihydroergotamine, Pimozide, Ergotamine, Astemizole.

Possible side effects of the medicine

When taking an antibiotic orally, headaches, disturbances in taste, nausea, vomiting, upset stomach, and sometimes abdominal pain may occur.

When Klacid is administered by intramuscular injection, muscle pain, phlebitis, increased intensity of liver enzymes, increased intensity of liver enzymes may occur.

In more rare cases, oral candidiasis, hypoglycemia, anaphylactic reactions, mental disorders, and insomnia can be observed. Dizziness, convulsions, temporary hearing problems, myalgia, stomatitis, as well as glossitis, pancreatitis, rash and urticaria are also not uncommon.

This medicine should be taken strictly as prescribed by the doctor and in the dosages that he specifies. There is no need to rely on what the pharmacist or instructions say and prescribe treatment yourself.

Instructions are average standards for taking medications. But each person is tested individually. And it is based on the test results, examination results, and previous records of diseases that a prescription and instructions for using the drug are issued.

These medications should not be taken carelessly. If the dose is written and the time when it should be taken, it means exactly that and at that time. If for some reason it was not possible to take it on time, under no circumstances should you take twice as much next time. Any medicine, including an antibiotic, is a poison that kills germs. But in large quantities, the medicine becomes poison for the human body.

Children should be especially careful when taking the medicine. As a rule, there are no restrictions on whether to take the medicine before or after meals.

But, it is very important to ensure that the medicine is washed down with water, and not juice or, worse, Coca-Cola. The reaction of the ingredients of the medicine with these substances is unpredictable and, at best, it will not have any effect; at worst, new, toxic substances can be formed that will either complicate the course of the disease or create another, new disease.

You should not make a decision about taking such a medicine (however, this applies to all antibiotics) based on the words of friends or relatives. You need to have a good understanding of antibiotics in order to prescribe treatment right away, based on external symptoms.

And then: maybe this, or maybe not. Symptoms, especially external manifestations, are very similar for many diseases, but are caused by different pathogens.

Some have viruses as pathogens, and in this case, the vast majority of antibiotics are useless in the fight against infection, but can be very effective in combating the internal microflora of the body, which will certainly weaken the body.

Others may have a bacterium as the causative agent of the disease, but the trouble is that each bacterium requires its own antibiotic. Many bacteria are resistant to almost all antibiotics except one or two. Accordingly, taking everyone else is simply a waste of money and unnecessary stress for the body. The medicine is already in the body and it has not been used for its intended purpose, which means that while it is eliminated, it will be used indirectly.

Pharmaceutical forms of Klacida

Klacid, in most cases, can be found in our pharmacies in three forms:

1. Tablets (sometimes yellow, sometimes light yellow). The tablets are coated with a special film designed to protect against the aggressive acidic environment of the stomach. It is necessary that the medicine be absorbed by the constant action of the acid, then its effectiveness will be maximum.
2. Powder for the preparation of suspension for oral administration. Granules with a slight fruity aroma (white or cream). The kit usually includes a dosing spoon and a dosing syringe.
3. Lyophilisate for the preparation of infusion solution (can be used both for injections and for droppers).

For children, powder is usually used. Children are not so willing to swallow tablets, but the suspension, which also smells pleasant, is quite acceptable for a child. But, again: the dosage and regimen must be strictly observed!

No amateur activities, especially for children. No self-selected substitute. Moreover, even within forms of the same medicine, one should not experiment.

If the doctor prescribed the powder, but the nearest pharmacy only has tablets, you should not take the tablets (unless the doctor has authorized such a replacement).

The active substance that the tablets and Klacid suspension contain is the same, but the excipients are different. Each of the excipients is also there for a reason, not “for volume”. It performs some kind of function: either helps it be absorbed or reduces the consequences of side effects.

In turn, the tablet form, depending on the type of shell (yellow or light yellow), in some cases can play a role, since the composition of this shell is different and is designed for different levels of absorption by the stomach and intestines, depending on the state of the gastrointestinal tract and other internal organs . In addition, you must be able to correctly calculate the dosage and carefully follow the instructions. Indeed, in the form of a suspension, absorption occurs more efficiently and one should take into account not only milligrams, but also the degree of “inevitable losses” depending on the dosage forms.