Azitrocin (Azithromycin)

Active Ingredient: Azithromycin
Dosage: 500 mg
Route of Administration: Oral
Dosage Form: Tablets
Quantity per package: 3 tablets

Azitrocin is an antibiotic that is used to treat acute bacterial sinusitis and acute bacterial otitis media, pharyngitis, tonsillitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia from mild to moderately severe, mild to moderate skin and soft tissue infections (eg folliculitis, cellulitis, erysipelas), urethritis and uncomplicated cervicitis produced by Chlamydia trachomatis, chancroid, migratory erythema, community-acquired pneumonia, infections of the lower respiratory tract, including bronchitis and pneumonia, as well as odontogenic, skin and soft tissue infections, otitis media and in upper respiratory tract infections, including sinusitis and pharyngotonsillitis, sexually transmitted infections. It is also indicated for the treatment of chancroid due to Haemophilus ducreyi, uncomplicated genital infections due to Neisseria gonorrhoeae. Currently, Azitrocin is unavailable. There is a drug with the same component – Zithromax. It has a similar therapeutic effect.

Indications

This antibiotic is prescribed for infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin:

• infections of the upper respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media);
• lower respiratory tract infections (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);
• urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis);
• the initial stage of Lyme disease (borreliosis) – erythema migrans.

Dosage and administration

Oral administration. Dosage regimen: 1 hour before or 2 hours after eating 1 time per day.

Adults and children over 12 years old with a bodyweight of over 45 kg for infections of the upper and lower respiratory tract, ENT organs, skin, and soft tissues: 0.5 g (2 capsules) 1 time per day for 1 dose for 3 days (course dose – 1.5 g).

For infections of the genitourinary tract caused by Chlamydia trachomatis (urethritis, cervicitis) – once 1 g (4 capsules).

In Lyme disease (the initial stage of borreliosis) – erythema migrans – 1 g (4 capsules) on the first day and 0.5 g (2 capsules) daily from 2 to 5 days (course dose – 3 g).

In case of impaired renal function: when used in patients with the impaired renal function of mild severity (CC more than 40 ml/min), dose adjustment is not required.

In case of impaired liver function: when used in patients with the impaired liver function of mild to moderate severity, dose adjustment is not required.

Elderly patients: dose adjustment is not required. Since older people may already have current proarrhythmogenic conditions, it is not recommended to prescribe it due to the high risk of developing cardiac arrhythmias, including pirouette type arrhythmias.

Contraindications

• Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the drug;
• Severe liver dysfunction (Child-Pugh class C);
• Severe renal impairment (creatinine clearance (CC) less than 40 ml/min);
• Concomitant use with ergotamine and dihydroergotamine;
• Children under 12 years old with a bodyweight of less than 45 kg;
• Breastfeeding.

Side effects

• Infectious diseases: infrequently – candidiasis, including the mucous membrane of the oral cavity and genitals, pneumonia, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; unknown frequency – pseudomembranous colitis.
• Blood and lymphatic system: infrequently – leukopenia, neutropenia, eosinophilia; very rarely – thrombocytopenia, hemolytic anemia.
• Metabolism and nutrition: infrequently – anorexia.
• Allergic reactions: infrequently – angioedema, hypersensitivity reaction; unknown frequency – anaphylactic reaction.
• Nervous system: often – headache; infrequently – dizziness, paresthesia, violation of taste, drowsiness, insomnia, nervousness; rarely – agitation; unknown frequency – hypesthesia, anxiety, aggression, fainting, convulsions, psychomotor hyperactivity, loss of smell, perversion of smell, loss of taste, myasthenia gravis, delirium, hallucinations.
• The organ of vision: infrequently – impaired vision.
• Hearing organ and labyrinth disorders: infrequently – hearing impairment, vertigo; unknown frequency – hearing impairment, including deafness and/or tinnitus.
• Сardiovascular system: infrequently – a feeling of palpitations, “flushing” of blood to the face; unknown frequency – lowering blood pressure, increasing the QT interval on the electrocardiogram, pirouette type arrhythmia, ventricular tachycardia.
• Respiratory system: infrequently – shortness of breath, nosebleeds.
• Gastrointestinal tract: very often – diarrhea; often – nausea, vomiting, abdominal pain; infrequently – flatulence, dyspepsia, gastritis, constipation, dysphagia, bloating, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely – discoloration of the tongue, pancreatitis.
• Liver and biliary tract: infrequently – hepatitis; rarely – impaired liver function, cholestatic jaundice; unknown frequency – liver failure (in rare cases with a fatal outcome mainly due to severe impairment of liver function), liver necrosis, fulminant hepatitis.
• Skin and subcutaneous tissues: infrequently – skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely – photosensitivity reaction; unknown frequency – Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
• Musculoskeletal system: infrequently – osteoarthritis, myalgia, back pain, pain in the neck; unknown frequency – arthralgia.
• Kidneys and urinary tract: infrequently – dysuria, pain in the kidneys; unknown frequency – interstitial nephritis, acute renal failure.
• Genitals and mammary gland: infrequently – metrorrhagia, impaired testicular function.
• Other: infrequently – asthenia, malaise, fatigue, swelling of the face, chest pain, fever, peripheral edema.
• Laboratory data: often – a decrease in the number of lymphocytes, bicarbonates, an increase in the number of eosinophils, basophils, monocytes, neutrophils; infrequently – an increase in the activity of aspartate aminotransferase, alanine aminotransferase, bilirubin in the blood plasma, an increase in the concentration of urea in the blood plasma, an increase in the concentration of creatinine in the blood plasma, a change in the potassium content in the blood plasma, an increase in the activity of alkaline phosphatase in the blood plasma, an increase in the content of chlorine in the blood plasma, an increase in the concentration of glucose in the blood, an increase in the number of platelets, an increase in hematocrit, an increase in the concentration of bicarbonates in the blood plasma.

Overdose

• Symptoms: nausea, temporary hearing loss, vomiting, diarrhea.
• Treatment: symptomatic therapy; gastric lavage.

Interaction

• Antacids do not affect the bioavailability of azithromycin but reduce the maximum concentration in the blood by 30%, so the drug should be taken at least 1 hour before or 2 hours after taking these drugs and food. When administered parenterally, azithromycin does not affect the plasma concentration when used together. However, the possibility of such interactions when azithromycin is intended for oral administration does not affect the concentration of cimetidine, efavirenz, fluconazole, indinavir, midazolam, triazolam, co-trimoxazole (sulfamethoxazole + trimethoprim).
• If necessary, the combined use with cyclosporine is recommended to control the content of cyclosporine in the blood.
• The combined use of digoxin and azithromycin implies control of the concentration of digoxin in the blood because many macrolides increase the absorption of digoxin in the intestine, thereby increasing its concentration in blood plasma.
• If necessary, it is recommended to carefully monitor prothrombin time when co-administrating with warfarin.
• The simultaneous administration of terfenadine and antibiotics of the macrolide class causes arrhythmia and lengthening of the QT interval.
• In the case of the combined use of azithromycin and zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in blood plasma or the excretion of zidovudine by the kidneys and its glucuronidated metabolite. Nevertheless, the concentration of the active metabolite, phosphorylated zidovudine, in the mononuclear cells of peripheral vessels increases. The clinical significance of this fact is unclear.
• With the simultaneous administration of macrolides with ergotamines and dihydroergotamine, their toxic effect is possible.