Sumamox pills 500mg, 3pcs

Composition

1 tablet contains: Active ingredient: azithromycin dihydrate 524.0 mg (equivalent to 500.0 mg of azithromycin). Auxiliary substances:  corn starch 250.0 mg, corn starch for pasta 40.0 mg, calcium phosphate 150.0 mg, talc 3.0 mg, magnesium stearate 2.0 mg, sodium carboxymethyl starch 3.0 mg, croscarmellose sodium 2.0 mg. Tablet shell:  Tablet coating “Tabcoat white” 46.0 mg (hypromellose 14.4 mg, macrogol 5.4 mg, titanium dioxide E 171 16.2 mg, talc 10.0 mg).

Pharmacological action

Pharmacotherapeutic group: antibiotic-azalide

ATX code:  J01FA 10

Pharmacological properties

Pharmacodynamics

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 peptidyl site, which leads to suppression of protein synthesis in bacterial cells.

Sensitive: aerobic gram – positive microorganisms Staphylococcus aureus (methicillinsusceptible), Streptococcus pneumoniae (penicillinsusceptible), 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 or insensitive: aerobic gram-positive microorganisms-Streptococcus pneumoniae (moderately sensitive or resistant to penicillin).

Resistant: aerobic gram-positive microorganisms – Enterococcus faecalis, Staphylococcus spp. (methicillin-resistant); Anaerobes: Bacteroides fragilis group. Streptococcus pneumoniae, beta-hemolytic Group A Streptococcus spp., Enterococcus faecalis and Staphylococcus aureus (including methicillin-resistant strains), resistant to erythromycin and other macrolides, lincosamides are also resistant to azithromycin.

Pharmacokinetics

After oral use, the bioavailability is 37%, the maximum concentration in blood plasma (Cmax) is created in 2-3 hours, the volume of distribution is 31 l/kg. Binding to plasma proteins is inversely proportional to the concentration in the blood and is 12-52%. Penetrates cell membranes (effective for infections caused by intracellular pathogens). It is transported by phagocytes, polymorphonuclear leukocytes and macrophages to the site of infection, where it is released in the presence of bacteria.

It easily passes through histohematic barriers and enters the tissues. The concentration in tissues and cells is 50 times higher than in blood plasma, and in the focus of infection-24-34% higher than in healthy tissues. It is slowly excreted from the tissues and has a long half-life of 2-4 days. The therapeutic concentration of azithromycin is maintained up to 5-7 days after the last dose. Azithromycin is mainly excreted unchanged-50% by the intestines,12% by the kidneys. In the liver, it is demethylated, losing its activity. In patients with renal insufficiency (creatinine clearance < 10 ml/min), the half-life of azithromycin is increased by 33%.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

• Infections of the upper respiratory tract and ENT organs (pharyngitis, tonsillitis, sinusitis, otitis media);
• Lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, including those caused by atypical pathogens);
• Skin and soft tissue infections (moderate acne simplex, erysipelas, impetigo, secondary infected dermatoses);
• The initial stage of Lyme disease (borreliosis) is erythema migrans.
• Uncomplicated urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis).

Use during pregnancy and lactation

The use of the drug during pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be decided.

Contraindications

Hypersensitivity to azithromycin, other macrolides, components of the drug, simultaneous use with ergot derivatives, severe hepatic / renal insufficiency, children under 12 years of age.

With caution

Prolonged Q-T interval syndrome, chronic renal failure (creatinine clearance greater than 40 ml / min), concomitant use with terfenadine, warfarin, digoxin, drugs that prolong the Q-T interval.

Side effects

From the side of hematopoietic organs:  lymphocytopenia, eosinophilia, leukopenia, thrombocytopenia, transient neutropenia, hemolytic anemia. Nervous system disorders:  dizziness, vertigo, drowsiness, headache, seizures, paresthesia, hyposthesia, asthenia, insomnia, hyperactivity, aggressiveness, restlessness, anxiety, nervousness. From the side of the senses:  hearing loss, deafness, ringing in the ears, perversion of taste or smell, decreased visual acuity. From the cardiovascular system:  palpitation, arrhythmia (including ventricular tachycardia, pirouette tachycardia), prolongation of the Q-T interval. From the digestive system:  nausea, vomiting, diarrhea, abdominal pain or abdominal cramps, loose stools, flatulence, digestive disorders, gastritis, anorexia, constipation, discoloration of the tongue, pseudomembranous colitis, hepatitis, cholestatic jaundice, impaired liver function tests, liver necrosis and liver failure (up to fatal outcome). From the musculoskeletal system:  arthralgia. From the genitourinary system:  vaginitis, interstitial nephritis, acute renal failure. Allergic reactions:  pruritus and rash, angioedema, urticaria, photosensitization, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylactic reactions. Laboratory parameters:  increased serum concentrations of bilirubin, urea, creatinine, and potassium ions, and decreased serum concentrations of bicarbonates. Other services:  candidiasis, chest pain, swelling, fainting, exacerbation of myasthenia gravis.

Interaction

Antacids reduce the maximum concentration of azithromycin by 30%, so azithromycin should be taken 1 hour before or 2 hours after taking antacids. When used concomitantly with cyclosporine, the concentration of cyclosporine in the blood should be monitored. When used concomitantly with indirect anticoagulants, the frequency of bleeding may increase, prothrombin time and international normalized ratio (INR) should be monitored. When used concomitantly with digoxin, it is possible to increase the concentration in the blood of the latter, so the concentration of digoxin in the blood should be monitored. When used concomitantly with ergotamine, ergotism may develop; concomitant use is not recommended. Concomitant use of macrolides and theophylline in some cases led to an increase in the concentration of the latter. Azithromycin increases the content of zidovudine triphosphate (the active metabolite of zidovudine) in mononuclear cells, the clinical significance of this phenomenon is unknown. Concomitant use with rifabutin may lead to neutropenia. Concomitant use of fluconazole reduces the maximum concentration of azithromycin by 18%.

How to take, course of use and dosage

Inside, once a day, at least 1 hour before or 2 hours after a meal. Adults (including the elderly) and children over 12 years of age with a body weight over 45 kg. For infections of the upper and lower respiratory tract, ENT organs, skin and soft tissues: 500 mg (1 tablet) 1 time a day for 3 days (course dose of 1.5 g)Initial stage of Lyme disease: once a day for 5 days: Day 1-1.0 g (2 tablets), then from day 2 to day 5-500 mg (1 tablet) (course dose 3.0 g)For uncomplicated urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis): 1 g (2 tablets) once. For acne: the course dose is 6 g: 500 mg (1 tablet) 1 time a day for 3 days, then 500 mg 1 time a week for 9 weeks. Use in patients with impaired renal function: no dose adjustment is necessary for patients with moderate renal impairment (creatinine clearance > 40 ml/min).

Overdose

Symptoms: temporary hearing loss, nausea and vomiting, diarrhea. Treatment: taking activated charcoal, maintaining vital body functions.

Special instructions

If one dose of the drug is missed – the missed dose should be taken as early as possible, and the subsequent ones should be taken at intervals of 24 hours.

For pharyngitis and tonsillitis caused by Streptococcus pyogenes, the antibiotics of choice are penicillins. The efficacy of azithromycin for the prevention of rheumatic fever is unknown.

When using azithromycin, as well as when using other antibiotics, there is a risk of developing superinfection (including fungal).

With prolonged use of azithromycin, pseudomembranous colitis caused by Clostridium difficile may develop. If diarrhea develops while taking azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded.

Influence on the ability to drive vehicles and work with mechanisms

In case of adverse reactions from the nervous system, patients are advised to refrain from driving a car and other mechanisms, as well as to exercise caution when engaging in activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store in a dry place protected from light at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 2 years. Do not take after the expiration date.

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets