Rovamycine coated pills 1,5ml IU N16
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Active ingredients
Spiramycin
Release form
Pills
Composition
1 tablet contains: spiramycin 1.5 million IU. Adjuvants: colloidal silicon dioxide - 1.2 mg, magnesium stearate - 4 mg, pregelatinized corn starch - 16 mg, hyprolosis - 8 mg, croscarmellose sodium - 8 mg, microcrystalline cellulose - up to 400 mg The composition of the shell: titanium dioxide (E171) - 1.694 mg, macrogol 6000 - 1.694 mg, hypromellose - 5.084 mg.
Pharmacological effect
Macrolide antibiotic. The mechanism of the antibacterial action is due to inhibition of protein synthesis in the microbial cell due to binding to the 50S subunit of the ribosome. Sensitive microorganisms (MIC <1 mg / l): gram-positive aerobes - Bacillus cereus, Corynebacterium diphtheriae, Enterococcus spp., Rhodococcus-cecus, ecology, ecology, ecology, corynebacterium diphtheriae, Enterococcus spp. (methicillin-sensitive and methicillin-resistant strains), Streptococcus B, unclassified streptococcus, Streptococcus pneumoniae, Streptococcus pyogenes; Gram-negative aerobes - Bordetella pertussis, Branhamella catarrhalis, Campylobacter spp., Legionella spp., Moraxella spp .; anaerobes - Actinomyces spp., Bacteroides spp., Eubacterium spp., Mobiluncus spp., Peptostreptococcus spp., Porphyromonas spp., Prevotella spp., Propionibacterium acnes; Different - Borrelia burgdorferi, Chlamydia spp, Coxiella spp, Leptospira spp, Mycoplasma pneumoniae, Treponema pallidum, Toxoplasma gondii.Umerenno sensitive microorganisms (antibiotic moderately active in vitro at concentrations of antibiotic in the inflammation ≥ 1 mg / l but <4... mg / l): gram-negative aerobes - Neisseria gonorrhoeae; aerobic - Clostridium perfringens; different - Ureaplasma urealyticum. Sustainable microorganisms (BMD> 4 mg / l; at least 50% of strains are resistant): gram-positive aerobes - Corynebacterium jekeium, Nocardia asteroides; gram-negative aerobes - Acinetobacter spp., Enterobacter spp., Haemophilus spp., Pseudomonas spp .; anaerobes - Fusobacterium spp .; different - Mycoplasma hominis.
Pharmacokinetics
Absorption Spiramycin is rapidly, but incomplete, with high variability (from 10% to 60%). After ingestion of Rovamycine orally at a dose of 6 ppm IU Cmax of spiramycin in plasma is about 3.3 μg / ml. Food intake does not affect absorption. Distribution Plasma protein binding is low (approximately 10%). Vd approximately 383 liters. The drug penetrates well into saliva and tissues (concentration in the lungs is 20-60 mcg / g, in the tonsils - 20-80 mcg / g, in the infected sinuses - 75-110 mcg / g, in the bones - 5-100 mcg / g) . 10 days after the end of treatment, the concentration of spiramycin in the spleen, liver, and kidneys is 5-7 mcg / g. Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). In humans, drug concentrations inside phagocytes are quite high. This explains the effectiveness of spiramycin against intracellular bacteria. It penetrates the placental barrier (the concentration in the blood of the fetus is about 50% of the concentration in the serum of the mother). Concentrations in placental tissue are 5 times higher than the corresponding serum concentrations.It is excreted in breast milk. Spiramycin does not penetrate into the cerebrospinal fluid. Metabolism and excretion Spiramycin is metabolized in the liver to form active metabolites with unidentified chemical structure. T1 / 2 from plasma is approximately 8 hours. Excreted mainly in bile (concentration 15-40 times higher than in serum). Renal excretion is about 10% of the injected dose. The amount of the drug excreted through the intestines (with feces) is very small.
Indications
Infectious and inflammatory diseases caused by susceptible microorganisms: - acute and chronic pharyngitis caused by beta-hemolytic streptococcus A (as an alternative to treatment with beta-lactam antibiotics, especially in the case of contraindications to their use); - acute sinusitis (given the sensitivity most often causing this pathology of microorganisms, the use of the drug Rovamycine is indicated in case of contraindications to the use of beta-lactam antibiotics); - acute and chronic tonsillitis caused by microorganisms sensitive to spiramycin; acute bronchitis caused by a bacterial infection that developed after acute viral bronchitis; exacerbation of chronic bronchitis; community-acquired pneumonia in patients without risk factors for adverse outcome, severe clinical symptoms and clinical signs of pneumococcal pneumonia; pneumonia, caused by atypical pathogens (such as Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Legionella spp.) or suspicion of it (regardless of the severity and the presence or the presence of risk factors for adverse outcome); - infections of the skin and subcutaneous tissue, including impetigo, impetiginization, ecthyma, infectious dermohypogermitis (especially erysipelas), secondary infected dermatoses, erythrasma; - infections of the oral cavity (including stomatitis, glossitis); - non-gonococcal infections of the genital organs; - toxoplasmosis, incl. during pregnancy - infections of the musculoskeletal system and connective tissue, including periodontal. Prevention of recurrent rheumatism in patients with an allergy to beta-lactam antibiotics. Eradication of Neuroseria meningitidis from the nasopharynx (with contraindications to receiving rifampicin) for prevention (but not treatment) : - in patients after treatment and before leaving the quarantine; - in patients who were within 10 days prior to hospitalization in contact with persons who excreted Neisseria meningitidis with saliva into the environment.
Contraindications
- lactation period; - glucose-6-phosphate dehydrogenase deficiency (risk of developing acute hemolysis); - children's age (for pills 1.5 million IU - up to 6 years, for pills 3 million IU - up to 18 years); - hypersensitivity to components With caution, prescribe Rovamycine for obstruction of the bile duct, for liver failure.
Use during pregnancy and lactation
Rovamycine can be prescribed during pregnancy according to indications. There is a lot of experience with the use of the drug Rovamycine during pregnancy. Reducing the risk of transmission of toxoplasmosis to the fetus during pregnancy is observed from 25% to 8% when using the drug in the first trimester, from 54% to 19% in the second trimester and from 65% to 44% in the third trimester. No teratogenic or fetotoxic effect was observed. When prescribing the drug Rovamycine during lactation, breastfeeding should be discontinued, since spiramycin may penetrate into breast milk.
Dosage and administration
The drug is taken orally. Adults are prescribed 2-3 tab. 3 million IU or 4-6 tab. 1.5 million IU (ie 6-9 million IU) per day. The daily dose is divided into 2 or 3 doses. The maximum daily dose is 9 million IU. In children and adolescents aged 6 to 18 years, only 1.5 million ME should be used. In children over 6 years, the daily dose is 150-300 thousand ME per kg of body weight, which divided by 2 or 3 receptions to 6-9 million ME. The maximum daily dose in children is 300 thousand ME per kg of body weight, but with a child’s body weight over 30 kg, it should not exceed 9 million ME. For the prevention of meningococcal meningitis, adults are prescribed 3 million IU 2 times / day for 5 days, children - 75 thousand IU / kg of body weight 2 times / day for 5 days. Patients with impaired renal function due to minor renal excretion of spiramycin do not need dose adjustment. Tablets are ingested, drinking plenty of water.
Side effects
The following classification is used to indicate the frequency of unwanted reactions: very often (≥10%), often (≥ 1%, <10); infrequently (≥ 0.1%, <1%); rarely (≥0.01%, <0.1%), very rarely, including individual messages (<0.01%), the frequency is unknown (according to the available data, the frequency cannot be determined). From the digestive system: nausea, vomiting, diarrhea; very rarely, pseudomembranous colitis (<0.01%); frequency is unknown - ulcerative esophagitis, acute colitis,acute damage to the intestinal mucosa in AIDS patients when using spiramycin in high doses for cryptosporidiosis (2 cases in total). From the liver and biliary tract: very rarely (<0.01%) - deviation of the liver function tests from normal values; cholestatic or mixed hepatitis. From the nervous system: very rarely (isolated cases) - transient paresthesia. From the hematopoietic system: very rarely (<0.01%) - acute hemolysis. From the side of the cardiovascular system: very rarely - prolongation of the QT interval by ECG. For the immune system: skin rash, urticaria, pruritus; very rarely (<0.01%) - angioedema, anaphylactic shock; in some cases - vasculitis, including Schoenlein-Genoh purpura. On the side of the skin and subcutaneous tissues: very rarely - acute generalized exantmatous pustus.
Overdose
No cases of spiramycin overdose are known. Symptoms: possible - nausea, vomiting, diarrhea. Cases of lengthening the QT interval, taking place when discontinuing the drug, were observed in newborns who received high doses of spiramycin or after IV injection of spiramycin in patients who are prone to lengthening the QT interval. in the presence of risk factors (hypokalemia, congenital lengthening of the QT interval, the simultaneous use of drugs, prolonging the duration of the QT interval and causing the development of ventricular tachi ardii type pirouette). There is no specific antidote. If spiramycin is suspected to be overdose, symptomatic therapy is recommended.
Interaction with other drugs
Inhibition of spiramycin absorption of carbidopa with a decrease in the concentration of levodopa in the plasma. With the simultaneous appointment of spiramycin, clinical monitoring and dose adjustment of levodopa are necessary. Numerous cases of an increase in the activity of indirect anticoagulants in patients taking antibiotics have been registered. The type of infection or the severity of the inflammatory response, the age and general condition of the patient are predisposing risk factors. Under such circumstances, it is difficult to determine to what extent the infection itself or its treatment plays a role in changing the MHO.However, when using certain groups of antibiotics, this effect is observed more often, in particular when using fluoroquinolones, macrolides, cyclins, a combination of sulfamethoxazole + trimethoprim, some cephalosporins.
special instructions
During treatment with a drug in patients with liver diseases, its function must be periodically monitored. If at the beginning of treatment a generalized erythema and pustules occur, accompanied by high body temperature, it should be assumed that acute generalized exanthematic pustus is assumed if such a reaction occurs, treatment should be stopped, and further use of spiramycin, both in monotherapy and in combination, is contraindicated. Use in pediatrics Tablets of 3 million ME in children do not apply because of the difficulty of swallowing them because of the large the diameter of the pills and the danger of airway obstruction. The effect on the ability to drive vehicles and control mechanisms. There is no information about the negative effect of the drug on the ability to drive a car and engage others in potential Hazardous activities. However, the severity of the patient's condition, which can affect the attention and speed of psychomotor reactions, should be taken into account. Therefore, the decision about whether you can drive a car or engage in other potentially hazardous activities in a particular patient should be made by your doctor.