Rulide coated pills 150mg N10
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Active ingredients
Roxithromycin
Release form
Pills
Composition
Active ingredient: roxithromycin Auxiliary substances: hydroxypropylcellulose, poloxamer, povidone K30, anhydrous colloidal silicon, magnesium stearate, talc, corn starch. Base volume: tablet Concentration of the active substance (mg): 150 mg.
Pharmacological effect
Semi-synthetic macrolide antibiotic for oral administration. The drug is usually sensitive: Bordetella pertussis; Borrelia burgdorferi; Moraxella (Branhamella) catarrhalis; Campylobacter coli, Campylobacter jejuni, Chlamydia trachomatis, psittaci and pneumoniae, Clostridium spp. (including Clostridium perfringens); Corynebacterium diptheriae; Enterococcus spp., Gardnerella vaginalis; Methi - S - Staphylococcus; Neisseria meningitidis; Helicobacter pylori; Legionella pneumophilia, Lysteria monocytogenes obiluncus; Mycoplasma pneumoniae; Pasteurella multocida; Peptostreptococcus spp., Porphyromonas spp., Propionibacterium acnes; Rhodococcus equi, Streptococcus pneumoniae, Streptococcus spp. For the drug moderately sensitive: Haemophilus influenzae, Ureaplasma urealyticum, Vibrio cholerae. For the drug resistant: Acinetobacter spp, Bacteroides fragilis; Enterobacteriaceae; Methi-R Staphylococcus; Pseudomonas spp; Fusobacterium; Mycoplasma hominis, Nocardia.
Pharmacokinetics
In adults, Roxithromycin is rapidly absorbed after oral administration. Roxithromycin is more stable than other macrolides in the acidic environment of the stomach. Taking the drug 15 minutes before a meal does not affect the pharmacokinetics. After taking the drug in a dose of 150 mg Cmax in the blood averages 6.6 mg / l and is achieved after 2.2 hours. Taking the drug with an interval of 12 hours ensures that effective blood concentrations are maintained throughout the day. T1 / 2 after a single dose of 150 mg is 10.5 hours. After a single dose of 300 mg of roxithromycin, the average Cmax in the blood is 9.7 mg / l and is reached after 1.5 hours. When re-prescribed roxithromycin (150 mg 2 times / day, for 10 days) equilibrium in plasma is reached between 2-4 days, amounting to Cmax 9.3 mg / l. Taking 300 mg of roxithromycin every 24 hours for 11 days provided a Cmax of 10.9 mg / l. Roxithromycin penetrates well into many tissues, especially in the lungs, palatine tonsils and prostate gland. The drug also penetrates well into cells, especially in neutrophilic leukocytes and monocytes, stimulating their phagocytic activity. Binding to blood proteins is 96%, is saturated and decreases at concentrations of Roxithromycin over 4 mg / l. Roxithromycin is metabolized only partially, more than half of the active substance. displayed in unchanged form mainly with feces, as well as urine. In adults with normal renal function and liver, 65% of roxithromycin is excreted. In renal failure, the excretion of roxithromycin and its metabolites through the kidneys is approximately 10% of the dose taken.The dose of the drug does not change in case of renal failure. In severe liver failure, T1 / 2 is lengthened (25 hours) and Cmax increases. Less than 0.05% of the taken dose of roxithromycin passes into breast milk.
Indications
upper respiratory tract infections: acute pharyngitis, tonsillitis, sinusitis; lower respiratory tract infections: pneumonia (among others), including those caused by such atypical pathogens such as Chlamydia psittaci, Chlamydia pneumonia, Moraxella (Branhamella) catarrhalis, Legionella pneumophilia, Ithropics. in chronic obstructive pulmonary diseases, infections of the skin and soft tissues, genital infections (except gonorrhea), including urethritis, cervicovaginitis, infections in dentistry.
Contraindications
hypersensitivity to macrolides, simultaneous administration of drugs such as ergotamine and dihydroergotamine. Warning: Combined use with ergotamine derivatives and ergotamine-like vasoconstrictor agents is not allowed, as it can lead to the development of ergotism and necrosis of limb tissues. Use with caution in patients with severe liver failure. Pregnancy and breastfeeding Roxithromycin is contraindicated during pregnancy. Small amounts of roxithromycin penetrate into breast milk, so you need to stop breastfeeding or taking the drug.
Precautionary measures
Do not exceed the recommended dose. Use with caution in patients with severe liver failure.
Use during pregnancy and lactation
Roxithromycin is contraindicated in pregnancy. Small amounts of roxithromycin penetrate into breast milk, so you need to stop breastfeeding or taking the drug.
Dosage and administration
Adults appoint 150 mg of Roxithromycin inside with an interval of 12 hours. In this case, the daily dose is 300 mg. You can assign 300 mg once a day. For children (body weight over 40 kg), 150 mg of roxithromycin is administered orally with an interval of 12 hours. The daily dose is 300 mg. This dosage form does not apply to children under 4 years old! In elderly patients, the dosage and daily dose of roxithromycin does not change. In the presence of renal failure, roxithromycin is administered at a dose of 150 mg 2 times a day. In patients with liver failure, 150 mg is administered once. The duration of administration of roxithromycin depends on the indication for use, the severity of the infectious process and the activity of the pathogen. Roxithromycin is taken before meals orally once or twice a day.The tablet should be washed down with enough water.
Side effects
Anaphylactic reactions: angioedema, bronchospasm, weakness, rarely anaphylactic shock. Skin reactions: rash, redness, urticaria. Gastrointestinal reactions: nausea, vomiting, abdominal pain, diarrhea (very rarely with blood). Reactions from the liver: increased liver enzymes (ALT, ACT, alkaline membrane). Cholestatic or hepatocellular acute hepatitis. Small changes in taste and olfactory sensations are possible. In some cases, symptoms of pancreatitis were observed. Headache, headache, paresthesias. Superinfection may occur due to the growth of insensitive microorganisms.
Overdose
In case of overdose, gastric lavage and symptomatic therapy are necessary. There is no specific antidote.
Interaction with other drugs
It is not recommended to take terfenadine at the same time, due to the increased concentration of the latter while taking macrolide antibiotics, which can lead to the development of severe ventricular arrhythmias. Although this complication was not observed in roxithromycin, and in the studies on volunteers no pharmacokinetic interactions or changes on the ECG were shown, the combination of roxithromycin and terfenadine is not recommended. Acceptance of drugs such as astemizole, cisapride, pimozide can lead to a prolongation of the QT interval and / or severe cardiac arrhythmias, as a result of an increase in their serum concentration, as a result of competitive influence for the CYP 3A isoenzyme between the above-mentioned drugs and macrolide antibiotics. Reciprocal The action with warfarin, carbamazepine, ranitidine, antacids, and oral contraceptives otsutstvuet.Pri simultaneous appointment of roxithromycin with vitamin K antagonists is recommended to monitor the prothrombin time and international normalized ratio (INR) .Roksitromitsin can replace protein bound disopyramide, leading to increased serum levels of disopyramide. Recommended ECG monitoring and, if possible, determination of the level of disopyramide in serum. If taken simultaneously with digoxin, the absorption of the latter may be increased. It is recommended to monitor the electrocardiogram and serum levels of cardiac glycoside.This is necessary when symptoms of an overdose of cardiac glycosides appear. Roxithromycin may increase the half-life of midazolam, leading to an increase and lengthening of its action.
special instructions
In appointing the drug to patients with liver failure, special care is needed, monitoring liver function and adjusting the dose. When prescribing the drug in patients with renal insufficiency, as well as in elderly patients, there is no need to adjust the dose.