Pharmacy No. 84. Delivery of medicines to your home and office.

Medicines

my basket

Apteka84.kz is an online pharmacy that offers its customers medicines, medicinal and decorative cosmetics, dietary supplements, vitamins, baby food, intimate products for adults, medical equipment and thousands of other medical and cosmetic products at low prices. All data presented on the Apteka84.kz website is for informational purposes only and is not a substitute for professional medical care. Apteka84.kz strongly recommends that you carefully read the instructions for use contained in each package of medicines and other products. If you currently have any symptoms of the disease, you should seek help from a doctor. You should always tell your doctor or pharmacist about all the medicines you take. If you feel you need further help, please consult your local pharmacist or contact our GP online or by telephone.

Rovamycin, 3 million IU, film-coated tablets, 10 pcs.

Pharmacodynamics

Antibiotic from the macrolide group.

The mechanism of antibacterial action is due to inhibition of protein synthesis in the microbial cell due to binding to the 50S ribosomal subunit.

Usually sensitive microorganisms (MIC≤1 mg/l): Streptococci. Methicillin-sensitive staphylococci. Enterococci. Rhodococcus equi. Bacillus cereus. Branhamella catarrhalis. Bordetella pertussis. Helicobacter pylori. Campylobacter spp. Legionella spp. Corynebacterium diphtheriae. Moraxella spp. Mycoplasma pneumoniae. Coxiella spp. Chlamydia spp. Treponema pallidum. Borrelia burgdorferi. Leptospira spp. Propionibacterium acnes. Actinomyces spp. Eubacterium spp. Porphyromonas spp. Mobiluncus spp. Bacteroides spp. Peptostreptococcus spp. Prevotella spp. Toxoplasma gondii.

Moderately sensitive microorganisms: Neisseria gonorrhoeae. Ureaplasma urealyticum. Clostridium perfringens. Against these pathogens, the antibiotic is moderately active in vitro; positive results can be observed at concentrations of the antibiotic at the site of inflammation higher than the MIC.

Resistant microorganisms (MIC>4 mg/l), at least 50% of strains are resistant: Methicillin-resistant staphylococci. Enterobacter spp. Pseudomonas spp. Acinetobacter spp. Nocardia asteroides. Fusobacterium spp. Haemophilus spp. Mycoplasma hominis. Corynebacterium jekeium.

Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrobiophages). In humans, drug concentrations inside phagocytes are quite high. These properties explain the effects of spiramycin on intracellular bacteria.

Pharmacokinetics

Suction

Absorption of spiramycin occurs quickly, but incompletely, with great variability (from 10% to 60%). After taking Rovamycin orally at a dose of 6 million IU, the Cmax of spiramycin in plasma is about 3.3 μg/ml.

Distribution

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.

Spiramycin does not penetrate into the cerebrospinal fluid; excreted in breast milk. Penetrates the placental barrier (the concentration in the fetal blood is approximately 50% of the concentration in the maternal blood serum). Concentrations in placental tissue are 5 times higher than corresponding concentrations in serum.

V d approximately 383 l. The drug penetrates well into saliva and tissues (the concentration in the lungs is 20-60 mcg/g, in the tonsils - 20-80 mcg/g, in 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. Plasma protein binding is low (approximately 10%).

Metabolism and excretion

Spiramycin is metabolized in the liver to form active metabolites with an unknown chemical structure.

It is excreted mainly in bile (concentration is 15-40 times higher than in serum). Renal excretion of active spiramycin is approximately 10% of the administered dose. T1/2 after taking 3 million IU of spiramycin orally is approximately 8 hours.

Pharmacokinetics in special clinical situations

T 1/2 is longer in older people. In patients with impaired renal function, no dosage adjustment is required.

Rovamycin 3 million No. 10 Tablets

Trade name: Rovamycin® International nonproprietary name: Spiramycin Dosage form: Film-coated tablets, 3.0 million IU Composition: One tablet contains the active substance - spiramycin 3.0 million IU, excipients: colloidal anhydrous silicon, magnesium stearate, corn starch pregelatinized, low-substituted hydroxypropylcellulose, croscarmellose sodium (sodium carboxymethylcellulose), microcrystalline cellulose, shell composition: titanium dioxide (E 171), macrogol 6000, hypromellose Description: Film-coated tablets 3.0 million IU - round biconvex film-coated tablets white or cream color with the marking “ROVA 3” on one side Pharmacotherapeutic group: Antibacterial drugs for systemic use. Macrolides, lincosamides and streptogramins. Macrolides. Spiramycin Pharmacological properties: Pharmacokinetics Absorption. Spiramycin is absorbed quickly, but not completely. Food intake does not affect the absorption of spiramycin. Distribution. After oral administration of 6 million IU of spiramycin, maximum plasma concentrations are 3.3 µg/ml. The plasma half-life is approximately 8 hours. Spiramycin does not penetrate the blood-brain barrier. However, it passes into breast milk. Plasma protein binding is low (10%). Distribution into tissue and saliva is very high (lungs: 20 to 60 µg/g, tonsils: 20 to 80 µg/g, infected sinuses: 75 to 110 µg/g, bones: 5-100 µg/g). Ten days after stopping treatment, 5 to 7 µg/g of the drug remains in the spleen, liver and kidneys. Macrolides penetrate and accumulate in phagocytes (neutrophils, monocytes, peritoneal and alveolar macrophages). In the human body, drug concentrations in phagocytes are high. These properties explain the effect of the macrolide on intracellular bacteria. Metabolism. Spiramycin is metabolized in the liver, forming chemically unknown but active metabolites. Excretion - in urine: 10% of the dose taken. - excretion in bile is very high: concentrations are 15-40 times higher than plasma concentrations. - Significant amounts of spiramycin can be found in feces.

Pharmacodynamics Antimicrobial action spectrum Critical concentrations that distinguish susceptible strains from intermediate strains, as well as the latter strains from resistant strains, are presented below: S ? 1 mg/l and R > 4 mg/l. The prevalence of acquired resistance may vary geographically and over time in some species. Therefore, it is useful to have local information on the prevalence of resistance, especially when treating severe infections. These data are only guidelines indicating the likelihood of a bacterial strain being susceptible to a given antibiotic. The obtained data on the prevalence of the resistance of bacterial strains in France are indicated in the table below: susceptible species gram-positive aerobic microorganisms Bacillus ceres corenebacterium diphtheriae enterococci 50-70% RHODOCOCOCOCOCUCUCUS EQUI STAPHYLOCOCCUCUSS Taphylococcus meti-r* 70-80% Streptococcus B Non-classified streptococcus 30-40 % Streptococcus pneumonia 35-70% Streptococcus pyogenes 16-31% Gram-negative aerobic microorganisms Bordetella pertussis Branhamella catarrhalis Campylobacter Legionella Moraxella Anaerobic microorganisms Actinomyces Bacteroides 30-60% Eubacterium Mobiluncus Peptostreptococcus 30-40% Porphyromonas Prevotella Pro pionibacterium acnes Miscellaneous Borellia burgdorferi Chlamydia Coxiella Leptospires Mycoplasma pneumoniae Treponema pallidum MODERATELY SUSPECTIVE SPECIES (intermediate susceptibility in vitro) Gram-negative aerobic microorganisms Neisseria gonorrhoeae Anaerobic microorganisms Clostridium perfringens Miscellaneous Ureaplasma urealyticum RESISTANT SPECIES Gram-positive aerobic microorganisms Corynebacterium jeikeium Nocardia asteroids Gram-negative aerobic microorganisms Acinetobacter Enterobacteria Haemophilus Pseudomonas Aerobic microorganisms Fusobacterium Miscellaneous Mycoplasma hominis Spiramycin is active against to Toxoplasma gondii in vitro and in vivo. The incidence of methicillin resistance is approximately 30 to 50% for all staphylococci and is found primarily in hospital settings. Indications for use: Therapeutic indications are based on the antibacterial activity and pharmacokinetic properties of spiramycin. Indications are presented taking into account both the clinical studies performed on this drug and its place in the range of antibacterial agents currently available on the market. The use of spiramycin is limited to the treatment of infections caused by microorganisms sensitive to the drug: - confirmed pharyngitis caused by beta- hemolytic streptococcus A, as an alternative to betalactam treatment, especially when betalactams cannot be used - acute sinusitis: taking into account the microbiological characteristics of these infections, the use of macrolides is indicated when betalactam treatment is not possible - superinfections of acute bronchitis - exacerbation of chronic bronchitis - community-acquired pneumonia in subjects: - without risk factors - without severe clinical symptoms - without clinical factors indicating pneumococcal etiology. If atypical pneumonia is suspected, the use of macrolides is appropriate regardless of the severity of the disease and medical history. - benign skin infections: impetigo, ecthyma, infectious dermo-hypodermatitis (especially erysipelas), erythrasma - oral infections - non-gonococcal genital infections - chemoprophylaxis of relapses of acute rheumatic fever in patients with an allergy to beta-lactams - toxoplasmosis in pregnant women Must be taken take into account official recommendations regarding the appropriate use of antibacterial agents. Directions for use and dosage : Patients with normal renal function: Adults: orally 2-3 tablets of 3 million IU per day in 2 or 3 divided doses. Children over 6 years of age: 1.5-3 million IU per 10 kg of body weight per day in 2 or 3 doses. The duration of treatment for sore throat is 10 days. Prevention of meningococcal meningitis: for adults 3 million IU/12 hours; for children 75,000 IU/kg/12 hours for 5 days. Tablets with a dosage of 3 million IU are not acceptable for children. They are used only in adults. Patients with renal insufficiency: No dose adjustment is required. The tablets must be swallowed whole with a glass of water. Side effects: - stomach pain, nausea, vomiting, diarrhea - rash, urticaria, itching Rarely - transient paresthesia Very rarely - pseudomembranous colitis - angioedema, anaphylactic shock - acute generalized exanthematous pustulosis (see "Special Instructions") - deviation from the norm liver function tests - cases of hemolytic anemia (see "Special Instructions"). Contraindications: - hypersensitivity to spiramycin and other components of the drug - lactation period Drug interactions: Combinations that must be taken into account: - Levodopa (in combination with carbidopa): inhibition of carbidopa absorption with reduced plasma concentrations of levodopa. Clinical monitoring and possible dosage adjustment of levodopa. Special problems associated with INR (international normalized ratio) imbalance Numerous cases of increased oral anticoagulant activity have been reported in patients undergoing antibiotic therapy. The severity of the infection or inflammation, the patient's age, and general health appear to be risk factors. Under these circumstances, it seems difficult to determine the extent to which the infection itself or its treatment plays a role in the INR imbalance. However, certain classes of antibiotics have been implicated to a greater extent, especially: fluoroquinolones, macrolides, cyclins, cotrimoxazole and some cephalosporins. Special instructions: If, at the beginning of treatment, patients experience generalized erythema and pustules, accompanied by a febrile state, acute generalized exanthematous pustulosis should be suspected (see “Side effects”). If such a reaction occurs, treatment should be stopped immediately, and further treatment with spiramycin in the form of monotherapy or in combination is contraindicated. The use of the tablets in children under 6 years of age is contraindicated due to the risk of accidental suffocation. Since the active substance is not excreted through the kidneys, there is no need to adjust the dose for patients with renal failure. Very rare cases of hemolytic anemia have been reported in patients with glucose-6-phosphate dehydrogenase deficiency. The use of spiramycin in these patients is therefore not recommended. Pregnancy and lactation The use of spiramycin may be considered during pregnancy if necessary. To date, widespread use of spiramycin during pregnancy has not proven the drug to be teratogenic or fetotoxic. Significant amounts of the drug are excreted into a woman's breast milk. Gastrointestinal disturbances have been reported in neonates. Breastfeeding while using the drug is not recommended. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. Does not affect. Overdose: Symptoms: No toxic doses are known for spiramycin. Symptoms expected at high doses are gastrointestinal disorders such as nausea, vomiting and diarrhea. Cases of QT prolongation that regresses after cessation of treatment have been reported in neonates treated with high doses of spiramycin, as well as after intravenous administration of spiramycin in patients at risk for QT prolongation. In case of overdose with spiramycin, an ECG is recommended to measure the QT interval, especially in the presence of other risk factors (hypokalemia, congenital long QTc interval, concomitant administration of other drugs that prolong the QT interval and/or induce torsade de pointes). Treatment: there is no specific antidote. Symptomatic treatment is recommended. Release form and packaging : 5 tablets of 3.0 million IU in blister packs made of polyvinyl chloride film and aluminum foil. 2 blister packs together with instructions for medical use in the state and Russian languages are placed in a cardboard pack.

Storage conditions: Store at a temperature not exceeding 25 °C. Keep out of the reach of children! Shelf life: For tablets 3 million IU – 4 years. Do not use after the expiration date. Conditions for dispensing from pharmacies: By prescription

Special instructions for the use of the drug Rovamycin

The dose of the drug in patients with renal failure does not need to be changed, since the excretion of Rovamycin in the urine does not exceed 10% of the administered dose. Considering isolated cases of the development of hemolytic anemia, the use of the drug in patients with glucose-6-phosphate dehydrogenase deficiency is not recommended. In case of allergic reactions, the drug is discontinued. It is necessary to interrupt breastfeeding during treatment with the drug, since Rovamycin passes into breast milk. The drug can be prescribed during pregnancy.

Side effects of the drug Rovamycin

Isolated cases of phlebitis of moderate severity (in exceptional cases, requires discontinuation of the drug); gastralgia, nausea, vomiting, diarrhea, in isolated cases - pseudomembranous colitis; allergic reactions (itching, rash, urticaria, extremely rarely - angioedema, anaphylactic shock); rarely - periodic transient paresthesia; very rarely - deviation from the norm in liver function tests; extremely rarely - hemolytic anemia; isolated cases of prolongation of the QT on the ECG.

Use of the drug Rovamycin

For adults, Rovamycin is prescribed orally at a daily dose of 6,000,000–9,000,000 IU in 2–3 divided doses, for children weighing more than 20 kg - at the rate of 1,500,000 IU per 10 kg of body weight per day in 2–3 divided doses. Prevention of meningococcal meningitis: adults are prescribed 3,000,000 IU every 12 hours for 5 days, children weighing more than 20 kg - 75,000 IU per 1 kg of body weight every 12 hours for 5 days. Rovamycin is prescribed as an intravenous infusion only to adults. To carry out the infusion, the contents of the bottle are dissolved in 4 ml of water, then in 100 ml of 5% glucose solution; The solution is administered over 1 hour. The dose of Rovamycin in acute processes is 1,500,000 IU every 8 hours (4,500,000 IU/day), in severe cases the dose may be doubled. The shelf life of the finished infusion solution is 12 hours. The duration of treatment is determined taking into account the clinical situation, usually it is 7–10 days.

Overdose of the drug Rovamycin, symptoms and treatment

The toxic dose of spiramycin has not been determined. An overdose may be accompanied by gastrointestinal symptoms (nausea, vomiting, diarrhea). In neonates who received spiramycin in high doses, as well as in patients at risk of prolongation of the QT on the ECG, cases of prolongation of the QT . In case of spiramycin overdose, ECG monitoring is indicated to monitor the duration of the QT , especially in the presence of additional risk factors (hypokalemia, congenital prolongation of the QT , use of a combination of drugs that can cause prolongation of the QT and/or cause flutter and ventricular fibrillation). There is no specific antidote. Treatment is symptomatic.

Indications for use of the drug Rovamycin

Infections caused by pathogens sensitive to the drug, including diseases of the ENT organs (sinusitis, tonsillitis, otitis media); acute bronchitis, chronic bronchitis in the acute phase, community-acquired pneumonia, including those caused by atypical pathogens (chlamydia, mycoplasma, legionella), skin infections (erysipelas, secondary infected dermatoses, abscesses and phlegmons); infections in dentistry, genital and urological non-gonococcal infections (prostatitis, urethritis), sexually transmitted diseases - genital and extragenital chlamydia, syphilis, gonorrhea (in case of allergies to penicillin drugs), toxoplasmosis (including toxoplasmosis in pregnant women).