Chemomycin lyophilizate for infusion solution 500mg 1pc

Composition

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of 1 fl. azithromycin dihydrate 524 mg, which corresponds to the content of azithromycin 500 mg

Auxiliary substances:  

Citric acid monohydrate-110 mg,

Mannitol-146 mg,

Sodium hydroxide – q. s.

Pharmacological action

Azithromycin is a macrolide antibiotic of the azalide group.

Reversibly binding to the 50S ribosomal subunit of bacterial cells, it disrupts the translocation of the growing polypeptide chain from the aminoacyl site to the peptide site, which leads to suppression of protein synthesis in bacterial cells.

Sensitive:  

aerobic gram – positive microorganisms Staphylococcus aureus (methicillin-susceptible), Streptococcus pneumoniae (penicillin-susceptible), Streptococcus pyogenes;

aerobic gram – negative microorganisms Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae;

anaerobic microorganisms Clostridium perfringens, Fusobacterium spp., Prevotella spp. Porphyromonas spp. ; other – Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.

Moderately sensitive:  

Streptococcus pneumoniae (moderately sensitive or resistant to penicillin).

Sustainable:  

aerobic gram-positive microorganisms – Enterococcus faecalis, beta-hemolytic Streptococcus spp. group A, Staphylococcus spp. (methicillin-resistant), including Staphylococcus aureus, resistant to erythromycin and other macrolides, lincosamides; anaerobes: Bacteroides fragilis.

Indications

• Severe community-acquired pneumonia caused by Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus, or Streptococcus pneumoniae.
• Infectious and inflammatory diseases of the pelvic organs of severe course (endometritis and salpingitis) caused by Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis.

Contraindications

• Hypersensitivity to azithromycin or other components of the drug;
• hypersensitivity to erythromycin, other macrolides, ketolides;
• severe liver function disorders;
• severe renal function disorders (creatinine clearance less than 40 ml / min);
• Children under 16 years of age;
• Concomitant use with ergotamine and dihydroergotamine.

With caution, myasthenia gravis, mild to moderate hepatic impairment, mild to moderate renal impairment (creatinine clearance greater than 40 ml / min), in patients with proarrhythmogenic factors (especially in elderly patients): patients with congenital or acquired prolongation of the QT interval, in patients receiving therapy with antiarrhythmic drugs of classes IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with impaired water-electrolyte balance balance, especially in the case of hypokalemia or hypomagnesemia, with clinically significant bradycardia, cardiac arrhythmia or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporine.

Side effects

From the central nervous system:  dizziness / vertigo, headache, drowsiness seizures; paresthesia, asthenia, insomnia, increased excitability, fainting, aggressiveness, restlessness, nervousness.

From the side of the senses:  tinnitus, reversible hearing loss up to deafness (when taking high doses for a long time), visual impairment, impaired perception of taste and smell.

From the cardiovascular system:  palpitation, arrhythmia, including ventricular tachycardia, increased QT interval, bidirectional ventricular tachycardia, decreased blood pressure.

From the digestive system:  nausea, vomiting, diarrhea, abdominal pain and asthma, loose stools, flatulence, indigestion, cholestatic jaundice, hepatitis, gastritis, changes in laboratory

liver function, constipation, discoloration of the tongue, pseudomembranous colitis, pancreatitis, liver necrosis, liver failure (possibly fatal).

From the circulatory and lymphatic systems:  thrombocytopenia, neutropenia, leukopenia, neutrophilia.

Allergic reactions:  pruritus, skin rashes, angioedema, urticaria, photosensitization, anaphylactic reaction, including edema (rarely fatal), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal disorders:  arthralgia.

From the genitourinary system:  nephritis, acute renal failure.

Local reactions:  pain and inflammation at the injection site.

Other services:  candidiasis, including oral and genital diseases, fatigue, malaise, anorexia, vaginitis.

Interaction

Azithromycin does not affect the concentration of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole, rifabutin and methylprednisolone in the blood when used together.

If combined use with cyclosporine is necessary, it is recommended to monitor the content of cyclosporine in the blood.

With the combined use of digoxin and azithromycin, it is necessary to monitor the concentration of digoxin in the blood, since many macrolides increase the absorption of digoxin in the intestine, thereby increasing its concentration in the blood plasma.

When combined with indirect anticoagulants (warfarin, other coumarin-type anticoagulants), it is recommended that patients carefully monitor prothrombin time.

Concomitant use of terfenadine and macrolide antibiotics causes arrhythmia and prolongation of the QT interval. These data should be taken into account when using terfenadine and azithromycin together.

When combined with nelfinavir, the frequency of side effects from azithromycin may increase.

Consideration should be given to the possibility of inhibition of the CYP3A4 isoenzyme by azithromycin when co-administered with cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs that are metabolized with the participation of this enzyme.

When azithromycin and zidovudine are co-administered, azithromycin does not affect the pharmacokinetic parameters of zidovudine in blood plasma or the renal excretion of it and its metabolite glucuronide.

However, the concentration of the active metabolite, phosphorylated zidovudine, increases in mononuclear cells of peripheral vessels. The clinical significance of this fact has not yet been determined.

When azithromycin is co-administered with ergotamine and dihydroergotamine, their toxic effects may occur (vasospasm, dysesthesia).

Pharmacologically incompatible with heparin.

How to take, course of use and dosage

The drug should be used only in inpatient medical institutions!

Recommended doses for intravenous use of azithromycin in the treatment of adults and patients over 18 years of age with the following diseases:

Community-acquired pneumonia (VP)

500 mg once a day intravenously (iv) for at least 2 days (if necessary, by the decision of the attending physician, the IV course can be extended, but should not be more than 5 days).

Intravenous use should be followed by oral use of azithromycin in the form of a single daily dose of 500 mg until the complete completion of the 7-10 day general course of treatment.

Infectious and inflammatory diseases of the pelvic organs

500 mg once a day intravenously for at least 2 days (iv course of treatment is no more than 5 days).

Intravenous use should be followed by oral use of azithromycin as a single daily dose of 250 mg until the full completion of the 7-day general course of treatment.

The timing of the transition to oral treatment is determined in accordance with the data of the clinical examination.

Patients with impaired renal function

When used in patients with mild to moderate renal impairment (creatinine clearance > 40 ml/min), no dose adjustment is required.

Patients with impaired liver function

When used in patients with mild to moderate hepatic impairment, no dose adjustment is required.

Elderly patients

No dose adjustment is required in elderly patients.

The infusion solution is prepared in 2 stages:

Stage 1 – preparation of the restored solution:

4.8 ml of sterile water for injection is added to the bottle with 500 mg of the drug and shaken thoroughly until the powder is completely dissolved.

1 ml of the resulting solution contains 100 mg of azithromycin.

The prepared solution remains stable for 24 hours at room temperature.

Stage 2-dilution of the reconstituted solution (100 mg / ml) It is performed immediately before use in accordance with the table below.

The reconstituted solution is introduced into a vial with a solvent (0.9% sodium chloride solution,5% dextrose, Ringer’s solution) until the final concentration of azithromycin is 1.0-2.0 mg / ml in the infusion solution.

Chemomycin solution should not be administered intravenously jet or intramuscularly!

It is recommended to administer the prepared solution intravenously drip for 3 hours-a solution for infusions at a concentration of 1 mg / ml, for 1 hour-at a concentration of 2 mg / ml.

Before use, the solution is subjected to visual inspection. If the finished solution contains particles of the substance, then it should not be used.

The prepared solution is stable at room temperature for 24 hours.

Overdose

Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea, abdominal pain, impaired liver function.

Treatment: symptomatic.

Special instructions

The safety and efficacy of the injectable form of Chemomycin in children under 16 years of age have not been established.

Do not administer the drug for longer courses than indicated in the instructions, because the pharmacokinetic properties of azithromycin allow you to use a short dosage regimen.

It is possible to attach a superinfection (including fungal) during treatment with Chemomycin (as with any antibiotic therapy).

When using the drug Chemomycin, diarrhea/ pseudomembranous colitis caused by Clostridium difficile may develop. Therefore, patients with diarrhea should be carefully monitored.

After discontinuation of treatment, hypersensitivity reactions may persist in some patients, which requires specific therapy under the supervision of a doctor.

Influence on the ability to drive vehicles and mechanisms

Given the likelihood of side effects from the central nervous system, caution should be exercised when driving vehicles and mechanisms.

Form of production

Lyophilizate for preparation of a solution for infusions in the form of powder or compacted into a tablet mass of white or almost white color.

Storage conditions

In a place protected from light, at a temperature not exceeding 20 °C.

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Purpose

For adults as directed by your doctor

Indications

Pharyngitis, Tonsillitis, Skin infections, Otitis media, Bronchitis, Sore throat, Respiratory tract infections, Urethritis, Pneumonia, Sinusitis, Infectious diseases