Vilprafen active substance. Treatment regimen for ureaplasma with vilprafen - composition, instructions for use, side effects and contraindications

Description of the dosage form

Characteristic

pharmachologic effect

Pharmacological effects - bactericidal, antibacterial.

Pharmacodynamics

Pharmacokinetics

Indications for the drug Vilprafen®

Contraindications

Side effects

Interaction

Directions for use and doses

Overdose

special instructions

Storage conditions for the drug Vilprafen®

In a place protected from light, at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life of the drug Vilprafen®

Do not use after the expiration date stated on the package.

1 tablet contains active substance- josamycin - 500 mg

Release form

Film-coated tablets for oral administration, 10 pieces per pack.

pharmachologic effect

Antibiotic of the macrolide group. The mechanism of action is associated with disruption of protein synthesis in the microbial cell due to reversible binding to the 50S ribosomal subunit. In therapeutic concentrations, as a rule, it has a bacteriostatic effect, slowing down the growth and reproduction of bacteria. When high concentrations are created at the site of inflammation, it has a bactericidal effect.

Josamycin is active against gram-positive bacteria: Staphylococcus spp. (including methicillin-sensitive strains of Staphylococcus aureus), Streptococcus spp. (including Streptococcus pyogenes, 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; susceptibility to Bacteroides fragilis may be variable; intracellular microorganisms: Chlamydia spp., in (including Chlamydia trachomatis), Chlamydophila spp. (including Chlamydophila pneumoniae, which was previously called Chlamydia pneumoniae), Mycoplasma spp. (including Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalium), Ureaplasma spp., Treponema pallidum, Borrelia burgdorferi.

As a rule, it is not active against enterobacteria, therefore it has little effect on the microflora of the gastrointestinal tract. Retains activity in case of resistance to erythromycin and other 14- and 15-membered macrolides. Resistance to josamycin is less common than to 14- and 15-membered macrolides.

Indication for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infections upper divisions respiratory tract and ENT organs (including tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis);
• diphtheria (in addition to treatment with diphtheria antitoxin);
• scarlet fever (with hypersensitivity to penicillin);
• infections lower sections respiratory tract (including acute bronchitis, exacerbation chronic bronchitis, community-acquired pneumonia, including those caused by atypical pathogens);
• whooping cough;
• psittacosis;
• infections in dentistry (including gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess);
• infections in ophthalmology (including blepharitis, dacryocystitis);
• infections of the skin and soft tissues (including folliculitis, furuncle, furunculosis, abscess, anthrax, erysipelas, acne, lymphangitis, lymphadenitis, phlegmon, panaritium);
• wound (including postoperative) and burn infections;
• infections urinary tract and genital organs (including urethritis, cervicitis, epididymitis, prostatitis, caused by chlamydia and/or mycoplasma);
• gonorrhea, syphilis (with hypersensitivity to penicillin), lymphogranuloma venereum;
• Gastrointestinal diseases associated with Helicobacter pylori (incl. peptic ulcer stomach and duodenum, chronic gastritis).

Directions for use and doses

Typically, the duration of treatment, determined by the doctor, ranges from 5 to 21 days, depending on the nature and severity of the infection. In accordance with WHO recommendations on the use of antibiotics, the duration of treatment for streptococcal tonsillitis should be at least 10 days.

In anti-Helicobacter therapy regimens, josamycin is prescribed at a dose of 1 g 2 times / day for 7-14 days in combination with other drugs in their standard dosages (famotidine 40 mg / day or ranitidine 150 mg 2 times / day + josamycin 1 g 2 times / day daily + 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 + tripotassium bismuth dicitrate 240 mg 2 times / day.

For ordinary and globular acne, 500 mg 2 times a day is prescribed for the first 2-4 weeks, then 500 mg 1 time a day as maintenance therapy for 8 weeks.

Contraindications

• severe liver dysfunction;
• children weighing less than 10 kg;
• hypersensitivity to other macrolide antibiotics;
• hypersensitivity to josamycin and other components of the drug.

special instructions

In the case of persistent severe diarrhea, one should keep in mind the possibility of developing life-threatening pseudomembranous colitis while taking 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).

The possibility of cross-resistance to various macrolide antibiotics should be taken into account (microorganisms resistant to treatment with antibiotics related in chemical structure may also be resistant to josamycin).

Storage conditions

The drug should be stored in a place protected from light, out of reach of children, at a temperature not exceeding 25°C.

Vilprafen is an antibiotic wide range action, part of the group of macrolides. His active substance is josamycin, which inhibits and destroys bacteria. The drug is not prescribed to premature babies. Vilprafen in liquid form can be taken by newborns and older children only after accurate weighing. After 14 years of age, antibiotics are prescribed in the same dosages as for adults.

Wilprafen: release form

The medication is available in solid and liquid form:

• white oblong coated tablets contain 500 mg of josamycin;
• sweet and fragrant soluble tablets Vilprafen Solutab contains 1000 mg of active ingredient;
• suspension – liquid preparation in dark vials, for every 10 ml of which there is 300 mg of josamycin;
• suppositories with josamycin.

The auxiliary ingredients of the medicine are magnesium stearate, microcrystalline cellulose, aluminum hydroxide, titanium dioxide, colloidal anhydrous silica.

Indications for use of Vilprafen

The instructions included with it do not recommend self-treatment with Vilprafen. Parents should consult a doctor and understand the intricacies of using the drug.

Indications for use, the instructions for Vilprafen disclose a number of pathologies that are often found in children:

1. infectious diseases occurring with inflammatory processes;
2. infections of the ENT organs and upper respiratory tract (tonsillitis, otitis media, sinusitis, tonsillitis, laryngitis, pharyngitis);
3. lower respiratory tract infections (whooping cough, pneumonia, bronchopneumonia, acute bronchitis);
4. infections of the skin and soft tissues (phlegmon, pyoderma, lymphadenitis, furunculosis, erysipelas);
5. infection of the genitourinary system (pyelonephritis, mycoplasmosis, epididymitis, ureaplasma, urethritis, chlamydia);
6. infectious lesion oral cavity(stomatitis, gingivitis, alveolitis, periodontal disease).

In pediatrics, Vilprafen is also prescribed to treat children from diphtheria and scarlet fever if their body is hypersensitive to penicillin. Instructions for use of the antibiotic Wilprafen state that the drug is good for gastrointestinal diseases caused by damage to the tract by the bacterium Helicobacter pylori.

How to be treated with Vilprafen: instructions

To improve the condition of infected children, Vilprafen is used in the form of diluted tablets of the Solutab variety or purchased immediately liquid form, which is called a suspension. Premature babies are not treated with this antibiotic; other patients weighing less than 10 kg are prescribed the drug in extreme cases.

How to give Vilprafen correctly small child? The printed instructions for use suggest that pediatricians and parents be guided by the exact weight of the baby:

• body weight up to 10 kg – dosage 40 – 50 mg/kg divided into 2 – 3 doses;
• weight 10 - 20 kg - dissolve half or a quarter of the tablet in water and give the child 2 p. in a day;
• with a weight of 20 - 40 kg, Vilprafen is given to children a whole tablet or half (1000 and 500 mg, respectively) twice a day;
• with a body weight of more than 40 kg, 1 whole tablet should be taken 2 times. per day.

If Wilprafen Solutab was purchased by parents, the instructions for use prescribe treatment with an antibiotic in two ways. If the child is able to swallow the tablet, it is given whole or crushed and asked to be washed down with water. Children under one year old are given a homemade suspension obtained by dissolving the tablet in a small amount water.

Parents often ask when it is better to give Vilprafen to the patient - before or after meals. In this regard, the instructions state that the medication is more effective when taken between main feedings.

Contraindications and possible side effects

Before agreeing to treatment with Vilprafen, you need to understand what contraindications exist for its use. Prematurity has already been mentioned. Other categories of patients who should not be prescribed Vilprafen are:

1. with an allergy to macrolide antibiotics;
2. characterized by hypersensitivity to josamycin and additional components of the drug;
3. having liver pathologies that disrupt the functionality of the organ and the functioning of the biliary system.

Vilprafen has many side effects, but this does not mean that they will necessarily appear in the child. Digestive system may react to the antibiotic with nausea, heartburn, vomiting, poor appetite, diarrhea or constipation. From the liver and biliary tract, cases of increased activity of liver enzymes in the blood, jaundice and impaired bile outflow were recorded.

From allergic reactions urticarial rashes, angioedema, bullous dermatitis, erythema and Stevens-Johnson syndrome were noted. TO rare events include hearing problems, thrush, capillary hemorrhages in the skin.

If treatment with Vilprafen does not produce results, or the drug is not suitable for a particular patient at all, drugs are prescribed instead similar action, because structural analogues this antibiotic does not.

Drugs replacing Wilprafen:

• Suprax;
• Azithromycin;
• Amoxiclav;
• Clarithromycin;
• Midecamycin;
• Sumamed;
• Erythromycin;
• Spiramycin.

Name:

Wilprafen

Pharmacological
action:

Macrolide antibiotic. It has a bacteriostatic effect due to inhibition of protein synthesis by bacteria. When high concentrations are created at the site of inflammation, it has a bactericidal effect.
Highly active against intracellular microorganisms: Chlamydia trachomatis and Chlamydia pneumonuae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila; against gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphtheriae; gram-negative aerobic bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis; against some anaerobic bacteria: Peptococcus, Peptostreptococcus, Clostridium perfringens.
The drug is also active against Treponema pallidum.

Pharmacokinetics.
Suction: After oral administration, josamycin is rapidly absorbed from the gastrointestinal tract. Cmax is achieved 1-2 hours after administration. 45 minutes after taking a dose of 1 g, the average concentration of josamycin in plasma is 2.41 mg/l.
Distribution: Plasma protein binding does not exceed 15%.
Taking the drug at intervals of 12 hours ensures preservation effective concentration josamycin in tissues during the day. An equilibrium state is achieved after 2-4 days of regular use.
Josamycin penetrates well through biological membranes and accumulates in various tissues: pulmonary, lymphatic tissue palatine tonsils, urinary system organs, skin and soft tissues. Particularly high concentrations are determined in the lungs, tonsils, saliva, sweat and tear fluid. The concentration of josamycin in human polymorphonuclear leukocytes, monocytes and alveolar macrophages is approximately 20 times higher than in other cells of the body.
Metabolism: Josamycin is biotransformed in the liver to less active metabolites.
breeding: Excreted mainly in bile, excretion in urine is less than 20%.

Indications for
application:

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
– infections of the upper respiratory tract and ENT organs (including pharyngitis, tonsillitis, paratonsillitis, otitis media, sinusitis, laryngitis);
– diphtheria (in addition to treatment with diphtheria antitoxin);
– scarlet fever (with hypersensitivity to penicillin);
– infections of the lower respiratory tract (including acute bronchitis, bronchopneumonia, pneumonia, including atypical form, whooping cough, psittacosis);
– oral infections (including gingivitis and periodontal disease);
– infections of the skin and soft tissues (including pyoderma, boils, anthrax, erysipelas / with hypersensitivity to penicillin /, acne, lymphangitis, lymphadenitis);
– infections of the urinary tract and genital organs (including urethritis, prostatitis, gonorrhea; with increased sensitivity to penicillin - syphilis, lymphogranuloma venereum);
– chlamydial, mycoplasma (including ureaplasma) and mixed infections of the urinary tract and genital organs.

Mode of application:

Vilprafen. The recommended dose of Vilprafen for adults and children weighing >40 kg is 1 g (initial); then the drug is prescribed at 1–2 g/day (2–4 tablets) in 2–3 doses. At severe course disease, the dose can be increased to 3 g.
Recommended dose for children over the age of 5 years with body weight<40 кг составляет 40–50 мг/кг массы тела в сутки, разделенная на несколько приемов.
If precise dosing is not possible, the drug for children is used in the form of a suspension.
Take the tablets without chewing with a small amount of liquid between meals.
Vilprafen Solutab. The recommended daily dose for adults is 1.5–2 g. In severe cases, the dose can be increased to 3 g. The daily dose is divided into 2–3 doses.
Recommended dose for children(over the age of 5 years) is 40–50 mg/kg/day, divided into 2–3 doses. Dispersible tablets can be taken in 2 ways: 1) swallow whole with water; 2) pre-dissolve the tablet in water. The tablets should be dissolved in at least 20 ml of water. Mix the resulting suspension thoroughly before use.
The duration of treatment is determined by the doctor. According to WHO recommendations regarding the use of antibiotics, the duration of treatment for streptococcal infections is at least 10 days.

Side effects:

From the gastrointestinal tract: rarely - loss of appetite, nausea, heartburn, vomiting and diarrhea. In cases of persistent severe diarrhea, the possibility of developing life-threatening pseudomembranous colitis due to antibiotics should be kept in mind.
Hypersensitivity reactions: In extremely rare cases, allergic skin reactions (for example, urticaria) are possible.
From the liver and biliary tract: in some cases, a transient increase in the activity of liver enzymes in the blood plasma was observed, in rare cases accompanied by a violation of the outflow of bile and jaundice.
From the hearing aid: In rare cases, dose-related transient hearing impairment has been reported.

Contraindications:

Increased sensitivity to the components of the drug and other antibiotics of the macrolide group, severe dysfunction of the liver and biliary tract. Due to the aspartame content in Vilprafen Solutab, the drug is contraindicated in patients with phenylketonuria.

Interaction
other medicinal
by other means:

Vilprafen/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 prescribed together with lincomycin, because a mutual decrease in their effectiveness is possible.

Vilprafen/xanthines. Some representatives of macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to possible intoxication. Clinical experimental studies indicate that josamycin has less effect on theophylline release than other macrolide antibiotics.

Vilprafen/antihistamines. After co-administration of josamycin and antihistamines containing terfenadine or astemizole, there may be a slowdown in the elimination of terfenadine and astemizole, which, in turn, can lead to the development of life-threatening cardiac arrhythmias.

Vilprafen/ergot alkaloids. There are individual reports of increased vasoconstriction following coadministration of ergot alkaloids and macrolide antibiotics. There was one case of patient's lack of tolerance to ergotamine while taking josamycin.

Therefore, the concomitant use of josamycin and ergotamine should be accompanied by appropriate monitoring of patients.

Vilprafen/cyclosporine. Co-administration of josamycin and cyclosporine may cause an increase in the level of cyclosporine in the blood plasma and the creation of nephrotoxic concentrations of cyclosporine in the blood. Plasma concentrations of cyclosporine should be regularly monitored.

Vilprafen/digoxin. When administered together, josamycin and digoxin may increase the level of the latter in the blood plasma.

Vilprafen/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 contraception.

Pregnancy:

Although there is currently no data regarding the embryotoxic effects of josamycin, use of the drug during pregnancy and breastfeeding is permissible in exceptional cases after assessing the risk/benefit ratio of therapy.

Overdose:

Until now no data on specific symptoms of poisoning. In case of overdose, the symptoms described in the “Side Effects” section should be expected, especially from the gastrointestinal tract.

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Vilprafen solutab are dispersible tablets that belong to the macrolide class of antibacterial agents. This original drug is produced by the Italian company Montepharmaco S, but the applicant for registration is the Dutch pharmaceutical concern Astellas Pharm Europe.

Vilprafen Solutab is available in the form of a solid dosage form - soluble tablets of white or yellowish color. They have an oblong oval shape, in the middle of the tablet there is a mark to divide the drug into equal parts. On one side of the tablet surface there is the inscription “IOSA”, and on the other - 1000, which corresponds to the amount of the active substance josamycin.

The drug is packaged in blisters of 5 cells and sold in a cardboard pack of 5 or 10 tablets. The active component is included in Vilprofen Solutab 1000 mg in the form of a salt - josamycin propionate. The excipients in the tablet are microcrystalline cellulose, weakly substituted hydroxypropylcellulose, sodium docusate, aerosil, aspartame (E951), magnesium stearate, strawberry flavor.

Josamycin belongs to the macrolide class of antibiotics, which have a broad spectrum of action and have a bacteriostatic effect. The bactericidal effect is exerted on microorganisms that are highly sensitive to the active substance.

Vilprafen solutab 1000 photos

The mechanism of action of the drug is due to reversible binding to the 50S ribosome of the microorganism, this inhibits the synthesis of proteins in the bacterial cell and causes inhibition of its growth.

An important feature of the drug is its ability to affect intracellular forms of microorganisms.

What does Vilprafen solutab help with?

Microorganisms that are sensitive to the drug include various types of staphylococci (including those producing beta-lactamase), streptococci of various types, anthrax bacilli, corynebacteria diphtheria, gonococci, meningococci, shigella, Haemophilus influenzae, pertussis, legionella, mycoplasma, chlamydia, treponema (pathogens syphilis), rickettsia, some anaerobic bacteria and fungi (Peptococcus spp, Bacteroides spp, Peptostreptococcus spp.).

Based on such great therapeutic activity, we can answer the question of what Vilprafen Solutab helps with:

• Infectious diseases of the respiratory system and ENT organs (gingitis, sinusitis, otitis media, laryngitis, pharyngitis, bronchitis, pneumonia, whooping cough, psittacosis);
• Diseases of the urinary and reproductive organs of infectious origin: prostatitis, gonorrhea, urethritis, chlamydia, syphilis, mycoplasmosis, ureaplasmosis;
• Bacterial skin lesions: pyoderma, acne, furunculosis, lymphadenitis, erysipelas, anthrax;
• Eye diseases (inflammation in the eyelids or nasolacrimal duct of infectious etiology);
• Other specific diseases: diphtheria, dysentery, scarlet fever, etc.

A special advantage of the drug is the possibility of its use in children in the treatment of bacterial respiratory tract infections, due to its pleasant taste and convenient dosage form. Vilprafen Solutab has proven itself well in the treatment of community-acquired pneumonia, especially in people with hypersensitivity to penicillins.

Vilprafen solutab is successfully used for the treatment of bacterial diseases of the reproductive system, which threaten loss of reproductive function, miscarriages and intrauterine infection of the fetus. Josamycin has far fewer side effects than other antibiotics and is less likely to cause the development of resistant strains.

Instructions for use Vilprafen Solutab, dosage

According to the instructions for use of Vilprafen Solutab 500\1000 - the maximum daily dose of the drug is 3g, they are divided into 2-3 doses per day. Typically, therapy is carried out at a rate of 1.5-2 g of josamycin per day.

The tablets can be swallowed with plain water without chewing or dissolved in a small amount of liquid (at least 1 tablespoon of water). The drug is used before or after meals.

• The duration of the course is determined by the attending physician depending on the pathogen and the patient’s condition; it can last from five days to three weeks.

The instructions indicate that for children over 1 year old, Vilprafen Solutab is prescribed based on the child’s weight, and his body weight should not be less than 10 kg. For 1 kg of the child’s body, 40-50 mg of the drug per day is prescribed and the resulting dosage is divided into 2-3 doses.

For body weights over 40 kg, the drug is taken in an adult dosage.

special instructions

Taking Vilprafen Solutab may affect the effect of certain medications:

• Taking this macrolide with some antiallergic drugs (terfenadine, astemizole) leads to life-threatening arrhythmias.
• Slowing the elimination of xanthines while taking josamycin can lead to theophylline intoxication.
• With the combined use of Vilprafen with ergot alkaloids, severe vasoconstriction may occur.
• An increase in nephrotoxicity is caused by the combined use of josamycin and cyclosporine.
• Taking the drug with bactericidal agents inhibits the activity of the active substance.

The drug does not affect the ability to drive vehicles in any way.

Side effects of Vilprafen Solutab, contraindications

The most common side effects are abdominal pain, nausea and allergies (hives and other skin reactions). Constipation, diarrhea, problems with appetite, and vomiting are much less common. There is a possibility of developing pseudomembranous colitis. Manifestations of liver dysfunction and jaundice are possible. Taking excessive doses of the drug can lead to hearing loss.

Contraindications to the use of Vilprafen Solutab tablets are:

• age up to 1 year;
• weight less than 10 kg;
• presence of liver failure;
• allergic reactions to the components of the drug;
• history of hypersensitivity to other macrolides.

During pregnancy and lactation, taking the drug is not contraindicated, but this requires clear indications and a balanced decision from the doctor. No cases of drug overdose have been reported so far, so there is no specific antidote and symptomatic treatment is expected along with detoxification therapy.

Analogues of Vilprafen Solutab, list of drugs

Today, among the analogues of Vilprafen Solutab there is only one drug - Vilprafen, it is produced by the same pharmaceutical company.

What is better Vilprafen or Vilprafen Solutab?

Vilprafen Solutab tablets differ from Vilprafen tablets in their solubility, which significantly affects the pharmacokinetics of the drug.

The use of Solutab technology ensures better bioavailability of the active component. It is achieved due to the uniform distribution of microparticles in the stomach and the controlled release of josamycin as water penetrates into the microparticles. Complete release occurs in the “reabsorption window” - the duodenum.

Also, the difference between the two forms of the drug is the dosage - 1000 mg and 500 mg, respectively, so Vilprafen Solutab can be used less frequently, which significantly reduces the risk of side effects.

The dispersible form of tablets has a pleasant taste and is easy to give to children starting from 1 year. In addition, the cost of treatment with Vilprafen Solutab is approximately 30% cheaper than just Vilprafen. Thus, we can say with confidence that the soluble form of tablets is much better and more convenient.

Vilprafen Solutab is a modern antibacterial agent with a wide spectrum of action, which can be used according to indications even for children and during pregnancy. The drug is convenient to take, has few side effects and a low likelihood of the emergence of resistant strains. The effectiveness of the drug is very high and clinically proven.