Clarithromycin is an antibiotic drug from the group of macrolides.
Release form and composition
Clarithromycin is available in the form:
- Capsules are white, gelatin, with a powder or a white mass with a yellowish tint or white (7 packs in blisters, 2 packs in cardboard packs; 14 packs in plastic jars, 1 can in carton packs );
- Tablets, coated - yellow, oval, biconvex (5 pieces in blisters, 1 or 2 blisters in carton packs);
- Film-coated tablets (250 mg each) - white, oval, biconvex (5 pieces in blister packs, 1-4 packs in cardboard packs; 7 pcs. And 12 pieces in blister packs, 1 each. -2 packs in carton packs; 10 packs in blister packs, 1-6, 8, 10 packs in carton packs; 10, 20, 30, 40, 50, 100 packs in polymeric containers, 1 pack in carton packs; 5, 10, 15, 20 pcs. in dark glass or polymer jars, 1 jar each in carton packs);
- Film-coated tablets (500 mg each) - white, oval, biconvex (3, 4, 5, 7, 8, 10 pcs. In blister packs, 1-6, 9, 10 packs in cartons; 14 pieces in blisters, 1 pack each in carton packs; 5, 7, 10, 14, 15, 20 pcs. In dark glass or plastic jars, 1 can in carton packs; 3, 4, 5, 7, 8, 10, 20, 30, 40, 50, 100 pieces in cans of polyethylene terephthalate, 1 can each in carton packs.
The composition of 1 capsule includes:
- Active ingredient: clarithromycin - 250 mg;
- Auxiliary components: corn starch, lactose monohydrate, polysorbate 80, povidone (medical low molecular weight polyvinylpyrrolidone), croscarmellose sodium, talc, calcium stearate;
- The composition of hard gelatin capsules: gelatin, titanium dioxide.
The composition of 1 coated tablet includes:
- Active ingredient: clarithromycin - 250 mg or 500 mg;
- Auxiliary components: potato starch, microcrystalline cellulose (MCC), povidone, pregelatinized starch; sodium lauryl sulfate, colloidal silicon dioxide (aerosil), magnesium stearate;
- Shell composition: Opadry II or other, of similar quality, registered in the territory of the Russian Federation.
The composition of 1 tablet, film coated, includes:
- Active ingredient: clarithromycin - 250 mg or 500 mg;
- Auxiliary components: povidone (K-30), pregelatinized starch, colloidal silicon dioxide, microcrystalline cellulose, croscarmellose sodium, magnesium stearate;
- Film coating composition: Opadry II white, including macrogol, polyvinyl alcohol, titanium dioxide, talc.
Indications for use
Clarithromycin is prescribed for the treatment of bacterial infections caused by susceptible microorganisms:
- Infections of the lower respiratory tract (atypical pneumonia, pneumonia, bronchitis), upper respiratory tract (pharyngitis, laryngitis, sinusitis, tonsillitis), soft tissue and skin (furunculosis, folliculitis, wound infection, impetigo), otitis media;
- Peptic ulcer and duodenal ulcer.
- A history of ventricular arrhythmia, prolongation of the QT interval or ventricular tachycardia such as "pirouette";
- Hypokalemia (due to the risk of prolonged QT interval);
- Severe hepatic impairment accompanied by renal failure;
- Cholestatic jaundice or a history of hepatitis, arising from the use of the drug;
- Simultaneous use with midazolam, colchicum
- The first trimester of pregnancy and the breastfeeding period (use of Clarithromycin in 2-3 trimesters of pregnancy is possible only in cases where the intended benefit to the mother is higher than the potential risk to the fetus);
- Hypersensitivity to the components of the drug or to other macrolides.
Dosing and Administration
Dosing regimen of clarithromycin doctor sets individually. When ingested a single dose for adults and children from 12 years of age is 0.25-1 g. For children under 12 years old, the drug is prescribed in a daily dose of 7.5-15 mg / kg. The frequency of admission - 2 times a day.
The duration of therapy is determined by indications.
Patients with impaired renal function (creatinine clearance (CK) less than 30 ml per minute or serum creatinine level more than 3.3 mg / dL) need to double the interval between doses or reduce the dose by 2 times.
The maximum daily dose is: adults - 2 g, children - 1 g.
During therapy may develop disorders of some body systems:
- The digestive system: often - pain in the abdomen, nausea, diarrhea, dyspepsia, vomiting; infrequently - proctalgia, esophagitis, gastritis, flatulence, gastroesophageal reflux disease, stomatitis, dry mouth, glossitis, constipation, abdominal distension, belching, increased concentration of bilirubin in the blood, increased activity of alanine aminotransferase (ALT), asparatetransferae syndrome, asparatetransferae syndrome, asparatetransferae syndrome, alfalfa therapy (GGT), alkaline phosphatase (alkaline phosphatase), lactate dehydrogenase (LDH), cholestasis, hepatitis, including hepatocellular and cholestatic; frequency not established - cholestatic jaundice, discoloration of the teeth and tongue, acute pancreatitis, liver failure;
- Respiratory system: infrequently - nasal bleeding, asthma, pulmonary thromboembolism;
- Musculoskeletal system: infrequently - myalgia, musculoskeletal stiffness, muscle spasm; frequency is not installed - myopathy, rhabdomyolysis;
- Blood coagulation system: infrequently - prolongation of prothrombin time, increase in the value of the international normalized ratio (MHO);
- Hematopoietic system: infrequently - thrombocythemia, leukopenia, eosinophilia, neutropenia; frequency not established - thrombocytopenia, agranulocytosis;
- Nervous system: often - insomnia, headache; infrequently - dyskinesia, loss of consciousness, dizziness, tremor, drowsiness, irritability, anxiety; frequency not established - psychotic disorders, convulsions, nightmares, hallucinations, confusion, depression, depersonalization, disorientation, mania, paresthesia;
- Urinary system: infrequently - change the color of urine, increasing the concentration of creatinine; frequency not established - interstitial nephritis, renal failure;
- Cardiovascular system: often - vasodilation; infrequently - atrial fibrillation, cardiac arrest, prolongation of the QT interval on an electrocardiogram (ECG), atrial flutter, extrasystole; frequency not established - ventricular tachycardia, including the type of "pirouette";
- Nutrition and metabolism: infrequently - loss of appetite, anorexia, changes in the ratio of albumin-globulin, increasing the concentration of urea;
- Sense organs: often - a perversion of taste, dysgeusia; infrequently - tinnitus, vertigo, hearing loss; frequency not established - agevziya, deafness, anosmia, parosmia;
- Skin: often - intense sweating; frequency is not installed - hemorrhage, acne;
- Parasitic and infectious diseases: infrequently - gastroenteritis, candidiasis, cellulitis, secondary infections (including vaginal); frequency not established - erysipelas, pseudomembranous colitis;
- The body as a whole: infrequently - chills, chest pain, malaise, asthenia, hyperthermia, fatigue;
- Allergic reactions: often - rash; infrequently - maculo-papular rash, hypersensitivity, anaphylactoid reaction, bullous dermatitis, urticaria, pruritus; frequency not established - toxic epidermal necrolysis, angioedema, anaphylactic reaction, Stevens-Johnson syndrome, drug rash with systemic symptoms and eosinophilia (DRESS syndrome).
Clarithromycin should be taken with caution in patients with severe and moderate renal and hepatic insufficiency, coronary heart disease, hypomagnesemia, severe heart failure, severe bradycardia (less than 50 beats per minute).
It must be borne in mind that persistent severe diarrhea may be due to the occurrence of pseudomembranous colitis.
There is cross-resistance between macrolide antibiotics.
The use of Clarithromycin leads to a change in the normal intestinal flora, therefore, superinfection caused by resistant microorganisms may occur.
It is necessary to periodically monitor the prothrombin time in patients who simultaneously receive clarithromycin with warfarin or other oral anticoagulants.
Do not use Clarithromycin with pimozide, cisapride, terfenadine at the same time.
In simultaneous reception Clarithromycin increases the blood concentration of drugs, metabolized in the liver via cytochrome P450, anticoagulants, theophylline, carbamazepine, rifabutin, astemizole, terfenadine, triazolam, phenytoin, midazolam, cisapride, digoxin, cyclosporin, disopyramide, lovastatin, alkaloids ergot, etc.
Clarithromycin reduces the absorption of zidovudine (between taking these medicines, you must observe at least 4 hours interval).
Perhaps the development of cross-resistance between Clarithromycin, clindamycin and lincomycin.
Terms and conditions of storage
Store in a dark, dry place inaccessible to children at temperature up to 25 ° C.
Shelf life - 2 years.