Clarithromycin OBL tablets

Composition 

1 tablet contains 500 mg of clarithromycin

Packaging

7 or 14 PCs.

Pharmacological action

Clarithromycin – antibiotic group macrolides – suppresses microbial cell protein synthesis by interacting with the 50S ribosomal subunit of bacteria. Active against Streptococcus agalactiae (pyogenes, viridans, pneumoniae), Haemophilus influenzae (parainfluenzae), Neisseria gonorrhoeae, Listeria monocytogenes, Legionella pneumophilia, Mycoplasma pneumoniae, Helicobacter pylori, Campilobacter jejuni, Chlamydia pneumoniae (trachomatis), Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Propionibacterium acnes, Mycobacterium avium, Mycobacterium leprae, Staphylococcus aureus, Ureaplasma urealyticum, Toxoplasma gondii. The ingestion of clarithromycin is metabolized to the primary metabolite 14 hydroxyclarithromycin, which has the same or 1-2 orders of magnitude smaller (depending on the type of microorganism) microbial activity than the unmodified substance.

Indications

Infections, caused by susceptible to clarithromycin microorganisms the infections of the upper respiratory tract (laryngitis, pharyngitis, tonsillitis and sinusitis), infections of the lower respiratory tract (bronchitis, bacterial pneumonia), infections of skin and soft tissues (folliculitis, furunculosis, impetigo, wound infection), infections caused by Mycobacterium avium, Chlamydia trachomatis, Helicobacter pylori, Ureaplasma urealyticum.

Contraindications

• hypersensitivity to antibiotics of macrolides group,
• co-administration with ergot derivatives,
• coadministration of the following drugs: cisapride, pimozide, terfenadine,
• children under 12 years old,
• pregnancy and lactation.

Method of application and doses

Dosing regimen and duration of treatment are determined individually, taking into account the indications, the severity of the infection, the sensitivity of the pathogen.

For adults and children over 12 years, the average dose is 250 mg twice a day. If necessary, clarithromycin can be prescribed 500 mg twice a day. The duration of the course of treatment — 5-14 days.

In the treatment of infections caused by Mycobacterium avium, sinusitis, severe infections, including Haemophilus influenzae, — at 500-1000 mg 2 times a day, maximum daily dose 2 g. Children up to 12 years at the rate of 7, 5 mg/kg of body weight every 12 hours with a maximum daily dose of 500 mg in patients with renal insufficiency (Cl creatinine less than 30 ml/min or serum creatinine concentrations more than 3, 3 mg/100 ml) dose should be reduced in 2 times. The maximum duration of treatment in patients of this group — no more than 14 days.

Side effect

The gastro-intestinal tract:

Nausea, vomiting, dyspepsia, diarrhea, abdominal pain, stomatitis, glossitis, pancreatitis, oral candidiasis, discoloration of the tongue and teeth, rarely — pseudomembranous enterocolitis. Teeth discoloration is reversible and usually restored by special treatment in a dental clinic. As with other antibiotics from the group of macrolides, liver function may be impaired, including increased activity of liver enzymes, hepatic cell and/or cholestatic hepatitis with or without jaundice. These liver disorders can be severe, but they are usually reversible. Very rarely there have been cases of liver failure and fatal outcome mainly due to severe comorbidities and/or concomitant drug therapy.

On the part of the blood system:

In exceptional cases-leukopenia and thrombocytopenia, increased serum creatinine. From the Central and peripheral nervous system:

Paresthesia, headache, disorders of smell, changes in taste, dizziness, excitement, insomnia, nightmares, fear, tinnitus, confusion, disorientation, hallucinations, psychosis, depersonalization, reversible hearing loss, convulsions.

From the cardiovascular system:

As with other macrolides, QT prolongation, ventricular tachycardia Polymorphic ventricular tachyarrhythmia (torsades de pointes).

From the musculoskeletal system:

Arthralgia, myalgia

From the urinary system:

Some cases of increased creatinine in blood plasma, interstitial nephritis, renal failure

Allergic reaction:

Urticaria, angioedema, anaphylactic shock, in rare cases – Stevenea-Johnson syndrome, toxic epidermal necrolysis.

Drug interaction

With simultaneous administration of clarithromycin with theophylline and carbamazepine, an increase in the content of the latter in blood plasma was noted.

Overdose

Symptoms: symptoms of gastro-intestinal tract, one of the patients when receiving 8 g of clarithromycin was a case of impaired mental status, paranoid behaviour, hypoglycemia, hypoxemia.

Treatment: gastric lavage, maintenance therapy. Hemodialysis or peritoneal dialysis is ineffective, as for other macrolides.

Storage conditions

Store in a dry, dark place out of reach of children at temperatures up to 25°C.

Shelf life

2 years.