Azithromycin (Tablets, Capsules, Powder) Instructions for Use
ATC Code
J01FA10 (Azithromycin)
Active Substance
Azithromycin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Antibiotic of the macrolide group – azalide
Pharmacotherapeutic Group
Systemic antibacterial agents; macrolides, lincosamides, and streptogramins; macrolides
Pharmacological Action
An antibiotic of the macrolide group, it is a representative of azalides. It has a broad spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with the suppression of microbial cell protein synthesis. By binding to the 50S ribosomal subunit, it inhibits peptidyltransferase at the translation stage, suppresses protein synthesis, and slows down the growth and reproduction of bacteria. In high concentrations, it has a bactericidal effect.
It is active against a number of gram-positive, gram-negative, anaerobic, intracellular, and other microorganisms.
Gram-positive cocci sensitive to azithromycin include: Streptococcus pneumoniae (penicillin-sensitive strains), Streptococcus pyogenes, Staphylococcus aureus (methicillin-sensitive strains); aerobic gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; some anaerobic microorganisms: Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyriomonas spp.; as well as Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi.
Microorganisms with acquired resistance to azithromycin: aerobic gram-positive microorganisms – Streptococcus pneumoniae (penicillin-resistant strains and strains with intermediate sensitivity to penicillin).
Microorganisms with natural resistance: aerobic gram-positive microorganisms – Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis (methicillin-resistant strains), anaerobic microorganisms – Bacteroides fragilis.
Cases of cross-resistance have been described between Streptococcus pneumoniae, Streptococcus pyogenes (group A beta-hemolytic streptococcus), Enterococcus faecalis and Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides.
Pharmacokinetics
After oral administration, Azithromycin is well absorbed and rapidly distributed in the body. After a single dose of 500 mg, the bioavailability is 37% due to the first-pass effect through the liver. Cmax in blood plasma is reached in 2-3 hours and is 0.4 mg/L.
Protein binding is inversely proportional to the concentration in plasma and is 7-50%. The apparent Vd is 31.1 L/kg. It penetrates cell membranes (effective against infections caused by intracellular pathogens). It is transported by phagocytes to the site of infection, where it is released in the presence of bacteria. It easily penetrates histohematic barriers and enters tissues. The concentration in tissues and cells is 10-50 times higher than in plasma, and at the site of infection it is 24-34% higher than in healthy tissues.
Azithromycin is metabolized in the liver. Metabolites do not possess antimicrobial activity.
T1/2 is very long – 35-50 hours. T1/2 from tissues is significantly longer. The therapeutic concentration of azithromycin persists for up to 5-7 days after the last dose. Azithromycin is excreted mainly unchanged – 50% via the intestine, 6% by the kidneys.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to azithromycin: infections of the upper respiratory tract and ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media); infections of the lower respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including that caused by atypical pathogens); skin and soft tissue infections (moderate acne vulgaris, erysipelas, impetigo, secondarily infected dermatoses); uncomplicated infections of the genitourinary tract caused by Chlamydia trachomatis (urethritis and/or cervicitis); the initial stage of Lyme disease (borreliosis) – migrating erythema (erythema migrans).
ICD codes
| ICD-10 code | Indication |
| A46 | Erysipelas |
| A48.1 | Legionnaires’ disease |
| A56.0 | Chlamydial infections of lower genitourinary tract |
| A56.1 | Chlamydial infections of pelvic organs and other genitourinary organs |
| A69.2 | Lyme disease |
| H66 | Suppurative and unspecified otitis media |
| J01 | Acute sinusitis |
| J02 | Acute pharyngitis |
| J03 | Acute tonsillitis |
| J04 | Acute laryngitis and tracheitis |
| J15 | Bacterial pneumonia, not elsewhere classified |
| J15.7 | Pneumonia due to Mycoplasma pneumoniae |
| J16.0 | Pneumonia due to chlamydia |
| J20 | Acute bronchitis |
| J31.2 | Chronic pharyngitis |
| J32 | Chronic sinusitis |
| J35.0 | Chronic tonsillitis |
| J37 | Chronic laryngitis and laryngotracheitis |
| J42 | Unspecified chronic bronchitis |
| L01 | Impetigo |
| L08.0 | Pyoderma |
| L08.8 | Other specified local infections of skin and subcutaneous tissue |
| L30.3 | Infectious dermatitis (infectious eczema) |
| L70 | Acne |
| N34 | Urethritis and urethral syndrome |
| N72 | Inflammatory disease of cervix uteri (including cervicitis, endocervicitis, exocervicitis) |
| ICD-11 code | Indication |
| 1A81.0 | Chlamydial infection of lower genitourinary tract |
| 1A81.1 | Chlamydial infection of internal reproductive organs |
| 1B70.0Z | Erysipelas, unspecified |
| 1B70.Z | Bacterial cellulitis or lymphangitis caused by unspecified bacterium |
| 1B72.0 | Bullous impetigo |
| 1B72.1 | Nonbullous impetigo |
| 1B72.Z | Impetigo, unspecified |
| 1B7Y | Other specified pyogenic bacterial infections of skin or subcutaneous tissue |
| 1C19.Z | Legionellosis, unspecified |
| 1C1G.13 | Lyme arthritis |
| 1C1G.1Z | Disseminated Lyme borreliosis, unspecified |
| 1C1G.Z | Lyme borreliosis, unspecified |
| 1C44 | Non-pyogenic bacterial infections of skin |
| AA9Z | Unspecified suppurative otitis media |
| CA01 | Acute rhinosinusitis |
| CA02.Z | Acute pharyngitis, unspecified |
| CA03.Z | Acute tonsillitis, unspecified |
| CA05 | Acute laryngitis or tracheitis |
| CA09.2 | Chronic pharyngitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| CA0F.Y | Other specified chronic diseases of the palatine tonsils and adenoids |
| CA0G | Chronic laryngitis or laryngotracheitis |
| CA20.1Z | Chronic bronchitis, unspecified |
| CA40.00 | Pneumonia due to Chlamydophila pneumoniae |
| CA40.04 | Pneumonia due to Mycoplasma pneumoniae |
| CA40.0Z | Bacterial pneumonia, unspecified |
| CA42.Z | Acute bronchitis, unspecified |
| EA50.3 | Staphylococcal scarlet fever |
| EA88.0Z | Infectious dermatitis, unspecified |
| EB21 | Pyoderma gangrenosum |
| ED80.Z | Acne, unspecified |
| GC02.Z | Urethritis and urethral syndrome, unspecified |
| GA0Z | Inflammatory diseases of female genital tract, unspecified |
| XA5WW1 | Cervix uteri |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take orally, once daily, at least 1 hour before or 2 hours after a meal.
For adults and children over 12 years of age weighing 45 kg or more, the standard dose for respiratory tract, skin, and soft tissue infections is 500 mg as a single daily dose for 3 days.
For uncomplicated urethritis/cervicitis caused by Chlamydia trachomatis, administer a single 1 gram (1000 mg) dose.
For the initial stage of Lyme disease (erythema migrans), prescribe 1 gram (1000 mg) on the first day, followed by 500 mg daily for the next 4 days (total course dose: 3 grams).
For children 6 months and older, calculate the dose based on body weight for a 3-day or 5-day course. For a 3-day course: 10 mg/kg once daily for 3 days. For a 5-day course: administer 10 mg/kg on day 1, followed by 5 mg/kg on days 2 through 5.
Do not administer the oral suspension to children under 6 months of age. Do not use 125 mg tablets in children under 3 years of age.
In patients with mild to moderate hepatic impairment or severe renal impairment (GFR <10 mL/min), use with caution; no specific dosage adjustment is recommended, but monitor for adverse effects.
Complete the entire prescribed course of therapy, even if symptoms improve. Do not use for longer than indicated regimens.
Adverse Reactions
From the hematopoietic system: infrequently – leukopenia, neutropenia, eosinophilia; very rarely – thrombocytopenia, hemolytic anemia.
Allergic reactions: rarely – skin rash, angioedema and anaphylaxis (in rare cases with fatal outcome) erythema multiforme, drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Some of these reactions that developed during the use of azithromycin became recurrent and required prolonged treatment and observation.
From the skin and subcutaneous tissues: infrequently – skin rash, itching, urticaria, dermatitis, dry skin, sweating; rarely – photosensitivity reaction; frequency unknown – Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
From the nervous system: frequently – headache; infrequently – dizziness, taste disturbance, paresthesia, somnolence, insomnia, nervousness; rarely – agitation; frequency unknown – hypoesthesia, anxiety, aggression, syncope, convulsions, psychomotor hyperactivity, loss of smell, parosmia, loss of taste, myasthenia, delirium, hallucinations.
From the organ of vision: infrequently – visual impairment.
From the organ of hearing and labyrinthine disorders: infrequently – hearing disorder, vertigo; frequency unknown – hearing impairment up to deafness and/or tinnitus.
From the cardiovascular system: infrequently – palpitations, flushing; frequency unknown – decreased blood pressure, increased QT interval on ECG, torsades de pointes arrhythmia, ventricular tachycardia.
From the respiratory system: infrequently – dyspnea, epistaxis.
From the digestive system: very frequently – diarrhea; frequently – nausea, vomiting, abdominal pain; infrequently – flatulence, dyspepsia, constipation, gastritis, dysphagia, abdominal distension, dry mouth, belching, oral mucosa ulcers, increased salivary gland secretion; very rarely – tongue discoloration, pancreatitis.
From the liver and biliary tract: infrequently – hepatitis; rarely – impaired liver function, cholestatic jaundice; frequency unknown – hepatic failure (in rare cases with fatal outcome mainly against the background of severe liver dysfunction), liver necrosis, fulminant hepatitis.
From the musculoskeletal system: infrequently – osteoarthritis, myalgia, back pain, neck pain; frequency unknown – arthralgia.
From the kidneys and urinary tract: infrequently – dysuria, renal pain; frequency unknown – interstitial nephritis, acute renal failure.
From the reproductive system: infrequently – metrorrhagia, testicular dysfunction.
Infectious diseases: infrequently – candidiasis (including of the oral and genital mucosa); frequency unknown – pseudomembranous colitis.
From laboratory parameters: frequently – decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased plasma bicarbonate concentration; infrequently – increased AST activity, ALT activity, increased plasma bilirubin concentration, increased plasma urea concentration, increased plasma creatinine concentration, change in plasma potassium content, increased plasma alkaline phosphatase activity, increased plasma chloride content, increased blood glucose concentration, increased platelet count, increased hematocrit, increased plasma bicarbonate concentration, change in plasma sodium content.
Other: infrequently – asthenia, malaise, anorexia, feeling of tiredness, facial edema, chest pain, fever, peripheral edema.
Contraindications
Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides; severe hepatic impairment; simultaneous use with ergotamine and dihydroergotamine; children under 6 months of age (for the powder for oral suspension dosage form); children under 3 years of age (for the 125 mg tablet dosage form), children under 12 years of age with body weight less than 45 kg (for the 500 mg tablet dosage form).
With caution: myasthenia gravis; mild to moderate hepatic impairment; end-stage renal failure with GFR less than 10 ml/min; patients with proarrhythmic factors (especially in the elderly) – with congenital or acquired prolongation of the QT interval, patients receiving therapy with class IA (quinidine, procainamide) and III (dofetilide, amiodarone and sotalol) antiarrhythmic agents, cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), with water-electrolyte imbalance, especially in hypokalemia or hypomagnesemia, with clinically significant bradycardia, arrhythmia or severe heart failure; simultaneous use of digoxin, warfarin, cyclosporine.
Use in Pregnancy and Lactation
Use during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. If it is necessary to use azithromycin during lactation, the issue of discontinuing breastfeeding should be decided.
Use in Hepatic Impairment
Contraindicated in severe hepatic impairment.
Use with caution in mild to moderate hepatic impairment.
Use in Renal Impairment
Use with caution in end-stage renal failure with GFR less than 10 ml/min.
Pediatric Use
Contraindicated in children under 6 months of age (for the powder for oral suspension dosage form); under 3 years of age (for the 125 mg tablet dosage form), under 12 years of age with body weight less than 45 kg (for the 500 mg tablet dosage form).
Geriatric Use
In elderly patients, proarrhythmic conditions may be present; Azithromycin should be used with caution due to the high risk of developing arrhythmias, including torsades de pointes ventricular arrhythmia.
Special Precautions
It should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe hepatic failure. If symptoms of liver dysfunction occur, such as rapidly increasing asthenia, jaundice, dark urine, tendency to bleed, hepatic encephalopathy, azithromycin therapy should be discontinued and liver function tests should be performed.
As with the use of other antibacterial drugs, during therapy with azithromycin, patients should be regularly examined for the presence of non-susceptible microorganisms and signs of superinfections, including fungal ones.
Azithromycin should not be used for longer courses than indicated in the instructions, because the pharmacokinetic properties of azithromycin allow recommending a short and simple dosing regimen.
With prolonged use of azithromycin, the development of pseudomembranous colitis caused by Clostridium difficile is possible, ranging from mild diarrhea to severe colitis. If antibiotic-associated diarrhea develops during the use of azithromycin, as well as within 2 months after the end of therapy, pseudomembranous colitis caused by Clostridium difficile should be ruled out. Drugs that inhibit intestinal peristalsis are contraindicated.
During treatment with macrolides, including azithromycin, prolongation of cardiac repolarization and the QT interval has been observed, increasing the risk of developing cardiac arrhythmias, including torsades de pointes arrhythmia.
The use of azithromycin may provoke the development of myasthenic syndrome or cause an exacerbation of myasthenia gravis.
Isolated cases of serious allergic reactions, including angioedema and anaphylaxis (rarely with fatal outcome), dermatological reactions, including acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms (DRESS syndrome) have been noted. Some of the reactions were recurrent and required longer observation and treatment.
Effect on ability to drive vehicles and operate machinery
If adverse effects from the nervous system and organ of vision develop, patients should exercise caution when performing activities requiring increased concentration and speed of psychomotor reactions.
Drug Interactions
Simultaneous use of antibiotics of the macrolide group, including azithromycin, with P-glycoprotein substrates, such as digoxin, leads to an increase in the concentration of the P-glycoprotein substrate in the blood serum. With simultaneous use of digoxin or digitoxin with azithromycin, a significant increase in the concentration of cardiac glycosides in the blood plasma and the risk of glycoside intoxication are possible.
Cases of enhancement of the effects of the latter have been described with simultaneous use of azithromycin with warfarin.
Azithromycin weakly interacts with the cytochrome P450 isoenzymes.
Given the theoretical possibility of ergotism, simultaneous use of azithromycin with ergot alkaloid derivatives is not recommended.
Simultaneous use of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not cause changes in atorvastatin plasma concentrations (based on HMG-CoA reductase inhibition analysis). However, in the post-marketing period, isolated reports of cases of rhabdomyolysis have been received in patients receiving Azithromycin and statins simultaneously.
In pharmacokinetic studies of the effect of a single dose of cimetidine on the pharmacokinetics of azithromycin, no changes in the pharmacokinetics of azithromycin were revealed, provided that cimetidine was administered 2 hours before azithromycin.
Potentiation of the anticoagulant effect has been reported after simultaneous use of azithromycin and indirect anticoagulants (coumarin derivatives). The need for frequent monitoring of prothrombin time should be considered when using azithromycin in patients receiving oral indirect anticoagulants (coumarin derivatives).
Caution should be exercised with simultaneous use with cyclosporine. If simultaneous use is necessary, monitoring of cyclosporine plasma concentration and appropriate dose adjustment should be carried out.
It has been established that the simultaneous use of terfenadine and macrolides can cause arrhythmia and QT interval prolongation.
A case of ventricular fibrillation development has been described with simultaneous use with disopyramide.
Cases of rhabdomyolysis development have been described with simultaneous use with lovastatin.
When used simultaneously with rifabutin, the risk of neutropenia and leukopenia increases.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Capsules 250 mg: 6 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Form
 |
Azithromycin Ecomed® | Capsules 250 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size No. 00, with a red body and cap; the contents of the capsules are a granulated powder white or almost white in color.
| 1 caps. | |
| Azithromycin dihydrate | 278.46 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: lactitol – 250 mg, povidone K17 – 9.3 mg, calcium stearate – 5.6 mg, sodium lauryl sulfate – 0.95 mg, microcrystalline cellulose 102 – to obtain a capsule weighing 560 mg.
Capsule body composition: titanium dioxide – 2.5%, crimson dye [Ponceau 4R] – 1.36%, iron oxide red dye – 0.85%, gelatin – up to 100%.
Capsule cap composition: titanium dioxide – 2.5%, crimson dye [Ponceau 4R] – 1.36%, iron oxide red dye – 0.85%, gelatin – up to 100%.
6 pcs. – blister packs (1) – cardboard packs.
Film-coated tablets, 250 mg: 6 pcs.
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Forms
|
Azithromycin Ecomed® | Film-coated tablets, 250 mg: 6 pcs. |
| Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow in color, capsule-shaped, biconvex; a cross-section shows two layers, the inner layer is white or almost white in color.
| 1 tab. | |
| Azithromycin dihydrate | 262.03 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: lactitol – 300 mg, croscarmellose sodium – 35 mg, hypromellose – 35 mg, pregelatinized starch – 20 mg, magnesium stearate – 14 mg, sodium lauryl sulfate – 3.5 mg, colloidal silicon dioxide – 3.5 mg, microcrystalline cellulose 102 – to obtain an uncoated tablet weighing 700 mg.
Coating composition hypromellose – 9.32 mg, titanium dioxide – 5.2 mg, macrogol 4000 – 3.74 mg, talc – 1.12 mg, povidone K17 – 0.42 mg, quinoline yellow dye – 0.2 mg.
6 pcs. – blister packs (1) – cardboard packs.
Film-coated tablets yellow in color, capsule-shaped, biconvex; a cross-section shows two layers, the inner layer is white or almost white in color.
| 1 tab. | |
| Azithromycin dihydrate | 524.06 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: lactitol – 600 mg, croscarmellose sodium – 70 mg, hypromellose – 70 mg, pregelatinized starch – 40 mg, magnesium stearate – 28 mg, sodium lauryl sulfate – 7 mg, colloidal silicon dioxide – 7 mg, microcrystalline cellulose 102 – to obtain an uncoated tablet weighing 1400 mg.
Coating composition hypromellose – 18.64 mg, titanium dioxide – 10.4 mg, macrogol 4000 – 7.49 mg, talc – 2.24 mg, povidone K17 – 0.83 mg, quinoline yellow dye – 0.4 mg.
3 pcs. – blister packs (1) – cardboard packs.
Powder for oral suspension 100 mg/5 ml: vial in a set with a dosing syringe and/or a measuring spoon
Powder for oral suspension 200 mg/5 ml: vial in a set with a dosing syringe and/or a measuring spoon
Marketing Authorization Holder
Avva Rus, JSC (Russia)
Dosage Forms
|
Azithromycin Ecomed® | Powder for oral suspension 100 mg/5 ml: vial in a set with a dosing syringe and/or a measuring spoon |
| Powder for oral suspension 200 mg/5 ml: vial in a set with a dosing syringe and/or a measuring spoon |
Dosage Form, Packaging, and Composition
Powder for oral suspension white or yellowish-white in color, with a faint fruity odor; prepared suspension: from white to light yellow in color, homogeneous, with a faint fruity odor.
| 5 ml of prepared susp. | |
| Azithromycin dihydrate | 104.82 mg, |
| Equivalent to azithromycin content | 100 mg |
Excipients: lactitol – 200 mg, anhydrous sodium carbonate – 83 mg, crospovidone (collidon CL-M) – 65 mg, strawberry flavor – 55 mg, sodium benzoate – 16.5 mg, xanthan gum – 15 mg, apple flavor – 13.75 mg, cinnamon flavor – 13.75 mg, titanium dioxide – 10 mg, colloidal silicon dioxide – 5.5 mg, mint flavor – 0.5 mg, sucrose – to a mass of 3.75 g.
16.5 g – dark glass vials with a capacity of 60 ml (1) in a set with a dosing syringe and/or a double-sided measuring spoon with a volume of 2.5 ml on one side and 5 ml on the other side – cardboard packs.
Powder for oral suspension white or yellowish-white in color, with a faint fruity odor; prepared suspension: from white to light yellow in color, homogeneous, with a faint fruity odor.
| 5 ml of prepared susp. | |
| Azithromycin dihydrate | 209.64 mg, |
| Equivalent to azithromycin content | 200 mg |
Excipients: lactitol – 400 mg, anhydrous sodium carbonate – 83 mg, crospovidone (collidon CL-M) – 65 mg, strawberry flavor – 55 mg, sodium benzoate – 16.5 mg, xanthan gum – 15 mg, apple flavor – 13.75 mg, cinnamon flavor – 13.75 mg, titanium dioxide – 10 mg, colloidal silicon dioxide – 5.5 mg, mint flavor – 0.5 mg, sucrose – to a mass of 3.75 g.
16.5 g – dark glass vials with a capacity of 60 ml (1) in a set with a dosing syringe and/or a double-sided measuring spoon with a volume of 2.5 ml on one side and 5 ml on the other side – cardboard packs.
Dispersible tablets 250 mg: 3 or 6 pcs.
Dispersible tablets 500 mg: 3 or 6 pcs.
Marketing Authorization Holder
Avexima JSC (Russia)
Manufactured By
Irbit Chemical Pharmaceutical Plant, JSC (Russia)
Dosage Forms
|
Azithromycin Avexima | Dispersible tablets 250 mg: 3 or 6 pcs. |
| Dispersible tablets 500 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets round, flat-cylindrical in shape, white or almost white in color with a small number of inclusions, with a specific odor, with a double-sided bevel and a score on one side.
| 1 tab. | |
| Azithromycin dihydrate | 265.3 mg |
| (calculated as Azithromycin) | 250 mg |
Excipients: crospovidone, “Lemon” flavor, sodium saccharin, vanillin, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose.
3 pcs. – blister pack (1) – cardboard packs.
3 pcs. – blister pack (2) – cardboard packs.
6 pcs. – jar (1) – cardboard packs.
Dispersible tablets oblong, biconvex in shape, white or almost white in color with a small number of inclusions, with a specific odor, with a score on one side.
| 1 tab. | |
| Azithromycin dihydrate | 530.6 mg |
| (calculated as Azithromycin) | 500 mg |
Excipients: crospovidone, “Lemon” flavor, sodium saccharin, vanillin, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose.
3 pcs. – blister pack (1) – cardboard packs.
3 pcs. – blister pack (2) – cardboard packs.
6 pcs. – jar (1) – cardboard packs.
Dispersible tablets 500 mg: 3 pcs.
Dispersible tablets 1000 mg: 1 pc.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Forms
|
Azithromycin Express | Dispersible tablets 500 mg: 3 pcs. |
| Dispersible tablets 1000 mg: 1 pc. |
Dosage Form, Packaging, and Composition
Dispersible tablets white or almost white in color, round, flat, with a bevel and a score on one side.
| 1 tab. | |
| Azithromycin dihydrate | 524.109 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: microcrystalline cellulose 101 – 19.891 mg, microcrystalline cellulose 102 – 310.2 mg, crospovidone (type A) – 99 mg, sodium saccharin dihydrate – 39 mg, aspartame – 39 mg, povidone K30 – 22 mg, colloidal silicon dioxide (aerosil) – 6.6 mg, magnesium stearate – 11 mg, sodium lauryl sulfate (sodium dodecyl sulfate) – 3.2 mg, Orange flavor* – 26 mg.
* Orange flavor composition: natural flavoring substance 18.49%, maltodextrin 57%, gum arabic 24.5%, butylated hydroxyanisole 0.01%.
3 pcs. – blister packs (1) – cardboard packs.
Dispersible tablets white or almost white in color, round, flat, with a bevel and with two perpendicular scores on one side.
| 1 tab. | |
| Azithromycin dihydrate | 1048.218 mg, |
| Equivalent to azithromycin content | 1000 mg |
Excipients: microcrystalline cellulose 101 – 39.782 mg, microcrystalline cellulose 102 – 620.4 mg, crospovidone (type A) – 198 mg, sodium saccharin dihydrate – 78 mg, aspartame – 78 mg, povidone K30 – 44 mg, colloidal silicon dioxide (aerosil) – 13.2 mg, magnesium stearate – 22 mg, sodium lauryl sulfate (sodium dodecyl sulfate) – 6.4 mg, Orange flavor* – 52 mg.
* Orange flavor composition: natural flavoring substance 18.49%, maltodextrin 57%, gum arabic 24.5%, butylated hydroxyanisole 0.01%.
1 pc. – blister packs (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 or 6 pcs.
Marketing Authorization Holder
FP Obolenskoe, JSC (Russia)
Dosage Form
|
Azithromycin Forte | Film-coated tablets, 500 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or white with a yellowish tint in color, oval.
| 1 tab. | |
| Azithromycin (in the form of dihydrate) | 500 mg |
Excipients: calcium stearate, starch 1500, potato starch, crospovidone (collidon CL-M), povidone (polyvinylpyrrolidone), lactose, talc, microcrystalline cellulose.
Coating composition hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene oxide 4000, polyethylene glycol 4000), titanium dioxide (titanium dioxide).
3 pcs. – blister packs (1) – cardboard packs.
3 pcs. – blister packs (2) – cardboard packs.
6 pcs. – blister packs (1) – cardboard packs.
3 pcs. – polymer jars (1) – cardboard packs.
6 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 or 6 pcs.
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Azithromycin Forte-AKOS | Film-coated tablets, 500 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or white with a yellowish tint in color, oval.
| 1 tab. | |
| Azithromycin dihydrate | 524 mg |
| Equivalent to azithromycin content | 500 mg |
Excipients: calcium stearate, starch 1500, potato starch, crospovidone, povidone, lactose monohydrate, talc, microcrystalline cellulose.
Coating composition hypromellose (hydroxypropyl methylcellulose), macrogol 4000 (polyethylene oxide 4000, polyethylene glycol 4000), titanium dioxide (titanium dioxide).
3 pcs. – blister packs (1) – cardboard packs.
3 pcs. – blister packs (2) – cardboard packs.
6 pcs. – blister packs (1) – cardboard packs.
Film-coated tablets, 500 mg: 2, 3, 4, 6, 8, 9, 10, 12, 15, 18, 24, 30, or 36 pcs.
Marketing Authorization Holder
Aliym, JSC (Russia)
Dosage Form
|
Azithromycin Forte-Alium | Film-coated tablets, 500 mg: 2, 3, 4, 6, 8, 9, 10, 12, 15, 18, 24, 30, or 36 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets light blue in color, biconvex, oblong in shape with rounded ends, with a score; the core on a cross-section is white or almost white in color.
| 1 tab. | |
| Azithromycin dihydrate (calculated as active substance) | 500 mg |
Excipients: microcrystalline cellulose type 101, sodium lauryl sulfate, crospovidone, hypromellose (hydroxypropylcellulose), magnesium stearate.
Coating composition Opadry II 85F30695 blue (polyvinyl alcohol, titanium dioxide, macrogol (polyethylene glycol), talc, aluminum lake based on indigo carmine dye, iron oxide yellow dye).
2 pcs. – blister packs (1) – cardboard packs.
2 pcs. – blister packs (2) – cardboard packs.
2 pcs. – blister packs (3) – cardboard packs.
2 pcs. – blister packs (4) – cardboard packs.
2 pcs. – blister packs (5) – cardboard packs.
2 pcs. – blister packs (6) – cardboard packs.
3 pcs. – blister packs (1) – cardboard packs.
3 pcs. – blister packs (2) – cardboard packs.
3 pcs. – blister packs (3) – cardboard packs.
3 pcs. – blister packs (4) – cardboard packs.
3 pcs. – blister packs (5) – cardboard packs.
3 pcs. – blister packs (6) – cardboard packs.
6 pcs. – blister packs (1) – cardboard packs.
6 pcs. – blister packs (2) – cardboard packs.
6 pcs. – blister packs (3) – cardboard packs.
6 pcs. – blister packs (4) – cardboard packs.
6 pcs. – blister packs (5) – cardboard packs.
6 pcs. – blister packs (6) – cardboard packs.
Film-coated tablets, 250 mg: 6 pcs.
Marketing Authorization Holder
Macleods Pharmaceuticals Ltd. (India)
Dosage Form
|
Azithromycin Macleods | Film-coated tablets, 250 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, capsule-shaped, biconvex.
| 1 tab. | |
| Azithromycin (in the form of dihydrate) | 250 mg |
Excipients: calcium hydrogen phosphate 26.48 mg, pregelatinized starch 22.50 mg, crospovidone 29.50 mg, polysorbate 80 30.00 mg, silicon dioxide 8.00 mg, microcrystalline cellulose 125.50 mg, sodium lauryl sulfate 8.00 mg, talc 3.02 mg, magnesium stearate 2.50 mg.
Film coating:
Hypromellose 7.00 mg, titanium dioxide 1.50 mg, macrogol 400 0.98 mg.
6 pcs. – strips made of aluminum foil (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Macleods Pharmaceuticals Ltd. (India)
Dosage Form
|
Azithromycin Macleods | Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, capsule-shaped, biconvex, with a score on one side.
| 1 tab. | |
| Azithromycin (in the form of dihydrate) | 500 mg |
Excipients: calcium hydrogen phosphate 52.96 mg, pregelatinized starch 45.00 mg, crospovidone 59.00 mg, polysorbate 80 60.00 mg, silicon dioxide 16.00 mg, microcrystalline cellulose 250.00 mg, sodium lauryl sulfate 16.00 mg, talc 6.09 mg, magnesium stearate 5.00 mg.
Film coating:
Hypromellose 14.40 mg, titanium dioxide 3.51 mg, macrogol 400 2.00 mg.
3 pcs. – strips made of aluminum foil (1) – cardboard packs.
Film-coated tablets, 125 mg: 6 pcs.
Film-coated tablets, 250 mg: 6 pcs.
Film-coated tablets, 500 mg: 6 pcs.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Forms
|
Azithromycin Renewal | Film-coated tablets, 125 mg: 6 pcs. |
| Film-coated tablets, 250 mg: 6 pcs. | ||
| Film-coated tablets, 500 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 131.027 mg, |
| Equivalent to azithromycin content | 125 mg |
Excipients: anhydrous calcium hydrogen phosphate, pregelatinized starch, microcrystalline cellulose 101, croscarmellose sodium, corn starch, magnesium stearate, hypromellose, colloidal silicon dioxide (aerosil), sodium lauryl sulfate.
Coating composition Vivacoat PC-IO-609 white [hypromellose, titanium dioxide, polysorbate 80, talc].
3 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 262.055 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: anhydrous calcium hydrogen phosphate, pregelatinized starch, microcrystalline cellulose 101, croscarmellose sodium, corn starch, magnesium stearate, hypromellose, colloidal silicon dioxide (aerosil), sodium lauryl sulfate.
Coating composition Vivacoat PC-IO-609 white [hypromellose, titanium dioxide, polysorbate 80, talc].
3 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
Film-coated tablets white or almost white, oval, biconvex, with a score on one side; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 524.109 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: anhydrous calcium hydrogen phosphate, pregelatinized starch, microcrystalline cellulose 101, croscarmellose sodium, corn starch, magnesium stearate, hypromellose, colloidal silicon dioxide (aerosil), sodium lauryl sulfate.
Coating composition Vivacoat PC-IO-609 white [hypromellose, titanium dioxide, polysorbate 80, talc].
3 pcs. – contour cell blisters (1) – cardboard packs.
3 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
Powder for the preparation of oral suspension 100 mg/5 ml: bottle 16.5 g
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
S.C. Sandoz, S.r.L. (Romania)
Dosage Form
|
Azithromycin Sandoz® | Powder for the preparation of oral suspension 100 mg/5 ml: bottle 16.5 g |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral suspension from white to white with a yellowish tint, with a specific caramel odor; the ready-to-use suspension is a homogeneous suspension from white to white with a yellowish tint, with a specific caramel odor.
| 1 dose | |
| Azithromycin monohydrate | 102.4 mg1, |
| Equivalent to azithromycin content | 100 mg |
Excipients: sucrose (powder)2 – 2665.13 mg, sucrose (powder) – 1142.1 mg, xanthan gum – 6.66 mg, hydroxypropylcellulose – 6.66 mg, anhydrous trisodium phosphate – 18.395 mg, anhydrous colloidal silicon dioxide – 4 mg, aspartame – 30 mg, creamy caramel flavor – 13 mg, titanium dioxide – 11.66 mg.
1content is adjusted if the quantitative determination result based on “as is” is not more than 99%.
2 the amount is adjusted depending on the initial mass of the active substance taken (mass adjustment).
16.5 g – polyethylene bottles (1) – cardboard packs.
Powder for the preparation of oral suspension 200 mg/5 ml: bottle 12.4 g, 16.5 g, 18.5 g, 24.8 g, or 31 g
Marketing Authorization Holder
Sandoz, d.d. (Slovenia)
Manufactured By
S.C. Sandoz, S.r.L. (Romania)
Dosage Form
|
Azithromycin Sandoz® | Powder for the preparation of oral suspension 200 mg/5 ml: bottle 12.4 g, 16.5 g, 18.5 g, 24.8 g, or 31 g |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral suspension from white to white with a yellowish tint, with a specific caramel odor; the ready-to-use suspension is a homogeneous suspension from white to white with a yellowish tint, with a specific caramel odor.
| 1 dose | |
| Azithromycin monohydrate | 204.8 mg1, |
| Equivalent to azithromycin content | 200 mg |
Excipients: sucrose (powder)2 – 2593.33 mg, sucrose (powder) – 1111.5 mg, xanthan gum – 6.66 mg, hydroxypropylcellulose – 6.66 mg, anhydrous trisodium phosphate – 18.395 mg, anhydrous colloidal silicon dioxide – 4 mg, aspartame – 30 mg, creamy caramel flavor – 13 mg, titanium dioxide – 11.66 mg.
1content is adjusted if the quantitative determination result based on “as is” is not more than 99%.
2 the amount is adjusted depending on the initial mass of the active substance taken (mass adjustment).
12.4 g – polyethylene bottles (1) – cardboard packs.
16.5 g – polyethylene bottles (1) – cardboard packs.
18.5 g – polyethylene bottles (1) – cardboard packs.
24.8 g – polyethylene bottles (1) – cardboard packs.
31 g – polyethylene bottles (1) – cardboard packs.
Film-coated tablets, 250 mg: 3 or 6 pcs.
Marketing Authorization Holder
Sanofi Russia JSC (Russia)
Manufactured By
Zentiva, k.s. (Czech Republic)
Dosage Form
|
Azithromycin Sanofi | Film-coated tablets, 250 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from white to almost white, round, biconvex.
| 1 tab. | |
| Azithromycin dihydrate | 262.026 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: pregelatinized corn starch – 42.5 mg, croscarmellose sodium – 9 mg, calcium hydrogen phosphate – 115.625 mg, magnesium stearate – 6.375 mg, sodium lauryl sulfate – 1.5 mg.
Coating composition hypromellose 2910/5 – 7.3 mg, titanium dioxide – 3.1 mg, macrogol 6000 – 0.7 mg, talc – 1.25 mg, simethicone emulsion SE4 (water – 67.4%, siloxanes and silicones – 30%, methylcellulose – 2.5%, sorbic acid – 0.1%) – 0.05 mg, polysorbate 80 – 0.1 mg.
3 pcs. – blisters (1) – cardboard packs.
3 pcs. – blisters (2) – cardboard packs.
6 pcs. – blisters (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Sanofi Russia JSC (Russia)
Manufactured By
Zentiva, k.s. (Czech Republic)
Dosage Form
|
Azithromycin Sanofi | Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets from white to almost white, oblong.
| 1 tab. | |
| Azithromycin dihydrate | 524.052 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: pregelatinized corn starch – 85 mg, croscarmellose sodium – 18 mg, calcium hydrogen phosphate – 231.25 mg, magnesium stearate – 12.75 mg, sodium lauryl sulfate – 3 mg.
Coating composition hypromellose 2910/5 – 14.6 mg, titanium dioxide – 6.2 mg, macrogol 6000 – 1.4 mg, talc – 2.5 mg, simethicone emulsion SE4 (water – 67.4%, siloxanes and silicones – 30%, methylcellulose – 2.5%, sorbic acid – 0.1%) – 0.1 mg, polysorbate 80 – 0.2 mg.
3 pcs. – blisters (1) – cardboard packs.
Capsules 250 mg: 3, 6, 10, 12, or 20 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Form
|
Azithromycin Velpharm | Capsules 250 mg: 3, 6, 10, 12, or 20 pcs. |
Dosage Form, Packaging, and Composition
Capsules No. 0 white; capsule contents – powder from white to white with a yellowish tint.
| 1 caps. | |
| Azithromycin dihydrate | 262 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: mannitol, corn starch, magnesium stearate, sodium lauryl sulfate.
Capsule shell composition titanium dioxide, gelatin.
3 pcs. – contour cell blisters (1) – cardboard packs.
3 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
6 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
Film-coated tablets 125 mg: 3, 6, 9, 10, 12, 15, 18, 20, 21, 24, 27, 30, 36, 40, 42, 48, 50, 54, 60, 70, 80, 90, or 100 pcs.
Film-coated tablets 500 mg: 3, 6, 9, 10, 12, 15, 18, 20, 21, 24, 27, 30, 36, 40, 42, 48, 50, 54, 60, 70, 80, 90, or 100 pcs.
Marketing Authorization Holder
Velpharm, LLC (Russia)
Dosage Forms
|
Azithromycin Velpharm | Film-coated tablets 125 mg: 3, 6, 9, 10, 12, 15, 18, 20, 21, 24, 27, 30, 36, 40, 42, 48, 50, 54, 60, 70, 80, 90, or 100 pcs. |
| Film-coated tablets 500 mg: 3, 6, 9, 10, 12, 15, 18, 20, 21, 24, 27, 30, 36, 40, 42, 48, 50, 54, 60, 70, 80, 90, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 131.027 mg, |
| Equivalent to azithromycin content | 125 mg |
Excipients: microcrystalline cellulose 101, lactose monohydrate, povidone K30 (kollidon K30), crospovidone (kollidon CL, kollidon CL-M), sodium lauryl sulfate, colloidal silicon dioxide (aerosil), magnesium stearate.
Coating composition: dry film coating mixture Opadry 03F180011 white, containing hypromellose, titanium dioxide, macrogol or hypromellose, titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000).
3 pcs. – contour cell blisters – cardboard packs.
3 pcs. – contour cell blisters (2) – cardboard packs.
3 pcs. – contour cell blisters (3) – cardboard packs.
3 pcs. – contour cell blisters (4) – cardboard packs.
3 pcs. – contour cell blisters (5) – cardboard packs.
3 pcs. – contour cell blisters (6) – cardboard packs.
3 pcs. – contour cell blisters (7) – cardboard packs.
3 pcs. – contour cell blisters (8) – cardboard packs.
3 pcs. – contour cell blisters (9) – cardboard packs.
3 pcs. – contour cell blisters (10) – cardboard packs.
6 pcs. – contour cell blisters – cardboard packs.
6 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (3) – cardboard packs.
6 pcs. – contour cell blisters (4) – cardboard packs.
6 pcs. – contour cell blisters (5) – cardboard packs.
6 pcs. – contour cell blisters (6) – cardboard packs.
6 pcs. – contour cell blisters (7) – cardboard packs.
6 pcs. – contour cell blisters (8) – cardboard packs.
6 pcs. – contour cell blisters (9) – cardboard packs.
6 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
70 pcs. – jars – cardboard packs.
80 pcs. – jars – cardboard packs.
90 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 524.109 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: microcrystalline cellulose 101, lactose monohydrate, povidone K30 (kollidon K30), crospovidone (kollidon CL, kollidon CL-M), sodium lauryl sulfate, colloidal silicon dioxide (aerosil), magnesium stearate.
Coating composition: dry mix for film coating Opadry 03F180011 white, containing hypromellose, titanium dioxide, macrogol or hypromellose, titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000).
3 pcs. – contour cell blisters – cardboard packs.
3 pcs. – contour cell blisters (2) – cardboard packs.
3 pcs. – contour cell blisters (3) – cardboard packs.
3 pcs. – contour cell blisters (4) – cardboard packs.
3 pcs. – contour cell blisters (5) – cardboard packs.
3 pcs. – contour cell blisters (6) – cardboard packs.
3 pcs. – contour cell blisters (7) – cardboard packs.
3 pcs. – contour cell blisters (8) – cardboard packs.
3 pcs. – contour cell blisters (9) – cardboard packs.
3 pcs. – contour cell blisters (10) – cardboard packs.
6 pcs. – contour cell blisters – cardboard packs.
6 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (3) – cardboard packs.
6 pcs. – contour cell blisters (4) – cardboard packs.
6 pcs. – contour cell blisters (5) – cardboard packs.
6 pcs. – contour cell blisters (6) – cardboard packs.
6 pcs. – contour cell blisters (7) – cardboard packs.
6 pcs. – contour cell blisters (8) – cardboard packs.
6 pcs. – contour cell blisters (9) – cardboard packs.
6 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (7) – cardboard packs.
10 pcs. – contour cell blisters (8) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – jars – cardboard packs.
20 pcs. – jars – cardboard packs.
30 pcs. – jars – cardboard packs.
40 pcs. – jars – cardboard packs.
50 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.
70 pcs. – jars – cardboard packs.
80 pcs. – jars – cardboard packs.
90 pcs. – jars – cardboard packs.
100 pcs. – jars – cardboard packs.
Powder for the preparation of oral suspension 200 mg/5 ml: bottle 14.5 g (15 ml) incl. with a dosing set
Marketing Authorization Holder
Zentiva, k.s. (Czech Republic)
Manufactured By
Zentiva Saglik Urunleri Sanayi Ve Ticaret, A.S. (Turkey)
Dosage Form
|
Azithromycin Zentiva | Powder for the preparation of oral suspension 200 mg/5 ml: bottle 14.5 g (15 ml) incl. with a dosing set |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral suspension from white to almost white, granular, with a characteristic banana odor; after dissolution in water – a homogeneous suspension from white to light yellow, with a characteristic banana odor.
| 1 bottle (15 ml) | |
| Azithromycin dihydrate | 730 mg, |
| Equivalent to azithromycin content | 697 mg |
Each 5 ml of the prepared suspension contains: azithromycin dihydrate – 209.6 mg (equivalent to Azithromycin 200 mg).
Excipients : sucrose (Alveo Sucre Fin) – 13,546 mg, sodium phosphate – 62 mg, hypromellose (Klucel LF) – 23 mg, xanthan gum – 23 mg, banana flavor – 116 mg.
14.5 g – high-density polyethylene bottles with a volume of 15 ml in a set with a dosing set (measuring spoon, measuring cap, syringe with cap, syringe adapter) – cardboard packs.
Powder for preparation of oral suspension 200 mg/5 ml: bottle 29 g (30 ml) in set with dosing set
Marketing Authorization Holder
Zentiva, k.s. (Czech Republic)
Manufactured By
Zentiva Saglik Urunleri Sanayi Ve Ticaret, A.S. (Turkey)
Dosage Form
|
Azithromycin Zentiva | Powder for preparation of oral suspension 200 mg/5 ml: bottle 29 g (30 ml) in set with dosing set |
Dosage Form, Packaging, and Composition
Powder for the preparation of oral suspension from white to almost white, granular, with a characteristic banana odor; after dissolution in water – a homogeneous suspension from white to light yellow, with a characteristic banana odor.
| 1 bottle (30 ml) | |
| Azithromycin dihydrate | 1459 mg, |
| Equivalent to azithromycin content | 1392 mg |
Each 5 ml of the prepared suspension contains: azithromycin dihydrate – 209.6 mg (equivalent to Azithromycin 200 mg).
Excipients : sucrose (Alveo Sucre Fin) – 27,093 mg, sodium phosphate – 124 mg, hypromellose (Klucel LF) – 46 mg, xanthan gum – 46 mg, banana flavor – 232 mg.
29 g – high-density polyethylene bottles with a volume of 30 ml in a set with a dosing set (measuring spoon, measuring cap, syringe with cap, syringe adapter) – cardboard packs.
Capsules 250 mg: 3, 6, or 10 pcs.
Marketing Authorization Holder
Advanced Pharma, LLC (Russia)
Dosage Form
|
Azithromycin-Advanced | Capsules 250 mg: 3, 6, or 10 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size No. 0; capsule body white, capsule cap orange; capsule contents – powder white or white with a slight yellowish tint.
| 1 caps. | |
| Azithromycin dihydrate | 262.25 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients : corn starch – 85 mg, magnesium stearate – 3.75 mg, sodium starch glycolate – 15 mg, talc – 9 mg.
Hard gelatin capsule No. 0:
Capsule body gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 3%.
Capsule cap: gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 2.2%, quinoline yellow dye (E104) – 0.25%, ponceau 4R dye (E124) – 0.05%.
3 pcs. – blisters (2) – cardboard packs
10 pcs. – blisters (1) – cardboard packs
3 pcs. – jars (1) – cardboard packs
6 pcs. – jars (1) – cardboard packs
10 pcs. – jars (1) – cardboard packs
Capsules 500 mg: 3, 6, or 10 pcs.
Marketing Authorization Holder
Advanced Pharma, LLC (Russia)
Dosage Form
|
Azithromycin-Advanced | Capsules 500 mg: 3, 6, or 10 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard, gelatin, size No. 00, capsule body white, cap – yellow; capsule contents – powder white or white with a slight yellowish tint.
| 1 caps. | |
| Azithromycin dihydrate | 524.1 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients : corn starch – 24.5 mg, magnesium stearate – 5.7 mg, sodium starch glycolate – 10 mg, talc – 5.7 mg.
Capsule body composition: gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 3%.
Capsule cap composition gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 1.84%, quinoline yellow dye (E104) – 0.52%.
3 pcs. – blisters (1) – cardboard packs.
3 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
3 pcs. – jars (1) – cardboard packs.
6 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
Capsules 250 mg: 6, 10, 12, or 20 pcs.
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Azithromycin-AKOS | Capsules 250 mg: 6, 10, 12, or 20 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size No. 0, white; capsule contents – granulated powder white or almost white.
| 1 caps. | |
| Azithromycin dihydrate | 262 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients : macrogol 4000 (polyethylene glycol 4000), sodium lauryl sulfate, crospovidone, talc, calcium stearate, microcrystalline cellulose.
Gelatin capsule composition titanium dioxide, gelatin.
6 pcs. – contour cell blisters (1) – cardboard packs.
6 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
Capsules 250 mg: 6 pcs.
Marketing Authorization Holder
Wockhardt Ltd. (India)
Manufactured By
Wockhardt Ltd. (India)
Labeled By
WOCKHARDT, Ltd. (India)
Or
Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)
Quality Control Release
WOCKHARDT, Ltd. (India)
Dosage Form
|
Azithromycin-Akrikhin | Capsules 250 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size No. 0, body and cap yellowish-white; capsule contents – white or almost white powder.
| 1 caps. | |
| Azithromycin dihydrate | 262.03 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients : lactose – 132.3 mg, corn starch – 33 mg, sodium lauryl sulfate – 2 mg, magnesium stearate – 8 mg.
Capsule composition (body and cap) quinoline yellow dye, sunset yellow FCF dye, titanium dioxide, gelatin, purified water, sodium lauryl sulfate, propylparaben (propylparahydroxybenzoate), methylparaben (methylparahydroxybenzoate).
6 pcs. – blisters (1) – cardboard packs.
Film-coated tablets, 250 mg: 6 pcs.
Marketing Authorization Holder
Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)
Manufactured By
Micro Labs Limited (India)
Dosage Form
|
Azithromycin-Akrikhin | Film-coated tablets, 250 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, oblong, biconvex; color of the fracture – white or almost white.
| 1 tab. | |
| Azithromycin (as dihydrate) | 262.5 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients : corn starch, lactose, calcium hydrogen phosphate, microcrystalline cellulose PH102, povidone K-30, croscarmellose sodium, sodium lauryl sulfate, talc, magnesium stearate, colloidal silicon dioxide.
Film coating composition hypromellose, titanium dioxide, talc, propylene glycol.
6 pcs. – blisters (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 or 10 pcs.
Marketing Authorization Holder
Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)
Manufactured By
Micro Labs Limited (India)
Dosage Form
|
Azithromycin-Akrikhin | Film-coated tablets, 500 mg: 3 or 10 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, oblong, biconvex, with a score on one side; color of the fracture – white or almost white.
| 1 tab. | |
| Azithromycin (as dihydrate) | 525 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients : corn starch, lactose, calcium hydrogen phosphate, microcrystalline cellulose PH102, povidone K-30, croscarmellose sodium, sodium lauryl sulfate, talc, magnesium stearate, colloidal silicon dioxide.
Film coating composition hypromellose, titanium dioxide, talc, propylene glycol.
3 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
Capsules 250 mg: 6 or 10 pcs.
Marketing Authorization Holder
Aliym, JSC (Russia)
Dosage Form
|
Azithromycin-Alium | Capsules 250 mg: 6 or 10 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size No. 1, with a blue cap and a light blue body; capsule contents – a mixture of powder and granules white or almost white.
| 1 caps. | |
| Azithromycin dihydrate | 262 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients : microcrystalline cellulose type 101, povidone K30 (low molecular weight polyvinylpyrrolidone), crospovidone, calcium stearate, sodium lauryl sulfate.
Capsule body composition titanium dioxide, patent blue dye, brilliant black dye, gelatin.
Capsule cap composition titanium dioxide, azorubine dye, ponceau 4R dye, patent blue dye, brilliant black dye, gelatin.
6 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
Film-coated tablets, 250 mg: 3 or 6 pcs.
Marketing Authorization Holder
Protek-SVM LLC (Russia)
Manufactured By
Jubilant Life Sciences, Ltd (India)
Dosage Form
|
Azithromycin-LEKSVM® | Film-coated tablets, 250 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, oval, biconvex; with engraving “AZ” and “250” on one side and smooth on the other.
| 1 tab. | |
| Azithromycin dihydrate | 262.02 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients : calcium dihydrogen phosphate – 96.73 mg, croscarmellose sodium – 25 mg, pregelatinized starch – 45 mg, hypromellose – 13.5 mg, sodium lauryl sulfate – 0.75 mg, magnesium stearate – 7 mg.
Film coating composition (Opadry II white 31K58902) lactose monohydrate – 5.4 mg, hypromellose – 3.78 mg, titanium dioxide – 3.24 mg, triacetin – 1.08 mg.
3 pcs. – Al/PVC blisters (1) – cardboard packs.
3 pcs. – Al/PVC blisters (2) – cardboard packs.
Film-coated tablets, 500 mg: 3 or 6 pcs.
Marketing Authorization Holder
Protek-SVM LLC (Russia)
Manufactured By
Jubilant Life Sciences, Ltd (India)
Dosage Form
|
Azithromycin-LEKSVM® | Film-coated tablets, 500 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, oval, biconvex; engraved with “AZ” and “500” on one side and smooth on the other.
| 1 tab. | |
| Azithromycin dihydrate | 524.04 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: calcium hydrogen phosphate dihydrate – 193.46 mg, croscarmellose sodium – 50 mg, pregelatinized starch – 90 mg, hypromellose – 27 mg, sodium lauryl sulfate – 1.5 mg, magnesium stearate – 14 mg.
Film coating composition (Opadry II white 31K58902): lactose monohydrate – 10.8 mg, hypromellose – 7.56 mg, titanium dioxide – 6.48 mg, triacetin – 2.16 mg.
3 pcs. – Al/PVC blisters (1) – cardboard packs.
3 pcs. – Al/PVC blisters (2) – cardboard packs.
Capsules 250 mg: 3, 6, or 10 pcs.
Capsules 500 mg: 3 or 10 pcs.
Marketing Authorization Holder
Scan Biotech LLC (India)
Manufactured By
Rozlex Pharm LLC (Russia)
Dosage Forms
|
Azithromycin-Rozlex | Capsules 250 mg: 3, 6, or 10 pcs. |
| Capsules 500 mg: 3 or 10 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #0, white body, orange cap; capsule contents – white powder or white powder with a slight yellowish tint.
| 1 caps. | |
| Azithromycin dihydrate | 262.05 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: microcrystalline cellulose 102 – 109.2 mg, magnesium stearate – 3.75 mg.
Capsule body composition: gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 3.3%, sodium lauryl sulfate – 0.1%.
Capsule cap composition: gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 2.2%, quinoline yellow (E104) – 0.25%, sodium lauryl sulfate – 0.1%, ponceau 4R (E124) – 0.05%.
3 pcs. – blisters (1) – cardboard packs.
3 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
3 pcs. – jars (1) – cardboard packs.
6 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
Capsules hard gelatin, size #00, white body, yellow cap; capsule contents – white powder or white powder with a slight yellowish tint.
| 1 caps. | |
| Azithromycin dihydrate | 524.1 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: microcrystalline cellulose 102 – 40.2 mg, magnesium stearate – 5.7 mg.
Capsule body composition: gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 3.3%, sodium lauryl sulfate – 0.1%.
Capsule cap composition: gelatin – up to 100%, purified water – 14.5%, titanium dioxide (E171) – 1.84%, quinoline yellow (E104) – 0.52%, sodium lauryl sulfate – 0.1%.
3 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
3 pcs. – jars (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
Dispersible tablets 125 mg: 6 pcs.
Dispersible tablets 250 mg: 6 pcs.
Dispersible tablets 500 mg: 3 or 6 pcs.
Dispersible tablets 1000 mg: 1 or 3 pcs.
Marketing Authorization Holder
Teva Pharmaceutical Industries, Ltd. (Israel)
Manufactured By
Pliva Hrvatska, d.o.o. (Croatia)
Dosage Forms
|
Azithromycin-Teva | Dispersible tablets 125 mg: 6 pcs. |
| Dispersible tablets 250 mg: 6 pcs. | ||
| Dispersible tablets 500 mg: 3 or 6 pcs. | ||
| Dispersible tablets 1000 mg: 1 or 3 pcs. |
Dosage Form, Packaging, and Composition
Dispersible tablets white or almost white, round, flat, with beveled edges and the inscription “TEVA 125” embossed on one side.
| 1 tab. | |
| Azithromycin dihydrate | 131.027 mg, |
| Equivalent to azithromycin content | 125 mg |
Excipients: sodium saccharin dihydrate – 9.75 mg, microcrystalline cellulose (type 101) – 4.973 mg, microcrystalline cellulose (type 102) – 82.2 mg, crospovidone type A – 20.65 mg, povidone K30 – 5.5 mg, sodium lauryl sulfate – 0.8 mg, colloidal silicon dioxide – 1.1 mg, magnesium stearate – 2.75 mg, banana flavor – 6.5 mg, aspartame – 9.75 mg.
6 pcs. – blisters (1) – cardboard packs×.
× protective stickers may additionally be applied.
Dispersible tablets white or almost white, round, flat, with beveled edges, with a score on one side and the inscription “TEVA 250” embossed on the other side.
| 1 tab. | |
| Azithromycin dihydrate | 262.055 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: sodium saccharin dihydrate – 19.5 mg, microcrystalline cellulose (type 101) – 9.945 mg, microcrystalline cellulose (type 102) – 164.4 mg, crospovidone type A – 41.3 mg, povidone K30 – 11 mg, sodium lauryl sulfate – 1.6 mg, colloidal silicon dioxide – 2.2 mg, magnesium stearate – 5.5 mg, orange flavor – 13 mg, aspartame – 19.5 mg.
6 pcs. – blisters (1) – cardboard packs×.
× protective stickers may additionally be applied.
Dispersible tablets white or almost white, round, flat, with beveled edges, with a score on one side and the inscription “TEVA 500” embossed on the other side.
| 1 tab. | |
| Azithromycin dihydrate | 524.109 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: sodium saccharin dihydrate – 39 mg, microcrystalline cellulose (type 101) – 19.891 mg, microcrystalline cellulose (type 102) – 328.8 mg, crospovidone type A – 82.6 mg, povidone K30 – 22 mg, sodium lauryl sulfate – 3.2 mg, colloidal silicon dioxide – 4.4 mg, magnesium stearate – 11 mg, orange flavor – 26 mg, aspartame – 39 mg.
3 pcs. – blisters (1) – cardboard packs×.
3 pcs. – blisters (2) – cardboard packs×.
× protective stickers may additionally be applied.
Dispersible tablets white or almost white, round, flat, with beveled edges, with two perpendicular scores on one side and the inscription “TEVA 1000” embossed on the other side.
| 1 tab. | |
| Azithromycin dihydrate | 1048.218 mg, |
| Equivalent to azithromycin content | 1000 mg |
Excipients: sodium saccharin dihydrate – 78 mg, microcrystalline cellulose (type 101) – 39.782 mg, microcrystalline cellulose (type 102) – 657.6 mg, crospovidone type A – 165.2 mg, povidone K30 – 44 mg, sodium lauryl sulfate – 6.4 mg, colloidal silicon dioxide – 8.8 mg, magnesium stearate – 22 mg, orange flavor – 52 mg, aspartame – 78 mg.
1 pcs. – blisters (1) – cardboard packs×.
1 pcs. – blisters (3) – cardboard packs×.
× protective stickers may additionally be applied.
Capsules 250 mg: 6 or 10 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Azithromycin-Vertex | Capsules 250 mg: 6 or 10 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size #0, white; capsule contents – white powder or white powder with a light yellow tint; the presence of conglomerates is allowed, which, when pressed with a glass rod, easily turn into a free-flowing powder.
| 1 caps. | |
| Azithromycin dihydrate | 262.02 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: lactose monohydrate – 61.98 mg, microcrystalline cellulose – 40.6 mg, magnesium stearate – 3.7 mg, povidone K17 (low molecular weight polyvinylpyrrolidone) – 1 mg, sodium lauryl sulfate – 0.7 mg.
Composition of hard gelatin capsules: titanium dioxide – 2%, gelatin – up to 100%.
6 pcs. – polymer jars (1) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
Film-coated tablets, 125 mg: 6 pcs.
Film-coated tablets, 500 mg: 3 or 6 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Forms
|
Azithromycin-Vertex | Film-coated tablets, 125 mg: 6 pcs. |
| Film-coated tablets, 500 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 131.009 mg, |
| Equivalent to azithromycin content | 125 mg |
Excipients: microcrystalline cellulose – 9 mg, lactose monohydrate – 8.366 mg, povidone K-30 – 6.5 mg, crospovidone – 6.5 mg, sodium lauryl sulfate – 0.325 mg, colloidal silicon dioxide – 1.65 mg, magnesium stearate – 1.65 mg.
Film coating composition[hypromellose, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000)] or [dry mix for film coating containing hypromellose, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000)].
3 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
Film-coated tablets white or almost white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 524.036 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: 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.
Film coating composition[hypromellose, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000)] or [dry mix for film coating containing hypromellose, talc, titanium dioxide, macrogol 4000 (polyethylene glycol 4000)].
3 pcs. – contour cell blisters (1) – cardboard packs.
3 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
![Azithromycin [Tablets, Capsules, Powder] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Azithromycin [Tablets, Capsules, Powder] 2")