Ziromin - Instructions For Use, Tablets 500 Mg, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ziromin

Ziromin: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Ziromin

ATX code: J01FA10

Active ingredient: azithromycin (Azithromycin)

Manufacturer: World Medical Ilach San ve Tij A. Sh. (World Medicine Ilac San. Ve Tic. AS) (Turkey)

Description and photo update: 2019-11-07

Ziromin is an antibacterial drug.

Release form and composition

Dosage form - tablets, film-coated: oblong, biconvex, white, with a dividing line on one side (3 pcs. In a blister, 1 blister in a cardboard box and instructions for use of Ziromin).

Composition of 1 tablet:

• active substance: azithromycin (in the form of a dihydrate) - 500 mg (524.1 mg);
• auxiliary components: croscarmellose sodium, calcium hydrogen phosphate dihydrate, sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silicon dioxide, anhydrous lactose, hydroxypropyl cellulose, pregelatinized starch (Starch 1500).

Pharmacological properties

Pharmacodynamics

Ziromin contains azithromycin as an active ingredient, an antibacterial agent of a wide spectrum of bacteriostatic activity from the group of macrolides-azalides. Its mechanism of action is due to the ability to suppress protein synthesis of the microbial cell. Due to the connection with the 50S-subunit of the ribosome, the drug inhibits peptide translocase at the translation stage and inhibits protein synthesis, which leads to a slowdown in the growth and reproduction of bacteria. When high concentrations are created, it has a bactericidal effect.

The antibiotic affects a number of anaerobes, gram-positive and gram-negative microorganisms, intracellular and other bacteria. Some pathogens may be initially resistant to its action or acquire resistance over time.

Minimum inhibitory concentration (MIC) of bacteria sensitive to azithromycin:

• Staphylococcus: ≤ 1 mg / L;
• Streptococcus A, B, C, G: ≤ 0.25 mg / L;
• Streptococcus pneumoniae: ≤ 0.25 mg / L;
• Haemophilus influenzae: ≤ 0.12 mg / L;
• Moraxella catarrhalis: ≤ 0.5 mg / L;
• Neisseria gonorrhoeae: ≤ 0.25 mg / L.

MIC of antibiotic-resistant bacteria:

• Staphylococcus:> 2 mg / L;
• Streptococcus A, B, C, G:> 0.5 mg / L;
• Streptococcus pneumoniae:> 0.5 mg / L;
• Haemophilus influenzae:> 4 mg / L;
• Moraxella catarrhalis:> 0.5 mg / L;
• Neisseria gonorrhoeae:> 0.5 mg / L.

In most cases, Ziromin is active against the following microorganisms:

• gram-positive aerobes: Streptococcus pyogenes, penicillin-sensitive strains of Streptococcus pneumoniae, methicillin-sensitive strains of Staphylococcus aureus;
• gram-negative aerobes: Moraxella catarrhalis, Legionella pneumophila, Haemophilus parainfluenzae, Haemophilus influenzae, Neisseria gonorrhoeae, Pasteurella multocida;
• anaerobes: Prevotella spp., Fusobacterium spp., Clostridium perfringens, Porphyromonas spp.;
• others: Chlamydia psittaci, Chlamydia pneumoniae, Chlamydia trachomatis, Borrelia burgdorferi, Mycoplasma hominis, Mycoplasma pneumoniae.

Gram-positive aerobes such as penicillin-resistant strains of Streptococcus pneumoniae are capable of developing resistance to azithromycin.

Initially resistant to Ziromin's action are:

• gram-positive aerobes: Staphylococcus spp. (methicillin-resistant strains of staphylococcus show a very high degree of resistance to macrolides), Enterococcus faecalis and erythromycin-resistant gram-positive bacteria;
• anaerobes: Bacteroides fragilis.

Pharmacokinetics

Azithromycin is well absorbed from the gastrointestinal tract, after which it is quickly distributed in the body. It is characterized by the effect of the first passage through the liver, after a single dose of Ziromin 500 mg, the bioavailability is 37%. After 2 - 3 hours the maximum plasma concentration (C _max) is reached, which is equal to 0.4 mg / l.

Azithromycin binds to plasma proteins by 7–50% (the relationship is inversely proportional to the concentration of the substance in the blood). The apparent volume of distribution is 31.1 l / kg. Penetrates through cell membranes (due to this, it is effective in infectious diseases caused by intracellular microorganisms). With the help of phagocytes, it is transported to the site of infection, where it is released in the presence of the pathogen. Easily passes histohematogenous barriers and penetrates into tissues. In cells and tissues, the concentration is 10–50 times higher than the plasma concentration, and in the focus of infection it is 24–34% higher than in healthy tissues.

In the liver, azithromycin undergoes a demethylation process and loses its activity.

The substance is characterized by a long half-life (T _1/2) - 35-50 hours, and T _1/2 from tissues is much more. At a therapeutic concentration, azithromycin can be determined up to 7 days after the last dose.

It is excreted mainly unchanged: through the intestines - 50%, by the kidneys - 6%.

Indications for use

Ziromin is used to treat infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

• urinary tract infections caused by Chlamydia trachomatis (cervicitis, urethritis);
• infections of the skin and soft tissues (acne vulgaris of moderate severity, secondarily infected dermatoses, impetigo, erysipelas);
• infections of the ENT organs and upper respiratory tract (sinusitis, tonsillitis, pharyngitis, otitis media);
• lower respiratory tract infections, including those caused by atypical pathogens (pneumonia, acute bronchitis and exacerbation of chronic bronchitis);
• the initial stage of Lyme disease (borreliosis) is erythema migrans (erythema migrans).

Contraindications

Absolute:

• severe liver dysfunction;
• rare hereditary galactose intolerance, glucose-galactose malabsorption syndrome, lactase deficiency;
• children under 12 years of age (body weight less than 45 kg);
• lactation period;
• the simultaneous appointment of ergotamine and dihydroergotamine;
• known hypersensitivity to azithromycin or Ziromin's auxiliary components, as well as ketolides, erythromycin or other macrolides.

Relative (Ziromin tablets are used with caution):

• end-stage renal failure (glomerular filtration rate less than 10 ml / min);
• mild to moderate hepatic dysfunction;
• myasthenia gravis;
• the presence of proarrhythmogenic factors (especially in the elderly): clinically significant bradycardia, congenital or acquired lengthening of the QT interval, cardiac arrhythmia, disturbances in the water and electrolyte balance (especially hypokalemia, hypomagnesemia), severe heart failure;
• simultaneous use of class IA antiarrhythmic drugs (procainamide, quinidine) or class III (amiodarone, dofetilide, sotalol);
• the joint use of the following drugs: terfenadine, cisapride, warfarin, digoxin, cyclosporin, fluoroquinolones (moxifloxacin, levofloxacin), antidepressants (citalopram), antipsychotic drugs (pimozide);
• pregnancy.

Ziromin, instructions for use: method and dosage

Ziromin is indicated for oral administration. The tablets should be swallowed whole, without chewing, with enough water, between meals (interval - at least one hour before and two hours after meals).

Recommended dosage regimens:

• uncomplicated urinary tract infections caused by Chlamydia trachomatis: 2 tablets, single dose;
• moderate acne vulgaris: 1 tablet per day daily for 3 days, then 1 tablet 1 time per week for 9 weeks (the first weekly tablet is taken 7 days after taking the first daily tablet, i.e. 8 day after the start of treatment, and then observe 7-day intervals);
• other infections of the skin and soft tissues, infections of the ENT organs, upper and lower respiratory tract: 1 tablet per day for 3 days;
• erythema migrans: initial dose - 2 tablets per day, during the next 4 days - 1 tablet per day. The course of treatment is 5 days, the total course dose is 3000 mg.

The daily dose is taken once a day. If you miss the next appointment, you should take Ziromin as soon as possible, and then observe the intervals of 24 hours.

Side effects

The side effects described below are classified by frequency of development as follows: ≥ 10% - very often, ≥1% but <10% - often, ≥ 0.1% but <1% - infrequently, ≥ 0.01%, but < 0.1% - rare, less than 0.01% - very rare, unknown frequency - available data do not allow to accurately estimate the frequency of occurrence:

• from the immune system: infrequently - hypersensitivity reactions, angioedema; unknown frequency - anaphylactic reactions;
• infectious diseases: infrequently - rhinitis, pharyngitis, respiratory diseases, gastroenteritis, pneumonia, candidiasis (including the mucous membrane of the oral cavity and genitals); unknown frequency - pseudomembranous colitis;
• from the gastrointestinal tract and metabolism: very often - diarrhea; often - abdominal pain, nausea, vomiting; infrequently - increased secretion of the salivary glands, dryness / ulcers of the oral mucosa, dyspepsia, belching, flatulence, bloating, constipation, dysphagia, gastritis, anorexia; very rarely - discoloration of the tongue, pancreatitis;
• on the part of the cardiovascular system: infrequently - flushing of the face, palpitations; unknown frequency - ventricular tachycardia, pirouette-type polymorphic ventricular tachycardia, an increase in the QT interval on an electrocardiogram (ECG), a decrease in blood pressure;
• from the side of the blood and lymphatic system: infrequently - eosinophilia, neutropenia, leukopenia; very rarely - hemolytic anemia, thrombocytopenia;
• from the hepatobiliary system: infrequently - hepatitis; rarely - cholestatic jaundice, liver dysfunction; unknown frequency - liver failure (in some cases with a fatal outcome, mainly in patients with severe functional disorders of the liver), fulminant hepatitis, liver necrosis;
• from the central and peripheral nervous system: often - headache; infrequently - a violation of taste, insomnia, drowsiness, paresthesia, nervousness, dizziness; rarely - agitation; unknown frequency - psychomotor hyperactivity, myasthenia gravis, convulsions, aggression, hallucinations, loss of taste, perversion or loss of smell, anxiety, hypesthesia, fainting, delirium;
• from the urinary system: infrequently - pain in the kidney area, dysuria; unknown frequency - interstitial nephritis, acute renal failure;
• from the respiratory system: infrequently - nosebleeds, shortness of breath;
• on the part of the musculoskeletal system: infrequently - neck / back pain, myalgia, osteoarthritis; unknown frequency - arthralgia;
• on the part of the skin and subcutaneous fat: infrequently - skin rashes, itching of the skin, sweating, dermatitis, urticaria, dry skin; rarely - photosensitivity; unknown frequency - toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme;
• from the genital organs: infrequently - dysfunction of the testicles, metrorrhagia;
• from the senses: infrequently - visual impairment, vertigo, hearing impairment; unknown frequency - hearing impairment, including tinnitus and / or deafness;
• laboratory data: often - a decrease in the number of lymphocytes and the concentration of bicarbonates in the blood plasma, an increase in the number of monocytes / eosinophils / basophils / neutrophils; infrequently - a change in the content of potassium / sodium in the blood plasma, an increase in the hematocrit and the number of platelets, an increase in the concentration of bilirubin / creatinine / urea in the blood plasma, an increase in the content of bicarbonates / glucose / chlorine in the blood plasma, an increase in the activity of aspartate aminotransferase / alanine aminotransferase in the blood plasma;
• other reactions: infrequently - a feeling of fatigue, malaise, asthenia, fever, facial edema, peripheral edema, chest pain.

Overdose

When an excessive dose of azithromycin is taken, the same adverse reactions are observed as when taking the drug in therapeutic doses. Typical symptoms of Ziromin overdose: diarrhea, nausea, vomiting, temporary hearing loss. The antidote is unknown. Treatment is symptomatic.

special instructions

During therapy, it is necessary to regularly examine the patient for the appearance of refractory microorganisms and signs of superinfection, including fungal.

Taking into account the pharmacokinetic properties, azithromycin is recommended for use for a short course, therefore, the recommended duration of treatment should not be exceeded.

With prolonged use of Ziromin, there is a risk of developing pseudomembranous colitis associated with Clostridium difficile. This disease can manifest itself as mild diarrhea or severe colitis. If antibiotic-associated diarrhea appears during therapy or in the period up to 2 months after its termination, it is necessary to conduct an examination for the development of Clostridial infection and pseudomembranous colitis caused by it. It is contraindicated to take medications that inhibit intestinal peristalsis.

Against the background of therapy with macrolides (including azithromycin), prolongation of the QT interval and cardiac repolarization is possible, which increases the risk of cardiac arrhythmias, including polymorphic ventricular tachycardia of the pirouette type.

Ziromin can cause exacerbation of myasthenia gravis or the development of myasthenic syndrome.

Influence on the ability to drive vehicles and complex mechanisms

Motor vehicle drivers and persons employed in potentially hazardous industries should be careful while taking Ziromin due to the risk of developing side effects from the organ of vision and the nervous system.

Application during pregnancy and lactation

Ziromin tablets during pregnancy are prescribed in cases where the expected benefit outweighs the potential risks to the fetus.

It is recommended to interrupt breastfeeding for the period of treatment.

Pediatric use

Ziromin is contraindicated in children under 12 years of age with a body weight of less than 45 kg.

With impaired renal function

With a GFR (glomerular filtration rate) of 10-80 ml / min, there is no need to adjust the dose, but treatment should be carried out with caution, constantly monitoring the functional state of the kidneys.

For violations of liver function

In severely impaired liver function, taking Ziromin is contraindicated.

There is no need to adjust the dose in patients with mild and moderate liver functional impairment, however, Ziromin should be used with caution, since there is a risk of severe hepatic failure and fulminant hepatitis. If signs of deterioration in liver function appear (darkening of urine, jaundice, a tendency to bleeding, rapidly increasing asthenia, hepatic encephalopathy), you should immediately stop taking the drug and conduct an appropriate examination.

Use in the elderly

The dose for elderly patients is not adjusted, however, care is taken during treatment, since in old age the risk of developing proarrhythmogenic conditions increases, which increases the risk of developing cardiac arrhythmias, including polymorphic ventricular tachycardia of the pirouette type.

Drug interactions

• antacids: do not affect bioavailability, but reduce the C _{max of} azithromycin in the blood (by 30%), therefore, you need to take Ziromin at least 1 hour before or 2 hours after taking antacids;
• didanosine (dideoxyinosine): when didanosine was used in a daily dose of 400 mg simultaneously with azithromycin in a daily dose of 1200 mg in six HIV-infected patients who took part in clinical trials, no changes in the pharmacokinetics of didanosine were observed in comparison with the placebo group;
• P-glycoprotein substrates (digoxin): macrolides (including azithromycin) cause an increase in the concentration of P-glycoprotein substrate in the blood serum;
• ergot alkaloids (derivatives of ergotamine and dihydroergotamine): there is no data on a possible interaction, however, the likelihood of developing ergotism is assumed, therefore such combinations are not recommended;
• cetirizine: in healthy volunteers who received cetirizine at a dose of 20 mg in conjunction with azithromycin for 5 days, no significant changes in the pharmacokinetics of drugs and the QT interval were revealed;
• atorvastatin: in clinical studies of the simultaneous use of azithromycin 500 mg per day and atorvastatin 10 mg per day, no changes in concentration were detected. However, in the course of the post-registration study, separate reports were received about the development of rhabdomyolysis with the combined use of statins and azithromycin;
• cimetidine: in a single dose, cimetidine does not affect the pharmacokinetic parameters of azithromycin, provided that the latter is taken no earlier than 2 hours after cimetidine;
• zidovudine: azithromycin in a single dose of 1000 mg and in multiple doses of 600 mg or 1200 mg insignificantly affects the pharmacokinetics of zidovudine and its glucuronide metabolite, including excretion by the kidneys, but causes an increase in the concentration of phosphorylated zidovudine (a pharmacologically active metabolite) in peripheral blood mononuclear cells. The clinical significance of this phenomenon has not been established;
• carbamazepine: in healthy volunteers who participated in the studies, a significant effect of azithromycin on the plasma concentration of carbamazepine and its active metabolite was not established;
• anticoagulants of indirect action (coumarin derivatives): in studies of the combined use of azithromycin and warfarin in a single dose of 15 mg in healthy volunteers, changes in the anticoagulant effect have not been established. There have been reports of increased action of indirect anticoagulants (coumarin derivatives). A causal relationship with azithromycin has not been established, but more intense control of prothrombin time is recommended;
• indinavir: a single dose of azithromycin at a dose of 1200 mg did not have a statistically significant effect on the pharmacokinetics of indinavir, which was used for 5 days three times a day at 800 mg;
• fluconazole: administration of azithromycin at a dose of 1200 mg did not change the pharmacokinetics of fluconazole taken at a dose of 800 mg. The total exposure and T _{1/2 of} azithromycin did not change, but its C _max decreased by 18%, which has no clinical significance;
• efavirenz: when taking azithromycin at a daily dose of 600 mg and efavirenz at a daily dose of 400 mg for 7 days, no clinically significant drug interactions were detected;
• rifabutin: no changes in drug concentrations were observed. However, cases of neutropenia have been reported. Its development was associated with rifabutin, a causal relationship with the use of the combination has not been established;
• nelfinavir: Nelfinavir, administered at 750 mg three times a day, causes an increase in serum equilibrium concentrations of azithromycin taken at a dose of 1200 mg. No serious side effects have been reported, so no dose adjustment is required;
• sildenafil: in studies of healthy volunteers who received azithromycin in a daily dose of 500 mg for 3 days, no changes in C _max and AUC (area under the pharmacokinetic curve) of sildenafil and its main circulating metabolite were detected;
• drugs metabolized with the participation of cytochrome P450 isoenzymes: azithromycin does not inhibit or induce cytochrome P450 isoenzymes, does not participate in pharmacokinetic interactions similar to erythromycin and other macrolides;
• trimethoprim, sulfamethoxazole, theophylline, methylprednisolone, triazolam, midazolam: no significant changes in the pharmacokinetics of the drugs were identified;
• terfenadine: no evidence of drug interactions with azithromycin has been obtained in studies. There are isolated reports on the basis of which the possibility of such an interaction cannot be completely ruled out, but there is no reliable recorded evidence. It has been established that the combination of macrolides with terfenadine can cause prolongation of the QT interval and the development of arrhythmias;
• cyclosporine: in a clinical study, healthy volunteers received azithromycin at a daily dose of 500 mg for 3 days, followed by cyclosporine at a daily dose of 10 mg / kg. An increase in C _max and AUC _{0-5 of} cyclosporine has been reliably established, therefore, caution should be exercised when prescribing this combination. It is required to control the plasma concentration of cyclosporine and, if necessary, adjust its dose.

Analogs

Ziromin's analogs are Azivok, Azidrop, Azitrox, Azitral, Azithromycin, ZI-Factor, Zitnob, Zitrocin, Zitrolide, Sumaklid, Sumamed, Tremak-Sanovel, Hemomycin, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° C out of reach of children.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ziromin

Reviews about Ziromin are few, but positive. Patients note the high efficiency, affordable cost and good tolerance of the antibiotic.

Price for Ziromin in pharmacies

Depending on the pharmacy chain and the region of sale, the price for Ziromin 500 mg is approximately 91‒125 rubles. per pack of 3 film-coated tablets.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!