Sanofi Azithromycin, pills 250mg, 6pcs

Composition

Each 250 mg film-coated tablet contains:

Active ingredient:

azithromycin 250,000 mg (as azithromycin dihydrate-262.026 mg);

excipients:

core:

pregelatinized corn starch-42,500 mg, croscarmellose sodium-9,000 mg, calcium hydrophosphate-115.625 mg, magnesium stearate-6.375 mg, sodium lauryl sulfate-1,500 mg

. shell:

hypromellose 2910/5 – 7,300 mg, titanium dioxide – 3,100 mg, macrogol 6000 – 0,700 mg, talc – 1,250 mg, simethicone emulsion SE 4 (water – 67,4%, siloxanes and silicones was 30.0%, methylated cellulose – 2,5%, sorbic acid, and 0.1%) – 0,050 mg, Polysorbate 80 – 0,100 mg.

Pharmacological action

Sanofi azithromycin is an antibiotic of the macrolide group, it is a representative of azalides. Inhibits RNA-dependent protein synthesis in sensitive microorganisms.

Active against gram-positive bacteria: Staphylococcus aureus, Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes /group A/); gram-negative bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Moraxella catarrhalis, Escherichia coli, Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi, Neisseria gonorrhoeae, Campylobacter spp., Legionella pneumophila; anaerobic bacteria: Bacteroides fragilis.

Azithromycin is also active against Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis, and Treponema pallidum.

It is also active against Toxoplasma gondii.

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);

Lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia, including those caused by atypical pathogens);

Skin and soft tissue infections (acne vulgaris of moderate severity, erysipelas, impetigo, secondary infected dermatoses);

Uncomplicated urinary tract infections caused by Chlamydia trachomatis (urethritis and / or cervicitis);

The initial stage of Lyme disease (borreliosis)is erythema migrans.

Contraindications

– Hypersensitivity to azithromycin, erythromycin, other macrolides, or ketolides, or other components of the drug;

– Violation of liver function, severe;

– Violation of kidney function severe (creatinine clearance < 40 ml/min);

– Children’s age up to 12 years with body weight less than 45 kg;

– the Period of breastfeeding;

– concomitant use with ergotamine and dihydroergotamine.

Side effects

The frequency of adverse reactions was determined according to the World Health Organization classification: very common (≥ 1/10); common (≥ 1/100 and < 1/10); infrequent (≥ 1/1000 and < 1/100); rare (≥ 1/10000 and < 1/1000); very rare (

Disorders of the blood and lymphatic system:  often eosinophilia, lymphocytopenia; infrequently-leukopenia, neutropenia; frequency unknown-thrombocytopenia, hemolytic anemia.

Nervous system disorders:  often-headache; infrequently-dizziness, paresthesia, impaired taste sensations, drowsiness; frequency unknown-hypesthesia, fainting, convulsions, psychomotor hyperactivity, loss of smell (or anosmia), perversion of smell, loss of taste sensations, myasthenia gravis.

Mental disorders:  infrequently-insomnia, nervousness; rarely-agitation; frequency unknown-aggressiveness, anxiety, delusions, hallucinations.

Visual disturbances:  infrequently-visual impairment.

Hearing disorders and labyrinth disorders:  infrequently hearing disorders, vertigo; frequency unknown – hearing disorders (including deafness), tinnitus.

Cardiac disorders:  infrequently-palpitation sensation; frequency unknown-prolongation of the QT interval, pirouette-type arrhythmia, ventricular tachycardia.

Vascular disorders:  infrequently – “hot flashes” of blood to the face; frequency unknown-decrease in blood pressure.

Disorders of the gastrointestinal tract:  very often – diarrhea; often-nausea, abdominal pain, vomiting; infrequently-dyspepsia, constipation, gastritis, dysphagia, bloating, dryness of the oral mucosa. belching, ulcers of the oral mucosa. increased salivary gland secretion; frequency unknown-discoloration of the tongue, pancreatitis.

Kidney and urinary tract disorders:  infrequently increased plasma urea and creatinine concentrations, dysuria, kidney pain; frequency unknown interstitial nephritis, acute renal failure.

Genital and breast disorders:  infrequently – metrorrhagia, testicular dysfunction.

Immune system disorders:  infrequently – hypersensitivity reactions, angioedema; anaphylactic reaction.

Skin and subcutaneous tissue disorders:  infrequently-pruritus, skin rash, urticaria, dry skin, sweating, dermatitis; rarely-photosensitization reaction, acute generalized exanthematous pustulosis; frequency unknown-erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Metabolic and nutritional disorders:  infrequently – anorexia.

Infectious and parasitic diseases:  infrequently-candidiasis, including oral and genital mucosa, vaginal infections, pneumonia, fungal infections, bacterial infections, pharyngitis, gastroenteritis, respiratory diseases, rhinitis; frequency unknown pseudomembranous colitis.

Liver and biliary tract disorders: rarely-impaired liver function, cholestatic jaundice; frequency unknown-liver failure (in rare cases with a fatal outcome, mainly against the background of severe liver dysfunction), liver necrosis, fulminant hepatitis.

Musculoskeletal and connective tissue disorders: infrequently-osteoarthritis, myalgia, back pain, neck pain; frequency unknown-arthralgia.

Respiratory, thoracic and mediastinal disorders: infrequently-nosebleeds, shortness of breath.

General disorders and disorders at the injection site: infrequently-weakness, chest pain, edema, peripheral edema, asthenia, malaise, facial edema, fever.

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

Injuries intoxication and manipulation complications:  infrequently – complications after the procedure.

The following is a list of possible or probable adverse reactions related to the prevention or treatment of Mycobacterium Avium Complex infections identified in clinical trials and post-marketing surveillance.

Metabolic and nutritional disorders:  often – anorexia.

Nervous system disorders:  often – headache, dizziness, paresthesia, impaired taste sensations.

Visual disturbances:  often-visual impairment.

Hearing disorders and labyrinth disorders:  often-deafness; infrequently-hearing disorders, tinnitus.

Cardiac disorders:  infrequently-palpitation sensation.

Disorders of the gastrointestinal tract:  very often – diarrhea, nausea, abdominal pain, abdominal discomfort, vomiting, bloating.

Liver and biliary tract disorders:  infrequently – hepatitis.

Skin and subcutaneous tissue disorders:  often – skin pruritus, skin rash; infrequently-Stevens-Johnson syndrome, photosensitization reaction.

Musculoskeletal and connective tissue disorders: often arthralgia.

General disorders and disorders at the injection site:  often-weakness; infrequently-asthenia, malaise.

Interaction

Antacids (aluminum – and magnesium-containing) slow and reduce the absorption of azithromycin (for oral forms), so the interval between their intake should be 1 hour before or 2 hours after meals and these medications.

When used together, azithromycin does not affect the concentration of atorvastatin in blood plasma, but there is a risk of developing rhabdomyolysis.

With the combined use of warfarin and azithromycin (in normal doses), no changes in prothrombin time were detected, however, given that the interaction of macrolides and warfarin may increase the anticoagulation effect, patients should carefully monitor prothrombin time.

When taking digoxin and azithromycin together, it is necessary to monitor the concentration of digoxin in the blood, since many macrolides increase the absorption of digoxin in the intestine, thereby increasing its concentration in the blood plasma.

If co-administered with cimetidine 2 hours before azithromycin administration, there is no effect on the pharmacokinetics of azithromycin.

When azithromycin is co-administered with rifabutin, the risk of neutropenia should be considered.

There are no data on the effect of azithromycin on the blood concentrations of triazolam, midazolam, efavirenz, fluconazole, indinavir, trimethoprim/sulfamethoxazole when they are used together, but the possibility of such an interaction should not be excluded, since the interaction of macrolides with the above drugs is known.

When azithromycin is co-administered with ergotamine or dihydroergotamine, their toxic effects may increase (vasospasm, dysesthesia). There are no data on a possible interaction between azithromycin and derivatives of ergotamine and dihydroergotamine, but due to the development of ergotism when macrolides are used simultaneously with derivatives of ergotamine and dihydroergotamine, these combinations are contraindicated.

Caution should be exercised when using terfenadine and azithromycin together, as it has been found that concomitant use of terfenadine and various types of antibiotics causes arrhythmia and prolongation of the Q-T interval. Based on this, the above-mentioned complications cannot be excluded with the combined use of terfenadine and azithromycin.

If concomitant use with cyclosporine is necessary, it is recommended to monitor the concentration of cyclosporine in blood plasma.

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

When used concomitantly with zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in blood plasma or the renal excretion of it and its metabolite glucuronide, but at the same time increases the concentration of the active metabolite – phosphorylated zidovudine – in peripheral vascular mononuclear cells. The clinical significance of this fact is unclear.

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

When co-administered, azithromycin does not affect the plasma concentrations of the following drugs: carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, cetirizine, trimethoprim/sulfamethoxazole, sildenafil, rifabutin and methylprednisolone.

How to take, course of use and dosage

Inside,1 hour before or 2 hours after a meal, without chewing,1 time a day.

Adults and children over 12 years and weighing more than 45 kg:

– infections of the upper and lower respiratory tract, ENT organs, infections of skin and soft tissues (with the exception of chronic erythema migrans) of 500 mg/day for 1 reception for 3 days (course dose – 1.5 g); – if vulgaris acne of moderate severity: 1 table. (500 mg) 1 time per day for 3 days, then 1 table. (500 mg) 1 time per week for 9 weeks; dose – 6 g First weekly pill should be taken after 7 days after the first daily tablets (8th day of treatment), followed by 8 weekly pill every 7 days; – in acute infections of the urinary organs (uncomplicated urethritis or cervicitis) – 1 g (table 2,500 mg) once;

– for Lyme disease (borreliosis) for the treatment of stage I (erythema migrans) – 1 g on the first day and from 2 to 5 day 500 mg daily (course dose – 3 g);

Elderly patients (over 65 years of age)

For the treatment of elderly patients, the same dosages are used as for adults. Taking into account that among elderly patients there may be people with the presence of arrhythmogenic factors, it is necessary to pay special attention to the possibility of developing cardiac arrhythmia and pirouette ventricular tachycardia.

If renal function is impaired (creatinine clearance is more than 40 ml / min), no dose adjustment is required.

Hepatic impairment: no dose adjustment is required for moderate hepatic impairment.

Overdose

Symptoms: nausea, temporary hearing loss, vomiting, diarrhea, abdominal pain, liver dysfunction.

Treatment: gastric lavage, symptomatic therapy (taking activated charcoal), monitoring of vital functions.

Special instructions

If you miss one dose of Azithromycin Sanofi, the missed dose should be taken as early as possible, and the subsequent dose should be taken at intervals of 24 hours.

Hypersensitivity reactions

As with the use of erythromycin and other macrolides, rare serious allergic reactions have been reported, including angioedema, anaphylactic reactions (rarely fatal), skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis (rarely fatal), drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Some of these reactions resulted in recurrent symptoms and required a longer period of follow-up and treatment. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be prescribed. After discontinuation of symptomatic therapy, allergic symptoms may recur.

Antacids

Azithromycin Sanofi should be used at least 1 hour before and 2 hours after taking antacids.

Myasthenia gravis

Exacerbation of myasthenia gravis symptoms and the first appearance of myasthenia gravis syndrome have been reported in patients treated with azithromycin.

Impaired liver function

Azithromycin Sanofi should be used with caution in patients with mild to moderate hepatic impairment due to the possibility of developing fulminant hepatitis and severe hepatic insufficiency. It is also necessary to take into account the possibility of patients with preclinical liver disease or concomitant treatment with hepatotoxic drugs. In the presence of symptoms of impaired liver function, such as rapidly increasing asthenia, jaundice, darkening of the urine, tendency to bleeding, hepatic encephalopathy, the drug should be discontinued and a study of the functional state of the liver should be conducted.

Impaired renal function

In patients with mild to moderate renal impairment (creatinine clearance > 40 ml / min), treatment with Azithromycin Sanofi should be carried out with caution, under the control of the state of renal function. In end-stage renal failure (creatinine clearance < 10 ml / min), there is a 33% increase in the concentration of azithromycin in blood plasma.

Ergot derivatives

Patients treated with ergot derivatives (ergotamine or dihydroergotamine) experienced ergotism when taking macrolide antibiotics. There are no data on the possibility of interaction between ergot derivatives and azithromycin. However, due to the theoretical possibility of ergotism, concomitant use of azithromycin and ergot derivatives is contraindicated.

Prevention of pharyngitis/tonsillitis

Azithromycin is not the drug of choice for the prevention of Streptococcus pyogenes pharyngitis/tonsillitis and the prevention of acute rheumatic fever.

As with other antibacterial agents, patients with Azithromycin Sanofi should be regularly examined for the presence of resistant microorganisms and signs of superinfections, including fungal infections.

Pseudomembranous colitis caused by Clostridium difficile

The drug Azithromycin Sanofi should not be used for longer courses than indicated in the instructions, because the pharmacokinetic properties of azithromycin allow us to recommend a short and convenient dosage regimen. With prolonged use of Azithromycin Sanofi, pseudomembranous colitis caused by Clostridium difficile may develop, both in the form of mild diarrhea and in the form of severe colitis. If diarrhea develops while taking azithromycin, as well as 2 months after the end of therapy, clostridial pseudomembranous colitis should be excluded. Drugs that inhibit intestinal motility are contraindicated.

Delayed ventricular repolarization syndrome

Delayed ventricular repolarization syndrome (QT prolongation syndrome) increases the risk of arrhythmias (including pirouette-type arrhythmias) when taking macrolides. Caution when using azithromycin should be observed in patients with prolonged QT interval, receiving therapy with antiarrhythmic agents of classes IA, III, cisapride, hypokalemia or hypomagnesemia, clinically significant bradycardia, arrhythmia or severe cardiac instability.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

3 years

Active ingredient

Azithromycin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets