Klacid is a macrolide antibiotic.
Release form and composition
Clacid dosage forms:
- Film-coated tablets - oval, biconvex, yellow 250 and 500 mg (250 mg - 10 pieces in blisters, 1 blister in a cardboard box; 500 mg - 7 pieces in blister, 2 blisters in a cardboard box);
- The powder from which the suspension is prepared for oral administration is granular, white or almost white in color, with a fruit aroma of 125 mg / 5 ml and 250 mg / 5 ml (125 mg / 5 ml - 42.3 g each in plastic bottles of 60 ml , 250 mg / 5 ml - 70.7 g in plastic bottles with a volume of 100 ml, in a cardboard bundle 1 bottle complete with a dosing syringe or dosing spoon);
- The lyophilisate for preparing a solution for intravenous (IV) infusions is white or almost white in color, with a faint aromatic odor (500 mg each in vials of colorless glass, in a cardboard bundle one bottle).
The active ingredient of the drug is clarithromycin. Its content is:
- 1 tablet - 250 or 500 mg;
- 5 ml of suspension - 125 or 250 mg;
- 1 bottle with lyophilisate - 500 mg.
Auxiliary components of tablets:
- 250 mg - croscarmellose sodium, stearic acid, pregelatinized starch, microcrystalline cellulose, silicon dioxide, povidone, magnesium stearate, talc, quinoline yellow dye (E104);
- 500 mg - croscarmellose, stearic acid, microcrystalline cellulose, silicon dioxide, povidone, magnesium stearate, talc.
The composition of the shell of tablets: hypromellose, sorbitan monooleate, propylene glycol, sorbic acid, titanium dioxide, giproloza, vanillin, dye quinoline yellow (E104).
Auxiliary components of the powder: Povidone K90, maltodextrin, xanthan gum, silicon dioxide, sucrose, carbomer (carbopol 974P), titanium dioxide, potassium sorbate, hypromellose phthalate, anhydrous citric acid, castor oil, fruit flavoring.
Auxiliary substances of the lyophilisate: lactobionic acid, 4% sodium hydroxide (to pH 4.8–6).
Indications for use
All Klacid dosage forms can be used for the following diseases caused by microorganisms susceptible to it:
- Respiratory tract infections (upper and lower sections), incl. sinusitis, pharyngitis, bronchitis and pneumonia;
- Infections of the skin and soft tissues, including folliculitis, erysipelas and inflammation of the subcutaneous tissue;
- Localized infections caused by Mycobacterium fortuitum, Mycobacterium kansasii and Mycobacterium chelonae;
- Common and localized mycobacterial infections caused by Mycobacterium intracellulare and Mycobacterium avium.
Additional indications for prescription pills:
- Odontogenic infections (only tablets in a dose of 250 mg);
- Eradication of Helicobacter pylori, as well as a decrease in the frequency of recurrence of duodenal ulcer;
- Prevention of the spread of infection caused by the Mycobacterium avium microbacterium complex (MAC) in HIV-infected patients with a CD4 (T-helper) lymphocyte count of not more than 100 in 1 mm 3 .
The suspension prepared from powder is also used in the treatment of acute otitis media.
For all dosage forms of Klacid:
- The need for simultaneous use of astemizole, terfenadine, pimozide, cisapride, and ergot alkaloids (ergotamine, dihydroergotamine);
- Hypersensitivity to clarithromycin, any auxiliary component of the drug or to other macrolides.
Additionally for tablets and suspensions:
- Simultaneous intake of midazolam, HMG-CoA reductase inhibitors (statins), which are largely metabolized by the CYP3A4 isoenzyme (simvastatin, lovastatin), colchicine, ticagrelor, ranolazine;
- A history of indications of ventricular arrhythmia, prolongation of the QT interval, ventricular tachycardia of the "pirouette" type;
- Severe hepatic impairment simultaneously with renal insufficiency;
- The presence in the history of the disease indications of cholestatic jaundice or hepatitis, developed with the use of clarithromycin;
- Insufficiency of sucrase-isomaltase, congenital fructose intolerance, glucose-galactose malabsorption syndrome (only for suspension);
- Children's age up to 12 years (only for tablets).
Additionally for intravenous administration:
- Age up to 18 years.
Inside the drug is prescribed with caution in the following cases:
- Medium and severe renal / hepatic impairment;
- Coronary heart disease, severe bradycardia (less than 50 beats per minute), hypomagnesemia, severe heart failure;
- Myasthenia gravis;
- Diabetes mellitus (for suspension, since it contains sucrose).
If necessary, intravenous administration of the drug with caution is prescribed to patients with moderate and severe renal insufficiency.
Dosing and Administration
Klacid tablets should be taken orally at any convenient time, regardless of meals.
Children over 12 years old and adults are prescribed 1 tablet of 250 mg 2 times a day. In severe cases, a single dose is increased to 500 mg. As a rule, the course of treatment is 5-14 days, with the exception of sinusitis and community-acquired pneumonia - it takes at least 6 days to cure them.
With mycobacterial infections, except for tuberculosis, the drug is taken on 1 tablet 500 mg 2 times a day.
In disseminated MAS infections in patients with AIDS, Klacid is prescribed in combination with other antibiotics active against these pathogens. The duration of therapy is set individually.
For the prevention of infections caused by MAS, the dose is also 500 mg 2 times a day.
Treatment of odontogenic infections is carried out with clarithromycin in a daily dose of 500 mg - 250 mg 2 times a day. The course is 5 days.
For eradication of Helicobacter pylori Klacid is prescribed 500 mg 2 times a day in combination with proton pump inhibitors and other antimicrobial drugs. The duration of therapy is 7-14 days.
Patients with renal insufficiency (with creatinine clearance less than 30 ml / minute) are prescribed 250 mg once a day, in severe cases 250 mg twice a day. The maximum duration of treatment is 14 days.
Suspension is taken orally, regardless of meals (with milk). Prepare it as follows: gradually add water to the mark in the bottle, close it and shake well. Shake the bottle is necessary before each reception. In this dosage form Klacid is prescribed to children.
The recommended daily dose for non-mycobacterial infections is 7.5 mg / kg 2 times a day, and the single dose should not exceed 500 mg of clarithromycin. The duration of treatment depends on the type of pathogen and the severity of the patient’s condition, as a rule, is 5-10 days.
The recommended daily dose for disseminated and local mycobacterial infections is 7.5-15 mg / kg 2 times a day. Additionally prescribe other antimicrobials. Therapy is continued for as long as the clinical effect persists.
Single doses, taking into account the weight of the child, at the rate of 7.5 mg / kg, for suspension in a dose of 125 mg / 5 ml and 250 mg / 5 ml:
- 8-11 kg - 2.5 ml and 1.25 ml;
- 12-19 kg - 5 ml and 2.5 ml;
- 20-29 kg - 7.5 ml and 3.75 ml;
- 30-40 kg - 10 ml and 5 ml.
Single doses, taking into account the weight of the child, at the rate of 15 mg / kg, for suspension in a dose of 125 mg / 5 ml and 250 mg / 5 ml:
- 8-11 kg - 5 ml and 2.5 ml;
- 12-19 kg - 10 ml and 5 ml;
- 20-29 kg - 15 ml and 7.5 ml;
- 30-40 kg - 20 ml and 10 ml.
For children with creatinine clearance (CK) less than 30 ml / minute, the dose is halved: 125 mg 1 time per day, for severe infections - 125 mg 2 times per day. Although usually the course of treatment is 5-10 days, in this case, therapy can last up to 14 days.
The solution prepared from the lyophilisate is administered only as a drip intravenous infusion for at least 60 minutes. Intramuscular and bolus use is prohibited!
Adults are usually prescribed 500 mg 2 times a day. In severe cases, treatment is continued from 2 to 5 days, then, if necessary, the patient is transferred to the oral form of Klacida.
Patients with impaired renal function and QA less than 30 ml / minute dose is halved.
Terms of preparation of the solution for infusion:
- Add 10 ml of sterile injectable water to the lyophilized vial (solvents containing inorganic salts and preservatives should not be used);
- Before the introduction, the prepared solution should be added to at least 250 ml of one of the following solvents: 5% glucose solution, 5% glucose solution in 0.3% sodium chloride solution, Ringer's lactate solution, 5% glucose solution in Ringer's lactate solution, 5% solution glucose in a 0.45% solution of sodium chloride, a solution of Normosol-M in a 5% solution of glucose, a solution of Normosol-R in a 5% solution of glucose, 0.9% solution of sodium chloride.
- Allergic reactions: often - rash; infrequently - bullous dermatitis 1 , anaphylactoid reaction 1 , pruritus, urticaria, hypersensitivity, maculopapular rash 2 ; unknown frequency - drug rash with eosinophilia and systemic symptoms (DRESS syndrome), angioedema, toxic epidermal necrolysis, anaphylactic reaction, Stevens-Johnson syndrome;
- Respiratory system: infrequently - pulmonary embolism 1 , asthma 1 , epistaxis 2 ;
- Sense organs: often - a perversion of taste, dysgeusia; infrequently - ringing in the ears, hearing loss, vertigo; frequency is unknown - anosmia, parosmia, loss of taste sensations, deafness;
- Nervous system: often - headache, insomnia; infrequently - drowsiness, anxiety, dizziness, tremor, dyskinesia 1 , loss of consciousness 1 , irritability 2 ; frequency unknown - confusion, psychotic disorders, depersonalization, hallucinations, disorientation, nightmares, depression, mania, paresthesia, convulsions;
- Urinary system: frequency unknown - interstitial nephritis, renal failure;
- The digestive system: often - nausea, dyspepsia, vomiting, abdominal pain, diarrhea; infrequently - dry mouth, constipation, belching, glossitis, stomatitis, gastritis, hepatitis (including cholestatic and hepatocellular 3 ), esophagitis 1 , bloating 3 , flatulence, cholestasis 3 ; frequency is unknown - discoloration of the tongue and teeth, cholestatic jaundice, acute pancreatitis, liver failure;
- Musculoskeletal system: infrequently - musculoskeletal stiffness 1 , muscle spasm 3 , frequency not known - myopathy;
- Metabolism and nutrition: infrequently - loss of appetite, anorexia;
- Cardiovascular system: often - vasodilation 1 ; infrequently - prolongation of the QT interval on ECG, atrial flutter, extrasystole 1 , atrial fibrillation 1 , cardiac arrest 1 ; frequency unknown - ventricular tachycardia (including the type of "pirouette");
- Skin: often - intense sweating; frequency is unknown - hemorrhage, acne;
- Infectious and parasitic diseases: infrequently - candidiasis, cellulitis 1 , secondary infections (including vaginal) 2 ; frequency unknown - erysipelas, pseudomembranous colitis;
- Laboratory indicators: often - a deviation in liver samples; infrequently - leukopenia, changes in the ratio of albumin – globulin 1 , increased concentrations of creatinine and urea 1 , thrombocythemia 2 , eosinophilia 3 , neutropenia 3 , increased blood concentrations of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase 3 and lactate dehydrogenase 3 ; frequency is unknown - change in urine color, increase in MHO, thrombocytopenia, agranulocytosis, increase in the concentration of bilirubin in the blood, prolongation of prothrombin time;
- Other: very often - phlebitis at the injection site 1 ; often - pain and inflammation at the injection site 1 ; infrequently - hyperthermia, malaise, asthenia, chills 3 , chest pain 3 , fatigue 3 .
Reports of some side effects were obtained when using Klacida in a specific dosage form:
1 - only in the form of intravenous infusion (lyophilisate for solution preparation);
2 - only in the form of a suspension prepared from powder.
3 - only in the form of film-coated tablets.
Prolonged use of Clacida can lead to the development of superinfection, manifested by the growth of fungi and bacteria that are insensitive to it. For this reason, it is important to conduct sensitivity testing, especially in patients with community-acquired pneumonia.
In the presence of chronic liver disease during therapy, it is necessary to regularly monitor serum enzymes.
If there are signs of hepatitis (abdominal pain on palpation, dark urine, jaundice, anorexia, itching), you should immediately stop the treatment with clarithromycin.
Data on the effect of clarithromycin on the reaction rate and ability to concentrate attention are missing. However, the potential risks of confusion, dizziness and disorientation must be taken into account. Therefore, it is recommended to be careful when taking up potentially hazardous activities and driving.
In connection with the possibility of serious side effects, the use of the following drugs in conjunction with Klacid is contraindicated:
- Cisapride, terfenadine, pimozide and astemizole - an increase in the QT interval, the occurrence of cardiac arrhythmias, including fibrillation of the ventricles and ventricular tachycardia of the "pirouette" type;
- Ergot alkaloids - there is a likelihood of vascular spasm, ischemia of the limbs and other tissues, including the central nervous system;
- HMG-CoA reductase inhibitors (statins) - increasing the risk of myopathy, incl. rhabdomyolysis.
Klacid is prescribed with caution, if necessary, the simultaneous use of the following drugs and drugs (may require dose adjustment or a switch to alternative therapy):
- Benzodiazepines (alprazolam, triazolam and midazol / in);
- Other ototoxic drugs (especially aminoglycosides);
- Preparations metabolized by CYP3A isoenzyme (for example, indirect anticoagulants, cyclosporine, Cilostazol, disopyramide, carbamazepine, methylprednisolone, rifabutin, quinidine, sildenafil, vinblastin, omeprazole, tacrolimus, etc.);
- Drugs that induce the CYP3A4 isoenzyme (for example, phenytoin, rifampicin, carbamazepine, phenobarbital, St. John's wort);
- Statins that do not depend on the metabolism of CYP3A isoenzyme (for example, fluvastatin);
- Slow calcium channel blockers metabolized by CYP3A4 isoenzyme (for example, amlodipine, verapamil, diltiazem);
- Antiarrhythmic drugs IA class (quinidine and procainamide) and class III (sotalol, amiodarone, dofetilide);
- Strong inducers of the cytochrome P450 system (rifampicin, nevirapine, rifabutin, rifapentin, efavirenz);
- Etavirin, fluconazole, ritonavir, tolterodine.
With simultaneous use with hypoglycemic agents and insulin may develop severe hypoglycemia, therefore, it is recommended to control the concentration of glucose.
In the case of the appointment of indirect anticoagulants (eg, warfarin), it is necessary to control the prothrombin time, because its increase is possible.
When taken jointly, the serum concentration of digoxin may increase. There are cases of clinical symptoms of poisoning, including potentially lethal arrhythmias. If necessary, the appointment of such a combination should be carefully controlled serum concentration of digoxin.
Orally administered clarithromycin may reduce the equilibrium concentration of zidovudine ingested in HIV-infected adults. Such undesirable interactions can be largely avoided if you take drugs at least at intervals of 4 hours.
Mutual increase in concentration can be observed with simultaneous use of clarithromycin with protease inhibitors (for example, atazanavir).
It should be borne in mind that between clarithromycin and clindamycin / lincomycin / other macrolide antibiotics, cross-resistance is possible.
Terms and conditions of storage
Store in a dark place, out of reach of children at a temperature: tablets - 15-30 ºС, powder - no higher than 30 ºС, lyophilisate - no more than 25 ºС.
The shelf life of the tablets is 5 years, the powder is 2 years, the lyophilisate is 4 years. The suspension prepared with their powder can be stored for 14 days at a temperature of 15-30 ° C, the solution prepared from the lyophilisate is kept for 24 hours at a temperature of 2-5 ° C.