Klacid powder for injection vial 500mg №1

Mechanism of action

An antibiotic group macrolides. Clarithromycin inhibits protein synthesis in the microbial cell by interacting with the 50S ribosomal subunit of bacteria. Highly active against a wide range of aerobic, anaerobic, gram-positive and gram-negative bacteria.
Clarithromycin has demonstrated high in vitro activity against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro studies confirm the high efficacy of clarithromycin against Legionella pneumophila and Mycoplasma pneumoniae.
Drug also active against aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Neisseria gonorrhoeae; other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis, Mycobacterium Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (Maccoterium chelonae chelonae, Mycobacterium fortuitum, Mycobacterium leprae, Mycobacterium chelonae, Mycobacterium leprae, Mycobacterium leprae, Mycobacterium pneumoniae, Mycobacterium, Mycobacterium, Mycobacterium, Mycobacterium, Mycobacterium, Mycobacterium, Mycobacterium, Mycobacterium, Mycobacterium, Mycobacterium
To clarithromycin insensitive Enterobacteriaceae, Pseudomonas spp., As well as other gram-negative bacteria that do not decompose lactose.
The production of b-lactamase does not affect the activity of clarithromycin. Most of the methicillin and oxacillin resistant staphylococci strains are resistant to clarithromycin.
Clarithromycin has an in vitro effect on most strains of the following microorganisms (however, the safety and efficacy of using clarithromycin in clinical practice has not been confirmed by clinical studies, and the practical significance remains unclear): aerobic gram-positive microorganisms: Streptococcus agalactiae, streptococci (groups C, F, G), Streptococcus group Viridans; aerobic gram-negative microorganisms: Bordeteila pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms: Сlostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni.
The microbiological activity of the metabolite is the same as that of the original substance, or 1-2 times weaker with respect to most microorganisms. An exception is Haemophilus influenzae, for which the efficiency of the metabolite is 2 times higher.The parent substance and its main metabolite have either an additive or a synergistic effect on Haemophilus influenzae in vitro and in vivo, depending on the bacterial culture.
Tablets of prolonged action are a homogeneous crystalline base, with the passage of which through the gastrointestinal tract provides a long-term release of the active substance.

Indications and usage

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract (pharyngitis, tonsillitis and sinusitis);
- infections of the lower respiratory tract (bronchitis, pneumonia);
- otitis media;
- infections of the skin and soft tissues (impetigo, folliculitis, cellulitis, abscesses);
- disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare;
- localized infections caused by Mycobacterium fortuitum, Mycobacterium kansasii, Mycobacterium chelonae.

Contraindications

- pronounced renal dysfunction (with CC less than 30 ml / min); these patients are prescribed quick-release clarithromycin;
- simultaneous reception of astemizol, cisapride, pimozide, terfenadine;
- porphyria;
- pregnancy;
- lactation (breastfeeding);
- Hypersensitivity to macrolide antibiotics.

Dosage and administration

CLACIDE
The average dose for oral administration for adults makes 250 mg 2 times / days. If necessary, you can assign 500 mg 2 times / day. Duration of treatment is 6-14 days.
For the treatment of infections caused by Mycobacterium aviumKlacid is prescribed by mouth - 1 g 2 times / day. The duration of treatment may be 6 months or more.

CLACIDE CP is prescribed for adults 500 mg (1 tab.) 1 time / day.
For severe infections The dose is increased to 1 g (2 tab.) 1 time / day.
In patients with renal failureat QC less than 30 ml / min, the dose should be reduced by 2 times. The maximum duration of the course in patients of this group should be no more than 14 days.
Tablets should be taken with food, swallowing whole, not breaking and not chewing.

CLACID injection prescribe for adults in a daily dose of 1 g, divided into 2 administrations (500 mg 2 times / day). Each injection is carried out in / in drip for 60 minutes. With mycobacterial infections dose may be doubled.
Elderly patients the drug is administered in the same doses as adults.
Have patients with severe impaired renal function (CC less than 30 ml / min) dose should be reduced by 50%.
When prescribing Klacida simultaneously with ritonavir in patients with impaired renal function (CC from 30 to 60 ml / min) the dose of clarithromycin should be reduced by 50%, while QC less than 30 ml / min - 75%. You should not prescribe clarithromycin in a dose of more than 1 g / day when it is used simultaneously with ritonavir.
V / m and / in the jet injection of the drug is prohibited!
In / in the drug is administered for 2-5 days, with the possible subsequent transition, if necessary, to receive clarithromycin inside.
Terms of preparation of the solution for on / in the introduction
The solution for the on / in the introduction is prepared by adding 10 ml of sterile water for injection into a vial with 500 mg of lyophilized powder. Before the introduction, the prepared solution should be added to 250 ml of one of the following solvents: 5% dextrose solution, 5% dextrose solution in Ringer-lactate solution, 5% dextrose solution in 0.3% sodium chloride solution, 5% dextrose solution in 0.45% sodium solution chloride, Normosol-M solution in 5% dextrose solution, Normosol-R solution in 5% dextrose solution, Ringer-lactate solution, 0.9% sodium chloride solution. The concentration of the resulting solution is 2 mg / ml.

CLACID suspension intended for use in pediatrics.
For children, the drug is prescribed in a daily dose of 15 mg / kg body weight, divided into 2 doses (7.5 mg / kg body weight 2 times / day). The maximum daily dose is 500 mg for non-mycobacterial infection.
Duration of treatment is 5-10 days, with streptococcal pharyngitis - at least 10 days.

Children weighing <8 kg appoint doses at the rate of 7.5 mg / kg. The multiplicity of reception - 2 times / day.
HIV-infected children Klacid is prescribed in the following doses:

*Children weighing <8 kg appoint doses at the rate of 15 - 30 mg / kg. The multiplicity of reception - 2 times / day.

In children with renal failureat QC less than 30 ml / min, the drug dose should be reduced by 2 times (250 mg 1 time / day or to 250 mg 2 times / day for more severe infections). The duration of treatment is at least 14 days.
The prepared suspension can be taken with meals, with milk, as well as between meals. Before each use, it is recommended to vigorously shake the vial with the suspension.
Suspension preparation rules
When using a 60 ml vial, the granules are vigorously shaken in 32 ml of water to obtain a 60 ml suspension containing 125 mg of clarithromycin in 5 ml.

Since the cardiovascular system: rarely, ventricular arrhythmia, including ventricular tachycardia (with an increase in the QT interval).
From the digestive system: nausea, abdominal pain, vomiting, diarrhea, gastralgia, pancreatitis, glossitis, stomatitis, oral candidiasis, discoloration of the tongue and teeth; rarely - pseudomembranous enterocolitis. Teeth discoloration is reversible and is usually restored by professional cleaning by a dentist. Liver dysfunction was rarely observed, incl. increased liver enzyme activity, hepatic cell and / or cholestatic hepatitis with or without jaundice. These abnormal liver functions can be severe, but usually they are reversible. Very rarely, there have been cases of liver failure and death mainly due to severe concomitant diseases and / or concomitant drug therapy.
From the side of the central nervous system: transient headaches, dizziness, anxiety, insomnia, nightmares, tinnitus, depersonalization, hallucinations, convulsions, fear; rarely - psychosis, confusion; in some cases, hearing loss (with the discontinuation of clarithromycin, hearing was restored), a change in smell (usually accompanied by distortion of taste sensations).
Allergic reactions: urticaria, skin flushing, pruritus, anaphylaxis, Stevens-Johnson syndrome.
From the hemopoietic system: leukopenia, thrombocytopenia.
From the laboratory indicators: increased creatinine levels in the blood; rarely - hypoglycemia (while taking hypoglycemic drugs).
Other: development of microbial resistance.

The safety of clarithromycin during pregnancy and lactation has not been studied.
It is known that clarithromycin is excreted in breast milk.
Therefore, the use of the drug Klatsid SR during pregnancy and lactation should only be in cases where there is no safer alternative, and the risk associated with the disease itself exceeds the possible harm to the mother and fetus.

WITH caution prescribe the drug to patients with impaired liver function. In the presence of chronic liver disease it is necessary to conduct regular monitoring of serum enzymes.
Also, caution should be prescribed the drug to patients with mild and moderate renal impairment. In case of marked impaired renal function (CC less than 30 ml / min), rapid-release clarithromycin should be prescribed (tablets 250 mg or 500 mg).
In the case of co-administration with Warfarin or other indirect anticoagulants, it is necessary to control the prothrombin time.

Symptoms: nausea, vomiting, abdominal pain, diarrhea. In one patient with a bipolar disorder in the history after taking clarithromycin in a dose of 8 g, mental changes, paranoid behavior, hypokalemia and hypoxemia appeared.
Treatment: unabsorbed drug should be removed from the gastrointestinal tract and symptomatic therapy should be carried out. Hemodialysis and peritoneal dialysis have no significant effect on serum clarithromycin levels.

Simultaneous administration of clarithromycin with drugs metabolized with CYP3A isoenzyme cytochrome P₄₅₀, can lead to an increase in plasma concentrations of drugs such as alprazolam, astemizol, Carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, Omeprazole, oral anticoagulants, Ip, Ip, Ip, Ip, Ip, Io, I, etc., Sildenafil, Simvastatin, tacrolimus, terfenadine, triazolam, vinblastine. A similar mechanism of interaction is noted when using drugs that are metabolized by another cytochrome P isoenzyme.₄₅₀- phenytoin, theophylline and valproate. With simultaneous use of theophylline and carbamazepine with clarithromycin, a moderate but significant (p <0.05) increase in the content of theophylline and carbamazepine in plasma was noted.
While taking clarithromycin with HMG-CoA reductase inhibitors (for example, lovastatin and simvastatin), rare cases of rhabdomyolysis are described.
With simultaneous use of clarithromycin with cisapride, an increase in the concentration of cisapride was observed.This can cause an increase in the QT interval, arrhythmia, ventricular tachycardia, fibrillation and flutter-ventricular fibrillation. Similar effects were observed in patients taking clarithromycin simultaneously with pimozide.
Macrolide drugs affect the metabolism of terfenadine. The level of terfenadine in the blood increases, which may be accompanied by an increase in the QT interval, the development of arrhythmias, ventricular tachycardia, fibrillation, and flutter-ventricular fibrillation. The content of acid metabolites of terfenadine increases by 2-3 times, the QT interval increases, but this does not cause any clinical manifestations. The same picture was observed while taking astemizole with macrolide group drugs.
There are reports of the development of trembling-ventricular fibrillation with simultaneous use of clarithromycin with quinidine and disopyramide. With the simultaneous appointment of these drugs requires monitoring of their concentration in the blood.
With simultaneous use of clarithromycin with Digoxin, an increase in the content of digoxin in serum was observed. In such patients, it is necessary to monitor the content of digoxin in serum.
With simultaneous oral administration of clarithromycin and zidovudine in HIV-infected patients, there was a decrease in the equilibrium level of concentration of zidovudine. Since clarithromycin affects zidovudine absorption, the intake of these two drugs should be separated in time.
Ritonavir significantly slows down the metabolism of clarithromycin while taking it. The value of C_max clarithromycin increased by 31%, C_min - by 182%, AUC - by 77%. A significant slowdown in the formation of 14-hydroxylarithromycin has been observed. In this case, patients without renal dysfunction do not need to adjust the dose of clarithromycin. When QA 60-30 ml / min, the dose of clarithromycin should be reduced by 50% to a maximum dose of 500 mg (1 tablet of prolonged action) 1 time / day. When taking ritonavir should not simultaneously prescribe a dose of clarithromycin more than 1 g / day.
Cross-resistance between clarithromycin and other macrolide drugs such as Lincomycin and Clindamycin may develop.

The drug should be stored in a dark place, out of the reach of children at a temperature not higher than 30 ° C.

tablets - 3 years; The shelf life of the powder d / prigot. suspen - 2 years
After preparation, the suspension should be stored at a temperature of from 15 ° to 30 ° C in high density polypropylene bottles with a polypropylene cap and used within 14 days.
Expiration date lyof. powder d / prigot. r-ra d / in. - 4 years. The prepared solution (in 10 ml of water for injection) is stable for 24 hours when stored at temperatures up to 25 ° C or 48 hours at 5 ° C.

Pharmacy sales terms
The drug is available on prescription.