Azitral caps. 500mg 3 pcs

$6.96

Azitral caps. 500mg 3 pcs

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Description

Composition
Active substance:
1 capsule contains: 500 mg of azithromycin in the form of 525 mg of azithromycin dihydrate.
Excipients:
Sodium lauryl sulfate, magnesium stearate.
shell composition: Titanium dioxide 1.1999%, water 14.5 ± 1.5%, 0.08% sodium lauryl sulfate, methyl parahydroxybenzoate 0.64 to 0.8%, propyl parahydroxybenzoate 0.16 to 0.2% gelatin .
Description:
Hard gelatine capsules, size “0”, the body and cap of white color. Contents of capsules – white powder.
Product form:
Capsules 500 mg.
3 capsules in the blister.
1 blister pack in a cardboard, together with instructions for use.
Contraindications
Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides, or other components of the formulation; severe liver failure (class C Child-Pugh); severe renal impairment (creatinine clearance (CC) of less than 40 ml / min); lactase deficiency, lactose intolerance, glucose-galactose malabsorption; lactation period (the period of treatment is suspended); Children under 12 years of age with a body weight less than 45 kg; concomitant use with ergotamine and dihydroergotamine.
CAREFULLY
myasthenia gravis; easy and mild liver dysfunction; mild and moderate renal impairment (creatinine clearance of more than 40 ml / min); patients with presence proaritmogennoe factors (especially in the elderly): with congenital or acquired lengthening the interval QT, in patients receiving antiarrhythmic drug therapy class IA (quinidine, procainamide), III (dofetilide, amiodarone and sotalol), cisapride, terfenadine, antipsychotic drugs (pimozide), antidepressants (citalopram), fluoroquinolones (moxifloxacin and levofloxacin), impaired with fluid and electrolyte balance, particularly in the case of hypokalemia or hypomagnesemia with clinically significant bradycardia iey, cardiac arrhythmia or severe heart failure; concurrent use of digoxin, warfarin, cyclosporine; pregnancy.
Dosage
500 mg
Indications
Infectious-inflammatory diseases caused by microorganisms sensitive to azithromycin:
Infections of the upper respiratory tract and ENT (tonsillitis, sinusitis, tonsillitis, pharyngitis, otitis media);
Infections of the lower respiratory tract (bacterial pneumonia, including those caused by atypical pathogens, bronchitis);
skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses);
Urogenital tract infections (uncomplicated urethritis and / or cervicitis) caused by Chlamydia trachomatis; Lyme disease (Lyme disease), for the treatment of early stage (erythema migrans) ;.
Interaction with other drugs
Antacids (aluminum and magnesium-containing) foods and reduce the absorption of azithromycin, so the interval between their intake should be 1 hour before or 2 hours after meals and these drugs.
cetirizine
Simultaneous application for 5 days in healthy volunteers azithromycin with cetirizine (20 mg) did not result in a substantial pharmacokinetic interaction and change interval QT.
DdI (dideoxyinosine)
The simultaneous use of azithromycin (1200 mg / day) and didanosine (400 mg / day) in 6 HIV-infected patients revealed no changes in readings pharmacokinetic ddI compared to the placebo group. If necessary, co-administration with warfarin is recommended that careful control of the prothrombin time.
cimetidine
The pharmacokinetic studies influence of single dose azithromycin pharmacokinetics cimetidine revealed no changes in the pharmacokinetics of azithromycin, cimetidine, subject to application of 2 hours prior to the azithromycin. While the use of zidovudine, azithromycin had little effect on the pharmacokinetics, including renal excretion of zidovudine or its glucuronide metabolite. However, the use of azithromycin caused an increase in the concentration of phosphorylated AZT, clinically active metabolite in peripheral blood mononuclear cells. The clinical significance of this is unclear. Azithromycin weakly interacts with the cytochrome P450 isozymes system. Not found that azithromycin is involved in pharmacokinetic interactions similar to erythromycin and other macrolides. Azithromycin is not an inhibitor and inducer of cytochrome P450 isoenzymes.
efavirenz
The simultaneous use of azithromycin (600 mg / day one) and efavirenz (400 mg / day) daily for 7 days did not cause kakogolibo clinically significant pharmacokinetic interactions.
fluconazole
The simultaneous use of azithromycin (1200 mg single dose) did not alter the pharmacokinetics of fluconazole (800 mg dose). Total exposure and half-life of azithromycin is not changed while the application of fluconazole, however, the observed reduction in Cmax of azithromycin (18%), which had no clinical significance.
indinavir
The simultaneous use of azithromycin (1200 mg single dose) caused no statistically significant effect on the pharmacokinetics of indinavir (800 mg three times a day for 5 days).
methylprednisolone
Azithromycin has no significant effect on the pharmacokinetics of methylprednisolone. Digoxin
The simultaneous use of macrolide antibiotics, including azithromycin with substrates of P-glycoprotein, such as digoxin, increases the concentration of substrate of P-glycoprotein in serum.
Ergotamine and dihydroergotamine: increased toxic effect (vasospasm, dysesthesia). Triazolam: decrease in clearance and an increase in the pharmacological action of triazolam. The simultaneous use of azithromycin atorvastatin and atorvastatin did not cause changes in plasma concentrations (based inhibition assay MMC-CoA reductase). However, in the post-registration period, some were reported cases of rhabdomyolysis in patients receiving both azithromycin and statins. In a pharmacokinetic study in healthy volunteers for 3 days ingested azithromycin (500 mg / day one), and then the cyclosporin (10 mg / kg / day once) revealed a significant increase in the maximum plasma concentration (Cmax) and area under the curve “concentration-time» (AUC0-5) cyclosporin. Caution must be exercised while the use of these drugs. If necessary, the simultaneous use of these drugs, it is necessary to monitor the concentration of cyclosporine in the blood plasma and adjust the dose. The simultaneous use of azithromycin and nelfinavir causes an increase in the equilibrium concentrations in the serum azithromycin. No clinically significant side effects were observed and correction dose of azithromycin when applied simultaneously with nelfinavir not required. The simultaneous use of azithromycin and rifabutin did not affect the concentration of each of the drugs in serum. With simultaneous use of azithromycin and rifabutin sometimes observed neutropenia. Despite the fact that neutropenia associated with the use of rifabutin, a causal relationship between the use of a combination of azithromycin and rifabutin and neutropenia has not been established.
sildenafil
When applied in healthy volunteers received no evidence for an effect of azithromycin (500 mg / day, daily for 3 days) on the AUC and Cmax of sildenafil or its main circulating metabolite. Care must be taken with co-administration of terfenadine and azithromycin, since it has been found that simultaneous reception of terfenadine and various antibiotics causes arrhythmia and QT interval elongation. On this basis, we can not exclude the above-mentioned complications during coadministration of terfenadine and azithromycin.
theophylline
Revealed no interaction between azithromycin and theophylline.
Triazolam / midazolam
Significant changes pharmacokinetic parameters, while the application of azithromycin with midazolam or triazolam in therapeutic doses have been identified. Trimethoprim / sulfamethoxazole
The simultaneous use of trimethoprim / sulfamethoxazole with azithromycin showed no significant effect on the Cmax, the overall exposure or excretion by the kidneys trimethoprim or sulfamethoxazole. Serum concentration of azithromycin corresponded detectable in other studies.
Overdose
Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea.
Treatment should be focused on presenting symptoms.
Specific safener (counter material) does not exist.
pharmachologic effect
Pharmacological group:
Antibiotic azalide.
Pharmacodynamics:
Broad-spectrum antibiotic. It is a representative subgroup of macrolide antibiotics – azalides. It has a broad spectrum of antimicrobial action. By binding to the 50S-ribosomal subunit, inhibits protein biosynthesis microorganism. When creating in inflammation in high concentrations has a bactericidal effect. It is active against gram-positive aerobic microorganisms: Streptococcus spp. (Groups a, b, c, g), Streptococcus pneumoniae (penitsillinchuvstvitelny), Streptococcus pyogenes, Staphylococcus aureus (metitsillinchuvstvitelny); Gram-negative aerobic organisms: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila, Neisseria gonorrhoeae, Pasteurella multocida; Some anaerobes: Prevotella spp, Clostridium perfringens, Fusobacterium spp, Porphyriomonas spp .;.. and Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Borrelia burgdorferi. Microorganisms capable of developing resistance to azithromycin: Gram-positive aerobes (streptococcus pneumoniae (penitsillinustoychivy)). Initially resistant microorganisms: Gram-positive aerobes (. Enterococcus faecalis, staphylococcus spp (methicillin-resistant staphylococci exhibit a very high degree of resistance to macrolide), Gram-positive bacteria resistant to erythromycin); anaerobes (bacteroides fragilis).
Pharmacokinetics:
Azithromycin is rapidly absorbed from the gastrointestinal tract, due to its stability in an acidic medium and lipophilicity. After ingestion of 500 mg of azithromycin maximum concentration in plasma is reached after 2.5 – 2.96 hr and 0.4 mg / l. Bioavailability is 37%. Azithromycin well into the respiratory tract, organs and tissues of the urogenital tract (in particular in the prostate gland), in skin and soft tissue. The high concentration in tissues (10-50 times higher than in blood plasma) and a long half-life of azithromycin due to low binding to plasma proteins as well as its ability to penetrate into eukaryotic cells and concentrated in a low pH environment surrounding the lysosomes. This, in turn, defines a large apparent volume of distribution (31.1 l / kg) and high plasma clearance. The ability of azithromycin accumulate mainly in lysosomes, particularly important for the elimination of intracellular pathogens. It is shown that phagocytes deliver azithromycin localization of infection in places where it is released in the process of phagocytosis. The concentration of azithromycin in the foci of infection was significantly higher than in healthy tissue (on average 24-34%) and correlated with the degree of inflammatory edema. Despite the high concentration in phagocytes, azithromycin did not significantly affect their function. Azithromycin remains in bactericidal concentrations for 5-7 days after the last dose, which allowed the development of short (3-day and 5-day) courses of treatment. 50% was excreted in bile as unchanged, 6% – kidney demethylated metabolites formed are not active in the liver. Excretion of azithromycin from plasma takes place in 2 stages: half-life of 14-20 hours in the range of from 8 to 24 hours after drug administration and 41 hours – in the range from 24 to 72 hours, which allows the use of drug 1 time / day. Food intake was significantly alters the pharmacokinetics (depending upon the dosage form): capsule – maximum plasma concentration (Cmax) is reduced (by 52%) and the index of the area under the curve “concentration-time» (AUC) (43%). In older men (65-85 years) the pharmacokinetic parameters do not change in women increases the Cmax (30-50%).
Pregnancy and breast-feeding
It can be used when the potential benefit to the mother is significantly greater than the potential risk to the fetus. If necessary, use during lactation should decide the issue of termination of breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of side effects is classified in accordance with the recommendations of the World Health Organization: very often – at least 10%; often – at least 1% but less than 10%; infrequently – at least 0.1% but less than 1%; rarely – at least 0.01% but less than 0.1%; very rarely – less than 0.01%; unknown frequency – can not be estimated from available data.
Infectious diseases: infrequently – candidiasis, including oral and genital mucosa, pneumonia, pharyngitis, gastroenteritis, respiratory infections, rhinitis; unknown frequency – pseudomembranous colitis.
From the blood and lymphatic system: rarely – leukopenia, neutropenia, eosinophilia; very rarely – thrombocytopenia, hemolytic anemia.
On the part of metabolism and nutrition: rarely – anorexia.
Allergic reactions: infrequently – angioneurotic edema, hypersensitivity reactions; unknown frequency – an anaphylactic reaction.
From the nervous system: often – headache; rarely – dizziness, dysgeusia, paraesthesia, somnolence, insomnia, nervousness; seldom – agitation; unknown frequency – hypoesthesia, anxiety, aggression, fainting, seizures, psychomotor hyperactivity, loss of smell, sense of smell distortion, loss of taste, myasthenia gravis, delirium, hallucinations.
From the side of view: rare – impaired vision.
On the part of ear and labyrinth disorders: rare – frustration of hearing, vertigo; unknown frequency – hearing impairment, including deafness and / or tinnitus.
Cardio-vascular system: rarely – palpitations, “tides” of blood to the face; unknown frequency – low blood pressure, increased QT interval in the electrocardiogram, arrhythmia type “pirouette”, ventricular tachycardia.
The respiratory system: rarely – shortness of breath, nasal bleeding.
Gastro-intestinal tract: often – diarrhea; often – nausea, vomiting, abdominal pain; infrequently – flatulence, dyspepsia, constipation, gastritis, dysphagia, abdominal distension, dryness of the oral mucosa, belching, ulcers of the oral mucosa, increased secretion of the salivary glands; very rarely – to change the language of color, pancreatitis.
Of the liver and biliary tract: rarely – hepatitis; rarely – liver dysfunction, cholestatic jaundice; unknown frequency – hepatic failure (in rare cases, fatal mainly the presence of severe liver dysfunction); necrosis of the liver, fulminant hepatitis.
Skin and subcutaneous tissue disorders: rare – skin rash, itching, hives, dermatitis, dry skin, sweating; rarely – photosensitivity reactions; unknown frequency – Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
On the part of the musculoskeletal system: osteoarthritis, myalgia, back pain, neck pain; unknown frequency – arthralgia.
On the part of the kidney and urinary tract: rarely – dysuria, pain in the kidneys; unknown frequency – interstitial nephritis, acute renal failure.
On the part of genitals and mammary gland: Infrequent – metrorrhagia, impaired testicular function.
Other: rarely – fatigue, malaise, fatigue, swelling of the face, chest pain, fever, peripheral edema.
Laboratory data: often – a reduction in the number of lymphocytes, increase in the number of eosinophils, basophils increase in the number, increase in the number of monocytes, increased neutrophil count, decreased bicarbonate concentration in the blood plasma; infrequently – increase of aspartate aminotransferase activity, alanine, increasing the concentration of bilirubin in blood plasma, increasing concentrations of urea in plasma creatinine concentration in blood plasma, the potassium content variation in the blood plasma, increased alkaline phosphatase activity in plasma, increasing chlorine content in the blood plasma , increasing the concentration of glucose in the blood, increased platelet count, increased hematocrit, increased bicarbonate concentration in the blood plasma, changes in soda Jania sodium in the blood plasma.
special instructions
In the case of missing dosing missed dose should be taken as early as possible, and subsequent -. At intervals of 24 hours Azitral drug should be taken at least one hour before or two hours after ingestion of food and antacids. Azitral drug should be used with caution in patients with mild to moderate hepatic impairment because of the possibility of development of fulminant hepatitis and severe hepatic insufficiency. In the presence of liver disease symptoms, such as rapidly increasing fatigue, jaundice, dark urine, bleeding tendency, hepatic encephalopathy therapy with Azitral should stop and study the functional state of the liver. Patients with impaired renal function (creatinine clearance of more than 40 ml / min), mild and moderate severity Azitral drug therapy should be performed with care under the control of renal functions. In applying the drug Azitral both in patients receiving and 2-3 weeks after cessation of treatment may develop diarrhea caused by Clostridium difficile (pseudomembranous colitis). In mild cases enough discontinuation of treatment and use of ion exchange resins (colestyramine, colestipol), in severe cases shown compensation fluid loss, electrolytes, protein, vancomycin, metronidazole or bacitracin. You can not use medicines which inhibit intestinal motility. As well as any antibiotic therapy during the treatment with azithromycin may accession superinfection (including fungal). When pharyngitis and tonsillitis caused by Streptococcus pyogenes, selection antibiotics are penicillins. azithromycin is effective for the prevention of rheumatic fever is unknown. Application Azitral drug can trigger the development of myasthenic syndrome or aggravate myasthenia gravis. After discontinuation of treatment hypersensitivity reactions in some patients may persist, which requires specific therapy under medical supervision. Azitral The drug should not be used longer course than indicated in the instructions, as the pharmacokinetic properties of azithromycin can recommend short and simple dosing regimen.
INFLUENCE of drugs on driving ability, the mechanism of azithromycin at doses exceeding recommended, may affect the ability to drive a vehicle or equipment.
Storage conditions
In a dry place at a temperature not higher than 25 ° C. Keep out of the reach of children.
Dosing and Administration
Inside for 1 hour before or 2 hours after eating 1 time per day.
Adults (including the elderly) and children over 12 years weighing more than 45 kg.
In infections of the upper and lower respiratory tract, upper respiratory tract, skin and soft tissue – 500 mg / day for 1 reception for 3 days (a course dose 1.5 g).
When the urogenital tract infections (uncomplicated urethritis, or cervicitis) caused by Chlamydia trachomatis – single 1 g
When Lyme disease (borreliosis) for the treatment of step I (erythema migrans) – 1 g on the first day and 500 mg daily from 2 to 5 days (a course dose – 3 g).
When applied in patients with impaired renal function, mild and moderate severity (CC 40 ml / min), in patients with impaired liver function mild to moderate severity, as well as in older patients the dose correction is not required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

SHREYA

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