Antibiotic macrolide Vilprafen solutab (abstract, how to use, how to replace, doses, side effects, effects, from what, when prohibited). Vilprafen Solutab: what is prescribed, dosage, prices Antibiotic Vilprafen Solutab 1000 instructions for use
Instructions for use
Active ingredients
Release form
Pills
Composition
1 tablet contains: josamycin propionate 1067.66 mg, which corresponds to the content of josamycin 1000 mg Excipients: microcrystalline cellulose - 564.53 mg, hyprolose - 199.82 mg, sodium docusate - 10.02 mg, aspartame - 10.09 mg, colloidal silicon dioxide - 2.91 mg, strawberry flavor - 50.05 mg, magnesium stearate - 34.92 mg.
Pharmacological effect
Antibacterial drug from the macrolide group. The mechanism of action is associated with a violation of protein synthesis in a microbial cell due to reversible binding to the 50S-subunit of the ribosome. In therapeutic concentrations, as a rule, it has a bacteriostatic effect, slowing down the growth and reproduction of bacteria. When high concentrations are created in the focus of inflammation, a bactericidal effect is possible. Josamycin is active against gram-positive bacteria: Staphylococcus spp. (including methicillin-sensitive strains of Staphylococcus aureus), Streptococcus spp. (including Streptococcus pyogenes and Streptococcus pneumoniae), Corynebacterium diphtheriae, Listeria monocytogenes, Propionibacterium acnes, Bacillus anthracis, Clostridium spp. Peptococcus spp., Peptostreptococcus spp .; gram-negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Bordetella spp., Brucella spp., Legionella spp., Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Campylobacter jejuni, Bacteroides fragilis susceptibility may be variable; as well as Chlamydia spp. (including Chlamydia trachomatis), Chlamydophila spp. (including Chlamydophila pneumoniae / previously called Chlamydia pneumoniae /), Mycoplasma spp., incl. Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma spp., Treponema pallidum, Borrelia burgdorferi. As a rule, it is not active against enterobacteria, therefore it slightly affects the microflora of the gastrointestinal tract. In some cases, it remains active with resistance to erythromycin and other 14- and 15-membered macrolides (streptococci, staphylococci). Josamycin resistance is less common than 14- and 15-membered macrolides.
Pharmacokinetics
Absorption: After oral administration, josamycin is rapidly absorbed from the gastrointestinal tract. Food intake does not affect bioavailability. Cmax is reached within 1 hour after administration. When taken in a dose of 1 g, Cmax in blood plasma is 2-3 μg / ml. Distribution: Plasma protein binding is about 15%. Josamycin is well distributed in organs and tissues (with the exception of the brain), creating concentrations that exceed plasma levels and remain at a therapeutic level for a long time. Josamycin creates especially high concentrations in the lungs, tonsils, saliva, sweat and lacrimal fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Passes the placental barrier, secreted into breast milk. Metabolism: Josamycin is metabolized in the liver to less active metabolites. Excretion: Excreted mainly in the bile, excretion in the urine does not exceed 10%. T1 / 2 - 1-2 hours. Pharmacokinetics in special clinical cases In patients with impaired liver function, an increase in T1 / 2 is possible.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: Infections of the upper respiratory tract and ENT organs (pharyngitis, tonsillitis, paratonsillitis, laryngitis, otitis media, sinusitis). Diphtheria (in addition to treatment with diphtheria antitoxin). Scarlet fever (with hypersensitivity to penicillin). Lower respiratory tract infections ( acute bronchitis, exacerbation chronic bronchitis, community-acquired pneumonia, including caused by atypical pathogens). Whooping cough. Psittacosis Oral cavity infections (gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess). Eye infections (blepharitis, dacryocystitis). Infections of the skin and soft tissues (folliculitis, furuncle, furunculosis, abscess, acne, lymphangitis, lymphadenitis, phlegmon, panaritium, wound / including postoperative / and burn infections). Anthrax. Erysipelas (with hypersensitivity to penicillin). Infections urinary tract and genitals (urethritis, cervicitis, epididymitis, prostatitis caused by chlamydia and / or mycoplasma). Lymphogranuloma venereum. Gonorrhea, syphilis (with hypersensitivity to penicillin). Diseases of the gastrointestinal tract associated with Helicobacter pylori (including gastric ulcer and duodenum, chronic gastritis).
Contraindications
Severe liver dysfunction. Children weighing less than 10 kg. Hypersensitivity to the components of the drug. Hypersensitivity to macrolide antibiotics.
Precautionary measures
From the side digestive system: often - stomach discomfort, nausea; infrequently - abdominal discomfort, vomiting, diarrhea; rarely - stomatitis, constipation, loss of appetite; very rarely - pseudomembranous colitis. Allergic reactions: rarely - urticaria, Quincke's edema and anaphylactoid reaction; very rarely - bullous dermatitis, erythema multiforme exudative (including Stevens-Johnson syndrome). From the liver and biliary tract: very rarely - hepatic dysfunction, jaundice. From the senses: in rare cases, it has been reported about dose-dependent transient hearing impairment.
Application during pregnancy and lactation
Allowed for use during pregnancy and during breastfeeding after a medical benefit / risk assessment. The WHO European Office recommends josamycin as the drug of choice for the treatment of chlamydial infection in pregnant women.
Method of administration and dosage
Recommended daily dose the drug for adults and adolescents over the age of 14 years is 1-2 g in 2-3 doses. If necessary, the dose can be increased to 3 g / day. Children aged 1 year have an average body weight of 10 kg. The daily dose for children weighing at least 10 kg is prescribed on the basis of 40-50 mg / kg of body weight daily, divided into 2-3 doses: children weighing 10-20 kg are prescribed 250-500 mg (1 / 4-1 / 2 tab., Dissolved in water) 2 times / day, children weighing 20-40 kg are prescribed 500-1000 mg (1/2-1 tab., Dissolved in water) 2 times / day, children with a body weight of more than 40 kg - 1000 mg (1 tab.) 2 times / day. Usually, the duration of treatment is determined by the doctor and ranges from 5 to 21 days, depending on the nature and severity of the infection. In accordance with the WHO recommendations, the duration of treatment for streptococcal tonsillitis should be at least 10 days. In the schemes of anti-Helicobacter pylori therapy, josamycin is prescribed at a dose of 1 g 2 times / day for 7-14 days in combination with other drugs in their standard doses: - famotidine 40 mg / day or ranitidine 150 mg 2 times / day + josamycin 1 g 2 times / day + metronidazole 500 mg 2 times / day; - omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 times / day + amoxicillin 1 g 2 times / day + josamycin 1 g 2 times / day; - omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 times / day + amoxicillin 1 g 2 times / day + josamycin 1 g 2 times / day + bismuth tripotassium dicitrate 240 mg 2 times / day; - famotidine 40 mg / day + furazolidone 100 mg 2 times / day + josamycin 1 g 2 times / day + bismuth tripotassium dicitrate 240 mg 2 times / day). In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed by pH-metry: amoxicillin 1 g 2 times / day + josamycin 1 g 2 times / day + bismuth tripotassium dicitrate 240 mg 2 times / day. For acne vulgaris and acne, it is recommended to prescribe josamycin at a dose of 500 mg 2 times / day for the first 2-4 weeks, then 500 mg of josamycin 1 time / day as a maintenance treatment for 8 weeks. Dispersible tablets Vilprafen Solutab can be taken in different ways: the tablet can be swallowed whole with water or dissolved in water before taking it. The tablets should be dissolved in at least 20 ml of water. Stir the resulting suspension thoroughly before taking.
Side effects
On the part of the digestive system, often - stomach discomfort, nausea. infrequently - abdominal discomfort, vomiting, diarrhea. rarely - stomatitis, constipation, loss of appetite. very rarely - pseudomembranous colitis.Allergic reactions rarely - urticaria, angioedema and anaphylactoid reaction. very rarely - bullous dermatitis, exudative erythema multiforme (including Stevens-Johnson syndrome). On the part of the liver and biliary tract very rarely - hepatic dysfunction, jaundice. very rarely, purpura.
Overdose
Until now, there are no data on the specific symptoms of an overdose of the drug Vilprafen Solutab. In case of an overdose, the occurrence and intensification of the manifestations of side effects, especially from the digestive system, should be assumed.
Interaction with other drugs
Because bacteriostatic antibiotics in vitro are capable of reducing the antimicrobial effect of bactericidal antibiotics; their combined use should be avoided. Josamycin should not be co-administered with lincosamides because a mutual decrease in their effectiveness is possible. Some members of the macrolide group slow down the elimination of xanthines (theophylline), which can lead to signs of intoxication. Clinical and experimental studies indicate that josamycin has less effect on the elimination of theophylline than other macrolides. With the joint appointment of josamycin and antihistamines containing terfenadine or astemizole, the risk of developing life-threatening arrhythmias may increase. There are separate reports of increased vasoconstriction after the combined administration of ergot alkaloids and antibiotics from the macrolide group, incl. single observation while taking josamycin. The joint appointment of josamycin and cyclosporine can cause an increase in the level of cyclosporine in the blood plasma and increase the risk of nephrotoxicity. Plasma concentrations of cyclosporine should be monitored regularly. With the joint appointment of josamycin and digoxin, an increase in the level of the latter in the blood plasma is possible.
special instructions
In the case of persistent severe diarrhea, one should bear in mind the possibility of developing life-threatening pseudomembranous colitis against the background of josamycin. In patients with renal failure treatment should be carried out taking into account the results of appropriate laboratory tests (determination of endogenous creatinine clearance). Consideration should be given to the possibility of cross-resistance to various antibiotics from the macrolide group (microorganisms that are resistant to treatment with chemically related antibiotics may also be resistant to josamycin). Influence on the ability to drive vehicles and control mechanisms: There was no effect of the drug on the ability to drive vehicles and work with mechanisms.
The recommended daily dosage for adults and adolescents over the age of 14 is 1 to 2 g of josamycin. The daily dose should be divided into 2-3 doses. If necessary, the dose can be increased to 3 g per day. Children aged 1 year have an average body weight of 10 kg. The daily dosage for children weighing at least 10 kg is prescribed based on the calculation of 40-50 mg / kg of body weight daily, divided into 2-3 doses: for children weighing 10-20 kg, the drug is prescribed at 250-500 mg ( 1 / 4-1 / 2 tablets dissolved in water) 2 times a day, for children weighing 20-40 kg the drug is prescribed 500 mg-1000 mg (1/2 tablet -1 tablet dissolved in water) 2 times per day, more than 40 kg - 1000 mg (1 tablet) 2 times a day. Usually, the duration of treatment is determined by the doctor, ranging from 5 to 21 days, depending on the nature and severity of the infection. In accordance with the WHO recommendations, the duration of treatment for streptococcal tonsillitis should be at least 10 days. In anti-Helicobacter pylori therapy regimens, josamycin is prescribed at a dose of 1 g 2 times a day for 7-14 days in combination with other drugs in their standard dosages (famotidine 40 mg / day or ranitidine 150 mg 2 r / day + josamycin 1 g 2 r / day + metronidazole 500 mg 2 r / day; omeprazole 20 mg (ilansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 r / day + amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day; omeprazole 20 mg (ilansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 r / day + amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day + bismuth tripotassium dicitrate 240 mg2 p / day: famotidine 40 mg / day + furazolidone 100 mg 2 r / day + josamycin 1 g 2 r / day + bismuth tripotassium dicitrate 240 mg 2 r / day). In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed by pH-metry: Amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day + bismuth tripotassium dicitrate 240 mg 2 r / day. For acne vulgaris and acne globules, it is recommended to prescribe josamycin at a dose of 500 mg twice a day for the first 2-4 weeks, then 500 mg of josamycin once a day as a maintenance treatment for 8 weeks. Dispersible tablets can be taken in different ways: the tablet can be swallowed whole with water or dissolved in water before taking. The tablets should be dissolved in at least 20 ml of water. Stir the resulting suspension thoroughly before use.
Vilprafen solutab (form - tablets) belongs to the group of antimicrobial drugs for systemic use. Important features of the medication from the instructions for use:
- Sold by prescription only
- During pregnancy: with caution
- When breastfeeding: with caution
- V childhood: carefully
- For violations of liver function: contraindicated
- In case of impaired renal function: with caution
Package
Wilprafen Solutab - official instruction by application
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Indications Contraindications Dosage Warnings Interactions Manufacturer
INSTRUCTION
(information for specialists)
on medical use drug
Wilprafen Solutab
Registration number:
Trade name: VILPRAFEN SOLUTAB
International non-proprietary name(INN): Josamycin
Dosage form: dispersible tablets
Composition for 1 tablet
Active substance:
Josamycin - 1000 mg (equivalent to josamycin propionate) - 1067.66 mg.
Excipients:
Microcrystalline cellulose - 564.53 mg, hyprolose - 199.82 mg, sodium docusate - 10.02 mg, aspartame - 10.09 mg, colloidal silicon dioxide - 2.91 mg, strawberry flavor - 50.05 mg, magnesium stearate - 34.92 mg.
Description:
White or white oblong tablets with a yellowish tinge, sweet, with a strawberry smell. With the word "JOSA" and a notch on one side of the tablet and the word "1000" on the other.
Pharmacotherapeutic group: antibiotic, macrolide.
ATC code: J01FA07
Pharmacological properties
Pharmacodynamics.
The drug is used to treat bacterial infections; the bacteriostatic activity of josamycin, like other macrolides, is due to inhibition of bacterial protein synthesis. When high concentrations are created in the focus of inflammation, it has a bactericidal effect.
Josamycin is highly active against intracellular microorganisms (Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila); gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphteriae), gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, perfusion bacteria, some bacteria), aerobic bacteria Slightly affects enterobacteriaceae, therefore, little changes the natural bacterial flora gastrointestinal tract... Effective in erythromycin resistance. Resistance to josamycin develops less frequently than to other antibiotics from the macrolide group.
Pharmacokinetics.
After oral administration, josamycin is rapidly and completely absorbed from the gastrointestinal tract; food intake does not affect bioavailability. The maximum concentration of josamycin in serum is reached within 1-2 hours after administration. About 15% of josamycin binds to plasma proteins. Especially high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and tears. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in bone tissue. Passes the placental barrier, secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and is excreted mainly in the bile. Excretion of the drug in the urine is less than 20%.
Indications for use
Acute and chronic infections caused by microorganisms sensitive to the drug, for example:
Upper respiratory tract and ENT organs infections:
Angina, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), as well as scarlet fever in case of hypersensitivity to penicillin.
Lower Respiratory Tract Infections:
Acute bronchitis, exacerbation of chronic bronchitis, pneumonia (including those caused by atypical pathogens), whooping cough, psittacosis.
Dental infections
Gingivitis and periodontal disease. Infections in ophthalmology Blepharitis, dacryocystitis.
Skin and soft tissue infections
Pyoderma, furunculosis, anthrax, erysipelas (with hypersensitivity to penicillin), acne, lymphangitis, lymphadenitis, lymphogranuloma venereum.
Genitourinary tract infections
Prostatitis, urethritis, gonorrhea, syphilis (with hypersensitivity to penicillin), chlamydial, mycoplasma (including ureaplasma) and mixed infections.
Contraindications
hypersensitivity to antibiotics macrolides severe liver dysfunction
Pregnancy and lactation
Allowed for use during pregnancy and during breastfeeding after a medical assessment of the benefits / risks. The WHO European Office recommends josamycin as the drug of choice for the treatment of chlamydial infection in pregnant women.
Method of administration and dosage
The recommended daily dosage for adults and adolescents over the age of 14 is 1 to 2 g of josamycin. The daily dose should be divided into 2-3 doses. If necessary, the dose can be increased to 3 g per day.
Children aged 1 year have an average body weight of 10 kg.
The daily dosage for children weighing at least 10 kg is prescribed based on the calculation of 40-50 mg / kg of body weight daily, divided into 2-3 doses: for children weighing 10-20 kg, the drug is prescribed at 250-500 mg ( 1 / 4-1 / 2 tablets dissolved in water) 2 times a day, for children weighing 20-40 kg the drug is prescribed 500 mg-1000 mg (1/2 tablet -1 tablet dissolved in water) 2 times per day, more than 40 kg - 1000 mg (1 tablet) 2 times a day.
Usually, the duration of treatment is determined by the doctor. In accordance with the recommendations of the World Health Organization on the use of antibiotics, the duration of treatment for streptococcal infections should be at least 10 days.
In anti-Helicobacter pylori therapy regimens, josamycin is prescribed at a dose of 1 g 2 times a day for 7-14 days in combination with other drugs in their standard dosages (famotidine 40 mg / day or ranitidine 150 mg 2 r / day + josamycin 1 g 2 r / day + metronidazole 500 mg 2 r / day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 r / day + amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) 2 r / day + amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day + bismuth tripotassium dicitrate 240 mg 2 r / day: famotidine 40 mg / day + furazolidone 100 mg 2 r / day + josamycin 1 g 2 r / day + bismuth tripotassium dicitrate 240 mg 2 r / day).
In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed by pH-metry: Amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day + bismuth tripotassium d and citrate 240 mg 2 r / day.
For acne vulgaris and acne globules, it is recommended to administer josamycin 500 mg twice a day for the first 2-4 weeks, then 500 mg josamycin once a day as a maintenance treatment for 8 weeks.
Dispersible tablets Vilprafen Solutab can be taken in different ways: the tablet can be swallowed whole with water or dissolved in water before taking it. The tablets should be dissolved in at least 20 ml of water. Stir the resulting suspension thoroughly before use.
Influence on the ability to drive vehicles and work with mechanisms
The effect of the drug on the ability to drive vehicles and work with mechanisms was not observed.
Side effect
From the gastrointestinal tract
Rarely - loss of appetite, nausea, heartburn, vomiting, dysbiosis and diarrhea. In the case of persistent severe diarrhea, the possibility of life-threatening pseudomembranous colitis developing against the background of antibiotics should be borne in mind.
Hypersensitivity reactions:
In extremely rare cases, skin allergic reactions(for example, hives).
From the liver and biliary tract
In some cases, a transient increase in the activity of hepatic enzymes in the blood plasma was observed, in rare cases accompanied by a violation of the outflow of bile and jaundice.
From the side of the hearing aid
In rare cases, dose-dependent transient hearing impairment has been reported.
Others: very rarely - candidiasis.
Overdose and other mistakes when taking
To date, there is no data on specific symptoms of poisoning. In case of an overdose, the occurrence of the symptoms described in the section "Side effects" should be expected, especially from the gastrointestinal tract. If one appointment is missed, you must immediately take the dose of the drug. However, if it is time to take the next dose, do not take the "forgotten" dose, but return to the usual treatment regimen. Do not take a double dose. Interruption in treatment or early discontinuation of the drug will reduce the likelihood of treatment success.
Interaction with other medicinal products
Vilprafen Solutab / other antibiotics
Since bacteriostatic antibiotics can reduce the bactericidal effect of other antibiotics, such as penicillins and cephalosporins, co-administration of josamycin with these types of antibiotics should be avoided. Josamycin should not be administered in conjunction with lincomycin, as there may be a mutual decrease in their effectiveness.
Wilprafen Solutab / xanthines
Some representatives of macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to possible intoxication. Clinical and experimental studies indicate that josamycin has less effect on theophylline release than other macrolide antibiotics.
Vilprafen Solutab / antihistamines
After the joint appointment of josamycin and antihistamines containing terfenadine or astemizole, there may be a slowdown in the excretion of terfenadine and astemizole, which in turn can lead to the development of life-threatening cardiac arrhythmias.
Wilprafen Solutab / ergot alkaloids
There are individual reports of increased vasoconstriction after co-administration of ergot alkaloids and macrolide antibiotics. There was one case of a patient's lack of tolerance to ergotamine while taking josamycin. Therefore, the concomitant use of josamycin and ergotamine should be accompanied by appropriate supervision of patients.
Wilprafen Solutab / cyclosporine
The joint appointment of josamycin and cyclosporine can cause an increase in the level of cyclosporine in the blood plasma and the creation of a nephrotoxic concentration of cyclosporine in the blood. Plasma concentrations of cyclosporine should be monitored regularly.
Wilprafen Solutab / digoxin
With the joint appointment of josamycin and digoxin, an increase in the level of the latter in the blood plasma is possible.
Vilprafen Solutab / hormonal contraceptives
In rare cases, the contraceptive effect of hormonal contraceptives may be insufficient during treatment with macrolides. In this case, it is recommended to additionally use non-hormonal contraceptives.
In patients with renal insufficiency, treatment should be carried out taking into account the results of appropriate laboratory tests.
Consideration should be given to the possibility of cross-resistance to various macrolide antibiotics (for example, microorganisms that are resistant to treatment with chemically related antibiotics may also be resistant to josamycin).
Release form: dispersible tablets 1000 mg.
Standard packing:
5 or 6 tablets are dispersed in a blister made of polyvinyl chloride film and aluminum foil. 2 blisters with instructions for use in a cardboard box.
Expiration date: 2 years
Vilprafen Solutab should not be used after the expiry date indicated on the package.
Storage conditions
List B.
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Store the medicinal product out of the reach of children!
Conditions of dispensing from pharmacies
Dispensed by prescription
Registration applicant (owner of RU)
Atsllas Pharma Europe B.V., Elizabethoff 19, 2353 EB Leiderdorp,
Netherlands / "Astellas Pharma Europe B.V.",
Elisabethhof 19.2353 EW Leiderdorp, The Netherlands.
Manufacturer:
Montefarmaco S.
Italy / Montefarmaco S.p.A.
Via Galilei, n. 7,20016 Pero (MI), Italia
Packer (primary packaging)
Montefarmaco S.p.A., Italy
Packer (secondary / tertiary packaging)
Montefarmaco S.p.A., Italy or Temmler Italia S.r.L., Italy
Issuing quality control
Temmler Italia S.R.L., Italy
Subject to packaging at CJSC "ORTAT"
Manufacturer Montefarmaco S.
Italy / Montefarmaco S.p.A. Via Galilei, n. 7,20016 Pero (MG), Italia
Packer and issuing control
CJSC "ORTAT", Russia
157092, Kostroma region, Susaninsky
district, with. Severnoye, Mr. Kharitonovo.
Send claims to the Moscow Representative Office of Astellas
Pharma Yuroy B.V. by the address:
109147 Moscow, Marksistskaya st. 16,
"Mosalarko Plaza-1" business center,
Wilprafen Solutab - medicinal product antibacterial (bactericidal and bacteriostatic) action for oral administration.
Release form and composition
The drug is available in the form of dispersible tablets: oblong, white or white with a slight yellowish tinge, with a line and the IOSA inscription on one side and the inscription "1000" on the other, sweet taste, with a strawberry smell (5 pcs. In blisters, in a pack of cardboard 2 blisters and instructions for the use of Vilprafen Solutab).
Composition for one tablet:
- active substance: josamycin (in the form of josamycin propionate) - 1000 mg;
- auxiliary components: aspartame, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, sodium docusate, strawberry flavor, hyprolose.
Pharmacological properties
Pharmacodynamics
Vilprafen Solutab is used to treat bacterial infections. The bacteriostatic effect of the drug is due to the inhibition of protein synthesis of pathogenic microorganisms. At high concentrations josamycin in the focus of inflammation has a bactericidal effect.
Wilprafen Solutab is highly active against the following bacteria:
- intracellular microorganisms: Ureaplasma urealyticum, Mycoplasma pneumoniae, Chlamydia trachomatis, Legionella pneumophila, Chlamydia pneumoniae, Mycoplasma hominis;
- gram-negative bacteria: Haemophilus influenzae, Neisseria meningitidis, Bordetella pertussis, Neisseria gonorrhoeae;
- gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Corynebacterium diphtheriae, Staphylococcus aureus;
- anaerobic bacteria: Peptostreptococcus, Peptococcus, Clostridium perfringens.
Josamycin slightly alters the natural intestinal microflora, since its effect on enterobacteria is small.
The drug is effective against erythromycin-resistant bacteria. Resistance to josamycin itself develops much less frequently than to other macrolide antibiotics.
Pharmacokinetics
After taking the tablet inside, josamycin is rapidly and completely absorbed in the intestinal walls. Food intake does not alter the bioavailability of the drug. The maximum concentration in serum is observed 1-2 hours after taking Vilprafen Solutab.
About 15% active substance binds to plasma proteins. The highest concentrations of josamycin are found in the tonsils, lungs, lacrimal fluid, sweat and saliva. In sputum content active ingredient 8-9 times more than in blood plasma. Josamycin passes through the placental barrier, is excreted with breast milk and also accumulates in bone tissue.
Metabolism takes place in the liver. It is excreted mainly in the bile in the form of less active metabolites. Less than 20% of the drug is excreted in the urine.
Indications for use
Vilprafen Solutab 1000 mg tablets are used for acute and chronic infections caused by bacteria sensitive to josamycin, including:
- dental infections: periodontal disease, gingivitis;
- infections of the upper and lower respiratory tract, as well as ENT organs: pharyngitis, laryngitis, tonsillitis, sinusitis, paratonsillitis, diphtheria (in combination with diphtheria toxoid), otitis media, scarlet fever (with increased sensitivity to penicillin antibiotics), exacerbation of chronic bronchitis and acute bronchitis, whooping cough, pneumonia (including atypical), psittacosis;
- ophthalmic infections: dacryocystitis, blepharitis;
- genitourinary infections: urethritis, syphilis (with increased sensitivity to penicillin antibiotics), prostatitis, gonorrhea; mycoplasma, chlamydial and mixed infections;
- infections of soft tissues and skin: furunculosis, erysipelas (with increased sensitivity to penicillin antibiotics), pyoderma, acne, anthrax, lymphangitis, lymphogranuloma venereum, lymphadenitis.
Contraindications
Vilprafen Solutab is contraindicated in patients with severely impaired liver function, premature babies and individuals with increased individual sensitivity to drug components or other macrolide antibiotics.
Vilprafen Solutab: instructions for use (dosage and method)
The tablets should be taken orally in one of the following ways:
- swallow whole with water;
- dissolve in 20 ml or more of water, mix thoroughly and drink as a suspension.
For adults and adolescents over 14 years old, Vilprafen Solutab is prescribed in a dose of 1000-2000 mg (1-2 tablets) per day. The daily dose should be divided into 2-3 doses. If necessary, it is possible to increase the dose to 3000 mg per day.
- 10–20 kg - 250–500 mg per day in two doses;
- 20-40 kg - 500-1000 mg per day in two divided doses;
- more than 40 kg - 1000 mg per day in two doses.
When you skip the next dose of the drug, you should immediately take the missed pill, however, if it is time to take the next dose, Vilprafen Solutab is taken in normal mode without doubling the dose. Interruptions in treatment, as well as premature termination of therapy, reduce the likelihood of a successful cure.
The duration of the course is determined by the doctor. At streptococcal infections the duration of antibiotic administration should be at least 10 days.
Side effects
- digestive system: rarely - nausea, vomiting, loss of appetite, heartburn, loose stools, dysbiosis, pseudomembranous colitis (in case of persistent and severe diarrhea);
- liver and biliary tract: isolated cases - a transient increase in the activity of liver enzymes, sometimes accompanied by jaundice and impaired outflow of bile;
- sense organs: rarely - dose-dependent transient hearing impairment;
- others: extremely rarely - allergic skin reactions, candidiasis.
Overdose
There are no data on specific symptoms of Vilprafen Solutab poisoning.
In case of an overdose, symptoms similar to those of side effects, especially from the digestive system.
special instructions
With the development of dangerous pseudomembranous colitis, Vilprafen Solutab should be canceled and appropriate treatment should be started. Medicines that reduce intestinal motility are contraindicated in this case.
It is necessary to take into account the likelihood of cross-resistance to various antibiotics from the macrolide group (for example, bacteria that are resistant to therapy with structurally related drugs may also be resistant to josamycin).
Influence on the ability to drive vehicles and complex mechanisms
Vilprafen Solutab does not affect the patient's ability to drive vehicles or work with dangerous machinery.
Application during pregnancy and lactation
Vilprafen Solutab can be used in pregnant and lactating women after assessing the expected benefits for the mother and possible risk for a fetus or baby.
For chlamydial infection that occurs during pregnancy, josamycin is the drug of choice.
Childhood use
Josamycin is contraindicated in premature babies.
In newborns, liver function should be monitored during drug treatment.
With impaired renal function
In renal failure, it is necessary to adjust the dosage of josamycin in accordance with the value of creatinine clearance.
For violations of liver function
Vilprafen Solutab 1000 mg tablets are contraindicated in patients with severely impaired liver function.
Drug interactions
The simultaneous use of Vilprafen Solutab with cephalosporins and penicillins is not recommended due to a possible decrease in the bactericidal effect of the latter, as well as lincomycin (a mutual decrease in the effectiveness of antibiotics may occur).
Josamycin is able to slow down the excretion of antihistamines containing astemizole or terfenadine, which is fraught with the development of life-threatening cardiac arrhythmias.
Some macrolide antibiotics inhibit the excretion of xanthines (in particular, theophylline), which can lead to intoxication. Studies have shown that josamycin has less effect on theophylline elimination than other macrolides.
Vilprafen Solutab can increase the plasma concentration of cyclosporine (it is necessary to regularly monitor its plasma level) and digoxin.
After joint application with ergot alkaloids, increased vasoconstriction is likely.
Vilprafen Solutab can (rarely) reduce the contraceptive effect of hormonal contraceptives, therefore, during treatment with macrolides, additional use of non-hormonal contraceptives is recommended.
Analogs
The analogues of Vilprafen Solutab are Josamycin, Vilprafen, Azithromycin, Sumamed, Azitrox, Erythromycin, Oleandomycin, etc.
Terms and conditions of storage
Store in a dark, dry place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.
The drug Vilprafen Solutab is an antibiotic belonging to the macrolide used when there is a bacterial infection. They are treated with the permission of a doctor and having previously studied the instructions for use.
What does Wilprafen solutab contain and how is it produced?
The drug is produced in tablet form, while the tablets have a white color with a slight yellowish tinge, they are oblong, they have the inscription "IOSA" and "1000" on their surface, there is a risk, the medicine has a slightly sweet taste, has a strawberry aroma.
The active substance is josamycin propionate. Among the auxiliary compounds: strawberry flavor, microcrystalline cellulose, giprolose, magnesium stearate, sodium docusate, in addition to this colloidal silicon dioxide, aspartame is present, magnesium stearate is added.
The medication is placed in blisters and cartons. The antibiotic is dispensed in the prescription department of the pharmacy. It should be stored out of the reach of children, it should be dark and dry, at a temperature of no more than 25 degrees. The shelf life is two years.
How does Vilprafen Solutab influence?
The antibacterial drug Vilprafen Solutab belongs to macrolides. Thanks to the active substance, the drug disrupts the process of protein synthesis in the pathogenic cell, as it binds the so-called 50S-subunits of ribosomes. It has a bacteriostatic and bactericidal effect.
Antibiotic macrolide Vilprafen solutab is active against the following bacteria: Chlamydia spp. Staphylococcus spp., Peptococcus spp., Corynebacterium diphtheriae, Peptostreptococcus spp., Listeria monocytogenes, Neisseria gonorrhoeae, Propionibacterium acnes, Neisseria meningitidis, Bacillus. influenzae, Campylobacter jejuni, Mycoplasma spp., and some other microorganisms.
What does Vilprafen solutab help from?
The medicine Vilprafen Solutab is prescribed for those infectious diseases, which are caused by microorganisms sensitive to antibiotics, I will list these conditions:
With scarlet fever and with diphtheria;
If the patient has whooping cough;
In case of infection of the ENT organs and directly of the respiratory tract, both upper and lower, for example, with bronchitis, tonsillitis, with pneumonia, with otitis media, with pharyngitis and sinusitis;
An antibiotic is prescribed in the dental office and in ophthalmic practice, with dacryocystitis, with gingivitis, with blepharitis and periodontitis, as well as with alveolar abscess;
The drug is effective for anthrax;
With erysipelas;
Prescribe a remedy for infectious diseases of soft tissues and skin, for example, with lymphangitis, folliculitis, phlegmon, furunculosis, as well as with a burn infection;
With venereal lymphogranuloma;
With urethritis and cervicitis, with syphilis and gonorrhea, with epididymitis and prostatitis, with chlamydia.
Macrolide is also prescribed in the treatment of gastritis and peptic ulcer, which are provoked by the microorganism Helicobacter pylori.
Who is Vilprafen Solutab prohibited for use?
An antibiotic is not used in children whose body weight does not exceed 10 kg, in addition, the drug is not used for liver pathology, as well as for hypersensitivity to Vilprafen solutab.
How to use Vilprafen solutab and what doses?
The maximum daily dose of this antibiotic is three grams. The recommended daily allowance is up to 2 grams in three divided doses throughout the day. The dosage of the antibiotic is selected by the doctor taking into account clinical picture disease and severity of symptoms. The duration of therapy varies from five days to three weeks.
Dispersible tablets Vilprafen Solutab can be taken with a liquid, or they are previously dissolved in a small amount of water, 20 milliliters is enough, after which this solution is taken, which resembles a suspension.
Can there be an overdose from Wilprafen Solutab?
The instructions for use do not provide data on an overdose of the antibiotic Vilprafen Solutab. In the case of the simultaneous use of a large number of tablets, it is recommended to urgently flush the stomach, if necessary, the patient can consult a doctor, especially if an uncomfortable condition appears.
Side effects of Vilprafen solutab
I will list the side effects that are not excluded during treatment bacterial infection with this antibiotic, from the digestive system: decreased appetite, abdominal discomfort, nausea, vomiting, loose stools, stomatitis, constipation.
Allergic reactions may occur in the form of urticaria and Quincke's edema, anaphylaxis, bullous dermatitis are not excluded, erythema multiforme of an exudative nature may develop.
special instructions
In the case of persistent diarrhea, pseudomembranous colitis may develop. In patients with renal insufficiency, antibiotic therapy is carried out after appropriate laboratory tests, in particular, it is necessary to determine the creatinine clearance.
It should be borne in mind that when using Vilprafen solutab, cross-resistance to various drugs from the macrolide group.
How to replace Vilprafen solutab?
Wilprafen, Josamycin are analogs.
Conclusion
Treatment with the antibiotic Vilprafen Solutab is carried out according to the appropriate indications; in its own conviction, it is not recommended to use this drug. Moreover, its maximum use is calculated for three weeks, after which the medication is canceled.
