Zitrolid forte caps. 500mg 3 pcs

$4.74

Zitrolid forte caps. 500mg 3 pcs

Quantity:

Description

Composition
Active substance:
1 capsule contains: Azithromycin dihydrate (based on azithromycin) – 500 mg ;.
Excipients:
Microcrystalline Cellulose – 64.3 mg Magnesium stearate 5.7 mg; hard gelatin capsules – 118.0 mg: Casing: Titanium dioxide E171 – 2.0% gelatin – up to 100%; cover: titanium dioxide E 171 – 1.7434%, sunset yellow colorant E 110 – 0.4183% gelatin – up to 100%.
Description:
Capsules № 00, hull white, orange cap. Contents of capsules – powder from white to white with a yellowish tint, is prone to clumping.
Product form:
Capsules 500 mg.
3 capsules in blisters of PVC film and aluminum foil printed patent. 1 or 2 blisters together with instructions for use placed in a pile of cardboard.
Contraindications
-Increased sensitivity to azithromycin (including other macrolides), components of the drug; -heavy renal failure (creatinine clearance (CC) of less than 40 ml / min); -heavy hepatic failure (class B or higher on the Child-Pugh); is the period of lactation; -child under the age of 12 years with a body weight less than 45 kg; – Simultaneous reception with ergotamine and dihydroergotamine.
Carefully.
Pregnancy, arrhythmia, including predisposition to arrhythmia and lengthening the interval QT (the risk of ventricular arrhythmias and lengthening the interval QT), renal failure (creatinine clearance of more than 40 ml / min), hepatic failure (below class B Child-Pugh) myasthenia gravis, simultaneous with terfenadine, warfarin, digoxin.
Dosage
500 mg
Indications
Infectious-inflammatory diseases caused by microorganisms sensitive to azithromycin:
upper respiratory tract infections and otolaryngology (pharyngitis, tonsillitis, sinusitis, otitis media); lower respiratory tract infections (pneumonia, including atypical, the exacerbation of chronic, bronchitis including acute, exacerbation of chronic); skin and soft tissue infections (acne vulgaris, severity of the average, erysipelas, impetigo, secondarily infected dermatoses); urinary tract infections caused by Chlamydia trachomatis (urethritis, cervicitis); Lyme disease (initial stage – erythema migrans).
Interaction with other drugs
Antacids (aluminum and sodium-containing) have no influence on the bioavailability, but the lower the concentration of azithromycin in blood by 30%, so the interval between their intake should be 1 hour before or 2 hours after administration of said dosage forms.
While the use of derivatives of ergotamine and dihydroergotamine may increase the toxic action (vasospasm, dysesthesia) of the latter.
When combined with anticoagulants indirect coumarin (warfarin) and azithromycin (in normal doses) patients requires careful monitoring of the prothrombin time.
Care must be taken in the combined use of terfenadine and azithromycin, since it has been found that simultaneous reception of terfenadine and macrolide causes arrhythmia and Q-T interval prolongation. On this basis, we can not exclude the above-mentioned complications during coadministration of terfenadine and azithromycin.
In an application with necessary control digoxin concentration in the blood of digoxin (digoxin may increase the absorption in the gut).
While the use of cyclosporine is necessary to control the concentration of cyclosporine in the blood.
In an application with nelfinavir may increase the frequency of adverse reactions azithromycin (hearing loss, increased activity “liver” transaminase).
While the use of zidovudine azithromycin does not affect the pharmacokinetic parameters of AZT in the blood plasma or its renal excretion and its glucuronide metabolite, but increases the concentration of the active metabolite of the phosphorylated AZT in mononuclear cells of peripheral blood vessels. The clinical significance of this fact has not been determined.
Must consider the possibility of inhibiting the isozyme surZa4 azithromycin while the use of cyclosporine, terfenadine, ergot alkaloids, cisapride, pimozide, quinidine, astemizole and other drugs, metabolism which occurs with the enzyme.
Azithromycin concentration does not affect carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin and methyl prednisolone in the blood, while the application.
Overdose
Symptoms: severe nausea, temporary hearing loss, vomiting, diarrhea.
Treatment: removal of the drug, gastric lavage, administration of activated charcoal, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Antibiotic-azalide.
Pharmacodynamics:
Azithromycin – bacteriostatic antibiotic with broad-spectrum macrolide-azalides. It has a broad spectrum of antimicrobial action. The mechanism of action of azithromycin is associated with suppression of the synthesis of microbial cell protein. Communicating with the 50S-ribosomal subunit, inhibits peptidtranslokazu step of broadcasting and inhibits protein synthesis by slowing growth and reproduction of bacteria. In high concentrations it has a bactericidal effect.
It has activity against a number of Gram-positive, Gram-negative, anaerobic, intracellular and other organisms.
Microorganisms can initially be resistant to the antibiotic, or may acquire resistance to it.
In most cases sensitive microorganisms: Gram-positive aerobes 1. – Staphylococcus aureus Methicillin-sensitive – Streptococcus pneumoniae Penicillin-sensitive – Streptococcus pyogenes 2. aerobic Gram – Haemophilus influenza – Haemophilus parainjluenzae – Legionella pneumophila – Moraxella catarrhalis – Pasteurella multocida – Neisseria gonorrhoeas 3. Anaerobes – Clostridium perfringens – Fusobacterium spp. – Prevotella spp. – Porphyriomonas spp. 4. Other microorganisms – Chlamydia trachomatis – Chlamydia pneumonia – Chlamydia psittaci – Mycoplasma pneumonia – Mycoplasma hominis – Borrelia burgdorferi
Microorganisms capable of developing resistance to azithromycin:
Gram-positive aerobes – Streptococcus pneumoniae Penicillin-resistant
Initially resistant microorganisms:
Gram-positive aerobes – Enterococcus faecalis – Staphylococci (methicillin-resistant staphylococci exhibit a very high degree of resistance to macrolides) – Gram-positive bacteria resistant to erythromycin.
Anaerobes – Bacteroides fragilis.
Pharmacokinetics:
Absorption – high, is acid, lipophilic. Bioavailability after a single dose of 500 mg – 37% (the “first pass” through the liver), maximum concentration (Cmax) after oral administration of 500 mg – 0.4 mg / l, the time to reach maximum concentration (TSmah) – 2.5-2 9 h; in tissues and cells, the concentration is 10-50 times higher than in blood serum, the volume of – 31.1 L / kg. Easily passes blood-tissue barriers. It penetrates into the respiratory tract, genito-urinary organs and tissues in the prostate gland, the skin and soft tissues; It accumulates in low pH medium in the lysosomes (which is especially important for the eradication of intracellular pathogens located). It transported as phagocytes, polymorphonuclear leukocytes and macrophages. Penetrates through the cell membrane and creates a high concentration therein.
The concentration in the foci of infection was significantly higher (24-34%) than in healthy tissues, and is correlated with the severity of the inflammatory edema. In the area of ​​inflammation is maintained at effective concentrations for 5-7 days after the last dose. Communication with plasma proteins – 7-50% (inversely proportional to the concentration in the blood).
In the liver demetiliruetsa formed metabolites are inactive. The metabolism of the drug involved isozymes CYP3A4, CYP3A5, CYP3A7, an inhibitor which he is. Plasma clearance – 630 ml / min half-life (T1 / 2) between 8 and 24 h after administration is 14-20 hours, T1 / 2 in the range of from 24 to 72 h 41 h 50% excreted in the bile as unchanged. 6% -pochkami.
Food intake was significantly alters pharmacokinetics: Cmax decreased by 52%, area under the curve “concentration-time» (AUC) – 43%.
In older men (65-85 years) the pharmacokinetic parameters do not change in women increases Cmax (30-50%) in children aged 1 to 5 years, reduced Cmax, T1 / 2, AUC.
Pregnancy and breast-feeding
Azithromycin crosses the placenta. Application of pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of azithromycin during lactation should stop breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
From the digestive system: diarrhea, nausea, abdominal pain, flatulence, vomiting, melena, cholestatic jaundice, increased activity of “liver” trance and called, constipation, anorexia, gastritis, candidiasis of the oral mucosa, dyspepsia, hyperbilirubinemia, hepatitis, change color language, pancreatitis, pseudomembranous colitis, liver dysfunction, liver failure (in rare cases with fatal outcome, mainly on the background of abnormal liver function), liver necrosis, fulminant hepatitis.
From the cardiovascular system: palpitations, chest pain, decrease in blood pressure, increase in the interval Q-T, arrhythmia type “pirouette”, ventricular tachycardia.
From the nervous system: dizziness, headache, vertigo, drowsiness, headache (in the treatment of otitis media), hyperkinesia, anxiety, neurosis, insomnia, paresthesia, dysgeusia, hypoesthesia, aggression, fainting, seizures, psychomotor hyperactivity, loss of sense of smell , taste, myasthenia gravis.
From the senses: a violation of sharpness of vision, deafness, tinnitus.
From the urogenital system: increase of residual urea nitrogen, vaginal candidiasis, nephritis, hypercreatininemia, interstitial nephritis, acute renal failure.
From hemopoiesis system: leukopenia, neutropenia, thrombocytopenia, lymphopenia, eosinophilia, hemolytic anemia.
Allergic reactions: rash, hives, itchy skin, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions, photosensitivity, anaphylactic reaction.
Other: hyperglycemia, arthralgia, asthenia, photosensitivity, conjunctivitis, taste changes, fatigue, peripheral edema, malaise.
special instructions
When you miss taking a dose of the missed dose should be taken as soon as possible, and the next – with an interval of 24 hours. Azithromycin should be taken 1 hour before or 2 hours after taking antacid drugs.
Be used with caution in patients with hepatic impairment because of the possibility of development of fulminant hepatitis and severe liver disease in these patients. In the presence of liver disease symptoms (fast growing fatigue, jaundice, dark urine, bleeding tendency, hepatic encephalopathy) azithromycin therapy should be discontinued and a study of the functional state of the liver.
At moderate renal impairment (creatinine clearance of more than 40 ml / min) azithromycin should be under the control of renal function.
Contraindicated with concomitant use of azithromycin derivatives ergotamine and dihydroergotamine because of the possible development of ergotism.
In applying the drug, 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.
Since it is possible elongation Q-T interval in patients treated with macrolides, including azithromycin, when azithromycin, caution in patients with known risk factors elongation interval Q-T: old age; electrolyte imbalance (hypokalemia, hypomagnesemia); congenital syndrome interval elongation Q-T; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous reception of drugs capable to lengthen the interval Q-T (including antiarrhythmic drugs Ia and class III, tricyclic and tetracyclic antidepressants, neuroleptics, fluoroquinolones).
In the application of azithromycin may develop myasthenic syndrome or exacerbation of myasthenia gravis.
During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
The protected reflection 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 and children over 12 years weighing more than 45 kg:
-with infections of the upper and lower respiratory tract, upper respiratory tract, skin and soft tissue 500 mg per day for one reception for 3 days (a course dose 1.5 g).
-ugri ordinary – 500 mg per day for one reception for 3 days, then 500 mg per day, 1 time per week for 9 weeks. First weekly dose should be taken at 7 days after the first daily dose (Day 8 from the start of treatment), the next 8 weekly doses – with an interval of 7 days.
-with acute infections of urogenital organs (uncomplicated urethritis or cervicitis) – Once 1 year
-with Lyme disease – the treatment stage I (erythema migrans) -1 g on the first day and 500 mg daily from 2 to 5 days (a course dose – 3 g).
-with the treatment of pneumonia appoint 500 mg daily for 7-10 days; reception begin immediately after intravenous application of the dosage form (recommended dosage for intravenous administration of 500 mg once a day for at least 2 days).
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

Valenta Pharm

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