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Klabel 500 mg (14 tablets)




The instruction for use
medicine for experts


Trade name
of KLABEL 500

the International unlicensed

name Klaritromitsin Lekarstvennaya
the Tablet form, film coated, 500 mg

One tablet contains
active agent – klaritromitsin 500 mg,
excipients: sodium of a kroskarmelloz, starch prezhelatinizirovanny, aerosil 200, povidone, stearic acid, magnesium stearate, talc, cellulose microcrystalline,
structure of a cover: HPMC 2910/gipromelloza 15 sr, HPMC 2910/of a gipromelloz 6 sr, titan E 171 dioxide, propylene glycol, hydroxypropyl cellulose, polysorbate 80, quinolinic yellow aluminum of 18 – 24%, acid sorbic FCC, vanillin.

The description
of the Tablet, film coated yellow color, with a smooth surface, biconvex, an elliptic form.

Pharmacotherapeutic group
Antibacterial drugs of systemic action. Macroleads.
The code of automatic telephone exchange J01FA09
the Pharmacological

Pharmacokinetics Later properties of intake Klabel 500 is quickly soaked up from digestive tract. The absolute bioavailability Klabel 500 is approximately from 50% to 55%. A concomitant use Klabel 500 with food leads to insignificant delay of absorption of a klaritromitsin and increase time of achievement of peak concentration from 2 to 2.5 o’clock. At administration of drug in a dose of 500 mg each 8 – 12 h – time elimination half-life makes up to 5 – 7 h Klabel 500 forms the concentration several times exceeding concentration in blood plasma in fabrics.
Klaritromitsin is brought with urine in an invariable type of 15 – 20%, in the form of the main metabolite of a 14-hydroksiklaritromitsin – 10 – 15%.
The pharmacodynamics
Klabel 500 is a semi-synthetic antibiotic of group of macroleads. The mechanism of action consists in suppression of synthesis of protein in a bacterial cell. Klabel 500 is highly active concerning a wide range of aerobic, anaerobic, gram-positive and gram-negative bacteria.
The main metabolite of a klaritromitsin is the active metabolite – 14-hydroksiklaritromitsin which also has antibacterial activity. In particular, concerning Haemophilus influenzae the efficiency of a metabolite is twice higher than efficiency of a klaritromitsin. At the same time 14-hydroksiklaritromitsin in comparison with klaritromitsiny by from 4 to 7 times is less active concerning strains of Mycobacterium avium complex in comparison with klaritromitsiny.
Klabel 500 is active concerning the following microorganisms:
Aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.
Aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis.
Other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae.
Mycobacteria: Mycobacterium avium complex containing Mycobacterium avium, Mycobacterium intracellulare.
Helicobacter: Helicobacter pylori.

– pharyngitis and tonsillitis the caused Streptococcus pyogenes
– acute antritis the caused Haemophilus influenzae, Moraxella catarrhalis
or Streptococcus pneumoniae
– exacerbation of chronic bronchitis the caused Haemophilus influenzae,
Haemophilus parainfluenzae, Moraxella catarrhalis or
Streptococcus pneumoniae
– community-acquired pneumonia the caused Haemophilus influenzae,
Mycoplasma pneumoniae, Streptococcus pneumoniae or Chlamydia pneumoniae
– uncomplicated infections of integuments and soft tissues the caused
Staphylococcus aureus or Streptococcus pyogenes
– a disseminate mikobakterialny infection the caused
Mycobacterium avium, Mycobacterium intracellulare
– a peptic ulcer of a stomach and duodenum, is associated
ny with infection of H. pylori in an active phase in a combination from an ingiba
with Torahs of the protonew pump
– prevention of the disseminate infection caused
by Mycobacterium avium complex in patients with the progressing HIV infection.

Route of administration and doses

the Infectious disease / microorganism

the Dose
(each 12 h)


Pharyngitis, tonsillitis
of S. pyogenes

of 250 mg


Acute antritis
of H. influenzae,
M. catarrhalis,
S. pneumoniae

of 500 mg


Exacerbation of chronic bronchitis

of H. influenzae H. parainfluenza M. catarrhalis, S. pneumoniae

of 500

mg 500 mg 250 mg

7-10 7 7-10

Community-acquired pneumonia H. influenzae M. pneumoniae, S. pneumoniae, C. pneumoniae

of 250

mg 250 mg

7 7-10

Uncomplicated infections of integuments and soft
tissues S. aureus, S. pyogenes

of 250 mg


Side effects
– nausea, dyspepsia, pains in a stomach, vomiting, diarrhea
– headaches, dizzinesses
– uneasiness, insomnia, dreadful dreams, a ring in ears,
depersonalization, hallucinations, spasms, sensation of fear
– urticaria, a dermahemia, a skin itching, an anaphylaxis,
Stephens-Johnson’s syndrome
– increase in content of creatinine in blood
Is rare
– temporary increase in activity of transaminases
– gastralgias,
– a glossitis, stomatitis, oral cavity candidiasis, decolouration of language and teeth
– pancreatitis
– a pseudomembranous coloenteritis
– disturbances of a warm rhythm with increase in an interval of QT
– pechenochnokletochny and/or cholestatic hepatitis with jaundice or without
– psychoses, confusion of consciousness
– a hearing loss (at the termination of reception of a klaritromitsin the hearing
was restored)
– change of sense of smell (usually accompanied with distortions of flavoring
– a leukopenia,

Contraindication thrombocytopenia
– hypersensitivity to a klaritromitsin, erythromycin or
any other antibiotic from group of macroleads
– a concomitant use of a tsizaprid, Pimozidum, an astemizol, a terfenadin and
ergotamine or dihydroergotamine
– a concomitant use ranitidine citrate bismuth to patients
whose clearance of creatinine (CC) is lower than 25 ml/min.
– a sharp porphyria
– pregnancy, the lactation period

Medicinal interaction
Combined use of KLABEL 500 with:
– cyclosporine, Disopyramidum, alprazolamy, carbamazepine, Disopyramidum, to triazoles ergot alkaloids, Methylprednisolonum, midazolam, omeprazolum, Pimozidum, quinidine, rifabutiny, sildenafily, takrolimusy, vinblastine, lovastatiny and simvastatiny
leads to increase in their concentration in blood plasma. The similar mechanism of interaction is noted also at use of medicines, such as Phenytoinum, theophylline and Valproatum
– digoxin, leads to increase in content of digoxin in blood plasma. At such combination it is necessary to control digoxin content in serum in order to avoid digitalis intoxication
– a zidovudine, at concomitant oral administration at HIV-positive adult patients, leads to decrease in equilibrium level of concentration of a zidovudine. As klaritromitsin influences absorption of a zidovudine, intake of these two drugs should be divided in time with an interval not less than 4 h
– ritonaviry, significantly slows down metabolism of a klaritromitsin and values of serumal concentration of a klaritromitsin increase. Significant delay of process of forming of a 14-hydroksiklaritromitsin is observed. In this case patients without renal failure have no need to adjust a dose of a klaritromitsin. At KK of 60-30 ml/min. the dose of a klaritromitsin has to be reduced the maximum dose of 500 mg of 1 times/days. At reception of a ritonavir it is not necessary to appoint at the same time a dose of a klaritromitsin more than 1 g/days
– other drugs of group of macroleads, such as lincomycin and clindamycin, development of cross resistance
– flukonazoly is possible, leads to increase in average constant minimum concentration (Cmin) in a klaritromitsin and level in blood plasma (AUC), constant concentration 14-OH klaritromitsin essential does not change
– warfarin and other oral anticoagulants, klaritromitsin can exponentiate their action. At simultaneous use of a klaritromitsin and oral anticoagulants it is necessary to control a prothrombin time
– hypoglycemic drugs, the hypoglycemia
– triazolamy is observed, reduces clearance of a triazolam that can bring to on – to a vysheniye of pharmacological effect with development of drowsiness and is confused –
Nosta of consciousness
– quinidine and Disopyramidum, can lead to development of fibrillation of ventricles and cardiac arrhythmias. At co-administration of the specified drugs the monitoring of their concentration in blood

Special instructions is required
Cases of pseudomembranous colitis meet at use of almost all antibacterial agents and on weight can be from easy to life-threatening degree. Therefore, it is important to take into account this diagnosis at patients who have a diarrhea which followed after intake of antibacterial agent.
With care appoint drug to patients with abnormal liver functions. In the presence of chronic diseases of a liver it is necessary to carry out regular control of enzymes of blood serum. At patients with a liver failure and normal function of kidneys klaritromitsin it is possible to apply without dose adjustment. However in the presence the dose decline or increase in intervals between administrations of drug will be required from the patient of a renal failure of heavy degree regardless of the accompanying liver failure, perhaps.
Use in pediatrics
Safety and efficiency of use of a klaritromitsin for children was not younger than 6 months is established. Safety of use of a klaritromitsin for children with Mycobacterium avium is younger than 20 months is not investigated.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug it is necessary to be careful when driving and potentially dangerous mechanisms.

Symptoms: nausea, vomiting, abdominal pain, diarrhea, change of a mental state, paranoid behavior, hypopotassemia and anoxemia.
Treatment: immediate gastric lavage and symptomatic therapy. The hemodialysis and peritoneal dialysis are ineffective.

Form of release and packing
of the Tablet, film coated, 500 mg.
In the blister on 7 tablets, 2 blisters together with the instruction for use in a cardboard pack.

To Store storage conditions at a temperature not above 25 °C in dry, protected from light, the place.
To store out of children’s reach!

2 years
not to apply an expiration date after an expiration date.

Prescription status
According to the prescription

Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer
Almaty, Shevchenko St. 162 E.

To develop

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