Azithromycin (Tablets, Capsules, Lyophilisate) 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 blood 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 passes through 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% through the intestines, 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 Azithromycin orally as tablets or capsules, or receive it intravenously as a lyophilisate infusion.
For adults with upper and lower respiratory tract, skin, or soft tissue infections: administer 500 mg once daily for 3 days.
For uncomplicated genital infections caused by Chlamydia trachomatis: administer a single 1 gram (1000 mg) dose.
For the initial stage of Lyme disease (erythema migrans): administer 1 gram (1000 mg) on the first day, followed by 500 mg once daily for the next 4 days (total course dose: 3 grams).
For intravenous administration (lyophilisate): prepare a solution and infuse 500 mg once daily. The maximum duration of IV therapy is 5 days; subsequently, switch to oral administration to complete the course.
Take oral doses at least one hour before or two hours after a meal. Do not take with antacids.
For pediatric patients (over 6 months), calculate the dose based on body weight (10 mg/kg once daily for 3 days). Do not use 500 mg tablets in children under 12 years weighing less than 45 kg.
In patients with mild to moderate hepatic impairment or severe renal impairment (GFR <10 mL/min), use with caution and monitor for adverse effects.
Complete the full prescribed course even if symptoms improve. Do not exceed the recommended duration of therapy.
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 with 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 perversion, paresthesia, somnolence, insomnia, nervousness; rarely – agitation; frequency unknown – hypoesthesia, anxiety, aggression, syncope, convulsions, psychomotor hyperactivity, loss of smell, smell perversion, 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); in children under 3 years of age (for the 125 mg tablet dosage form), in children 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 appear, such as rapidly increasing asthenia, jaundice, dark urine, tendency to bleed, hepatic encephalopathy, azithromycin therapy should be discontinued and a study of the functional state of the liver should be conducted.
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 2 months after the end of therapy, pseudomembranous colitis caused by Clostridium difficile should be excluded. 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 enhanced effects of the latter have been described with simultaneous use of azithromycin with warfarin.
Azithromycin weakly interacts with the cytochrome P450 system 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-registration 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 during concomitant use with cyclosporine. If concomitant use is necessary, monitoring of cyclosporine plasma concentration should be performed and the dose should be adjusted accordingly.
Concomitant use of terfenadine and macrolides has been found to cause arrhythmia and QT interval prolongation.
A case of ventricular fibrillation has been described with concomitant use with disopyramide.
Cases of rhabdomyolysis have been described with concomitant use with lovastatin.
Concomitant use with rifabutin increases the risk of neutropenia and leukopenia.
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: 3, 6, or 10 pcs.
Capsules 500 mg: 3 or 10 pcs.
Marketing Authorization Holder
Jivdhara Pharma, Private Limited (India)
Manufactured By
Rozlex Pharm LLC (Russia)
Or
NPC Scan Biotek, LLC (Russia)
Dosage Forms
 |
Azithromycin | 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 dye (E104) – 0.25%, sodium lauryl sulfate – 0.1%, ponceau 4R dye (E 124) – 0.05%.
3 pcs. – blisters (1) – cardboard packs.
3 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (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 dye (E104) – 0.52%, sodium lauryl sulfate – 0.1%.
3 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
Capsules 500 mg: 3 pcs.
Marketing Authorization Holder
Kern Pharma S.L. (Spain)
Labeled By
SINTEZ, PJSC (Russia)
Dosage Form
|
Azithromycin | Capsules 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Azithromycin | 500 mg |
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (100) – cardboard boxes.
3 pcs. – contour cell packs (200) – cardboard boxes.
3 pcs. – contour cell packs (500) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer drums.
1000 pcs. – polyethylene bags (1) – polymer drums.
2000 pcs. – polyethylene bags (1) – polymer drums.
5000 pcs. – polyethylene bags (1) – polymer drums.
Capsules 500 mg: 3 pcs.
Marketing Authorization Holder
Kern Pharma S.L. (Spain)
Labeled By
DEKO COMPANY, LLC (Russia)
Dosage Form
|
Azithromycin | Capsules 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Azithromycin | 500 mg |
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (100) – cardboard boxes.
3 pcs. – contour cell packs (200) – cardboard boxes.
3 pcs. – contour cell packs (500) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer drums.
1000 pcs. – polyethylene bags (1) – polymer drums.
2000 pcs. – polyethylene bags (1) – polymer drums.
5000 pcs. – polyethylene bags (1) – polymer drums.
Capsules 500 mg: 3 pcs.
Marketing Authorization Holder
Kern Pharma S.L. (Spain)
Dosage Form
|
Azithromycin | Capsules 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Azithromycin | 500 mg |
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (100) – cardboard boxes.
3 pcs. – contour cell packs (200) – cardboard boxes.
3 pcs. – contour cell packs (500) – cardboard boxes.
500 pcs. – polyethylene bags (1) – polymer drums.
1000 pcs. – polyethylene bags (1) – polymer drums.
2000 pcs. – polyethylene bags (1) – polymer drums.
5000 pcs. – polyethylene bags (1) – polymer drums.
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Lok-Beta Pharmaceuticals (India), Private Limited (India)
Dosage Form
|
Azithromycin | Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets
| Azithromycin | 500 mg |
3 pcs. – blisters – cardboard packs (3 pcs.) – By prescription
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Repliek Farm Ltd. Skopje (Republic of North Macedonia)
Manufactured By
Repliek Farm Ltd. Skopje (Republic of North Macedonia)
Packaging and Quality Control Release
REPLEK FARM Ltd. Skopje (Republic of North Macedonia)
Or
Berezovsky Pharmaceutical Plant, CJSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, oval, biconvex, with a score on one side dividing the tablet into two equal halves; a white core and a thin white film coating are visible on the cross-section of the tablet.
| 1 tab. | |
| Azithromycin dihydrate | 524 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: pregelatinized starch – 63 mg, hypromellose – 63 mg, copovidone – 36 mg, crospovidone – 31.5 mg, anhydrous calcium hydrogen phosphate – 142 mg, talc – 22.5 mg, sodium lauryl sulfate – 7.2 mg, magnesium stearate – 10.8 mg.
Film coating composition hypromellose – 13.6 mg, macrogol 6000 – 2.7 mg, talc – 15 mg, titanium dioxide – 3.6 mg, dimethicone – 0.1 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion 500 mg: vial 1 or 5 pcs.
Marketing Authorization Holder
Argumentum, LLC (Russia)
Manufactured By
S.C. Rompharm Company S.R.L. (Romania)
Dosage Form
|
Azithromycin | Lyophilizate for the preparation of solution for infusion 500 mg: vial 1 or 5 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for solution for infusion – white or almost white lyophilized powder.
| 1 vial | |
| Azithromycin | 500 mg |
| (in terms of azithromycin dihydrate) | 524.03 mg |
Excipients: citric acid – 413.6 mg, sodium hydroxide – 130 mg, sodium hydroxide solution 25% (for pH adjustment).
500 mg – vials (1) – cardboard packs (1).
500 mg – vials (5) – cardboard packs (1).
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Artelar, LLC (Russia)
Manufactured By
Avva Rus, JSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets yellow, capsule-shaped, biconvex; two layers are visible on the cross-section, the inner layer is white or almost white.
| 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.
Film coating composition: hypromellose – 18.64 mg, titanium dioxide – 10.4 mg, macrogol-4000 – 7.49 mg, talc – 2.24 mg, povidone K-17 – 0.83 mg, quinoline yellow dye – 0.4 mg. Coated tablet mass 1440 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
Capsules 500 mg: from 2 to 120 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Azithromycin | Capsules 500 mg: from 2 to 120 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin size 00, white body, opaque, yellow cap, opaque; capsule contents – a mixture of powder and granules white or white with a yellowish tint; compaction of the capsule contents into lumps that are easily destroyed when pressed is allowed.
| 1 tab. | |
| Azithromycin dihydrate | 530.6 mg |
| Equivalent to azithromycin content | 500 mg |
Excipients: corn starch – 17.22 mg, microcrystalline cellulose – 9.38 mg, povidone K17 – 8.4 mg, magnesium stearate – 8.4 mg.
Capsule body composition: titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition: quinoline yellow dye – 0.75%, sunset yellow FCF dye – 0.0059%, titanium dioxide – 2%, gelatin – up to 100%.
From 2 to 10 pcs. – contour cell packs (from 1 to 12 pcs.) – cardboard packs.
From 3 to 120 pcs. – jars (1) – cardboard packs.
Film-coated tablets 125 mg: 3, 6, 9, 10, 12, 15, 18, 20, 24, 30, 36, 40, 50, 60, or 100 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets 125 mg: 3, 6, 9, 10, 12, 15, 18, 20, 24, 30, 36, 40, 50, 60, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex; two layers are visible on the cross-section – a white or almost white core and a coating.
| 1 tab. | |
| Azithromycin dihydrate | 133 mg, |
| Equivalent to azithromycin content | 125 mg |
Excipients: microcrystalline cellulose – 149.7 mg, pregelatinized starch – 36.7 mg, croscarmellose sodium – 7.3 mg, magnesium stearate – 3.3 mg.
Coating composition: polyvinyl alcohol — 4.69 mg, macrogol-4000 — 3.23 mg, titanium dioxide — 2.08 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
3 pcs. – contour cell packs (3) – cardboard packs.
3 pcs. – contour cell packs (4) – cardboard packs.
3 pcs. – contour cell packs (5) – cardboard packs.
3 pcs. – contour cell packs (6) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (3) – cardboard packs.
6 pcs. – contour cell packs (4) – cardboard packs.
6 pcs. – contour cell packs (5) – cardboard packs.
6 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Film-coated tablets 500 mg: 3, 6, 9, 10, 12, 15, 18, 20, 24, 30, 36, 40, 50, 60, or 100 pcs.
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets 500 mg: 3, 6, 9, 10, 12, 15, 18, 20, 24, 30, 36, 40, 50, 60, or 100 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, oval, biconvex, with a score on one side; two layers are visible on the cross-section – a white or almost white core and a coating.
| 1 tab. | |
| Azithromycin dihydrate | 531 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: microcrystalline cellulose — 240 mg, pregelatinized starch — 100 mg, croscarmellose sodium — 20 mg, magnesium stearate — 9 mg.
Coating composition polyvinyl alcohol — 14.07 mg, macrogol-4000 — 9.69 mg, titanium dioxide — 6.24 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
3 pcs. – contour cell packs (3) – cardboard packs.
3 pcs. – contour cell packs (4) – cardboard packs.
3 pcs. – contour cell packs (5) – cardboard packs.
3 pcs. – contour cell packs (6) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (3) – cardboard packs.
6 pcs. – contour cell packs (4) – cardboard packs.
6 pcs. – contour cell packs (5) – cardboard packs.
6 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.
20 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.
40 pcs. – jars (1) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.
60 pcs. – jars (1) – cardboard packs.
100 pcs. – jars (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 or 6 pcs.
Marketing Authorization Holder
Borisov Plant Of Medical Preparations, PJSC (Republic Of Belarus)
Dosage Form
|
Azithromycin | Film-coated tablets, 500 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets blue in color, round, biconvex, with a score; on the cross-section, two layers are visible: a white core and a blue film coating.
| 1 tab. | |
| Azithromycin (in the form of azithromycin dihydrate) | 500 mg (524.05 mg) |
Excipients: calcium hydrogen phosphate dihydrate, hypromellose (hydroxypropyl methylcellulose type 2910), corn starch, starch 1500, partially pregelatinized corn starch, sodium lauryl sulfate, magnesium stearate, microcrystalline cellulose, Opadry II (series 85 G, code 20425, blue) (including partially hydrolyzed polyvinyl alcohol, talc, macrogol 3350 (polyethylene glycol 3350), lecithin (soy), coloring pigment: titanium dioxide (E171), yellow iron oxide (E172), aluminum lacquer based on indigo carmine (E132)).
3 pcs. – contour cell packaging (1) – cardboard packs.
3 pcs. – contour cell packaging (2) – cardboard packs.
Film-coated tablets, 125 mg: 3, 6, 9, 10, 12, 18, 20, 24, 30, or 40 pcs.
Film-coated tablets, 500 mg: 3, 6, 9, 10, 12, 18, 20, 24, 30, or 40 pcs.
Marketing Authorization Holder
Bright Way, LLC (Russia)
Manufactured By
Velpharm, LLC (Russia)
Dosage Forms
|
Azithromycin | Film-coated tablets, 125 mg: 3, 6, 9, 10, 12, 18, 20, 24, 30, or 40 pcs. |
| Film-coated tablets, 500 mg: 3, 6, 9, 10, 12, 18, 20, 24, 30, or 40 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white in color, round, biconvex; on the cross-section, the core 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, crospovidone (Kollidon CL), sodium lauryl sulfate, colloidal silicon dioxide (aerosil), magnesium stearate.
Film coating composition ready dry mix for film coating Opadry® 03F180011 white, containing hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol), or hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000).
3 pcs. – contour cell packaging (1) – cardboard packs.
3 pcs. – contour cell packaging (2) – cardboard packs.
3 pcs. – contour cell packaging (3) – cardboard packs.
3 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
Film-coated tablets white or almost white in color, round, biconvex; on the cross-section, the core 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, crospovidone (Kollidon CL), sodium lauryl sulfate, colloidal silicon dioxide (aerosil), magnesium stearate.
Film coating composition ready dry mix for film coating Opadry® 03F180011 white, containing hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol), or hypromellose (hydroxypropyl methylcellulose), titanium dioxide, macrogol 6000 (polyethylene glycol 6000, polyethylene oxide 6000).
3 pcs. – contour cell packaging (1) – cardboard packs.
3 pcs. – contour cell packaging (2) – cardboard packs.
3 pcs. – contour cell packaging (3) – cardboard packs.
3 pcs. – contour cell packaging (4) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (3) – cardboard packs.
6 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
Film-coated tablets, 125 mg: 6 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 125 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white in color, round, biconvex; on the cross-section, the core is white or almost white.
| 1 tab. | |
| Azithromycin (in the form of dihydrate) | 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 – 3 mg, talc – 1 mg, titanium dioxide – 0.55 mg, macrogol 4000 – 0.45 mg.
3 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 or 6 pcs.
Marketing Authorization Holder
Vertex, JSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 500 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white in color, round, biconvex; on the cross-section, the core is white or almost white.
| 1 tab. | |
| Azithromycin (in the form of dihydrate) | 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 – 12 mg, talc – 4 mg, titanium dioxide – 2.2 mg, macrogol 4000 – 1.8 mg.
3 pcs. – contour cell packaging (1) – cardboard packs.
3 pcs. – contour cell packaging (2) – cardboard packs.
6 pcs. – contour cell packaging (1) – cardboard packs.
Capsules 250 mg: 6 or 10 pcs.
Marketing Authorization Holder
Dalkhimpharm, JSC (Russia)
Dosage Form
|
Azithromycin | Capsules 250 mg: 6 or 10 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Azithromycin | 250 mg |
6 pcs. – contour cell packaging (1) – cardboard packs.
6 pcs. – polymer bottles (1) – cardboard packs.
6 pcs. – dark glass jars (1) – cardboard packs.
6 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – dark glass jars (1) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – polymer bottles (1) – cardboard packs.
Film-coated tablets, 250 mg: 6 pcs.
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Iris, LLC (Russia)
Manufactured By
Avva Rus, JSC (Russia)
Dosage Forms
|
Azithromycin | 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; on the cross-section, two layers are visible, the inner layer is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 262.03 mg, |
| Equivalent to azithromycin content | 250 mg |
Excipients: lactitol – 300 mg, croscarmellose sodium – 35 mg, hyprolose – 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 – 700 mg.
Film coating composition: hypromellose – 9.49 mg, titanium dioxide – 5.2 mg, macrogol-4000 – 3.74 mg, talc – 1.12 mg, povidone K-17 – 0.42 mg, quinoline yellow dye – 0.03 mg.
6 pcs. – contour cell packaging (1) – cardboard packs.
Film-coated tablets yellow in color, capsule-shaped, biconvex; on the cross-section, two layers are visible, the inner layer is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 524.06 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: lactitol – 600 mg, croscarmellose sodium – 70 mg, hyprolose – 70 mg, pregelatinized starch – 40 mg, magnesium stearate – 28 mg, sodium lauryl sulfate – 7 mg, colloidal silicon dioxide – 7 mg, microcrystalline cellulose 102 – 1400 mg.
Film coating composition: hypromellose – 18.98 mg, titanium dioxide – 10.4 mg, macrogol-4000 – 7.49 mg, talc -2.24 mg, povidone K-17 – 0.83 mg, quinoline yellow dye – 0.06 mg.
3 pcs. – contour cell packaging (1) – cardboard packs.
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion, 500 mg: vial 1, 10 or 50 pcs.
Marketing Authorization Holder
Kraspharma, PJSC (Russia)
Dosage Form
|
Azithromycin | Lyophilizate for the preparation of concentrate for the preparation of solution for infusion, 500 mg: vial 1, 10 or 50 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a porous mass or powder from white to white with a yellowish tint.
| 1 vial | |
| Azithromycin dihydrate | 524.1 mg, |
| Equivalent to Azithromycin content | 500 mg |
Excipients: citric acid monohydrate – 420.56 mg, sodium hydroxide solution 10 M – to pH 6.3 – 6.7.
500 mg – vials – cardboard packs.
500 mg – vials (10) – cardboard boxes.
500 mg – vials (50) – cardboard boxes.
500 mg – vials (50) 1-50 pcs. – cardboard boxes (for hospitals).
Capsules 250 mg: 6, 10, or 20 pcs.
Marketing Authorization Holder
N.A. Semashko Moscow Chemical Pharmaceutical Preparations, JSC (Russia)
Dosage Form
|
Azithromycin | Capsules 250 mg: 6, 10, or 20 pcs. |
Dosage Form, Packaging, and Composition
| Capsules | 1 caps. |
| Azithromycin | 250 mg |
6 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
Capsules 250 mg: from 3 to 60 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Dosage Form
|
Azithromycin | Capsules 250 mg: from 3 to 60 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 0, body and cap yellow, with a slight brownish tint, opaque; capsule contents – powder white or white with a slight yellowish tint.
| 1 caps. | |
| Azithromycin dihydrate | 265.3 mg |
| Equivalent to azithromycin content | 250 mg |
Excipients: microcrystalline cellulose (MCC-112) – 104.7 mg, corn starch – 28 mg, povidone K17 – 6 mg, magnesium stearate – 6 mg.
Capsule body composition: titanium dioxide — 1%, yellow iron oxide dye — 0.0733%, gelatin — up to 100%.
Capsule cap composition: titanium dioxide — 1%, yellow iron oxide dye — 0.0733%, gelatin — up to 100%.
From 3 to 6 pcs. – contour cell packaging (from 1 to 10 pcs.) – cardboard packs.
From 3 to 60 pcs. – jars (1) – cardboard packs.
Capsules 250 mg: 6 pcs.
Capsules 500 mg: 3 pcs.
Marketing Authorization Holder
Production Of Medicaments, LLC (Russia)
Dosage Forms
|
Azithromycin | Capsules 250 mg: 6 pcs. |
| Capsules 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Capsules hard gelatin, size 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: microcrystalline cellulose (type 102) – 109 mg**, magnesium stearate – 3.75 mg.
Capsule body composition titanium dioxide (E171) – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide (E171) – 1.7434%, sunset yellow dye (E110) – 0.4183%, gelatin – up to 100%.
3 pcs. – contour cell packaging (2) – cardboard packs.
* the amount of active substance azithromycin dihydrate depends on its activity.
** the amount of microcrystalline cellulose (type 102) depends on the amount of active substance.
Capsules hard gelatin, size 00; capsule body white, capsule cap orange; 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: microcrystalline cellulose (type 102) – 40.2 mg**, magnesium stearate – 5.7 mg.
Capsule body composition titanium dioxide (E171) – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide (E171) – 1.7434%, sunset yellow dye (E110) – 0.4183%, gelatin – up to 100%.
3 pcs. – contour cell packaging (1) – cardboard packs.
* the amount of active substance azithromycin dihydrate depends on its activity.
** the amount of microcrystalline cellulose (type 102) depends on the amount of active substance.
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion, 500 mg: vial 1, 5 or 10 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Form
|
Azithromycin | Lyophilizate for the preparation of concentrate for the preparation of solution for infusion, 500 mg: vial 1, 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a compacted mass or powder of white or almost white color.
| 1 vial | |
| Azithromycin dihydrate | 524.1 mg |
| Equivalent to azithromycin content | 500 mg |
Excipients: citric acid monohydrate – 420.56 mg, sodium hydroxide 20% solution – to pH 6.2-6.8.
500 mg – vials (1) – cardboard packs.
500 mg – vials (5) – cardboard packs.
500 mg – vials (10) – cardboard packs.
500 mg – vials (50) – cardboard boxes (for hospitals).
Film-coated tablets, 125 mg: 3, 6, 10, 12, or 20 pcs.
Film-coated tablets, 250 mg: 3, 6, 10, 12, or 20 pcs.
Film-coated tablets, 500 mg: 3, 6, 10, 12, or 20 pcs.
Marketing Authorization Holder
Promomed Rus LLC (Russia)
Manufactured By
Biokhimik, JSC (Russia)
Dosage Forms
|
Azithromycin | Film-coated tablets, 125 mg: 3, 6, 10, 12, or 20 pcs. |
| Film-coated tablets, 250 mg: 3, 6, 10, 12, or 20 pcs. | ||
| Film-coated tablets, 500 mg: 3, 6, 10, 12, or 20 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 131 mg, |
| Calculated as Azithromycin | 125 mg |
Excipients: microcrystalline cellulose (type 101) – 30.5 mg, microcrystalline cellulose (type 12) – 29 mg, corn starch pregelatinized – 25 mg, croscarmellose sodium – 5 mg, magnesium stearate – 2.25 mg, talc – 2.25 mg.
Film coating composition: hypromellose – 5.9 mg, macrogol 6000 (polyethylene glycol 6000) – 2.3 mg, titanium dioxide – 0.93 mg, polysorbate 80 – 0.87 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – glass jars (1) – cardboard packs.
Film-coated tablets white, round, biconvex; the core on the cross-section is white or almost white.
| 1 tab. | |
| Azithromycin dihydrate | 262 mg, |
| Calculated as Azithromycin | 250 mg |
Excipients: microcrystalline cellulose (type 101) – 61 mg, microcrystalline cellulose (type 12) – 58 mg, corn starch pregelatinized – 50 mg, croscarmellose sodium – 10 mg, magnesium stearate – 4.5 mg, talc – 4.5 mg.
Film coating composition: hypromellose – 8.85 mg, macrogol 6000 (polyethylene glycol 6000) – 3.45 mg, titanium dioxide – 1.4 mg, polysorbate 80 – 1.3 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – glass jars (1) – cardboard packs.
Film-coated tablets 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 mg, |
| Calculated as Azithromycin | 500 mg |
Excipients: microcrystalline cellulose (type 101) – 122 mg, microcrystalline cellulose (type 12) – 116 mg, corn starch pregelatinized – 100 mg, croscarmellose sodium – 20 mg, magnesium stearate – 9 mg, talc – 9 mg.
Film coating composition: hypromellose – 11.8 mg, macrogol 6000 (polyethylene glycol 6000) – 4.6 mg, titanium dioxide – 1.86 mg, polysorbate 80 – 1.74 mg.
3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
6 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – glass jars (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Rapharma, JSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets pink, oblong, biconvex; the core on the cross-section is from white to white with a yellowish tint.
| 1 tab. | |
| Azithromycin dihydrate | 524.1 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: pregelatinized starch, calcium phosphate dibasic, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.
Coating composition Opadry II pink 85F34355 (polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, Allura Red AC (E129), Quinoline Yellow (E104), Indigo Carmine (E132)).
3 pcs. – contour cell packs (1) – cardboard packs.
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion, 500 mg: vial 1, 5 or 10 pcs.
Marketing Authorization Holder
Pharmpotrebsoyuz, LLC (Russia)
Manufactured By
Bryntsalov-A, JSC (Russia)
Dosage Form
|
Azithromycin | Lyophilizate for the preparation of concentrate for the preparation of solution for infusion, 500 mg: vial 1, 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of concentrate for the preparation of solution for infusion in the form of a lyophilized mass of white or almost white color.
| 1 vial | |
| Azithromycin dihydrate | 524.1 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: citric acid monohydrate – 420.56 mg, sodium hydroxide 20% solution – to pH 6.2 – 6.8.
500 mg – vials (1) – cardboard packs.
500 mg – vials (5) – cardboard packs.
500 mg – vials (10) – cardboard packs.
Film-coated tablets, 125 mg: 6 pcs.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 125 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, the core on the cross-section is almost white.
| 1 tab. | |
| Azithromycin dihydrate | 132.489 mg, |
| Equivalent to azithromycin content | 125 mg |
Excipients: calcium hydrogen phosphate – 16.301 mg, hypromellose – 1.5 mg, microcrystalline cellulose – 8.4 mg, corn starch – 5.05 mg, pregelatinized starch – 17.1 mg, sodium lauryl sulfate – 0.61 mg, croscarmellose sodium – 5.7 mg, colloidal silicon dioxide – 0.95 mg, magnesium stearate – 1.9 mg.
Film coating composition hypromellose – 3.4 mg, titanium dioxide – 0.66 mg, polysorbate-80 – 0.14 mg, talc – 2.8 mg.
6 pcs. – contour cell packs (1) – cardboard packs.
Film-coated tablets, 250 mg: 6 pcs.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 250 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, the core on the cross-section is almost white.
| 1 tab. | |
| Azithromycin dihydrate | 264.978 mg |
| Equivalent to azithromycin content | 250 mg |
Excipients: calcium hydrogen phosphate – 32.602 mg, hypromellose – 3 mg, microcrystalline cellulose – 16.8 mg, corn starch – 10.1 mg, pregelatinized starch – 34.2 mg, sodium lauryl sulfate – 1.22 mg, croscarmellose sodium – 11.4 mg, colloidal silicon dioxide – 1.9 mg, magnesium stearate – 3.8 mg.
Film coating composition hypromellose – 6.8 mg, titanium dioxide – 1.32 mg, polysorbate-80 – 0.28 mg, talc – 5.6 mg.
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
Film-coated tablets, 500 mg: 3 pcs.
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Azithromycin | Film-coated tablets, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, the core on the cross-section is almost white.
| 1 tab. | |
| Azithromycin dihydrate | 529.956 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: calcium hydrogen phosphate – 65.204 mg, hypromellose – 6 mg, microcrystalline cellulose – 33.6 mg, corn starch – 20.2 mg, pregelatinized starch – 68.4 mg, sodium lauryl sulfate – 2.44 mg, croscarmellose sodium – 22.8 mg, colloidal silicon dioxide – 3.8 mg, magnesium stearate – 7.6 mg.
Film coating composition hypromellose – 13.6 mg, titanium dioxide – 2.64 mg, polysorbate-80 – 0.56 mg, talc – 11.2 mg.
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
Lyophilizate for the preparation of solution for infusion, 500 mg: vial 1, 5 or 10 pcs.
Marketing Authorization Holder
PSK Pharma, LLC (Russia)
Dosage Form
|
Azithromycin PSK | Lyophilizate for the preparation of solution for infusion, 500 mg: vial 1, 5 or 10 pcs. |
Dosage Form, Packaging, and Composition
Lyophilizate for the preparation of solution for infusion white or almost white.
| 1 vial | |
| Azithromycin (as dihydrate) | 500 mg |
Excipients: citric acid monohydrate – 420.56 mg, sodium hydroxide – 188 mg.
Transparent colorless glass vials (1) – cardboard packs.
Transparent colorless glass vials (5) – cardboard packs.
Transparent colorless glass vials (10) – cardboard packs.
Lyophilisate for preparation of solution for infusion, 500 mg: 3 pcs.
Marketing Authorization Holder
Jodas Expoim, LLC (Russia)
Manufactured By
Jodas Expoim, Pvt. Ltd. (India)
Dosage Form
|
Azithromycin-J | Lyophilisate for preparation of solution for infusion, 500 mg: 3 pcs. |
Dosage Form, Packaging, and Composition
Film-coated tablets white or almost white, round, biconvex, the core on the cross-section is almost white.
| 1 tab. | |
| Azithromycin dihydrate | 529.956 mg, |
| Equivalent to azithromycin content | 500 mg |
Excipients: calcium hydrogen phosphate – 65.204 mg, hypromellose – 6 mg, microcrystalline cellulose – 33.6 mg, corn starch – 20.2 mg, pregelatinized starch – 68.4 mg, sodium lauryl sulfate – 2.44 mg, croscarmellose sodium – 22.8 mg, colloidal silicon dioxide – 3.8 mg, magnesium stearate – 7.6 mg.
Film coating composition hypromellose – 13.6 mg, titanium dioxide – 2.64 mg, polysorbate-80 – 0.56 mg, talc – 11.2 mg.
3 pcs. – contour cell packs (2) – cardboard packs.
6 pcs. – contour cell packs (1) – cardboard packs.
![Azithromycin [Tablets, Capsules, Lyophilisate] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Azithromycin [Tablets, Capsules, Lyophilisate] 2")