Azithromycin pills 500mg 3pcs – Pharmstandard

Composition

of 1 tab. azithromycin (in the form of dihydrate) 500 mg

Auxiliary substances:

microcrystalline cellulose – 36 mg,

lactose monohydrate-33.464 mg,

povidone (K-30) – 26 mg,

crospovidone-26 mg,

sodium lauryl sulfate-1.3 mg,

colloidal silicon dioxide-6.6 mg,

magnesium stearate-6.6 mg.

Composition of the film shell:

hypromellose-12 mg,

talc-4 mg,

titanium dioxide-2.2 mg,

macrogol 4000-1.8 mg

Pharmacological action

Broad-spectrum antibiotic. It is the first representative of a new subgroup of macrolide antibiotics – azalides. When creating high concentrations in the focus of inflammation, it has a bactericidal effect.

Gram-positive cocci are susceptible to Azithromycin: Streptococcus pneumoniae, Str. pyogenes, Str. agalactiae, CF and G group streptococci, Staphylococcus aureus, S. viridans; gram-negative bacteria: Haemophilus influenzae, Moraxella catarrhalis, Bordetella pertussis, B. parapertussis, Legionella pneumophila, H. ducrei, Campylobacter jejuni, Neisseria gonorrhoeae and Gardnerella vaginalis; some anaerobic microorganisms: Bacteroides bivius, Clostridium perfringens, Peptostreptococcus spp. ; and Clamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum, Treponema pallidum, Borrelia burgdoferi. Azithromycin is inactive against gram-positive bacteria resistant to erythromycin.

Indications

Infectious and inflammatory diseases caused by drug-sensitive pathogens:  ENT infections (sore throat, sinusitis, tonsillitis, otitis media); scarlet fever; respiratory tract infections (bacterial and atypical pneumonia, bronchitis); infections of skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses); infection of the urogenital tract (uncomplicated urethritis and/or cervicitis); Lyme disease (borelias) in the treatment of early stage (erythema migrans); diseases of the stomach and duodenum, associated with Helicobacter pylori.

Contraindications

Hypersensitivity to macrolide antibiotics.

Side effects

Most of the reported adverse reactions are reversible after the end of treatment or discontinuation of the drug.

WHO classification of frequency of side effects: very common (with a frequency of more than 1/10), common (with a frequency of at least 1/100, but less than 1/10), uncommon (with a frequency of at least 1/000, but less than 1/100), rare (with a frequency of at least 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10 000), including individual reports.

From the circulatory and lymphatic systems:  often-lymphocytopenia, eosinophilia; infrequently-leukopenia, neutropenia; rarely-thrombocytopenia, hemolytic anemia.

From the central nervous system:  often – dizziness, headache, paresthesia, impaired perception of taste sensations, anorexia; infrequently-anxiety, nervousness, hyposthesia, insomnia, drowsiness; rarely-agitation, delirium, hallucinations; very rarely-fainting, convulsions, psychomotor hyperactivity, aggression, anosmia, loss of taste sensations, parosmia, exacerbation of myasthenia gravis, perversion of smell.

From the side of the senses:  infrequently – hearing disorders, vertigo, visual disturbances; unknown frequency – hearing disorders, including deafness and / or tinnitus.

Respiratory and ENT system disorders:  infrequently-shortness of breath, nosebleeds.

From the cardiovascular system:  infrequently-palpitations, “flushes” of blood to the face; very rarely-decreased blood pressure, arrhythmia, ventricular tachycardia, increased QT interval, arrhythmia of the “pirouette” type.

Infectious diseases:  infrequently – rhinitis, respiratory diseases, pharyngitis, pneumonia, candidiasis, including oral and genital mucosa, gastroenteritis.

From the digestive system:  very often – nausea, diarrhea, abdominal pain, flatulence (bloating), often-vomiting; infrequently-belching, dysphagia, gastritis, constipation, dry oral mucosa, ulcers of the oral mucosa, increased salivary gland secretion; very rarely – discoloration of the tongue, pseudomembranous colitis, pancreatitis.

Liver and biliary tract disorders:  infrequently – hepatitis, hyperbilirubinemia, increased activity of “hepatic” transaminases; very rarely-cholestatic jaundice, liver failure (in rare cases with a fatal outcome, mainly against the background of impaired liver function), fulminant hepatitis, liver necrosis.

Allergic reactions:  often-pruritus, rash; infrequently-Stevens-Johnson syndrome, photosensitization, urticaria; rarely-anaphylactic reactions (including angioedema) in rare cases with fatal outcome, toxic epidermal necrolysis, erythema multiforme.

Skin and subcutaneous tissue disorders:  dry skin, dermatitis, sweating.

From the musculoskeletal system:  often-arthralgia; infrequently-osteoarthritis, myalgia, neck pain, back pain.

From the genitourinary system:  infrequently-increased residual urea nitrogen and plasma creatinine concentration, dysuria, kidney pain, metrorrhagia, testicular dysfunction; very rarely-interstitial nephritis, acute renal failure.

Others: often-weakness; infrequently-chest pain, peripheral edema, asthenia (malaise, feeling tired); infrequently-facial edema, fever.

Laboratory data:  often – an increase in the number of basophils, monocytes, neutrophils, a decrease in the concentration of bicarbonates in blood plasma; infrequently-an increase in the activity of alkaline phosphatase, an increase in the content of chlorine, an increase in the concentration of glucose, an increase in the concentration of bicarbonates in blood plasma, an increase in the number of platelets, an increase in hematocrit, a change in the content of sodium in blood plasma, a change in the concentration of potassium in blood plasma.

Any side effect should be reported to your healthcare provider.

Interaction

Antacids (aluminum and magnesium-containing) They do not affect the bioavailability of azithromycin, but reduce its maximum concentration in the blood by 30%, so the drug should be taken at least one hour before or two hours after taking these drugs. When combined with coumarin-type indirect anticoagulants (warfarin) and azithromycin (in normal doses), patients should carefully monitor prothrombin time.

Concomitant use of fluconazole reduces the maximum concentration of azithromycin in the blood by 18%, which is not clinically significant.

When used concomitantly with cyclosporine, it is necessary to adjust the dose of cyclosporine and monitor its concentration in the blood.

When taking digoxin and azithromycin together, 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 maximum concentration in the blood.

Concomitant use of macrolides with ergotamine and dihydroergotamine may result in toxic effects (vasospasm, dysesthesia) – concomitant use is contraindicated.

Caution should be exercised when co-prescribing terfenadine and azithromycin, as simultaneous use of terfenadine or cisapride and macrolide antibiotics has been found to cause arrhythmia and prolongation of the QT interval. Based on this, the above-mentioned complications cannot be excluded when taking terfenadine and azithromycin together.

With simultaneous use of azithromycin and rifabutin, in rare cases, neutropenia may develop, the mechanism of development of which, as well as the presence of a causal relationship with taking the drug, have not been established.

When azithromycin and zidovudine are co-administered, azithromycin has little effect on the pharmacokinetics, including renal excretion of zidovudine or its glucuronide metabolite. The concentration of the active metabolite, phosphorylated zidovudine, increases in peripheral blood mononuclear cells. The clinical significance of this fact has not been determined.

Simultaneous use of azithromycin (1200 mg) and nelfinavir (750 mg 3 times a day) causes an increase in the steady-state concentration of azithromycin in blood plasma. No clinically significant side effects were observed and no dose adjustment of azithromycin is required when co-administered with nelfinavir.

Azithromycin does not affect the concentration of carbamazepine, cimetidine (if cimetidine is used 2 hours before azithromycin), didanosine, efavirenz, indinavir, midazolam, theophylline, triazolam, trimethoprim/sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin and methylprednisolone in the blood when used simultaneously.

There have been isolated reports of rhabdomyolysis in patients taking concomitant azithromycin and statins.

Azithromycin weakly interacts with cytochrome P%^%450 isoenzymes. Azithromycin has not been shown to be involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inducer or inhibitor of cytochrome P450 isoenzymes.

How to take it, course of use and dosage

Inside, at least 1 hour before or 2 hours after a meal, once a day.

Adults and children over 12 years of age with a body weight of more than 45 kg (Azithromycin 250 and 500 mg tablets):

For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues (with the exception of the initial stage of Lyme disease (erythema migrans) and acne of moderate severity) – 500 mg per day for 1 reception for 3 days (course dose-1.5 g).

In the initial stage of Lyme disease (erythema migrans) – 1000 mg per day on the first day at a time, then 500 mg per day daily from day 2 to 5 (the course dose is 3 g).

If indicated, acne vulgaris (acne) of moderate severity on the 1st,2nd and 3rd days of treatment, take 500 mg 1 time a day, then take a break from the fourth to the seventh day, from the eighth day of treatment, take 500 mg 1 time a week for 9 weeks. The course dose is 6.0 g.

For urinary tract infections caused by Chlamydia trachomatis (urethritis,

cervicitis) for the treatment of uncomplicated urethritis/cervicitis, a single dose of 1000 mg is prescribed.

Children from 3 to 12 years of age with a body weight of up to 45 kg (Azithromycin 125 mg tablets):

For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues – at the rate of 10 mg/kg of body weight once a day for 3 days.

For pharyngitis / tonsillitis caused by Streptococcus pyogenes-20 mg / kg once a day for 3 days (a course dose of 60 mg / kg). The maximum daily dose is 500 mg.

In the treatment of the initial stage of Lyme disease (erythema migrans) – 20 mg/kg 1 time per

day on the first day, then at the rate of 10 mg/kg 1 time per day from day 2 to day 5 (a course

dose of 60 mg/kg).

With impaired renal function.

When used in patients with mild renal impairment

, no dose adjustment is required.

With impaired liver function.

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

Elderly patients.

When used in elderly patients, no dose adjustment is required.

Overdose

When taking high doses of the drug, there may be an increase in side effects: temporary hearing loss, nausea, vomiting, diarrhea.

In this case, gastric lavage and symptomatic therapy are indicated.

Special instructions

If one dose of the drug is missed, the missed dose should be taken as early as possible, and subsequent doses should be taken at intervals of 24 hours. Azithromycin should be taken at least 1 hour before or 2 hours after taking antacid medications.

Azithromycin should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe hepatic insufficiency in such patients. In the presence of symptoms of impaired liver function (rapidly increasing asthenia, jaundice, darkening of the color of urine, tendency to bleeding, hepatic encephalopathy), azithromycin therapy should be discontinued and a study of the functional state of the liver should be conducted.

In patients with mild to moderate renal insufficiency, azithromycin should be administered under the supervision of renal function.

Concomitant use of azithromycin with derivatives of ergotamine and dihydroergotamine is contraindicated due to the possible development of ergotism.

When using the drug, both against the background of taking it, and 2-3 weeks after stopping treatment, diarrhea caused by Clostridium difficile (pseudomembranous colitis) may develop. In mild cases, it is sufficient to cancel treatment and use ion exchange resins (colestyramine, colestipol), in severe cases, compensation for fluid, electrolyte and protein loss is indicated, and the appointment of vancomycin, bacitracin or metronidazole is indicated.

Drugs that inhibit intestinal motility are contraindicated. Since prolongation of the QT interval is possible in patients receiving macrolides, including azithromycin, caution should be exercised when using azithromycin in patients with known risk factors for prolongation of the QT interval: heart disease (heart failure, myocardial infarction, bradycardia), elderly age, electrolyte imbalance (hypokalemia, hypomagnesemia), congenital QT prolongation syndrome, concomitant use of drugs that can prolong the QT interval (including antiarrhythmic drugs of classes IA and III, tricyclic and tetracyclic antidepressants, neuroleptics, fluoroquinolones). Azithromycin can trigger the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis. As with other antibacterial agents, patients with Azithromycin should be regularly evaluated for the presence of non-susceptible microorganisms and signs of superinfections, including fungal infections.

The drug should not be taken for longer courses than indicated in the instructions, since the pharmacokinetic properties of azithromycin allow us to recommend a short and simple dosage regimen.

Form of production

Film-coated tablets of white or almost white color, round, biconvex; on a cross-section, the core is white or almost white.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults, Children over 12 years of age, Pregnant women as prescribed by a doctor

Indications

Skin Infections, Tonsillitis, Infectious Diseases, Pneumonia, Otitis Media, Pharyngitis, Sore Throat, Bronchitis, Urethritis