Klacid: the first and original clarithromycin. Varieties, names, composition and forms of release. When is this medicine prescribed - indications for use

Suspension Klacid is actively and often used in the treatment of many infectious processes in children caused by bacterial pathogens. The active ingredient is clarithromycin. It belongs to the group of macrolides. structural feature antibiotic is the presence of a methoxy group in the lactone ring. This significantly increases the acid resistance of Klacid in comparison with erythromycin, a classic macrolide. However, the drug has the greatest pharmacological effect with neutral or alkaline indicators.

Klacid suspension also has clinical significance in combination therapy Helicobacter pylori infection, which is the most common cause development of gastritis and peptic ulcer in humans. Also, the drug is used for HIV infection. Very often in microbial pathology of organs respiratory system the doctor has a choice - Klacid or Sumamed.

Pharmacological properties of the drug

Klacid or clarithromycin refers to semi-synthetic drugs. In the human body, it is able to selectively bind to the 50S subunit of the bacterial ribosome, thus inhibiting protein synthesis. This leads to the inability of microorganisms to reproduce and further colonize tissues.

Additionally, in this state, bacteria lose their resistance to factors immune protection organism (antibodies, macrophages, leukocytes). In pharmacology, this action is called bacteriostatic. In laboratory experiments, clarithromycin also becomes capable of destroying the biological membranes of microorganisms, however, this property is of no practical importance.

When taken orally, the drug is rapidly absorbed into the body. Bioavailability is 50%. It is noteworthy that food intake only increases this indicator (unlike azithromycin). Therefore, it is often advised to take an antibiotic for children during meals. In the body, Klacid is metabolized over time to 14-hydroxyclarithromycin, which also retains an antimicrobial effect, although it is less for many pathogens.

The drug binds well to blood proteins. Through the blood-brain barrier, the antibiotic penetrates poorly, so it is not prescribed for the treatment of meningitis and encephalomeningitis. Like other macrolides, clarithromycin accumulates in tissues. The experiment showed that the concentration of Klacid in the lungs exceeds that in the blood plasma by 5-6 times. This is partly achieved due to the penetration of the active substance into the cells of the immune system, which then migrate to areas of inflammation.

During therapy, the maximum dose of clarithromycin is recorded on the second or third day. The half-life is 4 hours.

Therapeutic concentration in the tissues remains for some time after the last dose of the drug. Klacid is excreted from the body mainly through the kidneys and intestines. However, if the function is broken excretory system, then an alternative mechanism of intestinal secretion is activated.

The issue of antibiotic resistance

Clarithromycin is not a beta-lactam antibiotic, so it is resistant to the effects of penicillinases and beta-lactamases. However, there is a presence of cross-resistance in some strains of staphylococci, which are not affected by methicillin and oxacillin. To date, Klacid for children is used to treat pathologies caused by:

Several studies of the resistance of Helicobacter pylori infection in the population of our country have been carried out. Their data showed that only in 3-4% of patients strains of microorganisms resistant to clarithromycin were found. However, there are countries where this indicator exceeds 20-30%. They give priority to other drugs.

Indications for taking Klacid

Klacid for children can only be prescribed by a qualified doctor after carefully collecting all the patient's complaints and conducting full complex diagnostics. It is also desirable to bacteriological research with the study of the resistance of the isolated strain to antimicrobials. Self-medication often leads to side effects and development of superinfection. Klacid is prescribed for the following infectious pathologies in a patient:

As practice shows, Klacid is most often used for angina and bronchitis.

Contraindications to the appointment of Klacid

The drug should not be prescribed for following states in the patient:

increased hypersensitivity to macrolides, or a history of an allergic reaction after taking them;
porphyria;
chronic liver pathologies with hypofunction;
child under 6 months of age.

Reliable evidence has been obtained that clarithromycin is also found in breast milk. Therefore, when appointing this antibiotic during lactation, it is recommended to temporarily transfer the child to artificial nutrition.

During pregnancy, the drug crosses the placenta and may affect the fetus. However, there is no reliable information on the toxicity of Klacid due to the impossibility of conducting large studies. Therefore, the drug can be prescribed when there are indications for this, and there is no alternative therapy with antibacterial drugs (penicillins).

With extreme caution, an antibiotic should be used in patients with a decrease in the activity of the liver. When using clarithromycin, a biochemical analysis should be carried out every 2-3 days to study the amount of liver enzymes and bilirubin.

drug overdose

An overdose of Klacid mainly occurs when the drug is used incorrectly, when the patient mistakenly believes that with the help of large doses He will be able to recover faster with antibiotics. It can also be caused by a decrease glomerular filtration, in which the accumulation of the drug in the patient's body is observed.

Overdose symptoms include dyspeptic symptoms, dizziness, general weakness, pallor or yellowness of the skin and increased liver enzymes in the blood.

First aid should begin with the withdrawal of the drug. After that, you need to immediately rinse the stomach with a large amount of ordinary water and let the sorbents be taken ( Activated carbon or others).

Adverse reactions

Most often after taking Klacid observed various disorders from the digestive tract, which were due to changes in the composition of the microflora and motor disorders. Clinically, this was manifested by diarrhea, flatulence, sensations of stagnation or heaviness, nausea, vomiting, or bitterness in the mouth. The most severe course was observed in pseudomembranous colitis with pain, tenesmus, intoxication, dehydration and falling blood pressure. Cases of the development of intestinal perforation and megacolon with late seeking medical help are described.

At long-term use antibiotics have also been noted toxic effect on the central nervous system with the occurrence of headache, dizziness, anxiety, insomnia, tinnitus, changes taste sensations, disorientation and psychosis. All of these symptoms were transient.

Taking the medication sometimes also has a hepatotoxic effect. It is also reported about toxic or cholestatic hepatitis while taking the medication. It almost always has a transient character and quickly passes after the abolition of antibiotic therapy.

Some patients experience allergic reactions varying degrees severity during Klacid therapy. They present with hives, rashes, anaphylactic shock, Stevens-Johnson syndrome and Quincke's edema.

Like other macrolides, Klacid affects cardiac conduction. It prolongs the QT interval and in patients with cardiovascular pathology sometimes causes the development of ventricular tachyarrhythmia. Also sometimes observed interstitial nephritis drug induced.

If any suspicious symptoms occur, the general condition of the child is aggravated, it is necessary to consult with the attending physician. For side effects that do not worsen general state patient, it is advisable to continue therapy.

Interaction with other drugs

A feature of the metabolism of Klacid in the body is that it occurs in the liver under the influence of the cytochrome P450 system. Many drugs are inactivated by the same mechanism. Therefore, when they are taken together, an increase in the concentration of these drugs in the blood plasma is observed. This often leads to various side effects. Drugs that should be used with caution because of this reason include: metronidazole, statins, proton pump inhibitors, oral anticoagulants, cyclosporine, cisapride, carbamazepine, vinblastine, quinidine, and many others.

Preparations of the macrolide group cannot be combined with antibacterial agents with a bactericidal effect (penicillins, cephalosporins, fluoroquinolones, carbanems). Due to the different mechanism of action, they act as antagonists.

Of great importance is the influence of Klacid on antiretroviral drugs that are used to treat human HIV infection. Simultaneous administration of clarithromycin reduces the concentration of zidovudine. And in the presence of ritonavir in therapy, a decrease in the effectiveness of the antibacterial drug was observed.

Klacid is not recommended for patients taking digoxin. An increase in the concentration of this cardiac glycoside, which led to various violations rhythm. Therefore, these drugs can be combined under regular control of their serum levels at the patient.

Release form of the drug

For children, Klacid is available in the form of granules for suspension. The finished syrup is opaque with a white color and fruity taste and contains 125 mg or 250 mg of clarithromycin in 5 ml. The drug is produced by the Italian pharmaceutical company Abbott SpA.

The granules are packaged in bottles of 60 or 100 ml. To prepare an antibiotic, it is enough to add the required amount of water. After that, you need to shake the bottle. You can use the suspension from 6 months.

Klacid tablets is used to treat adults or older children.

Klacid's analogs

Often, analogues from the penicillin or macrolide group can be used instead of clarithromycin. The most optimal option is Sumamed (or Amoxiclav). It's a combination penicillin antibiotic amoxicillin and clavulanic acid.

Has good tolerance in children. Used to treat bronchitis, tracheitis, laryngitis and other similar pathologies. There are analogues of Klacid among macrolides.

Azithromycin, the first antibacterial drug of the azalide subgroup, stands out here. The indications and side effects of the drugs are similar. It is worth remembering that only a qualified doctor can prescribe analogues.

Rules for taking Klacid

Because food has no negative influence on the bioavailability of the drug, the suspension can be taken regardless of the time of the meal. Its great advantage is the ability to measure the required amount of antibiotic using a special dosing syringe. The drug is recommended for children to give in its pure form.

After that, you can give the child to drink it plain water. Juices, carbonated drinks and coffee cannot be used for this purpose. Babies can mix the drug into breast milk.

During antibiotic therapy, it is necessary that Klacid is taken at the same time every day. If it was missed, then it is necessary to take a new dose of medication as soon as possible.

Dosage of Klacida suspension

For the treatment of non-mycobacterial infections in children single dose Klacida is calculated individually from the ratio of 7.5 mg of the drug per 1 kg of body weight. Take an antibiotic should be 2 times a day.

It should also be noted that 1 ml of a suspension of 125 mg / 5 ml contains 25 mg, and in the form of 250 mg / 5 ml - 50 mg of clarithromycin. Based on this information, you can find out the individual dose of the drug for any child weighing up to 40 kg. There are also standard dosages indicated in the instructions for the antibacterial drug for different weights:

8-11 kg - 2.5 ml (125 mg / 5 ml) or 1.25 ml (250 mg / 5 ml);
12-19 kg - 5 ml (125 mg / 5 ml) or 2.5 ml (250 mg / 5 ml);
20-29 kg - 7.5 ml (125 mg / 5 ml) or 3.75 ml (250 mg / 5 ml);
30-40 kg - 10 ml (125 mg/5 ml) or 5 ml (250 mg/5 ml).

With mycobacterial infection, children can increase the dose of the drug twice, especially when severe course pathology. The maximum daily amount of clarithromycin should not exceed 500 mg. Usually therapy lasts more than 5 days. With a non-mycobacterial infection, the term of treatment does not exceed 14-21 days. It is impossible to stop taking Klacid on your own without the permission of a doctor. In mycobacterial pathology, therapy is often longer (sometimes several months).

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The antibiotic Klacid contains an active ingredient, as well as additional components: sodium calcium alginate, sodium alginate, lactose, anhydrous citric acid hydrogen phosphate, stearic acid, povidone KZO, magnesium stearate.

Release form

Klacid 500 mg and 250 mg are produced as coated tablets. yellow color. The tablets are oval in shape, the presence of two layers is noted along the cut: a yellow film and a whitish core. A blister made of foil can hold 7, 10 or 14 tablets, 1, 2 or 3 such blisters are packed in a cardboard box.

pharmachologic effect

Active substance clarithromycin belongs to the group of macrolides, semi-synthetic. The antibacterial effect is produced by suppressing the bacterial protein synthesis. The consistency of the tablet is such that the active ingredient is released gradually as the drug passes through the gastrointestinal tract. Clarithromycin active against isolated and standard cultures of bacteria. A high effect is noted when using the agent for the treatment of legionnaires' disease, pneumonia of mycoplasmal etiology. Gram-negative bacteria are not sensitive to clarithromycin .

The active substance acts as an antibacterial agent against group A streptococci , pneumococcus , golden staphylococcus , microorganism pathogens hemophilic infection , listeriosis , pneumonia , pneumochlamydiasis , leprosy , , faces , sporotrichosis.

Those pathogens that do not show sensitivity to and Methicillin , are also resistant to clarithromycin .

Also noted positive impact clarithromycin in relation to the following microorganism (efficacy and safety not confirmed in the process clinical research): viridescent streptococcus, peptococcus, group B, C, F, G streptococci; causative agents of pasteurellosis in birds, human toxicoinfections, , borreliosis, enterocolitis.

During the metabolism clarithromycin the body releases active 14-hydroxyclarithromycin, which exhibits microbiological activity. Metabolism occurs in the human liver. If a person took the drug regularly, there was no increase in the activity of its influence.

Pharmacokinetics and pharmacodynamics

Substance clarithromycin binds well to blood proteins. The highest concentration of the drug is determined within 6 hours. The larger the dose of the drug taken by the patient, the longer the period of time it is excreted from the body. The amount of the metabolite (14-hydroxyclarithromycin) does not increase in parallel with an increase in the dose of clarithromycin. The larger is accepted dose Klacida, the less 14-hydroxyclarithromycin is formed in the body.

The drug is excreted from the body through the kidneys and intestines (respectively, 40% and 30% of the dose). After oral intake clarithromycin, and its metabolite is distributed to tissues and body fluids, tissues typically contain twice as much drug as serum.

Dosage adjustment is not required for liver diseases. With kidney disease, the elimination period clarithromycin from the body increases. Also, the elimination period of the drug increases in the elderly.

Indications for use

The use of the drug Klacid is indicated for the following diseases and states:

infectious diseases respiratory tract, lower sections ( pneumonia , and etc.);
infectious diseases of the respiratory tract, upper sections (with, etc.);
infectious lesions of soft tissues, skin ( folliculitis , erysipelas and etc.);
mycobacterial infections caused by Mycobacterium intracellulare and Mycobacterium avium;
infections provoked by Mycobacterium fortuitum, Mycobacterium chelonae, Mycobacterium kansasii.

It is also practiced to take the remedy to prevent infection provoked by the Mycobacterium avium complex (MAC). It is prescribed to reduce the frequency of manifestations of recurrence of ulcers. duodenum.

Contraindications

Do not take an antibiotic in the following cases:

with the body to the means of the macrolide group;
at porphyria ;
during pregnancy and breastfeeding ;
children up to 3 years of age.

Carefully, the remedy is prescribed for violations of the kidneys and liver.

Can't be taken at the same time clarithromycin and such medicines: Dihydroergotamine , pimozide , Erhotamine , BUTstemizol .

Side effects

If Klacid is administered intravenously or oral administration of the agent is carried out, a number of manifestations are possible side effects. If such effects occur after intravenous administration or oral administration of tablets, it is necessary to inform the specialist about this. The following manifestations are possible:

CNS functions : change palatability, .
Digestive system : nausea , stomach ache, .
Local reactions when introducing a solution : inflammation at the injection site, phlebitis , pain during palpation.
Laboratory indicators : increased activity of liver enzymes.

In addition to these side effects, side effects that occur less frequently are possible:

oral cavity;
thrombocytopenia , leukopenia ;
hypoglycemia ;
mental disorders,;
, convulsions ;
myalgia ;
reversible hearing loss;
ventricular;
stomatitis , spicy , ;
liver dysfunction;
increased levels of creatinine in the blood.

Instructions for use Klacid (Method and dosage)

Instructions for the use of Klacid for children and adults provide for oral administration, regardless of the meal.

Adult patients are shown taking 250 mg of clarithromycin twice a day. If treatment is being serious illnesses, mycobacterial infections, the dose may be increased to 500 mg twice a day. In most cases, treatment lasts from 5 to 14 days.

If prescribed for treatment suspension Klacid instructions for use must be followed exactly. The suspension is prescribed for the treatment of children, it can be taken regardless of food intake, it can be taken with milk. To prepare the suspension for use, you need to gradually add water to the vial to the mark, then shake. 5 ml of a 60 ml suspension contains 125 mg of clarithromycin; 5 ml of a 100 ml suspension contains 250 mg of clarithromycin. The suspension can be stored for two weeks at room temperature.

Before giving the antibiotic Klacid to children, you need to shake the suspension thoroughly. A day is recommended for children to use a dose of 7.5 mg per 1 kg of body weight twice a day. The largest allowable dose- 500 mg twice a day. Therapy can last from 5 to 10 days.

Overdose

When taking very large doses of this drug, patients may show signs of impaired functioning of the digestive system. It is important to remove the remnants of the drug from the gastrointestinal tract as soon as possible, after which symptomatic treatment is carried out.

Interaction

Combination is strictly not allowed. clarithromycin and drugs Astemizol , pimozide , Terfenadine , Cisapride , as in this case, the development of serious side effects is likely. In particular, the manifestation of cardiac arrhythmias, including ventricular fibrillation, ventricular tachycardia.

Concomitant use of clarithromycin and Ergotamine or probably acute poisoning with ergotamines. In particular, ischemia of the extremities, vascular spasm, etc. may occur. Simultaneous administration of clarithromycin and ergot alkaloids is not allowed.

CYP3A inducers induce the metabolism of clarithromycin. As a result, the concentration of clarithromycin and its effectiveness decreases. If clarithromycin is used concomitantly, the plasma concentration increases Rifabutina and the concentration of clarithromycin decreases.

Preparations Nevirapine , Efavirenz , Rifabutin , Rifapentine able to accelerate the metabolism of clarithromycin, thereby reducing its plasma concentration and increasing the concentration of its metabolite - 14-OH-clarithromycin. As a consequence, therapeutic efficacy may decrease.

Decreased concentration clarithromycin observed when taken together with etravirine .

It is necessary to adjust the dose of drugs when co-administered clarithromycin and ritonavir .

With simultaneous treatment with Klacid and oral hypoglycemic drugs or insulin, severe hypoglycemia may occur. Glucose levels should be constantly monitored.

At simultaneous reception antibiotic with quinidine , disopyramide possible ventricular tachycardia.

With caution, clarithromycin should be taken by those who receive drugs - substrates of the CYP3A isoenzyme, as well as in combination with statins.

Concomitant treatment with clarithromycin and is contraindicated.

It is important to monitor the patient's condition during joint treatment and clarithromycin due to the risk of bleeding.

When taking clarithromycin and , there is a need to reduce the dosage of the latter drugs.

Simultaneous treatment with antibiotics and or carbamazepine leads to an increase in the concentration of these drugs in the bloodstream.

When using clarithromycin and triazolam likely to affect the central nervous system, as a result, drowsiness and confusion develop.

People who have impaired liver or kidney function should not take clarithromycin and colchicine at the same time.

With simultaneous treatment with clarithromycin, the effect of the latter is enhanced. Required constant control serum digoxin levels.

There is a bidirectional effect of drugs while taking clarithromycin and atazanavir , as well as clarithromycin and itraconazole, clarithromycin and saquinavir .

When treated simultaneously with an antibiotic and, diltiazem increases the likelihood of developing arterial hypotension.

Terms of sale

In pharmacies, the antibiotic is sold by prescription.

Storage conditions

It is necessary to protect the antibiotic from the access of children, it should be stored at a temperature not exceeding 30 ° C.

Best before date

The shelf life of the antibiotic is 3 years.

special instructions

In people with liver disease, there may be a change in the levels of serum enzymes, from which tablets should be prescribed carefully.

Caution is given to people taking other drugs that are metabolized by the liver in parallel.

At long-term treatment antibiotics may form colonies with large quantity insensitive fungi and bacteria.

At chronic diseases liver need to regularly monitor serum enzymes.

Possible manifestation pseudomembranous colitis during antibiotic treatment. It is also possible to change normal microflora intestines.

Caution should be given to people with severe heart failure, bradycardia, hypomagnesaemia. It is necessary to constantly monitor the ECG, determining the increase in the QT interval.

May increase symptoms in people who take clarithromycin.

The powder for the preparation of a suspension of Klacid contains sucrose, which should be taken into account by people suffering.

In the treatment of clarithromycin, you need to carefully manage transport and perform activities that require a high concentration of attention.

Synonyms

Clarithromycin

Klacid's analogs

Coincidence in the ATX code of the 4th level:

Klacid's analogues are agents that belong to the same group and have an active substance similar to Klacid. These are medicines Clarexide , Binocular , Claricite , Clarithrosin , Clarithromycin , Claromin etc. You can replace the drug only after the approval of the doctor, since each of these drugs has certain features of use and side effects.

The price of analogues can be either higher or lower. Differences Klacid and Klacid SR in that the latter drug is a prolonged-release drug, that is, the active substance is released more slowly.

With alcohol

According to the instructions, Klacid and alcohol are incompatible. If the patient consumes alcohol during treatment with this antibiotic, the risk of side effects increases dramatically, since the toxicity of the drug greatly increases.

Klacid for children

Klacid for children can be used from the age of three. In most cases, children are prescribed Klacid suspension. Reviews for children indicate that this drug is quite effective. At the same time, the price of the suspension is quite high. The dosage for children is as follows: 7.5 mg of the drug per 1 kg of the child's weight twice a day. The largest daily dose- 500 mg.

Children who are already 12 years old are prescribed 250 mg (tablets) twice a day. There is evidence that children tolerate Klacid more easily than other antibiotics. Therefore, the drug is often prescribed for , bronchitis , pneumonia etc. However, we should not forget that side effects still occur.

During pregnancy and lactation

There is no precise information on the safety of using Klacid for treatment. and nursing mothers. Therefore, the use during the period of gestation is not practiced.

Every time a pediatrician prescribes an antibiotic for a child, the mother has many questions. How effective is the drug? Will strong medicine harm the child? How to correctly calculate the dose so that the antibiotic works, but does not cause side effects? Of particular concern are new drugs, such as Klacid, which has recently appeared on the pharmaceutical market. Our review will help you, the parent, draw conclusions about the appropriateness, effectiveness and possible consequences its application.

Klacid does not kill pathogens, but deprives them of the opportunity to multiply. This is enough for recovery.

Features of the drug

Modern powerful drug Klacid belongs to the class of macrolides - the least toxic, and therefore the safest antibiotics. Similar action a wide spectrum has a long familiar and familiar Erythromycin. However, as evidenced by numerous reviews on parent forums, Klacid for children is a more effective and convenient tool. A new generation antibiotic, unlike its predecessor, has a relatively pleasant taste and fruity aroma. And this is important when the baby does not yet understand the purpose of stuffing him with bitter medicine. In addition, you need to take it only two, and not four times a day, which reduces the risk of side effects and negative impact drug on a delicate children's body.

AT recent times microbes and pathogens have managed to adapt to antibiotics such as penicillin and cephalosporin, losing sensitivity to them. In this regard, Klacid often turns out to be one of the most effective and at the same time sparing options.

Suspension is the most convenient dosage form for children.

The drug is produced by Abbott Laboratories Limited (UK). The price of a medicine in the form of a powder for the preparation of suspensions varies between 300-400 rubles. A: The larger the dosage, the higher the cost. Tablets can be bought on average for 600-800 rubles. Their cost also depends on the dosage and the number of tablets in the pack.

Analogues

The drug has a number of analogues, which include the same basic substance - clarithromycin. These include Klarbakt, Clarithromycin, Fromilid, Exoterin and some others. Interchangeability medicines in each case, only a pediatrician can confirm.

When is this medicine prescribed - indications for use

For children, the remedy is prescribed for inflammatory processes in the body caused by a large number varieties of microbes. The appointment of the drug is advisable when there are:

typically childhood infections - scarlet fever, whooping cough;
diseases of the lower respiratory tract - lung abscess, pneumonia, bronchitis;
upper respiratory tract infections - tonsillitis,;
ENT diseases - otitis media;
gonorrheal or chlamydial nature;
ulcerative lesions of the stomach and duodenum (the medicine is used here as part of complex therapy);
infections of the skin (for example, erysipelas) and soft tissues.

A more detailed list of problems eliminated by Klacid is given in the instructions for its use, which can be.

Klacid: variety of forms

The antibiotic is produced in the form:

tablets;
powder for the preparation of a suspension taken orally;
powder for the preparation of a suspension used for infusions (droppers).

Children under the age of three years Klacid in the form of tablets is not prescribed.

Of course, in the case of pediatric patients, it is better to opt for the Klacid suspension: its semi-liquid consistency is the most convenient and pleasant for babies.

Many parents naturally have a question: what do the markings on the packages mean: 125, 250, 500? These numbers indicate the amount of active substance clarithromycin in one tablet or 5 ml of the prepared suspension. For example, if it is Klacid 125 powder, then 5 ml of suspension (about a teaspoon) contains 125 ml of the active ingredient. This information is important for the correct calculation of the dosage corresponding to the weight and age of the child.

The powder is available in vials (60 and 100 ml), in which the suspension is convenient to store and dilute.

Operating principle

Klacid acts extremely gently and sparingly: he does not kill pathogenic bacteria, and deprives them of the possibility of reproduction. In this case, the drug has a prolonged effect. Even after the end of the intake, it continues to be in the body for some time and perform its function, inhibiting the growth of microbes.

The effectiveness of the drug is also explained by its ability to accumulate in the same places where 99% of pathogens are usually concentrated - in the lungs and bronchi. At the same time, the antibiotic, unlike its predecessors, has a pronounced anti-inflammatory effect.

Suspension preparation and dosage calculation

Preparing the suspension is simple: just add water to the vial up to the risk and shake the liquid vigorously until the powder granules are completely dissolved. The result should be a white (or almost white) opaque liquid, which can be stored at room temperature (not higher than 30 degrees and away from sunlight) for about two weeks.

Shake the bottle before each use.

Before giving Klacid to a child, carefully read the instructions. The main criterion for the correct dosage is the weight of the patient. The medicine is given at the rate of 7.5 ml per 1 kg of the patient's body weight.

The numbers that complement the name of the medicine are also important. Children are usually prescribed suspensions of Klacid 125 or Klacid 250. The suspension drug is prescribed even to patients under two years of age in doses appropriate for age.

Consider the option of calculating the dosage of the drug Klacid 250 using a specific example.

The patient is a boy Egor, 8 years old. The child's weight is 25 kg. Therefore, for one dose (assuming the drug is taken twice a day), he needs an amount of syrup that would contain 187.5 ml of clarithromycin: 25 kg × 7.5 ml of the recommended dose per 1 kg of body weight. If the drug has a concentration of 250, then 5 ml contains 250 ml of the active substance, i.e. 1 ml of suspension contains 50 ml of clarithromycin (250 ml/5 ml). It turns out that Egor needs to take 3.75 ml of the suspension (187.5 ml / 50 ml - the dose of clarithromycin necessary for a particular child / the content of clarithromycin in 1 ml of the resulting syrup). This is 0.75 teaspoon, i.e. about 3/4.

The medication is taken twice a day. It is better to do this in the morning and in the evening at about the same time. Before or after a meal, it doesn't matter. To a small child You can give the suspension along with milk.

You can add the suspension to milk.

The course lasts from 5 to 10 days. A specific scheme, depending on the severity of the disease and the patient's response to the medicine, is made by a pediatrician. In the absence of improvements in for three days, the drug is canceled, and an adequate replacement is selected for it.

The maximum allowable daily dose of the drug in any case is 500 ml.

It is important to know the symptoms of an overdose of Klacid:

dizziness;
mental changes, in particular, the appearance of signs of paranoia.

The listed signs are the basis for stopping the drug and carrying out procedures aimed at removing the patient from dangerous state overdose:

removal from the stomach of the remnants of the drug that did not have time to be absorbed by taking activated charcoal;
peritoneal dialysis;
hemodialysis.

Side effects and contraindications

Klacid should be used with caution (or even stop using it) in children with problems with the liver, kidneys and biliary tract. The components of the drug with dysfunction of these organs are poorly excreted and accumulate in the body, overloading it. The same applies to young patients suffering from arrhythmia and increased anxiety, because the the drug provokes the release of adrenaline. It is important for parents of allergic and asthmatic children to know that Klacid slows down output antihistamines from the body. If a child takes antiallergic drugs constantly, during treatment with macrolides, their components may accumulate in excessive (toxic) doses. Be careful not to get poisoned.

An antibiotic prescribed to children of any age must meet several requirements at once. It must be effective enough to not expect results bacteriological culture, get the desired result; safe for all tissues and organs of a growing organism, as well as convenient to use, that is, to have various forms release. All these requirements are perfectly met by the antibiotic "Klacid" - the active substance clarithromycin, a modern representative of the macrolide group.

When the drug is prescribed and its mechanism of action

Clarithromycin has enough a wide range action, destroys gram-positive microorganisms (listeria, moraxella, diphtheroids), gram-negative (campylobacter, helicobacter, a number of clostridia), almost all mycobacteria (except for the classic Koch bacillus) and intracellular microorganisms (legionella, mycoplasma, chlamydia).

This antibacterial agent has a wide range of benefits. Among them, the most significant should be emphasized:

relatively high bioavailability, that is, the active substance and metabolite penetrate well into all tissues and organs;
antimicrobial activity is possessed not only by its main active substance, but also by all metabolites;
the drug is excreted approximately equally with urine and feces, which makes it possible to use it in patients with chronic diseases kidneys;
gastric juice does not adversely affect absorption, but rather promotes this process and potentiates the action of active metabolites.

All of the above properties of the drug "Klacid" allow you to use it as a first-line remedy for many infectious diseases of the respiratory and digestive tract

Indications

The drug "Klacid" is often used by pediatricians and family doctors. Its use is justified in the following situations:

infectious processes of the lower and upper divisions respiratory system (from sinusitis to bronchitis and pneumonia);
inflammatory changes in the skin and subcutaneous fat (staphylo- and streptoderma, phlegmon, abscess, erysipelas);
complex treatment inflammatory processes alimentary canal (eg. modern scheme peptic ulcer therapy).

An important feature of clarithromycin is the lack of experience with the use and, accordingly, safety data in children under 12 years of age. The instruction of the drug allows its use only in children. adolescence. Another important nuance- this is the caution and validity of the use in patients with impaired liver function, since the active substance is metabolized in the liver with the help of cytochrome P450. It becomes clear that the independent appointment of this remedy can end sadly.

The well-known pediatrician Evgeny Olegovich Komarovsky emphasizes the need for reasonable use of antibiotics with active substance clarithromycin, as complications from the kidneys and liver are possible.

Contraindications

All macrolides, including Klacid, are contraindicated for use in the following cases:

a history of episodes allergic reactions or hypersensitivity to any macrolide;
age up to 12 years;
severe kidney and / or liver disease;
hereditary pathology, manifested by insufficient production of lactose, absorption of galactose and glucose;
taking drugs based on ergot.

Only a specialist can assess the potential risk and the desired benefits. Only a doctor can suspect the occurrence of side effects in time and prevent their progression.

Dosages

The traditional dosage of the drug "Klacid" is 125-500 mg (depending on the severity of the condition) per day once, if necessary. maximum dose can be divided into 2 doses. Average duration course of treatment should be at least 1-2 weeks.

Composition and form of release of the drug

Powder for the preparation of a suspension for oral administration white or almost white color, granulated, with fruity aroma; when shaken with water, an opaque suspension of white or almost white color is formed, with a fruity aroma.

Excipients: carbomer (carbopol 974P) - 150 mg, povidone K90 - 35 mg, hypromellose phthalate - 304.2 mg, - 32.1 mg, silicon dioxide - 10 mg, maltodextrin - 238.7 mg, sucrose - 2276.2 mg, titanium dioxide - 35.7 mg, xanthan gum - 3.8 mg, fruit flavor - 35.7 mg, potassium sorbate - 20 mg, lemon acid- 4.24 mg.

70.7 g - 100 ml plastic bottles (1) complete with dosing spoon or dosing syringe - packs of cardboard.

pharmachologic effect

Semi-synthetic macrolide antibiotic. Suppresses the synthesis of proteins in the microbial cell, interacting with the 50S ribosomal subunit of bacteria. It acts mainly bacteriostatically, as well as bactericidal.

Active against gram-positive bacteria: Streptococcus spp., Staphylococcus spp., Listeria monocytogenes, Corynebacterium spp.; Gram-negative bacteria: Helicobacter pylori, Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Borrelia burgdorferi; anaerobic bacteria: Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus; intracellular microorganisms: Legionella pneumophila, Chlamydia trachomatis, Chlamydophila pneumoniae, Ureaplasma urealyticum, Mycoplasma pneumoniae.

It is also active against Toxoplasma gondii, Mycobacterium spp. (except for Mycobacterium tuberculosis).

Pharmacokinetics

When administered orally, clarithromycin is well absorbed from the gastrointestinal tract. Eating slows down absorption, but does not affect the bioavailability of the active substance.

Clarithromycin penetrates well into biological fluids and tissues of the body, where it reaches a concentration 10 times greater than in.

Approximately 20% of clarithromycin is immediately metabolized to form the main metabolite 14-hydroclarithromycin.

At a dose of 250 mg T 1/2 is 3-4 hours, at a dose of 500 mg - 5-7 hours.

It is excreted in the urine unchanged and as metabolites.

Indications

Treatment of infectious and inflammatory diseases caused by pathogens sensitive to clarithromycin: infections of the upper respiratory tract and ENT organs (tonsillopharyngitis, otitis media, acute sinusitis); infections lower divisions respiratory tract ( acute bronchitis, exacerbation of chronic bronchitis, community-acquired bacterial and atypical pneumonia); odontogenic infections; skin and soft tissue infections; mycobacterial infections (M.avium complex, M.kansasii, M.marinum, M.leprae) and their prevention in AIDS patients; eradication of Helicobacter pylori in patients with duodenal ulcer or gastric ulcer (only as part of combination therapy).

Contraindications

A history of QT prolongation, ventricular arrhythmia, or torsades de pointes; hypokalemia (risk of prolongation of the QT interval); severe hepatic failure, occurring simultaneously with kidney failure; cholestatic jaundice/hepatitis in history, developed during the use of clarithromycin; porphyria; I trimester of pregnancy; lactation period ( breastfeeding); simultaneous administration of clarithromycin with astemizole, cisapride, pimozide, terfenadine; with ergot alkaloids, eg ergotamine, dihydroergotamine; with midazolam for oral administration; with HMG-CoA reductase inhibitors (statins), which are largely metabolized by the CYP3A4 isoenzyme (, simvastatin), with colchicine; with ticagrelor or ranolazine; hypersensitivity to clarithromycin and other macrolides.

Dosage

Individual. When taken orally for adults and children over 12 years of age, a single dose is 0.25-1 g, the frequency of administration is 2 times / day.

For children under 12 years of age, the daily dose is 7.5-15 mg / kg / day in 2 divided doses.

In children, clarithromycin should be used in the appropriate dosage form intended for this category of patients.

The duration of treatment depends on the indications.

In patients with impaired renal function (CC less than 30 ml / min or serum creatinine more than 3.3 mg / dl), the dose should be reduced by 2 times or the interval between doses should be doubled.

Maximum daily doses: for adults - 2 g, for children - 1 g.

Side effects

From the digestive system: often - diarrhea, vomiting, dyspepsia, nausea, pain in the abdomen; infrequently - esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence, increased blood bilirubin concentration, increased activity of ALT, ACT, GGT, alkaline phosphatase, LDH, cholestasis, hepatitis , incl. cholestatic and hepatocellular; frequency unknown - acute pancreatitis, discoloration of the tongue and teeth, liver failure, cholestatic jaundice.

Allergic reactions: often - rash; infrequently - anaphylactoid reaction, hypersensitivity, bullous dermatitis, itching, urticaria, maculo-papular rash; frequency unknown - anaphylactic reaction, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome).

From the nervous system: often - headache, insomnia; infrequently - loss of consciousness, dyskinesia, dizziness, drowsiness, tremor, anxiety, irritability; frequency unknown - convulsions, psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, nightmares, paresthesia, mania.

From the side of the skin: often - intense sweating; frequency unknown - acne, hemorrhages.

From the sense organs: often - dysgeusia; infrequently - vertigo, hearing loss, ringing in the ears; frequency unknown - deafness, ageusia, parosmia, anosmia.

From the side of cardio-vascular system: often - vasodilation; infrequently - cardiac arrest, atrial fibrillation, prolongation of the QT interval on the ECG, extrasystole, atrial flutter; frequency unknown - ventricular tachycardia, incl. pirouette type.

From the urinary system: infrequently - an increase in the concentration of creatinine, a change in the color of urine; frequency unknown - renal failure, interstitial nephritis.

From the side of metabolism and nutrition: infrequently - anorexia, loss of appetite, increased urea concentration, changes in the albumin-globulin ratio.

From the musculoskeletal system: infrequently - muscle spasm, musculoskeletal stiffness, myalgia; frequency unknown - rhabdomyolysis, myopathy.

From the respiratory system: infrequently - asthma, epistaxis, pulmonary embolism.

From the hematopoietic system: infrequently - leukopenia, neutropenia, eosinophilia, thrombocythemia; frequency unknown - agranulocytosis, thrombocytopenia.

From the blood coagulation system: infrequently - an increase in the value of MHO, prolongation of prothrombin time.

Local reactions: very often - phlebitis at the injection site, often - pain at the injection site, inflammation at the injection site.

From the body as a whole: infrequently - malaise, hyperthermia, asthenia, pain in chest, chills, fatigue.

drug interaction

Clarithromycin inhibits the activity of the CYP3A4 isoenzyme, which leads to a slowdown in the rate of metabolism of astemizole with their simultaneous use. As a result, there is an increase in the QT interval and an increased risk of developing ventricular arrhythmia of the "pirouette" type.

Simultaneous administration of clarithromycin with lovastatin or simvastatin is contraindicated due to the fact that these statins are largely metabolized by the CYP3A4 isoenzyme, and combined use with clarithromycin increases their serum concentrations, which leads to an increased risk of myopathy, including rhabdomyolysis. Cases of rhabdomyolysis have been reported in patients taking clarithromycin concomitantly with these drugs. If clarithromycin is required, lovastatin or simvastatin should be discontinued for the duration of therapy.

Clarithromycin should be used with caution in combination therapy with other statins. It is recommended to use statins that do not depend on the metabolism of CYP3A isoenzymes (for example, fluvastatin). If co-administration is necessary, it is recommended to take the lowest dose of the statin. The development of signs and symptoms of myopathy should be monitored. With simultaneous use with atorvastatin, the concentration of atorvastatin in the blood plasma moderately increases, and the risk of developing myopathy increases.

Drugs that are CYP3A inducers (eg, phenytoin, carbamazepine, phenobarbital, St. It is necessary to control the plasma concentration of the CYP3A inducer, which may increase due to inhibition of CYP3A by clarithromycin.

When combined with rifabutin, the concentration of rifabutin in the blood plasma increases, the risk of developing uveitis increases, and the concentration of clarithromycin in the blood plasma decreases.

When combined with clarithromycin, an increase in plasma concentrations of phenytoin, carbamazepine,.

Strong inducers of isoenzymes of the cytochrome P450 system, such as efavirenz, nevirapine, rifampicin, rifabutin and rifapentine are able to accelerate the metabolism of clarithromycin and, thus, reduce the concentration of clarithromycin in plasma and weaken it therapeutic effect, and at the same time increase the concentration of 14-OH-clarithromycin, a metabolite that is also microbiologically active. Since the microbiological activity of clarithromycin and 14-OH-clarithromycin differs in relation to different bacteria, the therapeutic effect may be reduced when clarithromycin and enzyme inducers are used together.

Plasma concentration of clarithromycin decreases with the use of etravirine, while the concentration of the active metabolite 14-OH-clarithromycin increases. Since 14-OH-clarithromycin has low activity against MAC infections, the overall activity against their pathogens may change, so an alternative treatment should be considered for the treatment of MAC.

A pharmacokinetic study showed that co-administration of ritonavir 200 mg every 8 hours and clarithromycin 500 mg every 12 hours resulted in a marked suppression of clarithromycin metabolism. When co-administered with ritonavir, C max of clarithromycin increased by 31%, C min increased by 182% and AUC increased by 77%, while the concentration of its metabolite 14-OH-clarithromycin was significantly reduced. Ritonavir should not be co-administered with clarithromycin at doses greater than 1 g/day.

Clarithromycin, atazanavir, saquinavir are substrates and inhibitors of CYP3A, which determines their bidirectional interaction. When saquinavir is co-administered with ritonavir, the potential effect of ritonavir on clarithromycin should be considered.

With simultaneous use with zidovudine, the bioavailability of zidovudine is slightly reduced.

Colchicine is a substrate for both CYP3A and P-glycoprotein. Clarithromycin and other macrolides are known to be inhibitors of CYP3A and P-glycoprotein. When clarithromycin and colchicine are co-administered, inhibition of P-glycoprotein and/or CYP3A may lead to an increased effect of colchicine. development should be controlled clinical symptoms colchicine poisoning. There have been post-marketing reports of cases of colchicine poisoning when taken concomitantly with clarithromycin, more often in elderly patients. Some of the reported cases have occurred in patients with renal insufficiency. Some cases were reported to end lethal outcome. The simultaneous use of clarithromycin and colchicine is contraindicated.

With the combined use of midazolam and clarithromycin (500 mg orally 2 times / day), an increase in the AUC of midazolam was noted: 2.7 times after intravenous administration of midazolam and 7 times after oral administration. Co-administration of clarithromycin with oral midazolam is contraindicated. If intravenous midazolam is used with clarithromycin, the patient should be carefully monitored for possible correction doses. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3A, including triazolam and alprazolam. For benzodiazepines whose excretion is independent of CYP3A (temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.

With the combined use of clarithromycin and triazolam, effects on the central nervous system, such as drowsiness and confusion, are possible. With this combination, it is recommended to monitor the symptoms of CNS disorders.

With simultaneous use with warfarin, it is possible to increase the anticoagulant effect of warfarin and increase the risk of bleeding.

It is assumed that digoxin is a substrate for P-glycoprotein. Clarithromycin is known to inhibit P-glycoprotein. With simultaneous use with digoxin, a significant increase in the concentration of digoxin in the blood plasma and the risk of developing glycoside intoxication are possible.

Perhaps the occurrence of ventricular tachycardia type "pirouette" with the combined use of clarithromycin and quinidine or disopyramide. While taking clarithromycin with these drugs, regular ECG monitoring should be carried out for an increase in the QT interval, and serum concentrations of these drugs should also be monitored. In post-marketing use, cases of hypoglycemia have been reported with the co-administration of clarithromycin and disopyramide. It is necessary to control the concentration of glucose in the blood while using clarithromycin and disopyramide. It is believed that it is possible to increase the concentration of disopyramide in the blood plasma due to inhibition of its metabolism in the liver under the influence of clarithromycin.

Co-administration of fluconazole at a dose of 200 mg daily and clarithromycin at a dose of 500 mg 2 times / day caused an increase in the average value of the minimum equilibrium concentration of clarithromycin (C min) and AUC by 33% and 18%, respectively. At the same time, co-administration did not significantly affect the average equilibrium concentration of the active metabolite 14-OH-clarithromycin. Dose adjustment of clarithromycin is not required in case of concomitant use of fluconazole.

Clarithromycin and itraconazole are substrates and inhibitors of CYP3A, which determines their bidirectional interaction. Clarithromycin may increase plasma concentrations of itraconazole, while itraconazole may increase plasma concentrations of clarithromycin.

With simultaneous use with methylprednisolone, the clearance of methylprednisolone decreases; with prednisone - cases of development of acute mania and psychosis are described.

With simultaneous use with omeprazole, the concentration of omeprazole increases significantly and the concentration of clarithromycin in the blood plasma slightly increases; with lansoprazole - glossitis, stomatitis and / or the appearance of a dark color of the tongue are possible.

With simultaneous use with sertraline, the development of serotonin syndrome cannot theoretically be excluded; with theophylline - it is possible to increase the concentration of theophylline in the blood plasma.

With simultaneous use with terfenadine, it is possible to slow down the rate of metabolism of terfenadine and increase its concentration in blood plasma, which can lead to an increase in the QT interval and an increased risk of developing ventricular arrhythmia of the "pirouette" type.

Inhibition of the activity of the isoenzyme CYP3A4 under the influence of clarithromycin leads to a slowdown in the rate of metabolism of cisapride with their simultaneous use. As a result, the concentration of cisapride in the blood plasma increases and the risk of developing life threatening violations heart rate, including ventricular arrhythmias of the "pirouette" type.

The primary metabolism of tolterodine is carried out with the participation of CYP2D6. However, in the part of the population lacking CYP2D6, metabolism occurs with the participation of CYP3A. In this population, suppression of CYP3A results in significantly higher serum concentrations of tolterodine. Therefore, in patients with low level CYP2D6-mediated metabolism may require dose reduction of tolterodine in the presence of CYP3A inhibitors such as clarithromycin.

With the combined use of clarithromycin and oral hypoglycemic agents (for example, sulfonylurea derivatives) and / or insulin, severe hypoglycemia may occur. Co-administration of clarithromycin with certain hypoglycemic agents (eg, nateglinide, pioglitazone, repaglinide, and rosiglitazone) may result in inhibition of CYP3A isoenzymes by clarithromycin, which may lead to hypoglycemia. It is believed that with simultaneous use with tolbutamide, there is a possibility of developing hypoglycemia.

With simultaneous use with fluoxetine, a case of the development of toxic effects caused by the action of fluoxetine is described.

While taking clarithromycin with other ototoxic drugs, especially aminoglycosides, care must be taken and the functions of the vestibular and hearing aids should be monitored both during and after therapy.

With simultaneous use with cyclosporine, the concentration of cyclosporine in the blood plasma increases, there is a risk of increased side effects.

With simultaneous use with ergotamine, dihydroergotamine, cases of increased side effects of ergotamine and dihydroergotamine are described. Post-marketing studies indicate that when clarithromycin is co-administered with ergotamine or dihydroergotamine, following effects, Related acute poisoning drugs of the ergotamine group: vascular spasm, ischemia of the extremities and other tissues, including the central nervous system. The concomitant use of clarithromycin and ergot alkaloids is contraindicated.

Each of these PDE inhibitors is metabolized according to at least, in part, with the participation of CYP3A. At the same clarithromycin is able to inhibit CYP3A. Co-administration of clarithromycin with sildenafil, tadalafil, or vardenafil may result in an increased inhibitory effect on PDE. With these combinations, dose reduction of sildenafil, tadalafil and vardenafil should be considered.

With the simultaneous use of clarithromycin and which are metabolized by the CYP3A4 isoenzyme (for example, verapamil, amlodipine, diltiazem), caution should be exercised, since there is a risk of arterial hypotension. Plasma concentrations of clarithromycin, as well as blockers calcium channels, may increase with simultaneous use. Arterial hypotension, bradyarrhythmia and lactic acidosis are possible while taking clarithromycin and verapamil.

special instructions

Clarithromycin should be used with caution in patients with moderate to severe renal impairment; liver failure moderate and severe, with ischemic heart disease, severe heart failure, hypomagnesemia, severe bradycardia (less than 50 bpm); simultaneously with benzodiazepines, such as alprazolam, triazolam, midazolam for intravenous administration; simultaneously with other ototoxic drugs, especially aminoglycosides; simultaneously with drugs that are metabolized by CYP3A isoenzymes (including carbamazepine, cilostazol, cyclosporine, disopyramide, methylprednisolone, omeprazole, indirect anticoagulants, quinidine, rifabutin, sildenafil, tacrolimus, vinblastine; simultaneously with CYP3A4 inducers (including rifampicin , phenytoin, carbamazepine, phenobarbital, St. John's wort); simultaneously with statins, the metabolism of which does not depend on the CYP3A isoenzyme (including fluvastatin); simultaneously with blockers of slow calcium channels, which are metabolized by CYP3A4 isoenzymes (including verapamil, amlodipine, diltiazem); simultaneously with class I A antiarrhythmic drugs (quinidine, procainamide) and class III (dofetilide, amiodarone, sotalol).

There is cross-resistance between macrolide antibiotics.

Antibiotic treatment alters the normal intestinal flora, so superinfection caused by resistant microorganisms is possible.

It should be borne in mind that severe persistent diarrhea may be due to the development of pseudomembranous colitis.

Prothrombin time should be monitored periodically in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.

Pregnancy and lactation

Use in the first trimester of pregnancy is contraindicated.

Application in II and III trimesters pregnancy is possible only in cases where the expected benefit to the mother exceeds potential risk for the fetus.