Fromilid pills coated 500mg N14
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Clarithromycin
Release form
Pills
Composition
1 tablet contains: Clarithromycin 500 mg Supplementary substances: corn starch, microcrystalline cellulose (Avicel PH 101, Avicel PH 102), anhydrous colloidal silicon dioxide, pregelatinized starch, potassium polacriline, talc, magnesium stearate. , quinoline yellow dye (E104), propylene glycol, titanium dioxide (E171).
Pharmacological effect
Semisynthetic macrolide antibiotic. Inhibits protein synthesis in the microbial cell. Basically has a bacteriostatic effect. In high concentrations, it has a bactericidal effect on Streptococcus pyogenes, Streptococcus pneumoniae and Moraxella catarrhalis. It is active against intracellular microorganisms: Legionella pneumophila, Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum, Iyour anti-respiration, Iyourchoracis, Chlamydia pneumoniae, Ureaplasma urealyticum, I, myrexella pneumophila, Chlamydia pneumonia. Gram-positive bacteria: Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus agalactiae, Streptococcus viridans, Staphylococcus aureus, Listeria monocytogenes, Corynebacterium spp., Bacillus spp .; Gram-negative bacteria: Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Borrelia burgdorferi, Pasteurella multocida, Campylobacter spp. and Helicobacter pylori; anaerobic bacteria: Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus. The drug is also active against Toxoplasma gondii, Mycobacterium spp. (except Mycobacterium tuberculosis).
Pharmacokinetics
AbsorptionAfter ingestion, clarithromycin is well absorbed from the gastrointestinal tract. Bioavailability by ingestion - 55%. Food slows down the absorption, but does not significantly affect the bioavailability of clarithromycin. Cmax is reached in less than 3 hours. The distribution of plasma protein binding is more than 90%. With regular intake of 250 mg / Css of unchanged substance is 0.62-0.84 mcg / ml, the main metabolite is 0.4-0.7 mcg / ml, respectively; when increasing the dose to 500 mg / Css, the unchanged substance is 1.77-1.89 μg / ml, its plasma metabolite is 0.67-0.8 μg / ml. Clarithromycin easily penetrates into tissues (lungs, palatine tonsils, saliva, sputum and middle ear, skin and soft tissues of the body) and body fluids, where it reaches a concentration almost 10 times higher than the serum concentration. Metabolism Approximately 20% of clarithromycin is immediately metabolized in the liver at participation of CYP3A4, CYP3A5 and CYP3A7 isoenzymes with the formation of the main metabolite - 14-hydroxy-clarithromycin, which has a pronounced activity against Haemophilus influenzae. Excretion of T1 / 2 after taking the drug in a dose of 250 mg ranges from 3 to 4 hours; after receiving a dose of 500 mg - from 5 to 7 hours. From 20 to 30% of clarithromycin (40% when taking a suspension) is excreted unchanged in the urine, the rest is excreted in the form of metabolites.
Indications
Treatment of infectious and inflammatory diseases caused by pathogens susceptible to the drug, including: - infections of the upper respiratory tract (acute and chronic tonsillopharyngitis, acute and chronic recurrent sinusitis, acute otitis media); - infections of the lower respiratory tract (acute bacterial bronchitis, exacerbation of chronic bronchitis, community-acquired bacterial pneumonia, including pneumonia caused by atypical pathogens; - infections of the skin and soft tissues; - infections caused by mycobacteria (Mycobacterium avium complex, Mycobacterium kansasii, Mycobacterium marinum, Mycobacterium leprae); - preventing the spread of infections caused by the Mycobacterium avium complex (MAC) in HIV-infected patients with a CD4 lymphocyte count (T-helper lymphocytes) of not more than 100 / mm3; - Eradication of Helicobacter porororum in patients with duodenal ulcer or stomach ulcer (always in combination
Contraindications
- severe liver failure; - hepatitis (in history); - porphyria; - I trimester of pregnancy; - lactation period; - simultaneous therapy with terfenadine, cisapride, pimozide or astemizole; - children up to 6 months (for the dosage form - granules for preparation of oral suspension) - there is not enough experience regarding the efficacy and safety of use; - children under 12 years old and / or children weighing less than 33 kg (for the dosage form - film-coated pills); - congenital non-transfer Immunity of fructose, malabsorption syndrome of glucose / galactose or deficiency of the enzyme sucrase-isomaltase (only for the dosage form - granules for the preparation of oral suspension); - hypersensitivity to the components of the drug; - hypersensitivity to other macrolide antibiotics.
Precautionary measures
The drug should be used with caution in patients with moderate to severe renal failure, with liver failure, in the second and third trimesters of pregnancy.
Use during pregnancy and lactation
The safety of using clarithromycin during pregnancy and during breastfeeding has not been established. Use of clarithromycin during pregnancy (especially in the first trimester) is possible only when there is no alternative therapy, and the potential benefit to the mother outweighs the potential risk to the fetus. Clarithromycin is excreted in breast milk. If necessary, the reception during the breastfeeding period should be discontinued.
Dosage and administration
The drug is taken orally. Tablets should be swallowed whole, without breaking, with a small amount of liquid. Adults and children over 12 years old and / or with a body weight of> 33 kg are usually prescribed 250 mg every 12 hours. For the treatment of acute sinusitis, severe infections and, when the infection is caused by Haemophilus influenzae, 500 mg of clarithromycin is prescribed every 12 hours. The course of treatment is 7-14 days. With the aim of eradication of Helicobacter pylori, Fromilid is prescribed in a dose of 250-500 mg 2 times / day, usually within 7 days, in combination with other drugs.
Side effects
On the part of the digestive system: nausea, vomiting, diarrhea, abdominal pain, stomatitis, glossitis, short-term discoloration of teeth and tongue, pancreatitis, pseudomembranous enterocolitis, cholestatic jaundice, hepatitis. Impaired liver function can be severe, but usually reversible. Very rarely, there are cases of liver failure and death mainly due to severe concomitant diseases and / or concomitant drug therapy. For the CNS and peripheral nervous system: headache, vertigo, paresthesia, drowsiness, hallucinations, convulsions, psychosis, dizziness, confusion , fear, insomnia, nightmares, depersonalization, disorientation. On the side of the hematopoietic system: leukopenia, neutropenia, thrombocytopenia. On the part of the sense organs: taste change (dysgeus iya), smell, ringing in the ears, short-term hearing loss, passing after discontinuation of the drug. On the cardiovascular system: prolongation of the QT interval on the ECG, ventricular tachycardia of the pirouette type. On the part of the respiratory system: shortness of breath. arthralgia, myalgia. On the urinary system: interstitial nephritis, renal failure. On the side of metabolism: hypoglycemia in patients taking hypoglycemic drugs. Allergic reactions: skin rash, urticaria, skin Itching, swelling of the face, anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), angioedema of the Quincke. From the side of the blood coagulation system: unusual bleeding, hemorrhage. serum levels of bilirubin, creatinine, uric acid, prolongation of prothrombin time. Other: long-term use may develop cases of superinfection, candidiasis,resistance of microorganisms (pseudomembranous colitis, oral candidiasis).
Overdose
Symptoms: ingestion of a large dose of clarithromycin can cause symptoms of disorders of the gastrointestinal tract. In one patient with bipolar disorder in the history after taking 8 g of clarithromycin, changes in mental state, paranoid behavior, hypokalemia and hypoxemia are described. . Hemodialysis and peritoneal dialysis do not have a significant effect on the concentration of clarithromycin in serum, which is typical of other drugs of the macrolide group.
Interaction with other drugs
Clarithromycin is metabolized in the liver and can inhibit the activity of isoenzymes of the cytochrome P450 system. With the simultaneous use of clarithromycin and other drugs, metabolized with the participation of these isoenzymes, it is possible to increase the concentration of these drugs in the serum and the development of side effects. With simultaneous use of the drug Fromilid with terfenadine, cisapride, pimozide and astemizol, life-threatening arrhythmias may develop (these combinations are contraindicated). It is recommended to monitor plasma concentrations of theophylline, carbamazepine, digoxin, lovastatin, simvastatin, triazolam, midazolam and Istroma. , rifabutin, tacrolimus, itraconazole and ergot alkaloids, because increases the risk of side effects of these drugs when used simultaneously with clarithromycin.
special instructions
When prescribing the drug should be aware that among antibiotics of the macrolide group there is cross-resistance. Patients with impaired liver function of mild and moderate severity do not need to reduce the dose of the drug, if the kidney function is normal. Patients with severely impaired renal function should reduce the dose. In the presence of chronic liver diseases, regular monitoring of serum enzymes should be carried out. When drugs are given that are metabolized in the liver,It is recommended to control their concentration in blood serum. Treatment with antibiotics changes the normal flora of the intestine, therefore, superinfection caused by resistant microorganisms may develop. control prothrombin time in patients receiving clarithromycin simultaneously with warfarin or other oral anticoagulants.