Klacid, 1 piece, 70.7 g, 250 mg/5 ml, powder for suspension for oral administration

pharmachologic effect

The active substance clarithromycin belongs to the group of macrolides, semisynthetic antibiotics. It produces an antibacterial effect by suppressing 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 is active against isolated and standard bacterial cultures. A high effect is observed when using the drug for the treatment of Legionnaires' disease, pneumonia of mycoplasma etiology. Gram-negative bacteria are not sensitive to clarithromycin.

actively acts as an antibacterial agent against group A streptococci , pneumococcus , Staphylococcus aureus , microorganisms that cause Haemophilus influenzae , listeriosis , gonorrhea , pneumochlamydia , leprosy , chlamydia , erysipelas , sporotrichosis .

Those pathogens that do not demonstrate sensitivity to oxacillin and methicillin are also resistant to the effects of clarithromycin.

A positive effect of clarithromycin was also noted in relation to the following microorganisms (efficacy and safety were not confirmed in clinical trials): viridans streptococcus, peptococcus, group B, C, F, G streptococci; pathogens of avian pasteurellosis, whooping cough , human toxic infections, acne , borreliosis, syphilis , enterocolitis.

During the metabolism of clarithromycin in the body, active 14-hydroxyclarithromycin is released, 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.

Pharmacodynamics

Clarithromycin is a semisynthetic antibiotic of the macrolide group and has an antibacterial effect by interacting with the 50S ribosomal subunit of sensitive bacteria and inhibiting protein synthesis.

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

Clarithromycin has been shown to be highly active against
Legionella pneumophila
,
Mycoplasma pneumoniae
and
Helicobacter (Campilobacter) pylori.
Enterobacteriaceae, Pseudomonas spp.

, as well as other non-lactose-degrading gram-negative bacteria, are not sensitive to clarithromycin.

Clarithromycin has been shown to have an antibacterial effect against the following pathogens: aerobic gram-positive microorganisms - Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes;

aerobic gram-negative microorganisms -
Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila, Neisseria gonorrhoeae;
other microorganisms -
Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis
;
mycobacteria - Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum; Mycobacterium avium complex (MAC)
- a complex including:
Mycobacterium avium, Mycobacterium intracellulare.
Clarithromycin in vitro

is active 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;
),
Viridans group streptococci
;

— aerobic gram-negative microorganisms — Bordetella pertussis; Pasteurella multocida;

— anaerobic gram-positive microorganisms — Clostridium perfringens; Peptococcus niger; Propionibacterium acnes

;

— anaerobic gram-negative microorganisms — Bacteroides melaninogenicus;

— spirochetes — Borrelia burgdorferi; Treponema pallidum

;

- Campylobacter - Campylobacter jejuni.

The main metabolite of clarithromycin in the human body is the microbiologically active metabolite - 14-hydroxyclarithromycin (14-OH-clarithromycin). 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 H. influenzae

, for which the effectiveness of the metabolite is 2 times higher.
The parent substance and its major metabolite, when combined, have either additive or synergistic effects against H. influenzae in vitro
and
in vivo
, depending on the bacterial culture.

Pharmacokinetics and pharmacodynamics

The 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 eliminated from the body. The amount of metabolite (14-hydroxyclarithromycin) does not increase in parallel with increasing doses of clarithromycin. The larger the dose of Klacid taken, the less 14-hydroxyclarithromycin is formed in the body.

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

No dosage adjustment is required for liver diseases. In case of kidney disease, the period of elimination of clarithromycin from the body increases. Also, the elimination period of the drug increases in older people.

Pharmacokinetics

The first data on pharmacokinetics were obtained from the study of clarithromycin tablets. The drug is quickly absorbed into the gastrointestinal tract. The absolute bioavailability of clarithromycin 50 mg tablets is approximately 50%. Food slightly delayed the onset of absorption and the formation of the active metabolite of 14-OH-clarithromycin, but did not affect the bioavailability of the drug.

In vitro

in vitro studies

the binding of clarithromycin to plasma proteins averaged about 70% at clinically significant concentrations from 0.45 to 4.5 μg/ml.

Healthy

The bioavailability and pharmacokinetics of clarithromycin suspension were studied in healthy adults and children. When administered once in adults, the bioavailability of the suspension was equivalent to or slightly greater than that of the tablets (both 250 mg dose). As with tablets, food slightly delayed the absorption of clarithromycin suspension but did not affect the overall bioavailability of the drug. Cmax, AUC and T1/2 of clarithromycin when taking the pediatric suspension (after meals) were 0.95 mcg/ml, 6.5 mcg h/ml and 3.7 hours, respectively, and when taking a 250 mg tablet on an empty stomach - 1.1 µg/ml; 6.3 µg·h/ml and 3.3 h.

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, Tmax - 2.8 hours and T1/2 - 3.2 hours - for clarithromycin and, accordingly, 0. 67; 5.33; 2.9 and 4.9 for 14-OH-clarithromycin. In healthy subjects, serum concentrations peaked within 2 hours after oral administration. Css of the main metabolite - 14-OH-clarithromycin - is about 0.6 μg/ml, and T1/2 when using the drug at a dose of 250 mg every 12 hours is 5-6 hours. When prescribing clarithromycin at a dose of 500 mg every 12 hours, Css 14-OH-clarithromycin is slightly higher (up to 1 μg/ml), and T1/2 is about 7 hours. When using both doses, equilibrium concentrations of the metabolite are usually achieved within 2–3 days. When clarithromycin is prescribed at a dose of 250 mg every 12 hours, approximately 20% of the dose is excreted unchanged by the kidneys. When used at a dose of 500 mg every 12 hours, approximately 30% of the dose is excreted unchanged by the kidneys. 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-OH-clarithromycin, which accounts for 10–15% of the dose (250 or 500 mg every 12 hours).

Sick

Clarithromycin and its 14-OH metabolite are well distributed into tissues and body fluids. Tissue concentrations are usually several times higher than serum concentrations. Table 1 provides examples of tissue and serum concentrations.

Table 1

Concentrations when administered at a dose of 250 mg every 12 hours

In children requiring oral antibiotic treatment, clarithromycin has high bioavailability. Moreover, its pharmacokinetic profile was similar to those in adults taking the same suspension. The drug is quickly and well absorbed in children. Food slightly delays the absorption of clarithromycin, but does not significantly affect its bioavailability or pharmacokinetic properties.

The steady-state parameters of clarithromycin pharmacokinetics achieved after 5 days (ninth dose) were as follows: Cmax - 4.6 μg/ml, AUC - 15.7 μg·h/ml and Tmax - 2.8 hours; corresponding values ​​for 14-OH metabolite: 1.64 μg/ml; 6.69 mcg h/ml and 2.7 hours. Estimated T1/2 of clarithromycin and its metabolite are 2.2 and 4.3 hours, respectively.

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

Liver dysfunction

Steady-state concentrations of clarithromycin in patients with impaired liver function did not differ from those in healthy subjects, while levels of 14-OH-clarithromycin were lower. The decrease in the formation of 14-OH-clarithromycin in patients with impaired liver function was, at least partially, offset by an increase in the renal clearance of clarithromycin compared with that in healthy subjects.

Renal dysfunction

The pharmacokinetics of clarithromycin also changed in patients with impaired renal function who received the drug orally at a dose of 500 mg repeatedly. In such patients, plasma levels, T1/2, Cmax, Cmin and AUC of clarithromycin and its 14-OH 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 (see “Dosage and Administration”).

Aged people

In a comparative study in elderly healthy subjects receiving repeat oral clarithromycin 500 mg, plasma levels of the drug were increased and elimination was slower compared with those in younger healthy subjects. However, there was no difference between the two groups when adjustment was made for creatinine Cl. It was concluded that changes in the pharmacokinetics of clarithromycin reflect renal function and not the age of the patient.

Patients with mycobacterial infections

Css of clarithromycin and 14-OH-clarithromycin in patients with HIV infection who received clarithromycin in usual doses in the form of tablets in adults and suspension in children were similar to those in healthy people. However, when clarithromycin is used in higher doses, which may be required to treat mycobacterial infections, antibiotic concentrations may be significantly higher than usual.

In children with HIV infection receiving clarithromycin at a dose of 15–30 mg/kg/day in 2 divided doses, steady-state Cmax values ​​typically ranged from 8 to 20 mcg/ml. However, in children with HIV infection who received a clarithromycin suspension at a dose of 30 mg/kg/day in 2 divided doses, Cmax 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 concentrations and T1/2 duration when clarithromycin is prescribed at higher doses is consistent with the known nonlinearity of the pharmacokinetics of the drug.

Indications for use

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

• infectious diseases of the lower respiratory tract: pneumonia , bronchitis , etc.;
• infectious diseases of the upper respiratory tract: sore throat , sinusitis , pharyngitis , etc.;
• infectious lesions of soft tissues, skin: folliculitis , erysipelas , etc.;
• mycobacterial infections caused by Mycobacterium intracellulare and Mycobacterium avium;
• infections caused by Mycobacterium fortuitum, Mycobacterium chelonae, Mycobacterium kansasii.

It is also practiced to take the drug to prevent infection caused by Mycobacterium avium complex (MAC). Prescribed to reduce the frequency of relapses of duodenal ulcers .

Rules of application

The effectiveness of the drug is not affected by food intake. But at the same time, the tablet must be swallowed and washed down with a sufficient amount of clean water.

The recommended dosage of the tablet according to the instructions is 2 tablets of 250 mg per day in two doses. On the doctor’s recommendation, a similar regimen of 500 mg tablets is prescribed for the treatment of severe infectious diseases. Against the background of renal failure, the dosage is halved: 1 tablet per day. Duration of treatment is 5-14 days.

For infusion, a solution is prepared from the lyophilisate. The administration takes place over an hour or more.

The recommended dose is 1 g/day, which should be divided into 2 doses. A suspension can be used to treat children. The dosage is calculated depending on the weight and age of the child.

Contraindications

You should not take an antibiotic in the following cases:

• with high sensitivity of the body to drugs from the macrolide group;
• with porphyria ;
• during pregnancy and lactation ;
• children under 3 years of age.

The drug is prescribed with caution in cases of kidney and liver dysfunction.

You cannot take clarithromycin and the following medications at the same time : terfenadine , cisapride , dihydroergotamine , pimozide , ergotamine , and stemizole .

Klacid: contraindications

A contraindication to taking the drug is hypersensitivity to macrolides and other components of the drug. Their list is indicated in the instructions for use.

Drug treatment is not prescribed during pregnancy and lactation. This is due to the fact that appropriate studies that would confirm the absence of negative effects of the drug on the fetus and newborn child have not been conducted. For the same reason, the drug is contraindicated for children under the age of 12 years.

Absolute contraindications include the hereditary pathology of porphyria. The disease is associated with metabolic disorders. A characteristic feature of hereditary pathology is extensive symptoms.

Klacid should be prescribed with caution if there are problems with liver function. This is primarily due to the fact that the main substance is mainly excreted by this organ. Treatment with the drug for renal failure should be carried out under strict supervision. It is also important to consider the interaction of Klacid with other drugs.

Side effects

If Klacid is administered IV or taken orally, a number of side effects may occur. If such effects occur after intravenous administration or ingestion of tablets, you must inform your specialist.

The following manifestations are possible:

• the central nervous system: changes in taste, headaches .
• Digestive system: nausea , abdominal pain, diarrhea , vomiting , dyspepsia .
• Local reactions when injecting the solution: inflammatory processes at the injection site, phlebitis , pain during palpation.
• Laboratory indicators: increased activity of liver enzymes.

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

• oral candidiasis;
• thrombocytopenia , leukopenia ;
• anaphylactic reactions;
• hypoglycemia;
• mental disorders, insomnia ;
• dizziness , convulsions ;
• myalgia;
• reversible hearing loss;
• ventricular tachycardia ;
• stomatitis , acute pancreatitis , glossitis ;
• liver dysfunction;
• hives , rash ;
• increased creatinine levels in the blood.

Negative effects and overdose

Negative reactions when taking the drug were noted in the gastrointestinal tract. These are nausea, vomiting, diarrhea and pain in the abdomen. Klacid 500 can cause changes in taste sensations and headaches.

Very rarely, even when the dosage was observed, malfunctions in the liver were observed. This was expressed by the manifestation of jaundice. But at the same time, liver dysfunction disappears naturally after stopping the medication.

When administered orally, there is a risk of allergic reactions. They manifest themselves as rashes on the skin, and in severe cases, urticaria. Additionally, insomnia and internal anxiety may occur. If the conditions of contraindications are violated, hallucinations and confusion are observed.

The instructions for the drug indicate other side effects that may occur when taking the drug. It is necessary to familiarize yourself with them before starting treatment. If any negative manifestations occur, the drug should be discontinued.

An overdose causes pronounced disturbances in the functioning of the digestive system. In severe cases, mental disorders may occur. If negative reactions occur, it is important to immediately perform gastric lavage, take absorbents and carry out symptomatic therapy.

Instructions for use Klacida (Method and dosage)

Instructions for use of Klacid for children and adults include taking the drug orally, regardless of food intake.

Adult patients are advised to take 250 mg of clarithromycin twice a day. If severe diseases, mycobacterial infections are being treated, the dose can be increased to 500 mg twice a day. In most cases, treatment lasts from 5 to 14 days.

If Klacid suspension is prescribed for treatment, the instructions for use must be strictly followed. The suspension is prescribed for treatment for children; it can be taken regardless of food intake, and can be taken with milk. To prepare the suspension for use, you need to gradually add water to the bottle to the mark, then shake. 5 ml of 60 ml suspension contains 125 mg of clarithromycin; 5 ml of 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, shake the suspension thoroughly. It is recommended to use a dose of 7.5 mg per 1 kg of body weight twice a day for children. The highest permissible dose is 500 mg twice a day. Therapy can last from 5 to 10 days.

Description of the dosage form

Powder for suspension for oral administration 125 mg/5 ml

- white or almost white, granular powder, with a fruity aroma. When shaken with water - a white or almost white opaque suspension with a fruity aroma.

Powder for suspension for oral administration 250 mg/5 ml

- white or almost white granules with a fruity aroma. When water is added, a white or almost white opaque suspension is formed with a fruity aroma.

Interaction

Astemizole , Pimozide , terfenadine , cisapride is strictly prohibited , since in this case the development of serious side effects is likely. In particular, the manifestation of cardiac arrhythmias, including ventricular fibrillation and ventricular tachycardia, is possible.

With the simultaneous use of clarithromycin and ergotamine or dihydroergotamine , acute poisoning with drugs of the ergotamine group is possible. In particular, limb ischemia, vascular spasm, etc. may occur. The simultaneous use 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 decrease. If clarithromycin and Rifabutin are used simultaneously , the plasma concentration of Rifabutin increases and the concentration of clarithromycin decreases .

The drugs Nevirapine , Efavirenz , Rifabutin , Rifapentine can accelerate the metabolism of clarithromycin, thereby reducing its concentration in plasma and increasing the concentration of its metabolite - 14-OH-clarithromycin. As a result, therapeutic effectiveness may decrease.

A decrease in the concentration of clarithromycin is observed when taken together with etravirine .

It is necessary to adjust drug doses when taking clarithromycin and ritonavir .

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

When taking an antibiotic simultaneously with Quinidine , Disopyramide , ventricular tachycardia is possible.

Clarithromycin should be taken with caution in those receiving medications that are substrates of the CYP3A isoenzyme, as well as in combination with statins.

Concomitant treatment with clarithromycin and Simvastatin .

It is important to monitor the patient's condition during co-treatment with arfarin and clarithromycin due to the likelihood of bleeding.

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

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

When using clarithromycin and triazolam , an effect on the central nervous system is likely, resulting in drowsiness and confusion.

People who have impaired liver or kidney function should not take clarithromycin and colchicine

With simultaneous treatment with clarithromycin and Digoxin , the effect of the latter is enhanced. Constant monitoring of the level of digoxin in the blood serum is necessary.

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

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

Klacid 125 mg/5 ml 100 ml gran.d/susp. for oral administration

Instructions for medical use of the drug CLACID Trade name Klacid International nonproprietary name Clarithromycin Dosage form Granules for the preparation of suspension, 125 mg/5 ml or 250 mg/5 ml 60 ml, 100 ml Composition 5 ml of suspension contain the active substance - clarithromycin 125 or 250 mg, excipients of granules: carbopol 974 R, povidone (K90), purified water, granule shell: hypromellose phthalate (HP-55), castor oil; other excipients: colloidal silicon dioxide, maltodextrin, sucrose, titanium dioxide (E 171), xanthan gum, combined fruit flavor, potassium sorbate, anhydrous citric acid. Description Free-flowing granules, white to almost white in color, with a fruity aroma. Reconstituted suspension is an opaque suspension containing white to off-white particles with a fruity aroma. Pharmacotherapeutic group Antimicrobial agents for systemic use. Macrolides. ATC code J01F A09 Pharmacological properties Pharmacokinetics Clarithromycin is quickly and well absorbed from the digestive tract. Microbiologically active 14-OH-clarithromycin is formed during the first passage through the liver. Food does not significantly affect the bioavailability of the drug. Although the pharmacokinetics of clarithromycin is not linear, stable concentrations are established over 2 consecutive days of dosing. Pharmacokinetic parameters after taking the fifth dose are: maximum concentration (Cmax) 1.98 mcg/ml, area under the concentration-time curve (AUC) 11.5 mcg h/ml, time of maximum plasma concentration (Tmax) 2 .8 hours and a half-life (T½) of 3.2 hours for clarithromycin and 0.67 μg/ml, 5.33 μg·h/ml, 2.9 hours and 4.9 hours for 14-OH-clarithromycin, respectively. Concentrations of clarithromycin in body tissues are several times higher than in blood serum. The highest concentrations are observed in tonsillar and pulmonary tissues. Concentrations of clarithromycin in middle ear fluid exceed concentrations in serum. Binding to blood plasma proteins is 80%. 14-OH-clarithromycin is the main metabolite, which is excreted by the kidneys and accounts for approximately 10–15% of the dose taken. The remainder of the dose, 5-10%, is excreted in feces, mainly in bile. In patients with impaired renal function using 500 mg of clarithromycin, the values ​​of pharmacokinetic parameters increase according to the severity of renal failure. The age of patients does not affect the pharmacokinetic parameters of clarithromycin. In HIV-infected children, when taking clarithromycin in doses of 15 - 30 mg/kg/day (dose divided into two doses), higher plasma concentrations of clarithromycin and a longer half-life are observed. Pharmacodynamics Klacid® is a semisynthetic antibiotic of the macrolide group. The antibacterial effect of Klacid® is determined by its binding to the 5OS-ribosomal subunit of sensitive bacteria and inhibition of protein biosynthesis. The drug is highly effective against a wide range of aerobic and anaerobic gram-positive and gram-negative microorganisms, including hospital strains. The minimum inhibitory concentrations (MIC) of Klacid® are usually two times lower than the MIC of erythromycin. Klacid® is highly effective against Legionella pneumophila and Mycoplasma pneumonie. It has a bactericidal effect against H. Pylori; the activity of Klacid® at neutral pH is higher than at acidic pH. Strains of Enterobacteriaceae and Pseudomonas, as well as gram-negative bacteria that do not produce lactose, are not sensitive to Klacid®. The drug exhibits antibacterial activity against the following spectrum of microorganisms (in clinical practice): Aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes. Aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Legionella pneumophila. Other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR). Mycobacteria: Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC), which includes Mycobacterium avium, Mycobacterium intracellulare. Helicobacter: Helicobacter Pylori. Beta-lactamases of microorganisms do not affect the effectiveness of clarithromycin. Most methicillin- and oxacillin-resistant strains of staphylococci are not sensitive to clarithromycin. Klacid® is active in vitro against most strains of the following microorganisms, but the clinical effectiveness and safety of its use have not been established. Aerobic gram-positive microorganisms: Streptococcus agalactiae, Streptococci (groups C,F,G,) Viridans group streptococci. Aerobic gram-negative microorganisms: Bordetella pertussis, Pasteurella multocida. Anaerobic gram-positive microorganisms: Clostridium perfringens, Peptococcus niger, Propionibacterium acnes. Anaerobic gram-negative microorganisms: Bacteriodes melaninogenicus. Spirochetes: Borrelia burgdorferi, Treponema pallidum. Campylobacter: Campylobacter jejuni. Klacid® has a bactericidal effect against several strains of bacteria: Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, H. Pylori, Campylobacter spp. Indications for use - infections of the lower respiratory tract (bronchitis, pneumonia, etc.) - infections of the upper respiratory tract (sinusitis, pharyngitis, etc.) - infections of the skin and soft tissues (folliculitis, erysipeloid, etc.) - disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium kansasii - acute otitis media Method of administration and dosage The suspension is used regardless of food intake (can be taken with milk). For the treatment of non-mycobacterial infections, the recommended dose for children of Klacid® in the form of a suspension ranges from 7.5 mg/kg 2 times a day to a maximum of 500 mg 2 times a day. The duration of treatment is usually 5–10 days, depending on the type of pathogen and the severity of the disease. Table 1 Dosage of the drug depending on the child’s body weight Child’s body weight* (kg) 125 mg/5 ml dose (ml) x 2 times a day 250 mg/5 ml dose (ml) x 2 times a day 8 – 11 2, 5 ml 1.25 ml 12 – 19 5.0 ml 2.5 ml 20 – 29 7.5 ml 3.75 ml 30 – 40 10.0 ml 5.0 ml * For children weighing up to 8 kg, the dose must be calculated per kilogram of body weight (7.5 mg/kg 2 times a day). Dosing for renal failure| For children with creatinine clearance less than 30 ml/min, the dose of Klacida® should be reduced by 50%. Treatment should last no more than 14 days. Mycobacterial infections For the treatment of mycobacterial infections, the recommended dose of Klacida® for children is from 7.5 mg/kg to 15 mg/kg 2 times a day. The duration of treatment is determined individually, based on clinical effectiveness. It is possible to add other antimycobacterial drugs. Table 2 Dosage recommended for children with mycobacterial infection, depending on body weight Body weight* of the child (kg) Single dose of Klacida suspension 250 mg/5 ml, 2 times a day 7.5 mg/kg x 2 times a day 15 mg /kg x 2 times a day 8 – 11 1.25 ml 2.5 ml 12 – 19 2.5 ml 5 ml 20 – 29 3.75 ml 7.5 ml 30 – 40 5.0 ml 10 ml * Children with body weight up to 8 kg, the dose should be calculated per kilogram of body weight (15 – 30 mg/kg/day). Method for preparing the suspension To prepare the suspension, add water to the bottle containing granules up to the mark on it and shake well. If necessary, add water to the indicated mark. Before each use of the drug, shake the bottle with the prepared suspension vigorously. Side effects Often - headache - change in taste - nausea, vomiting, abdominal pain, dyspepsia, diarrhea - increased activity of liver enzymes Rarely - oral candidiasis - leukopenia, thrombocytopenia - anaphylactic reactions, urticaria, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis - hypoglycemia - psychosis, hallucinations, disorientation, confusion, depersonalization, depression, anxiety, insomnia, bad/nightmarish dreams - convulsions, dizziness, loss/impairment of taste and/or smell, parosmia - myalgia - hearing loss (usually recovers after withdrawal drug), tinnitus - prolongation of the QT interval, ventricular tachycardia, including torsades de pointes - acute pancreatitis, glossitis, stomatitis, discoloration of the tongue and teeth, liver failure, hepatitis, including cholestatic hepatitis, cholestatic jaundice, hepatocellular jaundice, liver dysfunction - interstitial nephritis, increased creatinine levels Very rarely - fatal liver failure (due to severe concomitant diseases and/or use of other drugs) In isolated cases - development of colchicine toxicity (including fatal outcome ) with the combined use of clarithromycin and colchicine Patients with impaired immune system. Adverse reactions during the treatment of mycobacterial infections in HIV-infected children (except for those caused by the underlying disease). Often - ringing in the ears, deafness - nausea, vomiting, abdominal pain - pancreatitis, increased amylase levels - purpura Rarely - significant increase in the level of total bilirubin, ALT, thrombocytopenia Contraindications - hypersensitivity to the components of the drug and macrolide antibiotics in the history - simultaneous use of Klacid ® and one of the following drugs: astemizole, cisapride, pimozide, terfenadine, ergotamine or dihydroergotamine Drug interactions The use of the following drugs is strictly contraindicated due to the possible development of severe consequences of the interaction. Concomitant use of cisapride, pimozide, terfenadine, astemizole with clarithromycin can lead to cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation and torsade de pointes). The simultaneous use of Klacid® and ergotamine or dihydroergotamine is associated with signs of acute ergotism, which is characterized by vasospasm and ischemia of the limbs and other tissues, including the central nervous system. The influence of other drugs on the pharmacokinetics of clarithromycin. Efavirenz, nevirapine, rifampicin, rifabutin and rifapentine can accelerate the metabolism of Klacida®, reducing its plasma concentration. Fluconazole: no dose adjustment of Klacida® is required. Ritonavir The use of ritonavir and Klacid® leads to a significant inhibition of the metabolism of clarithromycin. In patients with renal failure, dose adjustment is necessary: ​​in patients with creatinine clearance of 30–60 ml/min, the dose should be reduced by 50%. Doses of Klacida® exceeding 1 g/day should not be used with ritonavir. Effect of Klacida® on the pharmacokinetics of other drugs. Antiarrhythmic drugs There are reports of the development of torsades de pointes (TdP) that occurred with the simultaneous use of Klacida® with quinidine or disopyramide. CYP3A Klacid® is an inhibitor of the CYP3A enzyme, which may lead to increased plasma concentrations of a drug metabolized by this enzyme. This may enhance or prolong its therapeutic effect and increase the risk of adverse reactions. Caution should be exercised when using Klacida® in patients receiving therapy with the following drugs (CYP3A substrates): alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (for example, warfarin ), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine, phenytoin, theophylline, valproate. HMG-CoA reductase inhibitors Klacid® increases the concentration of lovastatin and simvastatin. Rarely, rhabdomyolysis has been reported in patients using these drugs together. Oral anticoagulants The combined use of Klacid® and oral anticoagulants may potentiate the effect of the latter, so prothrombin time should be carefully monitored. There is a possibility of increased plasma concentrations of phosphodiesterase inhibitors (sildenafil, tadalafil and vardenafil) when used together with Klacid®, which may require a reduction in the dose of phosphodiesterase inhibitors. There is a slight increase in the concentration of theophylline or carbamazepine in the blood plasma when used simultaneously with Klacid®. A dose reduction of tolterodine may be required when used with Klacid®. When triazolbenzodiazepines (eg, alprazolam, midazolam, triazolam) are used concomitantly, the patient should be carefully monitored for timely dose adjustment. The combined use of oral midazolam with Klacid® should be avoided. For benzodiazepines whose elimination does not depend on CYP3A (temazepam, nitrazepam, lorazepam), the development of a clinically significant interaction with Klacid® is unlikely. Other interactions Klacid® may lead to increased exposure to colchicine. Patients should be monitored for clinical signs of colchicine toxicity. The concentration of digoxin in the blood serum of patients should be carefully monitored when used with Klacid®. A decrease in the equilibrium concentrations of zidovudine in the blood serum is possible. It is necessary to observe the interval between doses of Klacid® and zidovudine. Bidirectional drug interactions between Klacid® and atazanovir, intraconazole, and saquinavir are also possible. The development of arterial hypotension, bradyarrhythmia and lactic acidosis has been reported with the combined use of clarithromycin and verapamil. Special instructions Long-term or repeated use of antibiotics can cause excessive growth of insensitive bacteria and fungi. If superinfection occurs, use of Klacida® should be discontinued and appropriate therapy should be initiated. Diarrhea, ranging from mild to fatal pseudomembranous colitis caused by Clostridium difficile (CDAD), has been reported with virtually all antibacterial drugs, including Klacida®. The possibility of developing Clostridium difficile diarrhea should always be kept in mind in all patients with diarrhea after antibiotic use. In addition, a careful history must be taken as diarrhea caused by Clostridium difficile has been reported 2 months after the use of antibacterial drugs. Increased symptoms of myasthenia gravis have been reported in patients using Klacid®. The drug is excreted by the liver and kidneys. Caution should be exercised when using the drug in patients with liver failure or moderate or severe renal failure. Attention should be paid to the possibility of cross-resistance between Klacid® and other macrolides, as well as lincomycin and clindamycin. Some patients may develop H. pylori resistance to Klacid®. Pregnancy and lactation The safety of Klacida® during pregnancy and lactation has not been established. If pregnancy occurs, Klacid® should not be used unless the benefits outweigh the risks. Klacid® is excreted in breast milk. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. Not known. This form of the drug is intended for use in children. Overdose Gastrointestinal symptoms. Treatment: gastric lavage and symptomatic therapy. It is unlikely that hemodialysis or peritoneal dialysis will significantly affect the serum levels of Klacid®. Release form and packaging Bottles of 60 or 100 ml made of high-density polyethylene (HDPE), sealed with a screw-on polypropylene cap, with a low-density polyethylene gasket, with first opening control. The bottle, together with a measuring spoon made of white polystyrene/measuring syringe made of polypropylene and instructions for use in the state and Russian languages, are placed in a cardboard box. Storage conditions Store at a temperature not exceeding 30 °C. Keep out of the reach of children! Shelf life: 2 years The finished suspension in the bottle can be stored for 14 days from the date of preparation. Do not take the drug after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription Manufacturer Abbott Srl, Italy /Abbott Srl, Italy. Address: Via Pontina, Km 52, 04010 Campoverde di Aprilia LT, Italy / Via Pontina, Km 52, 04010 Campoverde di Aprilia LT, Italy. Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan Representative office of Abbott Laboratories S.A. in the Republic of Kazakhstan, Almaty, st. Masanchi 78, BC Alma, 4th floor tel./fax/58/59

special instructions

People with liver disease may experience changes in serum enzyme levels, for which tablets should be prescribed with caution.

It is prescribed with caution to people who are simultaneously taking other medications that are metabolized by the liver.

With prolonged treatment with antibiotics, the formation of colonies with a large number of insensitive fungi and bacteria is possible.

In case of chronic liver diseases, serum enzymes should be regularly monitored.

Pseudomembranous colitis may occur during antibiotic treatment. It is also possible to change the normal intestinal microflora.

The medicine should be prescribed with caution to people with severe heart failure, bradycardia, and hypomagnesemia. It is necessary to constantly monitor the ECG, determining the increase in the QT interval.

of myasthenia gravis may increase in people who take clarithromycin.

The powder for preparing the Klacid suspension contains sucrose, which should be taken into account by people suffering from diabetes .

When treating with clarithromycin, you need to carefully drive vehicles and perform activities that require high concentration.

Compound

Klacida's analogs

Level 4 ATC code matches:
Ecositrin

Azicine

Rovamycin

AzitRus

Safocid

Clarithromycin

Sumamed Forte

Klarbakt

Azithromycin

Azitro Sandoz

Sumamed

ZI-Factor

Azitral

Azimed

Azicide

Spiramycin-vero

Zitrolide

Ecomed

Macropen

Klacid SR

Analogues of Klacid are products that belong to the same group and have an active substance similar to Klacid. These are the medications:

• Klacid SR
• Clubax
• Fromilid
• Klarbakt
• Clerimed
• Clarexide
• Bacticap
• Binocular
• Claricite
• Clarithrosin
• Clarithromycin
• Claromine

You can replace the drug only after the doctor’s approval, since each of these drugs has certain features of use and side effects.

The price of analogues can be either higher or lower. The differences between Klacid and Klacid SR are that the latter drug is a long-acting drug, that is, the active substance is released more slowly.

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 per 1 kg of child’s weight twice a day. The highest daily dose is 500 mg.

Children over 12 years of age 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 sore throat , bronchitis , pneumonia , etc. However, we should not forget that side effects still occur.

Manufacturer

Klacid®, powder for oral suspension, 125 mg/5 ml

Abbott S.r.L.

Via Pontina Km. 52, Campoverde di Aprilia Latina, 04010, Italy.

Abbot SRL

Via Pontina Km. 52, Campoverde di Aprilia Latina, 04010, Italy.

Representative office of Abbott Laboratories in Russia

141400, Moscow region, Khimki, st. Leningradskaya, possession 39, building 5, Khimki Business Park.

Tel.; Fax.

Klacid®, powder for oral suspension, 250 mg/5 ml

Abbott S.P.A.

Via Pontina Km. 52, Campoverde di Aprilia Latina, 04010, Italy.

Abbot SPA

Via Pontina Km. 52, Campoverde di Aprilia Latina, 04010, Italy.

Representative office in Russia

141400, Moscow region, Khimki, st. Leningradskaya, possession 39, building 5, Khimki Business Park.

Tel.; Fax.

Reviews about Klacida

Reviews about Klacida are both positive and not too enthusiastic. Many patients note that the antibiotic is effective and significantly speeds up the healing process. But there are also stories that the drug provoked side effects, and as a result the doctor was forced to select a different antibiotic for treatment.

Parents who gave the drug to their children also leave different reviews of Klacid. No less important are the reviews of doctors, which indicate that experts consider this antibiotic to be effective and is often prescribed to both adults and children.

Klacida price, where to buy

You can buy this antibiotic at any pharmacy; its cost depends on the form and dosage.

The price of Klacid 250 mg tablets averages 650 rubles per pack of 10 tablets. The price of Klacid 500 mg is from 800 rubles per pack of 14 pcs. The price of granules for preparing Klacid suspension is on average 500 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Klacid tablets p.p.o.
  500 mg 14 pcs. Abbott S.r.L./ Ebbwy S.r.L. RUB 823 order
• Klacid tablets p.p.o. 250 mg 10 pcs. Abbott S.r.L./ Ebbwy S.r.L.

  RUR 669 order

Pharmacy Dialogue

• Klacid (tab. 250 mg No. 10) EbbVi

  RUR 631 order

• Klacid tablets 500 mg No. 14EbbVi

  RUB 812 order

• Klacid gran. d/prig. susp. 125mg/5ml 100ml (70.7g) EbbVie

  610 rub. order

• Klacid (portable d/p. suspension 250 mg/5 ml 49.5 g) EbbVi

  RUB 874 order

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Release form

Powder for the preparation of suspension for oral administration 125 mg/5ml.

In a plastic bottle closed with a polypropylene cap, 42.3 g of the drug. There is a mark in the form of a line on the bottle. 1 bottle of 60 ml complete with a dosing spoon or dosing syringe is placed in a cardboard box.

Powder for the preparation of suspension for oral administration 250 mg/5ml.

In a plastic bottle closed with a polypropylene cap, 70.7 g of the drug. There is a mark in the form of a line on the bottle. 1 bottle of 100 ml complete with a dosing spoon or dosing syringe is placed in a cardboard box.