Ровамицин®

General characteristics. Structure:

Contains in 1 tablet:
active agent: Spheromycinum - 1,5 million ME;
excipients: silicon dioxide colloid - 1,20 mg, magnesium stearate of-4,00 mg, starch corn prezhelatinizirovanny - 16,00 mg, a hypro rod - 8,00 mg, croscarmellose sodium - 8,00 mg, cellulose microcrystallic to 400 mg; cover: titanium dioxide (Е 171) - 1,694 mg, a macrogoal-6000 - 1,694 mg, a gipromelloza of-5,084 mg.
Contains in the I tablet:
active agent: Spheromycinum - 3 million ME;
excipients: silicon dioxide colloid - 2,40 mg, magnesium stearate of-8,00 mg, starch corn prezhelatinizirovanny - 32,00 mg, a hypro rod - 16,00 mg, croscarmellose sodium - 16,00 mg, cellulose microcrystallic to 800 mg; cover: titanium dioxide (Е 171) - 2,96 mg, a macrogoal-6000 - 2,96 mg, a gipromelloza of-8,88 mg. Description
For a dosage of 1,5 million ME
Biconvex, round tablets, coated, white or white with cream
shade of color. On one party there is an engraving of "RPR 107".
Look on cross section: color, white or white with a cream shade.
For a dosage of 3 million ME
Biconvex, round tablets, coated, color, white with a cream shade. On one party there is an engraving of "ROVA 3".
Look on cross section: color, white with a cream shade.

Pharmacological properties:

Pharmacodynamics. Spheromycinum belongs to antibiotics of group of macroleads. The mechanism of antibacterial action is caused by braking of synthesis of protein in a microbic cell due to binding from a 508-subunit ribosome. Antibacterial range of Spheromycinum
Sensitive microorganisms: minimum overwhelming concentration (MOC) <1 mg/l.
• Gram-positive aerobes
Bacillus cereus; Corynebacterium diphtheria; Enterococcus spp, Rhodococcus equi; Staphylococcus meti-S (Methicillinum - sensitive staphylococcus); Staphylococcus meti-R (Methicillinum - resistant staphylococcus); Streptococcus B; neklassitsirovanny streptococcus; Streptococcus pneumoniae; Streptococcus pyogenes.
• Gram-negative aerobes
Bordetella pertussis; Branhamella catarrhalis; Campylobacter spp; Legionella spp; Moraxella spp.
• Anaerobe bacterias
Actinomyces spp; Bacteroides spp; Eubacterium sp; Mobiluncus spp; Peptostreptococcus spp; Porphyromonas spp; Prevotella spp; Propionibacterium acnes.
• Different
Borrelia burgdorferi; Chlamydia spp; Coxiella spp; Leptospires spp; Mycoplasma
pneumoniae; Treponema pallidum; Toxoplasma gondii. Moderate and sensitive microorganisms: the antibiotic is moderately active in vitro at concentration of an antibiotic in the inflammation center> 1 mg/l, but <4 mg/l.
• Gram-negative aerobes of Neisseria gonorrhoeae.
• Anaerobe bacterias of Clostridium perfringens.
• Different
Ureaplasma urealyticum.
Steady microorganisms (MPK> of 4 mg/l): at least, 50% of strains are steady.
• Gram-positive aerobes of Corynebacterium jeikeium; Nocardia asteroides.
• Gram-negative aerobes
Acinetobacter spp; Enterobacteria spp; Haemophilus spp; Pseudomonas spp.
• Anaerobe bacterias of Fusobacterium spp.
Different
Mycoplasma hominis.
At Spheromycinum teratogenic action therefore it is possible without fear is not revealed
to accept it to pregnant women. Reduction of risk of transfer is observed
toxoplasmosis to a fruit during pregnancy from 25% to 8% when using in I
trimester, from 54% to 19% - when using in P and from 65% to 44% - when using in
Ш trimester.

Pharmacokinetics. Absorption
Absorption of Spheromycinum happens quickly, but is not full, with big variability (from 10 to 60%). Meal does not influence absorption.
After intake of 6 million ME of Spheromycinum the maximum concentration in plasma
makes about 3,3 mkg/ml.
Distribution
Spheromycinum does not get into cerebrospinal fluid. Spheromycinum is excreted in breast milk.
Communication with proteins of plasma - low (about 10%).
Gets through a placental barrier (concentration in blood of a fruit makes about 50% of concentration in blood serum of mother). Concentration in fabric of a placenta are 5 times higher, than the corresponding concentration in blood serum. Distribution volume - about 383 l.
Drug well gets into saliva and fabrics (concentration in lungs - from 20 to 60 mkg/g, almonds - 20 to 80 mkg/g infected nasal bosoms - from 75 to 110 mkg/g, bones - from 5 to 100 mkg/g). Ten days later after the end of treatment concentration of medicinal substance in a spleen, a liver and kidneys makes from 5 to 7 mkg/g.
Spheromycinum gets and collects in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). At the person of concentration of drug in phagocytes are   rather high. These properties explain action of Spheromycinum on intracellular bacteria. Metabolism
Spheromycinum is metabolized in a liver with formation of active metabolites with
unspecified chemical structure.
Removal
Plasma elimination half-life of blood makes about 8 hours. It is allocated from an organism, mainly, with bile (concentration in bile 15-40 times higher, than in serum). Renal excretion makes about 10% of the entered dose. The amount of drug which is marked out through intestines (with a stake), very slightly.

Indications to use:

• The infectious diseases caused    by microorganisms, sensitive to this drug:
- the acute and chronic pharyngitis caused by a beta and hemolitic streptococcus And (as an alternative to treatment beta лактамными antibiotics, especially in case of contraindications to their use);
- acute sinusitis (considering sensitivity of the microorganisms which are most often causing this pathology, use of the drug Rovamitsin® is shown in case of contraindications to use beta лактамных antibiotics);
- the acute and chronic tonsillitis caused by microorganisms, sensitive to Spheromycinum;
- the acute bronchitis caused by the bacterial infection which developed after acute viral bronchitis;
- exacerbation of chronic bronchitis;
- community-acquired pneumonia at patients without risk factors of a failure, heavy clinical symptoms and clinical signs of a pneumococcal etiology of pneumonia;
- the pneumonia caused by atypical activators (such as Chlamydia pneumoniae and trachomatis, Mycoplasma pneumoniae, Legionella spp) or suspicion of it (regardless of weight and existence or lack of risk factors of a failure);
- infections of skin and hypodermic cellulose, including impetigo, impetiginization, an ecthyma, an infectious dermo-hypodermitis (especially I will give rise), the secondary infected dermatosis, an erythrasma;
- oral cavity infections (stomatitises, glossites, etc.);
- not gonococcal infections of generative organs;
- a toxoplasmosis, including at pregnant women;
- infections of a musculoskeletal system and connecting fabric, including a periodontium.
• Prevention of a recurrence of rheumatism at patients with an allergy to a beta laktamye antibiotics;
• Eradikation Neisseria meningitidis from a nasopharynx (at contraindications to rifampicin reception) for prevention (but not treatments) a spotted fever at patients after performing treatment and before an exit from a quarantine or at the patients who were within 10 days before hospitalization in contact with the faces excreting Neisseria meningitidis with saliva to the environment.

Route of administration and doses:

Pill is taken inside, washing down with enough water.
Patients with normal function of kidneys
Adults
The daily dose makes 2-3 tablets on 3 million ME or 4-6 tablets on 1,5 million ME (that is 6-9 million ME) which is divided into 2 or 3 receptions. The maximum daily dose makes 9 million ME. Children
At children from 6 to 18 years it is necessary to apply only tablets of 1,5 million ME.
At children 6 years are more senior the daily dose makes from 150-300 thousand ME on body weight kg,
which is divided into 2 or 3 receptions to 6-9 million ME. The maximum daily dose at children
makes 300 thousand ME on body weight kg, but in case of the body weight of the child more than 30 kg, it
should not exceed 9 million ME.
Prevention of a spotted fever
Adults
On 3 million ME two times a day within 5 days; Children
On 75 thousand ME on body weight kg two times a day within 5 days. Patients with a renal failure
Due to the insignificance of renal excretion of drug of dose adjustment not
it is required.

Features of use:

During treatment by drug at patients with diseases of a liver it is necessary to control its function periodically.
Tablets on 3 million ME at children are not applied because of difficulties of their proglatyvaniye by children because of the big diameter of tablets and danger of obstruction of respiratory tracts. If in an initiation of treatment the patient has a generalized erythema and pustules which are followed by high temperature of a body it is necessary to assume acute generalized exanthematous пустулёз (see the section "Side effect"); if such reaction arises, then treatment needs to be stopped, and further use of Spheromycinum, both in monotherapy, and in a combination, contraindicated. Influence on ability to drive the car and to be engaged in other potentially dangerous types of activity
I am absent data on negative influence of drug on ability to drive the car and to be engaged in other potentially dangerous types of activity. However it is necessary to take weight of a condition of the patient which can affect attention and speed of psychomotor reactions into account. Therefore other potentially dangerous types of activity at the specific patient the attending physician has to accept the decision on a possibility of driving or occupation.

Side effects:

Disturbances from digestive tract
Nausea, vomiting, diarrhea and very exceptional cases of developing of pseudomembranous colitis (less than 0,01%). Isolated cases of an ulcer esophagitis and acute colitis are described. Also the possibility of development of acute injury of a mucous membrane of intestines in patients with AIDS at use of high doses of Spheromycinum concerning a cryptosporidiosis (only 2 cases) is noted. Disturbances from a nervous system Very seldom (separate cases) passing paresthesia. Disturbances from a liver and biliary tract
Seldom or never (less than 0,01%) - a deviation of functional trials of a liver from normal indicators; cholestatic hepatitis. From blood and lymphatic system
Very exceptional cases (less than 0,01%) of development of acute hemolysis (see. "Contraindications"); thrombocytopenia.
Disturbances from heart
Lengthening of an interval of QT on the electrocardiogram (ECG) (several cases only after intravenous administration of drug by the newborn) (see the section "Overdose" are described).
Disturbances from immune system
Skin rash, small tortoiseshell, itch. Very seldom (less than 0,01%) - a Quincke's disease, an acute anaphylaxis. Separate cases of a vasculitis, including Shenleyna-Genokh's purpura.
Disturbances from skin and hypodermic fabrics.
  Very seldom acute generalized exanthematous пустулез (see.  "special
instructions").

Interaction with other medicines:

With a levodopa
Inhibition Spheromycinum of absorption of a karbidopa with decrease in concentration of a levodopa in plasma. At co-administration of Spheromycinum clinical control and correction of doses of a levodopa is necessary. With indirect anticoagulants.
Numerous cases of increase in activity of indirect anticoagulants at the patients  accepting antibiotics are registered. The type of an infection or expressiveness of inflammatory reaction, age and the general condition of the patient are the contributing risk factors. Under similar circumstances it is difficult to define in what measure the infection or its treatment play a role in change of the International normalized relation (MHO). However at use of some groups of antibiotics this effect is observed more often, in particular at use of ftorkhinolon, macroleads, tsiklin, sulfamethoxazole + Trimethoprimum and some cephalosporins.

Contraindications:

• Hypersensitivity to Spheromycinum and other components of drug.
• Lactation period.
• Deficit of enzyme glyukozo-6-fosfatdegidrogenazy (risk of emergence of acute hemolysis).
• Children's age (up to 6 years - for tablets of 1,5 million ME, up to 18 years - for tablets of 3 million ME).

With care
• Obstruction of bilious channels.
• Liver failure. Pregnancy and period of a lactation Pregnancy
Ровамицин® it can be appointed, if necessary, during pregnancy. The wide experience of use of Spheromycinum during pregnancy did not reveal at it teratogenic or fetotoksichesky properties. Lactation period.
At appointment in the period of a lactation it is necessary to stop breastfeeding as penetration of Spheromycinum into breast milk is possible.

Overdose:

Cases of overdose of Spheromycinum are not known. Symptoms
It is possible to carry to possible symptoms of overdose: nausea, vomiting, diarrhea. Cases of lengthening of an interval of QT passing at drug withdrawal were observed at the newborns receiving high doses of Spheromycinum or after intravenous administration of Spheromycinum at the patients predisposed to lengthening of an interval of QT. At overdose of Spheromycinum ECG monitoring with determination of duration of an interval of QT, especially with risk factors (a hypopotassemia, inborn lengthening of an interval of QT, simultaneous use of the drugs extending duration of an interval of QT and causing development of ventricular tachycardia like "pirouette") is recommended. Treatment
The specific antidote does not exist. At suspicion on overdose of Spheromycinum symptomatic therapy is recommended.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity. For a dosage of 1,5 million ME: 3 years. For a dosage of 3 million ME: 4 years. Not to use drug after the termination of a period of validity.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated. For a dosage of 1,5 million ME:
On 8 tablets in the blister from PVC / aluminum foil. On 2 blisters together with the application instruction in a cardboard pack. For a dosage of 3 million ME:
On 5 tablets in the blister from PVC / aluminum foil. On 2 blisters together with the application instruction in a cardboard pack.