Clarbact is an antibacterial drug of the macrolide group.
Release form and composition
Dosage form of Klarbakta - coated tablets (capsule-shaped, white or almost white), 4 or 10 pcs. in a blister, in a cardboard box 1 blister.
The active ingredient of the drug is clarithromycin. Its content in 1 tablet is 250 or 500 mg.
Auxiliary components: sodium starch glycolate, purified talcum, colloidal silicon dioxide, polyvinylpyrrolidone, stearic acid, pregelatinized starch, corn starch, microcrystalline cellulose, magnesium stearate.
The composition of the shell: hydroxypropyl methylcellulose, polyethylene glycol 6000, purified talcum, methylene chloride, titanium dioxide, isopropanol, peppermint powder and lemon flavoring.
Indications for use
Treatment of infectious diseases, the causative agents of which are microorganisms sensitive to clarithromycin:
- Respiratory tract infections (lower and upper sections): bronchitis, pneumonia, pharyngitis, sinusitis;
- Infections of the skin and soft tissues, including erysipelas and folliculitis;
- Localized and common infections caused by Mycobacterium intracellulare and Mycobacterium avium;
- Localized infections caused by Mycobacterium kansasii, Mycobacterium fortuitum and Mycobacterium chelonae;
- Eradication of Helicobacter pylori and reduction in the frequency of recurrence of duodenal ulcer.
- Severe renal / liver dysfunction;
- The need for simultaneous use of ergot alkaloids, pimozide, terfenadine, cisapride, astemizole;
- Hypersensitivity to components of Clarbact or other macrolide antibiotics.
The safety of the drug during pregnancy has not been established, so it is prescribed only in extreme cases, after carefully evaluating the ratio of the expected benefits for the expectant mother and the possible risks to the fetus.
Clarithromycin is excreted in breast milk, so during lactation it is used with extreme caution.
Dosing and Administration
The drug should be taken orally.
- Adults - 250 mg 2 times a day, if necessary, a single dose is increased to 500 mg. The course of therapy is from 6 to 14 days;
- Children - 7.5 mg / kg per day, but not more than 500 mg. Duration of use - from 7 to 10 days.
For infections caused by Mycobacterium avium, Clarbact is prescribed 1000 mg 2 times a day. In this case, the treatment can last 6 months or more.
Patients with renal insufficiency (with creatinine clearance less than 30 ml / minute) reduce the dose by half. The course of treatment is up to 14 days.
Possible side effects from various body systems:
- Digestive: most often - abdominal pain, nausea, vomiting, diarrhea, dyspepsia; possible discoloration of the tooth enamel and tongue (usually reversible), candidiasis of the oral mucosa, stomatitis, glossitis, taste disorders, pseudomembranous colitis (up to life threatening), transient increase in the activity of liver enzymes; rarely - hepatitis, accompanied by an increase in the level of liver enzymes in the blood, the development of jaundice and cholestasis (these liver disorders can be severe, but usually reversible); fatal liver failure cases are known;
- Central and peripheral nervous system: dizziness, fear, anxiety, transient headache, insomnia, nightmares, confusion, hallucinations, tinnitus, disorientation, depersonalization, psychosis; rarely, paresthesias;
- Cardiovascular: rarely - an increase in QT-interval, ventricular arrhythmia (including flicker or flutter of the ventricles, ventricular paroxysmal tachycardia);
- Urinary: rarely - interstitial nephritis, increased serum creatinine, renal failure;
- Blood formation: in individual cases - leukopenia, thrombocytopenia;
- Sense organs: changes in taste perception, reversible hearing loss.
Allergic reactions such as skin rashes, urticaria, Stevens-Johnson syndrome, and anaphylactic reactions are sometimes noted.
In some cases, patients taking concurrently with Clarbact oral hypoglycemic agent or insulin, develop hypoglycemia.
Overdose symptoms: confusion, headache, diarrhea, nausea, vomiting. When taking too high a dose of the drug is recommended as soon as possible to make a gastric lavage. Peritoneal dialysis and hemodialysis are ineffective. Further treatment is aimed at eliminating unwanted symptoms.
Patients diagnosed with chronic liver disease, during the entire period of treatment with Clarbact, should regularly monitor the activity of liver enzymes.
Monitoring the patient is also required if, along with clarithromycin, he is prescribed drugs that are metabolized in the liver (you need to control their concentration in the blood plasma).
With prolonged or repeated use of Clarbact there is a chance of developing superinfection, manifested by the growth of fungi and bacteria that are not sensitive to it.
It should be borne in mind that between clarithromycin and other macrolide antibiotics, as well as clindamycin and lincomycin, cross-resistance is possible.
For patients with a history of heart disease, cisapride, terfenadine or astemizole are recommended to be taken along with Clarbact.
In the appointment of warfarin or other indirect anticoagulants should be monitored prothrombin time.
Clarithromycin increases the concentration of drug in the blood that is metabolized in the liver with cytochrome P450 isoenzymes such as oral anticoagulants, ergot alkaloids, triazolam, theophylline, cyclosporin, rifabutin, midazolam, carbamazepine, lovastatin, phenytoin, disopyramide, digoxin.
In addition, a significant (2-3 times) increase in plasma concentration is observed with simultaneous use of cisapride, terfenadine, astemizole and pimozide. At the same time there is a risk of prolongation of the QT interval and the development of cardiac arrhythmias, including fibrillation, atrial flutter or ventricular fibrillation, and ventricular paroxysmal tachycardia. For this reason, such a combination is contraindicated.
There are separate reports of cases of development of acute necrosis of skeletal muscles in patients who took HMG-CoA reductase inhibitors (simvastatin and lovastatin) during the treatment period with Clarbact.
Clarithromycin may increase plasma concentration of digoxin. Patients receiving both drugs need constant monitoring of its concentration in serum to prevent the development of digitalis intoxication.
Clarithromycin reduces the clearance of triazolam, resulting in drowsiness and confusion.
The combined use of Clarbact with ergot alkaloids can lead to acute ergotamine intoxication, manifested by a violation of sensitivity and severe peripheral vasospasm.
Ritonavir may increase the serum concentration of clarithromycin. Patients with normal renal function do not require dose adjustment, but Clarbact should not be administered in a daily dose of more than 1000 mg. Patients with creatinine clearance (CK) 30-60ml / minute reduce the dose of clarithromycin by 50%, with CK less than 30 ml / minute - by 75%.
Clarithromycin can reduce the equilibrium (stationary) concentration of zidovudine ingested in HIV-infected adults. This problem can be solved by taking drugs with an interval of at least 4 hours.
Terms and conditions of storage
Store at temperatures up to 25 ºС in a dry, dark and out of reach of children.
Shelf life - 2 years.