ZI-Factor - instructions for use, doses, side effects, contraindications

Excipientscorn starch, lactose (milk sugar), lactose anhydrous (lactopress), povidone (polyvinylpyrrolidone), sodium lauryl sulfate, silicon dioxide colloid (aerosil), magnesium stearate, hard gelatin capsules [titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, acetic acid, gelatin] .

Description:

Hard gelatin capsules № 0 of white color. Contents of capsules - a mixture of granules and powder white or white with a yellowish hue.

Pharmacotherapeutic group:Antibiotic - azalide

ATX: & nbsp

J.01.F.A.10 Azithromycin

Pharmacodynamics:

Azithromycin is a bacteriostatic antibiotic from the macrolide-azalide group. It has a wide spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of protein synthesis of a microbial cell. Communicating with 50S subunit of ribosomes, inhibits peptidranslokase at the stage of translation and suppresses protein synthesis, slows the growth and multiplication of bacteria. In high concentrations has a bactericidal effect.

It has activity against a number of extra- and intracellular gram-positive and gram-negative microorganisms, as well as a number of anaerobic microorganisms. Microorganisms may initially be resistant to the action of the antibiotic or may acquire resistance to it.

Microorganisms sensitive to azithromycin:

Gram-positive aerobes

Staphylococcus aureus methicillin-sensitive

Streptococcus pneumoniae penicillin-sensitive
Streptococcus pyogenes

Gram-negative aerobes

Haemophilus influenzae

Haemophilus parainfluenzae
Legionella pneumophila
Moraxella catarrhalis
Pasteurella multocida
Neisseria gonorrhoeae

Anaerobes

Clostridium perfringens

Fusobacterium spp.
Prevotella spp.
Porphyriomonas spp.

Other microorganisms

Chlamydia trachomatis

Chlamydia pneumoniae
Chlamydia psittaci
Mycoplasma pneumoniae
Mycoplasma hominis
Borrelia burgdorferi

Microorganisms that can develop resistance to azithromycin:

Gram-positive aerobes

Streptococcus pneumoniae penicillin-resistant

Microorganisms initially resistant to azithromycin:

Gram-positive aerobes

Enterococcus faecalis

Staphylococci (methicillin-resistant show a high degree of resistance to macrolides)

Gram-positive bacteria resistant to erythromycin.

Anaerobes

Bacteroides fragilis

Pharmacokinetics:

After oral administration azithromycin well absorbed and quickly distributed in the body. After a single dose 500 mg bioavailability - 37% (the effect of "first passage" through the liver), the maximum concentration in the blood plasma (0,4 mg / l) is created through 2-3 hour, the apparent volume of distribution - 31,1 l / kg, binding to plasma proteins is inversely proportional to the concentration in the blood and is - 7-50%. Penetrates through cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes to the site of infection, where it is released in the presence of the pathogen. Easily passes the histohematological barriers and enters the tissues. Concentration in tissues and cells in 10-50 times higher than in plasma, and in foci of infection - on 24-34% higher than in healthy tissues. In the liver, demethylated, losing activity. The half-life of azithromycin -35-50 h, the half-life of tissues is much longer. Therapeutic concentrations of azithromycin persist up to 5-7 days after the last dose. Azithromycin is output, basically, in the unmodified form - 50% intestine, 6% kidney.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- infections of the upper respiratory tract and ENT organs (pharyngitis / tonsillitis, sinusitis, otitis media);

- infection of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);

- infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses);

- the initial stage of Lyme disease (borreliosis) - migrating erythema (erythema migrans);

- urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Contraindications:

increased sensitivity to azithromycin and other macrolides;

severe violations of the liver and kidneys;

Children under 12 years of age with a body weight of less than 45 kg (for this dosage form);

breast-feeding;

simultaneous administration with ergotamine and dihydroergotamine;

genetic intolerance to galactose, insufficiency of lactase, glucose-galactose malabsorption (for a given dosage form containing lactose).

Carefully:

moderate violations of the liver and kidneys;

arrhythmia or predisposition, arrhythmia and lengthening of the interval QT;

co-administration of terfenadine, warfarin, digoxin.

Pregnancy and lactation:

Azithromycin is used in pregnancy only if the expected benefit from its use is greater than the possible risk to the fetus. At the time of treatment with azithromycin, breastfeeding is suspended.

Dosing and Administration:

Inside, 1 time per day, at least 1 hour before or 2 hours after eating.

With infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: 500 mg (2 capsules) once a day for 3 days (the course dose is 1500 mg).

With migratory erythema: 1 time per day for 5 days: 1st day - 1000 mg (4 capsules), then from the 2nd to the 5th day - 500 mg (2 capsules) (the course dose is 3000 mg).

In acute infections of the genitourinary tract caused by Chlamydia trachomatis: Uncomplicated urethritis / cervicitis - 1000 mg (4 capsules) once.

Assignment to patients with impaired renal function:

For patients with moderate renal dysfunction (CK> 40 ml / min) dose adjustment is not required.

Side effects:

Classification of adverse reactions according to the frequency of development (number of reported cases / number of patients): often (> 1/100, <1/10), infrequently (> 1/1000 and <1/100), rarely (> 1/10000 and <1 / 1000) and very rarely (<1/10 000).

From the central and peripheral nervous system: infrequently dizziness / vertigo, headache, convulsions, drowsiness; rarely - paresthesia,asthenia, insomnia, hyperactivity, aggressiveness, anxiety, nervousness.

From the sense organs: rarely - tinnitus, reversible hearing loss down to deafness (when taking high doses for a long time), a violation of the perception of taste and smell.

From the digestive system: often - nausea, vomiting, diarrhea, abdominal pain; infrequently - loose stools, flatulence, indigestion, anorexia; rarely - constipation, discoloration of the tongue, pseudomembranous colitis, cholestatic jaundice, hepatitis, changes in laboratory parameters of liver function; very rarely - necrosis of the liver.

From the cardiovascular system: rarely - palpitation, arrhythmia (including ventricular tachycardia), an increase in the interval QT.

From the blood and lymphatic system: rarely thrombocytopenia, neutropenia.

From the genitourinary system: nephritis, acute renal failure, vaginitis.

From the musculoskeletal system: infrequently - arthralgia.

Allergic reactions: infrequently - itching, skin rashes; rarely - angioedema, urticaria, photosensitivity, anaphylactic reaction, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Other: candidiasis.

Overdose:

Symptoms: nausea, temporary loss of hearing, vomiting, diarrhea.

Treatment: symptomatic.

Interaction:

Antacids reduce the maximum concentration of azithromycin in blood plasma by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs and food.

Azithromycin does not affect the concentration of carbamazepine, didanosine, rifabutin and methylprednisolone in blood plasma when combined. The effect of azithromycin (for oral administration) on the concentration of cimetidine, efavirenz, fluconazole, indinavir, midazolam, triazolam, trimethoprim / sulfamethoxazole in blood plasma can not be ruled out when combined.

Azithromycin does not affect the pharmacokinetics of theophylline, but when combined with other macrolides, the concentration of theophylline in the blood plasma may increase;

If it is necessary to use together with cyclosporine, it is recommended to monitor the content of the latter in blood plasma. Despite the fact that there are no data on the effect of azithromycin on the concentration of cyclosporine in blood plasma, other macrolides are capable of changing its level in blood plasma.

With the joint use of azithromycin with digoxin, it is necessary to monitor the level of the latter in blood plasma, because many macrolides increase the absorption of digoxin in the intestine, thereby increasing its concentration in the blood plasma.

When co-administered with warfarin, it is recommended that prothrombin time be carefully monitored.

It was found that the simultaneous administration of terfenadine and antibiotics of the macrolide class causes arrhythmia and lengthening of the interval QT. Proceeding from this, it is impossible to exclude the aforementioned side effect in the joint use of terfenadine and azithromycin.

Since it is possible to inhibit the isoenzyme CYP3A4 azithromycin in parenteral form when co-administered with cycloserine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs, the metabolism of which occurs with the participation of this enzyme, the possibility of such interaction in the administration of azithromycin for oral administration should be considered.

When combined azithromycin does not affect the pharmacokinetic parameters of zidovudine and its metabolite - glucuronide. Nevertheless, the concentration increases him active metabolite - phosphorylated zidovudine in mononuclear cells of peripheral vessels. The clinical significance of this fact is not clear.

With the simultaneous use of macrolides with ergotamine and dihydroergotamine, their toxic effect is possible.

Special instructions:

In case of missed intake of a single dose of the drug, the missed dose should be taken as soon as possible, and the subsequent dose should be taken at intervals of 24 hours.

As with any antibiotic therapy, in the treatment of azithromycin it is possible to join superinfection (including fungal).

In the treatment of pharyngitis / tonsillitis caused by Streptococcus pyogenes, as well as for the prevention of acute rheumatic fever, the drug of choice is usually penicillin. Azithromycin is also active against streptococcal infection in these cases, but is ineffective for the prevention of acute rheumatic fever.

Effect on the ability to drive transp. cf. and fur:

Azithromycin does not affect the ability to drive vehicles and other mechanisms.

Form release / dosage:Capsules of 250 mg.

Packaging:

For 6 or 10 capsules in a contour mesh package. For 10 capsules in a jar or a bottle of polymer materials.1 jar, vial or 1 contour pack of 6 or 10 capsules together with the instructions for use are placed in a pack of cardboard.

Storage conditions:

List B. In a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:2 of the year. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N002353 / 01

Date of registration:31.03.2008

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp14.08.2015

Illustrated instructions

Instructions

ZI-Factor® (ZI-Factor®)