Klacid instructions for use for adults. Indications for use of Klacida immediate release. Klacid SR indications for use
Antibiotic of the macrolide group.Drug: KLATSID ® SR
Active substance: clarithromycin
ATX code: J01FA09
KFG: Macrolide antibiotic
Reg. number: P No. 015763/01
Registration date: 06/15/04
Owner reg. cred.: ABBOTT LABORATORIES Limited (UK)
DOSAGE FORM, COMPOSITION AND PACKAGING
Extended-release film-coated tablets yellow color, oval; on the cross section two layers are visible: the core is almost white, surrounded by a yellow film.
Excipients: anhydrous citric acid hydrogen phosphate, sodium alginate, sodium calcium alginate, lactose, povidone K30, talc, stearic acid, magnesium stearate.
Shell composition: hypromellose, polyethylene glycol 400, polyethylene glycol 8000, titanium dioxide, quinoline yellow dye (E104), sorbic acid.
5 pieces. - blisters (1) - cardboard packs.
5 pieces. - blisters (2) - cardboard packs.
7 pcs. - blisters (1) - cardboard packs.
7 pcs. - blisters (2) - cardboard packs.
10 pieces. - blisters (1) - cardboard packs.
14 pcs. - blisters (1) - cardboard packs.
The description of the drug is based on the officially approved instructions for use.
PHARMACHOLOGIC EFFECT
Antibiotic of the macrolide group. Clarithromycin inhibits protein synthesis in microbial cells by interacting with the 50S ribosomal subunit of bacteria.
Clarithromycin has demonstrated high in vitro activity against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro studies confirm high efficiency clarithromycin against Legionella pneumophila and Mycoplasma pneumoniae.
The drug is also active against aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Legionella pneumophilis; other microorganisms: Mycoplasma pneumoniae Chlamydia pneumoniae(TWAR), Chlamydia trachomatis, mycobacteria Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC): Mycobacterium avium, Mycobacferium intracellulare.
To clarithromycin insensitive Enterobacteriaceae, Pseudomonas spp., as well as other non-lactose-degrading gram-negative bacteria.
The production of β-lactamase does not affect the activity of clarithromycin. Most strains of staphylococci resistant to methicillin and oxacillin are also resistant to clarithromycin.
Clarithromycin is effective in vitro against most strains of the following microorganisms (however, the safety and effectiveness of clarithromycin in clinical practice not confirmed clinical studies, And practical significance remains unclear): aerobic gram-positive microorganisms: Streptococcus agalactiae, streptococci ( groups C,F,G), streptococci of the Viridans group; aerobic gram-negative microorganisms: Bordeteila pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms:Сlostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni.
The main metabolite of clarithromycin in the human body is the microbiologically active metabolite 14-hydroxyclarithromycin. The microbiological activity of the metabolite is the same as that of the parent substance, or 1-2 times weaker against most microorganisms. The exception is Haemophilus influenzae, for which the effectiveness of the metabolite is 2 times higher. The parent substance and its main metabolite have either an additive or synergistic effect against Haemophilus influenzae in vitro and in vivo, depending on the bacterial culture.
Extended-release tablets are a homogeneous crystalline base, which, when passed through the gastrointestinal tract, ensures a long-term release of the active substance.
PHARMACOKINETICS
Suction and distribution
After taking the drug orally, the absolute bioavailability is 50%. With repeated doses of the drug, no accumulation was detected.
When taking Klacid SR at a dose of 500 mg, the equilibrium maximum concentrations of clarithromycin and 14-hydroxyclarithromycin are 1.3 μg/ml and 0.48 μg/ml, respectively.
When taking Klacid SR at a dose of 1 g, the C ss max of clarithromycin and 14-hydroxyclarithromycin is 2.4 μg/ml and 0.67 μg/ml, respectively.
When taking the drug in doses of 500 mg and 1 g/day, the time to reach Cmax in the blood plasma is about 6 hours.
Clarithromycin binds to plasma proteins by 70% at concentrations from 0.45 to 4.5 μg/ml. At a concentration of 45 μg/ml, the degree of binding decreases to 41%, probably as a result of saturation of binding sites. This is observed only at concentrations many times higher than the therapeutic value.
Clarithromycin and 14-hydroxyclarithromycin are widely distributed in tissues and body fluids. After oral administration The content of clarithromycin in tissues is usually several times higher than its content in the blood serum. After oral administration, the concentration of clarithromycin in cerebrospinal fluid remains low (in patients with an intact BBB it is 1-2% of the concentration in the blood plasma).
Metabolism and excretion
Clarithromycin is metabolized in the cytochrome P 450 system with the participation of the CYP3A isoenzyme. The main metabolite of clarithromycin is the microbiologically active metabolite 14-hydroxyclarithromycin. With repeated doses of the drug, the nature of metabolism in the human body did not change.
At steady state, the concentration of 14-hydroxyclarithromycin does not increase, and T1/2 of clarithromycin and its metabolite increases with increasing doses of the drug, which indicates nonlinearity of metabolism when taken in high doses.
About 40% of the dose is excreted in the urine, about 30% through the intestines.
When taking Klacid, the SR at a dose of 500 mg T1/2 of clarithromycin and 14-hydroxyclarithromycin are 5.3 hours and 7.7 hours, respectively.
When taking Klacid, the SR in a dose of 1 g T1/2 of clarithromycin and 14-hydroxyclarithromycin are 5.8 hours and 8.9 hours, respectively.
Pharmacokinetics in special clinical situations
In patients with moderate and severe violation liver function, but with preserved renal function C ss and systemic clearance of clarithromycin do not differ from these indicators in healthy patients. C ss of 14-hydroxyclarithromycin in people with impaired liver function is lower than in healthy volunteers.
In patients with impaired renal function, Cmax and Cmin in blood plasma, T1/2, AUC of clarithromycin and 14-hydroxyclarithromycin increase. The elimination constant and urinary excretion decrease. The degree of changes in these parameters depends on the degree of renal dysfunction.
In elderly patients, blood levels of clarithromycin and 14-hydroxyclarithromycin were higher and elimination was slower than in younger patients. It is believed that changes in pharmacokinetics in elderly patients are associated primarily with changes in QC and functional state kidneys, and not with the age of the patients.
INDICATIONS
Infections lower sections respiratory tract(such as bronchitis, pneumonia);
Infections upper sections respiratory tract (such as pharyngitis, sinusitis);
Skin and soft tissue infections (such as folliculitis, erysipelas).
DOSING REGIME
For adults Klacid SR is prescribed 500 mg (1 tablet) 1 time/day. At severe infections the dose is increased to 1 g (2 tablets) 1 time/day.
The tablets should be taken with meals, swallowed whole, without breaking or chewing.
SIDE EFFECT
From the outside of cardio-vascular system: rarely - ventricular arrhythmia, including ventricular tachycardia (with an increase in the QT interval).
From the outside digestive system: nausea, abdominal pain, vomiting, diarrhea, gastralgia, pancreatitis, glossitis, stomatitis, oral candidiasis, discoloration of the tongue and teeth; rarely - pseudomembranous enterocolitis. Tooth discoloration is reversible and usually recovers professional cleaning at the dentist. Rarely observed liver dysfunction, incl. increased activity of liver enzymes, hepatic cell and/or cholestatic hepatitis with or without jaundice. These liver problems can be severe, but are usually reversible. Very rarely observed cases liver failure And fatal outcome mainly against the backdrop of heavy concomitant diseases and/or concomitant drug therapy.
From the side of the central nervous system: transient headaches, dizziness, anxiety, insomnia, nightmares, ringing in the ears, depersonalization, hallucinations, convulsions, feelings of fear; rarely - psychosis, confusion; V in some cases- hearing loss (when clarithromycin was stopped, hearing was restored), changes in the sense of smell (usually accompanied by distortions in the sense of taste).
Allergic reactions: urticaria, skin hyperemia, itchy skin, anaphylaxis, Stevens-Johnson syndrome.
From the hematopoietic system: leukopenia, thrombocytopenia.
From the outside laboratory parameters: increase in creatinine content in the blood; rarely - hypoglycemia (with simultaneous administration hypoglycemic drugs).
Others: development of microbial resistance.
CONTRAINDICATIONS
Severe renal dysfunction (with CC less than 30 ml/min); such patients are prescribed immediate-release clarithromycin;
Concomitant use of astemizole, cisapride, pimozide, terfenadine;
Porphyria;
Pregnancy;
Lactation (breastfeeding);
Hypersensitivity to macrolide antibiotics.
PREGNANCY AND LACTATION
The safety of clarithromycin during pregnancy and lactation has not been studied.
Clarithromycin is known to be excreted in breast milk.
Therefore, Klacid SR should be used during pregnancy and lactation only in cases where there is no more safe alternative, and the risk associated with the disease itself exceeds possible harm for mother and fetus.
SPECIAL INSTRUCTIONS
The drug is prescribed with caution to patients with impaired liver function. In the presence of chronic diseases liver requires regular monitoring of serum enzymes.
Also, caution should be used when prescribing the drug to patients with lungs and moderate impairments kidney function. In case of severe renal impairment (creatinine clearance less than 30 ml/min), immediate-release clarithromycin (250 mg or 500 mg tablets) should be prescribed.
In case of co-administration with warfarin or other indirect anticoagulants it is necessary to monitor prothrombin time.
OVERDOSE
Symptoms: nausea, vomiting, abdominal pain, diarrhea. One patient with bipolar disorder changes in the medical history after taking clarithromycin at a dose of 8 g mental state, paranoid behavior, hypokalemia and hypoxemia.
Treatment: the unabsorbed drug should be removed from the gastrointestinal tract and symptomatic therapy. Hemodialysis and peritoneal dialysis do not have a significant effect on the level of clarithromycin in the serum, which is also typical for other macrolide drugs.
DRUG INTERACTIONS
Concomitant use of clarithromycin with drugs metabolized by the cytochrome P 450 isoenzyme CYP3A may lead to increased plasma concentrations of drugs such as alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (eg warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam, vinblastine. A similar mechanism of interaction is observed when using medicines, metabolized by another isoenzyme of the cytochrome P 450 system - phenytoin, theophylline and valproate. At simultaneous use theophylline and carbamazepine with clarithromycin showed moderate but significant (p<0.05) повышение содержания теофиллина и карбамазепина в плазме крови.
Rare cases of rhabdomyolysis have been reported when clarithromycin is taken concomitantly with HMG-CoA reductase inhibitors (for example, lovastatin and simvastatin).
With simultaneous use of clarithromycin with cisapride, an increase in the concentration of cisapride was observed. This may cause QT prolongation, arrhythmia, ventricular tachycardia, fibrillation, and torsade de pointes. Similar effects have been observed in patients taking clarithromycin concomitantly with pimozide.
Macrolide drugs affect the metabolism of terfenadine. The level of terfenadine in the blood increases, which may be accompanied by an increase in the QT interval, the development of arrhythmia, ventricular tachycardia, fibrillation and ventricular fibrillation. The content of acid metabolites of terfenadine increases 2-3 times, the QT interval increases, but this does not cause any clinical manifestations. The same picture was observed when taking astemizole simultaneously with drugs from the macrolide group.
There are reports of the development of ventricular fibrillation with simultaneous use of clarithromycin with quinidine and disopyramide. When prescribing these drugs simultaneously, monitoring their concentrations in the blood is required.
With simultaneous use of clarithromycin with digoxin, an increase in serum digoxin levels was observed. Serum digoxin levels should be monitored in such patients.
With simultaneous oral administration of clarithromycin and zidovudine in HIV-infected patients, a decrease in the steady-state concentration of zidovudine was observed. Because clarithromycin interferes with the absorption of zidovudine, the two drugs should be taken separately.
Ritonavir significantly slows down the metabolism of clarithromycin when administered concomitantly. In this case, the Cmax value of clarithromycin increases by 31%, Cmin - by 182%, AUC - by 77%. There is a significant slowdown in the formation of 14-hydroxyclarithromycin. In this case, in patients without renal impairment, there is no need to adjust the dose of clarithromycin. With a CC of 60-30 ml/min, the dose of clarithromycin should be reduced by 50% to a maximum dose of 500 mg (1 tablet of extended release) 1 time/day. When taking ritonavir, do not simultaneously prescribe a dose of clarithromycin greater than 1 g/day.
Cross-resistance may develop between clarithromycin and other macrolide drugs, as well as lincomycin and clindamycin.
CONDITIONS OF VACATION FROM PHARMACIES
The drug is available with a prescription.
CONDITIONS AND DURATION OF STORAGE
List B. The drug should be stored in a place protected from light, out of reach of children, at a temperature not exceeding 30°C. Shelf life - 3 years.
Klacid ® And Klacid ® SR(lat. Klacid® And Klacid® SR) - antibiotics of the macrolide class. The active ingredient is clarithromycin. In gastroenterology Klacid ® known as one of the antibiotic drugs used as part of complex therapy for eradication Helicobacter pylori.
Dosage forms of Klacida
Klacid and Klacid SR are available in the following dosage forms:- Klacid SR - tablets long-acting yellow, oval, film-coated, containing 500 mg of clarithromycin (clarithromycin is released gradually, during the time the tablet passes through the gastrointestinal tract).
- Klacid - tablets immediate release yellow, oval, film-coated, containing 250 mg of clarithromycin.
- Klacid - tablets immediate release light yellow oval, coated, containing 500 mg of clarithromycin.
- Klacid is a powder for the preparation of a suspension for oral administration, white or almost white, granular, with a fruity aroma, 5 ml of the finished suspension contains 125 mg of clarithromycin (“125 mg/5 ml”).
- Klacid is a powder for the preparation of a suspension for oral administration, white or almost white granules with a fruity aroma, 5 ml of the finished suspension contains 250 mg of clarithromycin (“250 mg/5 ml”).
- Klacid - lyophilisate for preparing a solution for infusion; white to almost white in color, with a faint aromatic odor; one vial contains 500 mg of clarithromycin.
Indications for use of Klacid SR extended release
Klacid SR and Klacid in the form of a lyophilisate for preparing a solution for infusion are used for the treatment of infectious and inflammatory diseases caused by microbes sensitive to the drug: the lower and upper respiratory tract and ENT organs (bronchitis, pneumonia, pharyngitis, sinusitis, etc.), skin and soft tissues, including folliculitis, inflammation of the subcutaneous tissue, erysipelas. Indications for use of Klacida suspension
Klacid in the form of a suspension is used to treat the infectious diseases listed above in the section “Indications for the use of Klacid SR prolonged action”, as well as mycobacterial infections, widespread or localized, caused by Mycobacterium avium And Mycobacterium intracellulare and localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum And Mycobacterium kansasii.In addition, Klacid in the form of a suspension is used as part of eradication regimens Helicobacter pylori and in the prevention of relapses of duodenal ulcers (only in combination with other drugs!).
Indications for use of Klacida immediate release
Klacid in immediate-release tablets is used to treat the infectious diseases listed above in the sections “Indications for the use of Klacid SR extended-release” and “Indications for the use of Klacid suspension”, as well as to prevent the spread of infection caused by the complex Mycobacterium avium, HIV-infected patients with a T-helper lymphocyte content of no more than 100 per 1 mm 3 and odontogenic infections.Application procedure and doses Klacida tablets (immediate release)
Klacid tablets are taken orally, without connection with food intake. Adults, unless the doctor prescribes otherwise, take one Klacid tablet containing 250 mg of clarithromycin, 2 times a day. In more severe cases, the dose is doubled. The duration of treatment is from 5 to 14 days.Patients with creatinine Cl less than 30 ml/min are prescribed one 250 mg tablet once a day, or for more severe infections - one 250 mg tablet 2 times a day for no more than 14 days.
For the treatment of mycobacterial infections, Klacid is taken based on a dose of 500 mg of clarithromycin 2 times a day. The duration of treatment is determined by the doctor
For common infections caused by Mycobacterium avium, in patients with AIDS: treatment with Klacid (in combination with other antimicrobial drugs) continues as long as there is a positive effect.
Klacid during eradication Helicobacter pylori and prevention of relapses of peptic ulcer disease are taken only as part of a complex of drugs, the dose and order of administration depends on the eradication “scheme” used (see article “Clarithromycin” or “Standards for the diagnosis and treatment of acid-dependent and Helicobacter pylori-associated diseases (fourth Moscow Agreement)”) .
Professional medical publications regarding the use of Klacid in the eradication of Helicobacter pylori
- Maev I.V., Samsonov A.A., Andreev N.G., Kochetov S.A. Clarithromycin as the main element of eradication therapy for diseases associated with Helicobacter pylori infection // Gastroenterology. 2011. No. 1.
Application procedure and doses Klacida in the form of a suspension
The Klacid suspension is prepared by gradually adding water to the bottle with granules to the level of the mark, after which the bottle is shaken. You should get 60 ml of a Klacid suspension containing 125 mg of clarithromycin in 5 ml, or 100 ml of a suspension containing 250 mg of clarithromycin in 5 ml. Klacida suspension is stored at room temperature for up to two weeks. The suspension is taken orally, with milk, with or without food. Before use, the bottle of Klacida suspension must be shaken well. Dosage of Klacida suspension in the treatment of non-mycobacterial infections in children. The duration of treatment is 5–7 days, depending on the pathogen and the patient’s condition. A single dose of Klacid suspension is calculated based on 7.5 mg of clarithromycin per kg of patient weight. The calculated dose is taken twice a day. The maximum dose of Klacid is 500 mg of clarithromycin 2 times a day. In order to determine a single dose of the Klacid suspension, one can proceed from the following:
- for children weighing up to 8 kg - proceed from the above 7.5 mg of clarithromycin per kg of weight
- for children weighing 8 to 11 kg, take half a teaspoon (5 ml) of Klacida suspension containing 125 mg of clarithromycin per 5 ml (“125 mg/5 ml”) twice daily
- for children weighing from 12 to 19 kg - take a teaspoon of Klacid suspension "125 mg/5 ml" or half a teaspoon of Klacid suspension containing 250 mg of clarithromycin per 5 ml ("250 mg/5 ml") twice a day
- for children weighing from 20 to 29 kg - take one and a half teaspoons of Klacida suspension "125 mg/5 ml" or 0.75 teaspoons of Klacida suspension "250 mg/5 ml" twice a day
- for children weighing from 30 to 40 kg - take 2 teaspoons of Klacida suspension "125 mg/5 ml" or one teaspoon of Klacida suspension "250 mg/5 ml" twice a day
Application procedure and doses Klacida SR (long-acting)
Swallow Klacid SR tablets whole, without cutting, chewing, or crushing, one tablet once a day during meals. For severe infections, take two tablets once a day. The duration of treatment is from 5 to 14 days. Use of Klacid during pregnancy, lactation and children
The use of Klacid in the first trimester of pregnancy is contraindicated. In the second and third trimesters of pregnancy, taking Klacid is possible if the expected benefit to the mother outweighs the potential risk to the fetus.
When treating a mother with Klacid, breastfeeding should be stopped.
Due to insufficient data on effectiveness and safety, it is not recommended to take Klacida for children under three years of age, and Klacida SR for children under 18 years of age.
Other medicines containing the active ingredient clarithromycin
Having (had) registration in Russia: Bacticap, Biotericin, Zimbaktar, Kispar, Clubax, Clubax OD, Clarbact, Clarithromycin-Verte, Clarithromycin-J, Clarithromycin Zentiva, Clarithromycin Protech, Clarithromycin Pfizer, Clarithromycin Retard-OBL, Clarithromycin SR, Clarithromycin-Teva, Clarithromycin Ecositrin, Clarithromycin -OBL , Clarithrosin, Claricin, Claricite, Claromin, Klasine, Clerimed, Coater, Lecoclair, Mycetinum, Romiclar, Seydon-Sanovel, SR-Klaren,Thank you
Klacid represents antibiotic from the group macrolides, has a detrimental effect on a wide range of pathogenic and opportunistic microorganisms. The drug is used to treat infectious and inflammatory diseases of various organs and systems caused by antibiotic-sensitive microbes. Since microorganisms sensitive to the action of antibiotics, as a rule, provoke infectious and inflammatory diseases of certain organs, Klacid is used to treat precisely these organ structures. Most often, the antibiotic is used to treat bronchitis, pneumonia, pharyngitis, tonsillitis, sinusitis, folliculitis and erysipelas.
A distinctive feature of Klacid is its activity against a wide range of microbes, including atypical pathogenic bacteria that cause infectious and inflammatory diseases of the respiratory tract. In addition, the antibiotic is highly effective in the treatment of acute otitis media, acute bronchitis, pneumonia, pharyngitis or tonsillitis in children.
Varieties, names, composition and release forms
Currently, the antibiotic Klacid is available in two varieties:- Klacid;
- Klacid SR.
Klacid SR is available in a single dosage form - these are extended-release (long-acting) tablets, and Klacid is available in three dosage forms, such as:
- Lyophilisate for the preparation of solution for infusion;
- Powder for the preparation of suspension for oral administration;
- Pills.
As an active substance, all dosage forms of both varieties contain clarithromycin in varying dosages. Thus, Klacid SR tablets contain 500 mg of the active substance. The lyophilisate for the preparation of solution for infusion contains 500 mg of clarithromycin per vial. Tablets of regular duration of action Klacid are available in two dosages - 250 mg and 500 mg of clarithromycin. The powder for preparing the suspension is also available in two dosages - 125 mg/5 ml and 250 mg/5 ml. This means that the finished suspension can have a concentration of active substance of 125 mg per 5 ml or 250 mg per 5 ml. In everyday life, various dosage forms, varieties and dosages of Klacid are called short and succinct names that reflect their main characteristics. Thus, tablets are often called Klacid 250 or Klacid 500, where the number next to the name reflects the dosage of the drug. Taking into account the same principle, the suspension is called Klacid 125 or Klacid 250, etc.
Tablets of both dosages of Klacid and extended-release Klacid SR have the same biconvex, oval shape and are coated with a yellow-colored coating. Tablets are available in packs of 7, 10, 14, 21 and 42 pieces.
Powder for the preparation of a suspension for oral administration is small granules, white or almost white in color and having a fruity odor. The powder is available in 42.3 g bottles complete with a dosing spoon and syringe. When the powder is dissolved in water, an opaque suspension is formed, colored white and having a fruity aroma.
The lyophilisate for preparing a solution for infusion is available in hermetically sealed bottles and is a white powder with a slight aroma.
Therapeutic effect of Klacida
Klacid is an antibiotic and, accordingly, has a detrimental effect on various pathogenic microorganisms that cause infectious and inflammatory diseases. This means that when taking Klacid, microbes die, which leads to the cure of an infectious-inflammatory disease. Klacid has a wide spectrum of action and harmful to the following types of microorganisms:
- Chlamydia pneumoniae (TWAR);
- Chlamydia trachomatis;
- Enterobacteriaceae and Pseudomonas;
- Haemophilus influenzae;
- Haemophilus parainftuenzae;
- Helicobacter (Campilobacter) pylori;
- Legionella pneumophila;
- Listeria monocytogenes;
- Moraxella catarrhalis;
- Mycobacterium leprae;
- Mycobacterium kansasii;
- Mycobacterium chelonae;
- Mycobacterium fortuitum;
- Mycobacterium avium complex (MAC) - a complex including: Mycobacterium avium, Mycobacterium intracellulare;
- Mycoplasma pneumoniae;
- Neisseria gonorrhoeae;
- Staphylococcus aureus;
- Streptococcus pneumoniae;
- Streptococcus pyogenes.
Detrimental to the following microorganisms the effect of Klacid is shown only in laboratory tests, but not confirmed by clinical practice:
- Bacteroides melaninogenicus;
- Bordetella pertussis;
- Borrelia burgdorferi;
- Campylobacter jejuni;
- Clostridium perfringens;
- Pasteurella multocida;
- Peptococcus niger;
- Propionibacterium acnes;
- Streptococcus agalactiae;
- Streptococci (groups C,F,G);
- Treponema pallidum;
- Viridans group streptococci.
Indications for use
Both varieties and all dosage forms of Klacid have the same following indications for use: - Infections of the lower parts of the respiratory system (bronchitis, pneumonia, bronchiolitis, etc.);
- Infections of the upper respiratory system (pharyngitis, tonsillitis, sinusitis, otitis media, etc.);
- Infections of the skin and soft tissues (folliculitis, erysipelas, infectious cellulitis, furunculosis, impetigo, wound infection, etc.);
- Infections caused by mycobacteria;
- Prevention of Mycobacterium avium complex (MAC) infection in HIV-infected people;
- Eradication of H. pylori to cure gastritis and gastric or duodenal ulcers;
- Treatment and reduction of the frequency of relapses of duodenal ulcers;
- Infections of the teeth and oral cavity (dental granuloma, stomatitis, etc.);
- Infections caused by Chlamydia trachomatis, Ureaplasma urealyticum (urethritis, colpitis, etc.).
Instructions for use
Let's consider the rules for using each dosage form of Klacida separately to avoid confusion.Klacid suspension (Klacid 125, Klacid for children) - instructions for use
Klacid suspension is not sold in finished form; it must be prepared independently from powder. Currently, powders for the preparation of suspensions are sold in two dosages - 125 mg/5 ml and 250 mg/5 ml. The 125 mg suspension is sold in 60 ml bottles, and the 250 mg suspension is sold in 100 ml bottles. Accordingly, if you purchased a powder with a concentration of 125 mg/5 ml, then to prepare a suspension from it you will need approximately 30 ml of water, and for 250 mg/5 ml - about 50 ml. A suspension should be prepared from the powder in the bottle immediately at the moment when it is planned to be used. This is due to the fact that the finished suspension can only be stored for 2 weeks, after which the drug should be thrown away, even if it is not completely used. If treatment lasts longer than two weeks, then every 14 days you should throw away the remains of the old suspension and prepare a new one. The suspension should be stored only at room temperature from 15 o to 30 o C, and shake well before each use.
To prepare the suspension You must carefully open the bottle. After this, add clean non-carbonated water to the mark and shake the bottle vigorously to form a homogeneous, opaque white solution. If a powder with an active substance concentration of 125 mg/5 ml was used, then after adding water you will get 60 ml of suspension. If 250 mg/5 ml powder was used, 100 ml of ready-to-use suspension will be obtained.
Klacid suspension is recommended for use in children because it is easy to dose in the required quantity. However, if necessary, adults can also take Klacid in the form of a suspension, measuring the appropriate dosage. But for adults it is more advisable to take Klacid tablets, because the suspension will be used very quickly and several vials will be needed for the course of treatment, which will ultimately lead to rather high unjustified costs.
From the age of 12, provided that the teenager’s body weight is 40 kg or more, it is recommended to give Klacid tablets.
The suspension can be taken regardless of food, at any convenient time. The required amount of suspension should be measured using the included dosing spoon or syringe. The suspension is given to children in its pure form, but if they do not like the taste, they can drink it with water, juice, tea, milk or another drink. For infants, the suspension can be mixed into milk, formula or water.
The dosage of Klacid suspension for children depends on the type of microorganism that caused the infectious disease, as well as on body weight. Thus, for the treatment of infections in children caused by mycobacteria, there are certain dosages of Klacid, and for diseases caused by any other microbes, other doses of the antibiotic are taken.
So, for the treatment of infections caused by non-mycobacteria, a single dosage of Klacid for children is calculated individually, based on the ratio of 7.5 mg per 1 kg of weight. The drug in the calculated dosage is given to the child 2 times a day. It must be remembered that the dosage is individually calculated only for children weighing less than 40 kg. If a child weighs more than 40 kg, then he is given Klacid in dosages for adults.
Let's look at the example of calculating the dose of a drug for a child weighing 20 kg. A single dosage of Klacid for a child weighing 20 kg is 20 kg * 7.5 mg = 150 mg. This means that the child needs to be given 150 mg of Klacid 2 times a day. Now you need to calculate how many milliliters of suspension need to be given to the child so that he receives the required 150 mg of the active substance. We will calculate for a suspension with a concentration of 125 mg/5 ml. To do this, we make the proportion as follows:
125 mg – 5 ml
150 mg – X ml,
where the concentration of the suspension is indicated in the top line (125 mg of active substance is contained in 5 ml). Next, in the bottom line, under the number indicating the content of the active substance in a certain volume of suspension (in our example, this is 125 mg), we write how much of this substance should be given to the child (in the example, this is 150 mg). And under the indication of the volume in the first line (in the example it is 5 ml), in the second we write X, since we need to calculate how many milliliters of the suspension contains the required 150 mg of the active substance. Next, we create an equation to calculate the value of X, which looks like this:
X = 150 mg * 5 ml / 125 mg = 6 ml.
This means that a child weighing 20 kg should be given 6 ml of a suspension with a concentration of 125 mg/5 ml 2 times a day.
The amount of suspension and the required dosage for children of any body weight are calculated in a similar way. This algorithm can be used as a sample by simply substituting your own data into it. In proportion, if we are talking about a suspension with a concentration of 250 mg/5 ml, in the first line they write not “125 mg – 5 ml”, but “250 mg – 5 ml”.
In addition, you don’t have to calculate the individual dosage each time, but use the following table, which shows approximate average doses for children with different body weights.
| Child's body weight | Single amount of suspension with a concentration of 125 mg/5 ml | Single amount of suspension with a concentration of 250 mg/5 ml |
| 8 – 11 kg | 2.5 ml (give 2.5 ml 2 times a day) | 1.25 ml (give 1.25 ml 2 times a day) |
| 12 – 19 kg | 5 ml | 2.5 ml |
| 20 – 29 kg | 7.5 ml | 3.75 ml |
| 30 – 40 kg | 10 ml | 5 ml |
Dosage of Klacida for children suffering from diseases caused by mycoplasmas, is also calculated individually, based on the ratio of 7.5 – 15 mg per 1 kg of weight, 2 per day. The calculated daily dose is also given 2 times a day. In principle, dosages for the treatment of mycoplasma diseases can not be calculated, but use the table given above, which indicates the amount of suspension required for a child with a given body weight, based on the calculation of 7.5 mg per 1 kg of weight. You just need to remember that this table shows the minimum dosages for the treatment of mycoplasma infections, and they can be increased by a maximum of two times. For example, to treat a non-mycoplasma infection, a child weighing 20 kg should be given 150 ml of a suspension with a concentration of 125 mg/5 ml 2 times a day. This means that a child weighing also 20 kg, but for the treatment of mycoplasma infection, it is necessary to give 150–300 ml of a suspension with a concentration of 125 mg/5 ml 2 times a day.
Maximum permissible daily dosage of Klacid for children weighing less than 40 kg for the treatment of any infections is 500 mg per day.
Taking Klacid with ergotamine or dihydroergotamine can cause the development of toxic effects of the latter, which are expressed in spasm of peripheral vessels and hypoxia of various organs and tissues, including the central nervous system.
Taking Klacid with Colchicine enhances the effect of the latter.
Taking Klacid with aminoglycoside antibiotics (for example, Levomycetin, etc.) increases the risk of complications from the hearing aid, since both drugs have ototoxicity.
Klacid for children
Klacid is used to treat infectious and inflammatory diseases in children. The oral suspension can be given to children from six months of age, Klacid tablets from 12 years of age, provided that the teenager’s body weight is at least 40 kg. It is optimal to give Klacid to a child under 12 years of age in the form of a suspension, and after reaching the age of 12 - in tablets. Klacid solution should not be administered intravenously or Klacid SR long-acting tablets should be given to children; these dosage forms are approved for use only from 18 years of age.Rules for the use and dosage of Klacid suspension and tablets for children are given in the relevant subsections of the instructions for use.
Side effects
Klacid can provoke the following side effects from various organs and systems: 1. Nervous system:
- Dizziness;
- Drowsiness;
- Dyskinesia (impaired motility of various organs, for example, the gallbladder, etc.);
- Anxiety;
- Excitability;
- Psychotic disorders;
- Confusion;
- Depersonalization;
- Disorientation;
- Nightmares;
- Paresthesia (feeling of goose bumps, numbness of the limbs);
- Mania.
- Skin rash;
- Anaphylactic reactions;
- Bullous dermatitis;
- Itchy skin;
- Angioedema;
- Stevens-Johnson syndrome;
- Toxic epidermal necrolysis;
- DRESS syndrome (skin rash, increased number of eosinophils in the blood).
- Increased sweating;
- Hemorrhages (point hemorrhages).
- Kidney failure;
- Interstitial nephritis.
- Anorexia;
- Hypoglycemia (low blood glucose levels).
- Muscle spasm;
- Musculoskeletal stiffness;
- Rhabdomyolysis;
- Myopathy.
- Vomit;
- Nausea;
Composition and release form of the drug
Film-coated tablets light yellow, oval, biconvex.
Excipients: croscarmellose - 65.6 mg, microcrystalline cellulose - 183.9 mg, silicon dioxide - 12 mg, - 25.5 mg, stearic acid - 21 mg, magnesium stearate - 12.6 mg, talc - 29.4 mg.
Film shell composition: hydroxypropylcellulose (hypromellose) - 22.1 mg, hydroxypropylcellulose - 1.7 mg, propylene glycol - 14.62 mg, sorbitan monooleate - 1.7 mg, titanium dioxide - 5.1 mg, sorbic acid - 0.94 mg, vanillin - 0.94 mg, quinoline yellow (E104) - 0.7 mg.
7 pcs. - blisters (1) - cardboard packs.
7 pcs. - blisters (2) - cardboard packs.
7 pcs. - blisters (3) - cardboard packs.
10 pieces. - blisters (1) - cardboard packs.
10 pieces. - blisters (2) - cardboard packs.
10 pieces. - blisters (3) - cardboard packs.
14 pcs. - blisters (1) - cardboard packs.
14 pcs. - blisters (2) - cardboard packs.
14 pcs. - blisters (3) - cardboard packs.
pharmachologic effect
Semi-synthetic antibiotic of the macrolide group. Suppresses protein synthesis in microbial cells by interacting with the 50S ribosomal subunit of bacteria. It acts mainly bacteriostatically and also bactericidally.
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.
Also active against Toxoplasma gondii, Mycobacterium spp. (except Mycobacterium tuberculosis).
Pharmacokinetics
When taken 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 body tissues, where it reaches a concentration 10 times higher than in.
Approximately 20% of clarithromycin is immediately metabolized to the major metabolite 14-hydroclarithromycin.
At a dose of 250 mg T1/2 is 3-4 hours, at a dose of 500 mg - 5-7 hours.
It is excreted in the urine unchanged and in the form of 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 of the lower 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 or gastric ulcer (only as part of combination therapy).
Contraindications
A history of QT prolongation, ventricular arrhythmia, or torsade de pointes; hypokalemia (risk of QT interval prolongation); severe liver failure occurring simultaneously with renal failure; history of cholestatic jaundice/hepatitis that developed while using clarithromycin; porphyria; I trimester of pregnancy; lactation period (breastfeeding); simultaneous use of clarithromycin with astemizole, cisapride, pimozide, terfenadine; with ergot alkaloids, for example, 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, the single dose is 0.25-1 g, the frequency of administration is 2 times a 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 (creatinine clearance less than 30 ml/min or serum creatinine level more than 3.3 mg/dl), the dose should be halved 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, abdominal pain; uncommon - esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence, increased concentration of bilirubin in the blood, increased activity of ALT, AST, 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; uncommon - anaphylactoid reaction, hypersensitivity, bullous dermatitis, itching, urticaria, maculopapular 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; uncommon - loss of consciousness, dyskinesia, dizziness, drowsiness, tremor, anxiety, increased excitability; frequency unknown - convulsions, psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, nightmares, paresthesia, mania.
From the skin: often - intense sweating; frequency unknown - acne, hemorrhages.
From the senses: often - dysgeusia; infrequently - vertigo, hearing loss, ringing in the ears; frequency unknown - deafness, ageusia, parosmia, anosmia.
From the cardiovascular system: often - vasodilation; uncommon - 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: uncommon - increased creatinine concentration, change in urine color; frequency unknown - renal failure, interstitial nephritis.
Metabolism and nutrition: uncommon - anorexia, decreased appetite, increased urea concentration, change in albumin-globulin ratio.
From the musculoskeletal system: uncommon - muscle spasm, musculoskeletal stiffness, myalgia; frequency unknown - rhabdomyolysis, myopathy.
From the respiratory system: uncommon - asthma, nosebleeds, pulmonary embolism.
From the hematopoietic system: uncommon - leukopenia, neutropenia, eosinophilia, thrombocythemia; frequency unknown - agranulocytosis, thrombocytopenia.
From the blood coagulation system: infrequently - increase in MHO value, 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: uncommon - malaise, hyperthermia, asthenia, chest pain, chills, fatigue.
Drug interactions
Clarithromycin inhibits the activity of the CYP3A4 isoenzyme, which leads to a slower rate of metabolism of astemizole when used simultaneously. As a result, there is an increase in the QT interval and an increased risk of developing ventricular arrhythmia of the “pirouette” type.
Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated due to the fact that these statins are largely metabolized by the CYP3A4 isoenzyme, and co-administration with clarithromycin increases their serum concentrations, which leads to an increased risk of developing myopathy, including rhabdomyolysis. Cases of rhabdomyolysis have been reported in patients taking clarithromycin concomitantly with these drugs. If clarithromycin is necessary, lovastatin or simvastatin should be discontinued during 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 coadministration is necessary, it is recommended to take the lowest dose of statin. The development of signs and symptoms of myopathy should be monitored. When used simultaneously with atorvastatin, the concentration of atorvastatin in the blood plasma increases moderately and the risk of developing myopathy increases.
Drugs that are CYP3A inducers (for example, phenytoin, carbamazepine, phenobarbital, St. John's wort) can induce the metabolism of clarithromycin, which can lead to subtherapeutic concentrations of clarithromycin and a decrease in its effectiveness. It is necessary to monitor the plasma concentration of the CYP3A inducer, which may increase due to the inhibition of CYP3A by clarithromycin.
When used together 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 used together with clarithromycin, plasma concentrations of phenytoin, carbamazepine, etc. may increase.
Strong inducers of isoenzymes of the cytochrome P450 system, such as efavirenz, nevirapine, rifampicin, rifabutin and rifapentine, can accelerate the metabolism of clarithromycin and, thus, reduce the concentration of clarithromycin in plasma and weaken its therapeutic effect, and at the same time increase the concentration of 14-OH-clarithromycin - metabolite, which is also microbiologically active. Since the microbiological activity of clarithromycin and 14-OH-clarithromycin differs against different bacteria, the therapeutic effect may be reduced when clarithromycin is used together with enzyme inducers.
The plasma concentration of clarithromycin decreases with the use of etravirine, while the concentration of the active metabolite 14-OH-clarithromycin increases. Because 14-OH-clarithromycin has low activity against MAC infections, overall activity against MAC infections may be affected, and alternative treatments 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 the metabolism of clarithromycin. When co-administered with ritonavir, clarithromycin C max increased by 31%, C min increased by 182% and AUC increased by 77%, while the concentration of its metabolite 14-OH-clarithromycin decreased significantly. Ritonavir should not be co-administered with clarithromycin in doses exceeding 1 g/day.
Clarithromycin, atazanavir, and saquinavir are substrates and inhibitors of CYP3A, which determines their bidirectional interaction. When taking saquinavir with ritonavir, consider the potential effect of ritonavir on clarithromycin.
When used simultaneously with zidovudine, the bioavailability of zidovudine is slightly reduced.
Colchicine is a substrate of both CYP3A and P-glycoprotein. Clarithromycin and other macrolides are known to be inhibitors of CYP3A and P-glycoprotein. When clarithromycin and colchicine are taken together, inhibition of P-glycoprotein and/or CYP3A may result in increased effects of colchicine. The development of clinical symptoms of colchicine poisoning should be monitored. There have been post-marketing reports of cases of colchicine poisoning when taken concomitantly with clarithromycin, most often in elderly patients. Some of the reported cases occurred in patients with renal failure. Some cases were reported to be fatal. The simultaneous use of clarithromycin and colchicine is contraindicated.
When midazolam and clarithromycin were used together (500 mg orally 2 times a day), an increase in midazolam AUC was noted: 2.7 times after intravenous administration of midazolam and 7 times after oral administration. Concomitant use of clarithromycin with oral midazolam is contraindicated. If intravenous midazolam is used concomitantly with clarithromycin, the patient's condition should be carefully monitored for possible dose adjustment. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3A, including triazolam and alprazolam. For benzodiazepines whose elimination is not dependent on CYP3A (temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.
When clarithromycin and triazolam are used together, effects on the central nervous system, such as drowsiness and confusion, are possible. With this combination, it is recommended to monitor symptoms of central nervous system disorders.
When used simultaneously with warfarin, the anticoagulant effect of warfarin may be enhanced and the risk of bleeding may increase.
Digoxin is thought to be a substrate for P-glycoprotein. Clarithromycin is known to inhibit P-glycoprotein. When used simultaneously with digoxin, there may be a significant increase in the concentration of digoxin in the blood plasma and the risk of developing glycoside intoxication.
Torsade de pointes-type ventricular tachycardia may occur with the combined use of clarithromycin and quinidine or disopyramide. When clarithromycin is coadministered with these drugs, ECG monitoring should be performed regularly to monitor for QT interval prolongation, and serum concentrations of these drugs should also be monitored. During post-marketing use, cases of hypoglycemia have been reported during co-administration of clarithromycin and disopyramide. It is necessary to monitor 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 a day caused an increase in the mean minimum equilibrium concentration of clarithromycin (C min) and AUC by 33% and 18%, respectively. However, co-administration did not significantly affect the average steady-state concentration of the active metabolite 14-OH-clarithromycin. No dose adjustment of clarithromycin is required when taking fluconazole concomitantly.
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.
When used simultaneously with methylprednisolone, the clearance of methylprednisolone decreases; with prednisone - cases of acute mania and psychosis have been described.
When used simultaneously with omeprazole, the concentration of omeprazole increases significantly and the concentration of clarithromycin in the blood plasma increases slightly; with lansoprazole - glossitis, stomatitis and/or the appearance of a dark color of the tongue are possible.
When used simultaneously 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.
When used simultaneously with terfenadine, it is possible to slow down the rate of metabolism of terfenadine and increase its concentration in the blood plasma, which can lead to an increase in the QT interval and an increased risk of developing ventricular arrhythmia of the torsade de pointes type.
Inhibition of the activity of the CYP3A4 isoenzyme under the influence of clarithromycin leads to a slower rate of metabolism of cisapride when used simultaneously. As a result, the concentration of cisapride in the blood plasma increases and the risk of developing life-threatening cardiac arrhythmias, including ventricular arrhythmias of the pirouette type, increases.
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, inhibition of CYP3A results in significantly higher serum concentrations of tolterodine. Therefore, in patients with low levels of CYP2D6-mediated metabolism, a reduction in the dose of tolterodine may be required in the presence of CYP3A inhibitors such as clarithromycin.
When clarithromycin is used together with oral hypoglycemic agents (for example, sulfonylureas) and/or insulin, severe hypoglycemia may occur. Concomitant use of clarithromycin with certain hypoglycemic drugs (for example, nateglinide, pioglitazone, repaglinide and rosiglitazone) may result in inhibition of CYP3A isoenzymes by clarithromycin, which may lead to hypoglycemia. It is believed that when used concomitantly with tolbutamide, there is a risk of developing hypoglycemia.
When used simultaneously with fluoxetine, a case of the development of toxic effects caused by the action of fluoxetine has been described.
When taking clarithromycin concomitantly with other ototoxic drugs, especially aminoglycosides, caution should be exercised and the functions of the vestibular and auditory systems should be monitored both during and after therapy.
When used simultaneously with cyclosporine, the concentration of cyclosporine in the blood plasma increases, and there is a risk of increased side effects.
When used simultaneously with ergotamine and dihydroergotamine, cases of increased side effects of ergotamine and dihydroergotamine have been described. Post-marketing studies show that when clarithromycin is used together with ergotamine or dihydroergotamine, the following effects associated with acute poisoning with drugs of the ergotamine group are possible: vascular spasm, ischemia of the limbs and other tissues, including the central nervous system. Concomitant use of clarithromycin and ergot alkaloids is contraindicated.
Each of these PDE inhibitors is metabolized, at least in part, by CYP3A. However, clarithromycin can inhibit CYP3A. Concomitant use of clarithromycin with sildenafil, tadalafil or vardenafil may lead to an increase in the inhibitory effect on PDE. With these combinations, consider reducing the dose of sildenafil, tadalafil and vardenafil.
When using clarithromycin simultaneously and those that are metabolized by the CYP3A4 isoenzyme (for example, verapamil, amlodipine, diltiazem), caution should be exercised as there is a risk of arterial hypotension. Plasma concentrations of clarithromycin, as well as calcium channel blockers, may increase with simultaneous use. Arterial hypotension, bradyarrhythmia and lactic acidosis are possible when taking clarithromycin and verapamil simultaneously.
special instructions
Clarithromycin should be used with caution in patients with moderate to severe renal impairment; moderate to severe liver failure, with ischemic heart disease, severe heart failure, hypomagnesemia, severe bradycardia (less than 50 beats/min); 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 the CYP3A4 isoenzyme (including verapamil, amlodipine, diltiazem); simultaneously with class I A (quinidine, procainamide) and class III antiarrhythmic drugs (dofetilide, amiodarone, sotalol).
Cross-resistance is observed between macrolide antibiotics.
Antibiotic treatment alters the normal intestinal flora, so superinfection caused by resistant microorganisms may develop.
It should be borne in mind that severe persistent diarrhea may be due to the development of pseudomembranous colitis.
Prothrombin time should be periodically monitored in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.
Pregnancy and lactation
Use in the first trimester of pregnancy is contraindicated.
Use in the second and third trimesters of pregnancy is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
In this medical article you can familiarize yourself with the drug Klacid. The instructions for use will explain in what cases the suspension, injections or tablets can be taken, what the medicine helps with, what are the indications for use, contraindications and side effects. The annotation presents the forms of release of the drug and its composition.
In the article, doctors and consumers can only leave real reviews about Klacid, from which one can find out whether the medicine has helped in the treatment of infectious pathologies in adults and children, for which it is also prescribed. The instructions list analogues of Riboxin, prices of the drug in pharmacies, as well as its use during pregnancy.
A broad-spectrum antibiotic is Klacid. Instructions for use prescribe taking tablets of 250 mg and 500 mg of CP, powder for preparing a suspension, injections in ampoules in the treatment of infectious diseases of the respiratory canals and soft tissues.
Release form and composition
Klacid is supplied to pharmacies in the following dosage forms:
- Lyophilisate for the preparation of solution for infusion (injections in ampoules).
- Film-coated tablets 250 mg and 500 mg (CP or extended release form of Klacida).
- Powder for the preparation of suspension for oral administration 125 mg and 250 mg.
Active substance – clarithromycin:
- 1 bottle of lyophilisate – 500 mg.
- 1 tablet – 250 or 500 mg.
- 5 ml of the finished suspension – 125 or 250 mg.
pharmachologic effect
The instructions for use of the drug Klacid belong to the group of macrolide antibiotics that have an antibacterial effect. The drug is active against Staphylococcus aureus, pneumococcus, viridans streptococcus, the causative agent of listeriosis, Haemophilus influenzae, streptococci of groups A, B, F, C and G, the causative agent of pneumochlamydia, sporotrichosis, chlamydia, peptococcus.
The medication is effective for pneumonia (including pneumonia of mycoplasma etiology), gonorrhea, leprosy, and also for Legionnaires' disease. When using Klacid, the causative agents of whooping cough, human toxic infections, avian pasteurellosis, acne, syphilis, borelliosis and enterocolitis are suppressed.
However, the use of the drug is ineffective in the treatment of Pseudomonas aeruginosa, Enterobacteriaceae and various other gram-negative bacteria that are unable to degrade lactose. Clarithromycin, the main active ingredient of the drug, is released during its travel throughout the gastrointestinal tract due to the fact that the tablets are a crystalline homogeneous mass.
What does Klacid help with?
Indications for use of the drug include the following diseases and conditions:
- infectious lesions of soft tissues, skin (folliculitis, erysipelas, etc.);
- infectious diseases of the respiratory tract, lower sections (pneumonia, bronchitis, etc.);
- infectious diseases of the respiratory tract, upper sections (for sore throat, sinusitis, pharyngitis, etc.);
- infections caused by Mycobacterium fortuitum, Mycobacterium chelonae, Mycobacterium kansasii;
- mycobacterial infections caused by Mycobacterium intracellulare and Mycobacterium avium.
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.
Instructions for use
Klacid tablets
The drug is taken orally regardless of food intake. Usually adults are prescribed 250 mg 2 times a day. In more severe cases, the dose is increased to 500 mg 2 times a day. Usually the duration of treatment is from 5-6 to 14 days. For mycobacterial infections, 500 mg is prescribed 2 times a day.
For common MAC infections in patients with AIDS, treatment should be continued as long as there is clinical and microbiological evidence of benefit. Clarithromycin should be prescribed in combination with other antimicrobial drugs. For infectious diseases caused by mycobacteria, except tuberculosis, the duration of treatment is determined by the doctor.
To prevent infections caused by MAC, the recommended dose of clarithromycin for adults is 500 mg twice daily. For odontogenic infections, the dose of clarithromycin is 250 mg 2 times a day for 5 days.
For eradication of Helicobacter pylori Combined treatment with three drugs: clarithromycin 500 mg 2 times a day + lansoprazole 30 mg 2 times a day + amoxicillin 1000 mg 2 times a day for 10 days; clarithromycin 500 mg 2 times a day + omeprazole 20 mg per day + amoxicillin 1000 mg 2 times a day for 7-10 days.
Combined treatment with two drugs: clarithromycin 500 mg 3 times a day + omeprazole 40 mg per day for 14 days with the prescription of omeprazole at a dose of 20-40 mg per day over the next 14 days; clarithromycin 500 mg 3 times a day + lansoprazole 60 mg per day for 14 days.
For complete healing of the ulcer, additional reduction in the acidity of gastric juice may be required.
Powder
To prepare the suspension, dilute with water, gradually adding it to the bottle up to the mark, then shake until a solution with a homogeneous structure is obtained. The suspension is taken orally before or after meals, and can be diluted with milk.
Recommended daily dosage for children: for non-mycobacterial infections - at the rate of 7.5 mg per 1 kg of child weight (but not more than 500 mg) 2 times a day for 5-10 days; for disseminated or local mycobacterial infections - 7.5-15 mg per 1 kg of body weight 2 times a day, treatment lasts until there is no clinical effect.
For the treatment of mycobacterial infections, the powder is prescribed in combination with other antimicrobial agents active against these pathogens. In case of renal failure, the usual doses are reduced by half, and the period of use is extended to 14 days. Before use, the contents of the bottle must be shaken well;
Ampoules 
The recommended dose for adults is 1 g per day, divided into 2 equal doses, each of which is administered intravenously after dissolution in the appropriate solvent by drop infusion for 60 minutes or more. There are no data on the dosage of Klacid in ampoules for children.
Intramuscular and bolus administration of the drug is prohibited. In patients with impaired renal function and creatinine clearance less than 30 ml/min, the dose of clarithromycin should be reduced by half the normal recommended dose.
Rules for preparing the solution
Add 10 ml of sterile water for injection to the vial with 500 mg of lyophilisate. It is recommended to use only sterile water for injection, as any other solvent may cause sedimentation. Do not use solvents containing preservatives or inorganic salts.
The reconstituted solution of the drug obtained by the method described above contains a sufficient amount of preservative and has a concentration of 50 mg/ml clarithromycin. The solution is stable for 48 hours at 5°C or 24 hours at 25°C.
The reconstituted solution of the drug should be used immediately after its preparation. If the drug is not used immediately after receiving its reconstituted solution, it is recommended to store it for no more than 24 hours at a temperature of 2°C to 8°C under aseptic conditions.
Before administration, the prepared solution of the drug (500 mg in 10 ml of water for injection) must be added to at least 250 ml of one of the following solvents for intravenous administration: 5% glucose solution in lactated Ringer's solution, 5% glucose solution, lactated Ringer's solution, 5% glucose dextrose solution in 0.3% sodium chloride solution, Normosol-M solution in 5% glucose solution, Normosol-R solution in 5% glucose solution, 5% glucose solution in 0.45% sodium chloride solution, 0.9% sodium solution chloride
Contraindications
- Age under 12 years (for Klacid tablets).
- Renal failure with creatinine clearance below 30 ml/min (only for Klacid SR extended-release tablets).
- The period of pregnancy and breastfeeding.
- Individual hypersensitivity to clarithromycin or macrolide antibiotics (for example, Lincomycin, Josamycin, Azithromycin, Roxithromycin, etc.).
- Porphyria.
- Cholestatic jaundice or hepatitis that developed in the past when using drugs containing clarithromycin.
- Age under 18 years (only for Klacid SR extended-release tablets and Klacid infusion solution).
- Hypokalemia (blood potassium levels below normal).
- Lactose intolerance, lactase deficiency or glucose-galactose malabsorption (only for Klacid SR).
- Previous episodes of ventricular arrhythmia or tachycardia of the “pirouette” type.
- Severe liver failure combined with renal failure.
- A history of QT interval prolongation on the ECG.
Side effects
During treatment with Klacid, patients sometimes develop negative reactions to clarithromycin: 
- Depression of liver function when the dose is exceeded.
- Vaginal candidiasis in women.
- Allergic skin reactions - rashes, urticaria, angioedema, anaphylactic shock.
- From the digestive tract - nausea, vomiting, dry mouth, diarrhea, development of colitis and pancreatitis, flatulence, abdominal cramps, lack of appetite.
- Changes in the clinical blood picture.
- From the nervous system - dizziness, weakness, lethargy, fatigue, lethargy, sleep disturbance, irritability, aggression, development of depression.
Children, pregnancy and breastfeeding
The use of the drug in the first trimester of pregnancy is contraindicated. Taking pills in the second and third trimesters of pregnancy is permissible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. If necessary, use during lactation should stop breastfeeding.
Klacid in tablet form is not used to treat children under 3 years of age.
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.
special instructions
Antibiotic treatment alters the normal intestinal flora, so superinfection caused by resistant microorganisms may develop. Severe persistent diarrhea may be due to the development of pseudomembranous colitis.
Prothrombin time should be periodically monitored in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.
Drug interactions
When using the drug Klacid simultaneously with anticoagulants, ergot alkaloids, rifabutin, vinblastine, omeprazole, methylprednisolone, an increase in the concentration of these drugs in the blood serum is observed.
When the drug is combined with cisapride, the concentration of the latter in the blood increases, which can lead to the development of ventricular tachycardia or ventricular flutter.
Analogues of the drug Klacid
Analogues are determined by structure:
- Seydon-Sanovel.
- Klacid SR.
- Arvicin retard.
- Fromilid.
- CP-Klaren.
- Claricite.
- Fromilid Uno.
- Crixan.
- Kispar.
- Binoculars.
- Clarbuckt.
- Claricin.
- Clubax.
- Klasine.
- Claritrosin.
- Clerimed.
- Zimbaktar.
- Ecositrin.
- Claromine.
- Coater.
- Arvicin.
- Clarithromycin.
Vacation conditions and price
The average price of Klacid (250 mg tablets No. 10) in Moscow is 460 rubles. The cost of the powder for preparing the suspension is 340 rubles (the bottle contains 42.3 g of clarithromycin). Lyophilisate for preparing an infusion solution will cost 550 rubles. Dispensed by prescription.
Store in a place protected from light at a temperature of 15 to 30 °C. Keep away from children. Shelf life: tablets – 5 years; powder – 2 years, ready-made suspension – 14 days; lyophilisate – 3 years.
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