Vilprafen solute - instructions for use, dose, side effects, contraindications

Active substanceJosamycinJosamycin

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Wilprafen®

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Astellas Farma Europe BV Netherlands

Wilprafen®

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Astellas Farma Europe BV Netherlands

Wilprafen® solutab®

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Astellas Farma Europe BV Netherlands

Dosage form: & nbsp

tablets, dispersible

Composition:

Active substance:

Josamycin -1000 mg

(equivalent to josamycin propionate) - 1067.66 mg.

Excipients:

Microcrystalline cellulose - 564.53 mg, giprolose - 199.82 mg, sodium docusate - 10.02 mg, aspartame - 10.09 mg, colloidal silicon dioxide - 2.91 mg, strawberry flavoring - 50.05 mg, magnesium stearate - 34.92 mg.

Description:White or white with a yellowish tinge of an oblong tablet shape, sweet, with the smell of strawberry. With the inscription "IOSA" and the risk on one side of the tablet and the inscription "1000" - on the other.

Pharmacotherapeutic group:Antibiotic-macrolide

ATX: & nbsp

J.01.F.A.07 Josamycin

Pharmacodynamics:

Antibacterial drug from the group of macrolides. The mechanism of action is associated with a violation of protein synthesis in the microbial cell due to reversible binding to the 508 subunit of the ribosome. In therapeutic concentrations, as a rule, has a bacteriostatic effect, slowing the growth and multiplication of bacteria.When creating high concentrations in the focus of inflammation, a bactericidal effect is possible.

Josamycin active at respect gram-positive bacteria (Staphylococcus spp., at t.h. methicillin-sensitive strains Staphylococcus aureus), Streptococcus spp., at t.h. Streptococcus pyogenes and Streptococcus pneumoniae, Corynebacterium diphtheriae, Listeria monocytogenes, Propionibacterium acnes, Bacillus anthracis, Clostridium spp. Peptococcus spp., Peptostrep-tococcus spp.), gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Bordetella spp. Brucella spp., Legionella spp., Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Campylobacter jejuni), sensitivity Bacteroides fragilis can be variable), Chlamydia spp., at t.h. FROM. trachomatis, Chlamydophila spp., at t.h. Chlamydophila pneumoniae (before was called Chlamydia pneumoniae), Mycoplasma spp., at t.h. Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma spp. Treponema pallidum, Borrelia burgdorferi.

As a rule it is not active against enterobacteria, therefore it negatively affects the microflora of the gastrointestinal tract. In a number of cases, it remains active in the resistance to erythromycin and other 14-and 15-member macrolides (streptococci, staphylococci). Resistance to josamycin is less common than to 14-and 15-member macrolides.

Pharmacokinetics:After oral administration josamycin quickly absorbed from the gastrointestinal tract, eating does not affect bioavailability. The maximum concentration of josamycin in plasma is reached after 1 hour after administration. When taken in a dose of 1 g, the maximum concentration in the blood plasma is 2-3 μg / ml. About 15% of josamycin binds to plasma proteins. Josamycin it is well distributed in organs and tissues (with the exception of the brain), creating concentrations exceeding the plasma concentration and remaining at the therapeutic level for a long time. Especially high concentrations josamycin creates in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in the sputum exceeds the concentration in the plasma by 8-9 times. Passes the placental barrier, is secreted into breast milk. Josamycin Meta-bolziruetsya in the liver to less active metabolites and excreted mainly with bile. The half-life of the drug is 1-2 hours, but it can lengthen in patients with impaired liver function. Excretion of the drug by the kidneys does not exceed 10%.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

Infections of the upper respiratory tract and LOP-organ:

tonsillitis, pharyngitis, paratonzillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), scarlet fever (in case of hypersensitivity to penicillin).

Lower respiratory tract infections:

acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia,including those caused by atypical pathogens, pertussis, psittacosis.

Infections in dentistry:

gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess.

Infections in ophthalmology:

blepharitis, dacryocystitis

Infections of skin and soft tissues:

folliculitis, furuncle, furunculosis, abscess, anthrax, mug, acne, lymphangitis, lymphadenitis, phlegmon, panaritium, wound (including postoperative) and burn infections.

Infections of the genitourinary system:

urethritis, cervicitis, epididymitis, prostatitis caused by chlamydia and / or mycoplasmas, gonorrhea, syphilis (with hypersensitivity to penicillin), venereal lymphogranuloma.

Diseases of the gastrointestinal tract associated with H.pylori

Stomach ulcer and duodenal ulcer, chronic gastritis, etc.

Contraindications:

- hypersensitivity to josamycin and other components of the drug;

hypersensitivity to other macrolides;

severe hepatic impairment;

- Children weighing less than 10 kg.

Pregnancy and lactation:Allowed use during pregnancy and during breastfeeding after medical evaluation of benefit / risk. The WHO European Office recommends josamycin as a drug of choice in the treatment of chlamydial infection in pregnant women.

Dosing and Administration:

The recommended daily dosage for adults and adolescents over the age of 14 years is 1 to 2 g of josamycin. The daily dose should be divided into 2-3 doses. If necessary, the dose may be increased to 3 g per day.

Children aged 1 year have an average body weight of 10 kg.

The daily dosage for children with a body weight of at least 10 kg is prescribed based on a calculation of 40-50 mg / kg of body weight daily, divided into 2-3 receptions: for children with a body weight of 10-20 kg, the drug is administered at 250-500 mg 1 / 4-1 / 2 tablets dissolved in water) 2 times a day, for children with a body weight of 20-40 kg, the drug is administered at 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 recommendations of the WHO, the duration of treatment of streptococcal tonsillitis should be at least 10 days.

In the anti-Helicobacter therapy josamycin is prescribed in 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 p / 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 p / day + amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day + bismuth tricalcium dicitrate 240 mg2 p / day: famotidine 40 mg / day + furazolidone 100 mg 2 r / day + josamycin 1 g 2 r / day + bismuth tricalcium dicitrate 240 mg 2 r / day).

In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed at pH-metry: Amoxicillin 1 g 2 r / day + josamycin 1 g 2 r / day + bismuth tricalcium dicitrate 240 mg 2 r / day.

In the case of common and globular acne, it is recommended that josamycin at a dose of 500 mg twice daily for the first 2-4 weeks, then 500 mg of josamycin once a day as maintenance treatment for 8 weeks.

Dispersible tablets Wilprafen® Solutab® can be taken in various ways: the tablet can be swallowed whole, washed down with water or beforehand, before taking, dissolved in water. Tablets should be dissolved in at least 20 ml of water.Before taking, carefully mix the resulting suspension.

Side effects:Undesirable reactions are listed according to the frequency of their registration according to the following gradation: very often: from> 1/10, often: from> 1/100 to <1/10, infrequently: from> 1/1000 to <1/100, rarely: from> 1/10 LLC to <1/1000, very rarely from <1/10 000.

From the gastrointestinal tract

Often - discomfort in the stomach, nausea

Infrequent - abdominal discomfort, vomiting, diarrhea

Rarely - stomatitis, constipation, decreased appetite

Very rarely - pseudomembranous colitis

Hypersensitivity reactions:

Rarely, urticaria, Quincke's edema and anaphylactoid reaction.

Very rarely - bullous dermatitis, multiforme exudative erythema, incl. Stephen-Johnson syndrome.

From the liver and bile ducts:

Very rarely - hepatic dysfunction, jaundice

From the sense organs:

In rare cases, there have been reports of dose-dependent transient hearing impairment

Other: very rarely - purpura

Overdose:To date, there is no evidence of specific symptoms of an overdose. In case of an overdose, the symptoms described in the "Side Effects" section should be expected, especially from the gastrointestinal tract.

Interaction:

- other antibiotics

Since bacteriostatic antibiotics in vitro can reduce the antimicrobial effect of bactericidal, joint use should be avoided. Josamycin It should not be administered together with lincosamides, as there may be a mutual decrease in their effectiveness.

- xanthines

Some representatives of the macrolide group slow down the elimination of xanthines (theophylline), which can lead to the appearance of signs of intoxication. Clinical and experimental studies indicate that josamycin has less effect on the elimination of theophylline than other macrolides.

- antihistamines

With the joint administration of josamycin and antihistamines containing terfenadine or astemizole, may increase the risk of life-threatening arrhythmias.

- alkaloids of ergot

There are some reports of increased vasoconstriction after co-administration of ergot alkaloids and antibiotics from the macrolide group, including a single observation with jozamycin.

- ciclosporin

The joint administration of josamycin and cyclosporine can cause an increase in the level of cyclosporine in the blood plasma and increase the risk of nephrotoxicity. The concentration of cyclosporine in the plasma should be monitored regularly.

- digoxin

With the joint administration 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 keep in mind the possibility of developing a pseudomembranous colitis dangerous for life against the background of josamycin.

In patients with renal insufficiency treatment should be conducted taking into account the results of appropriate laboratory tests (determination of the clearance of endogenous creatinine).

Consideration should be given to the possibility of cross-resistance to various antibiotics from the macrolide group (microorganisms resistant to treatment with antibiotic related chemical structures may also be resistant to josamycin).

Effect on the ability to drive transp. cf. and fur:The effect of the drug on the ability to drive vehicles and work with mechanisms has not been noted.

Form release / dosage:

Tablets are dispersible 1000 mg.

Packaging:

5 tablets per blister, made of PVC / PVDC / aluminum foil.

Two blisters together with instructions for medical use are placed in a cardboard box.

Storage conditions:

Store in a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001632

Date of registration:23.08.2010

The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands

Manufacturer: & nbsp

MONTEFARMACO, S.p.A. Italy

TEMMLER WERKE, GmbH Germany

FAMAR LYON France

Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands

Information update date: & nbsp15.02.2017

Illustrated instructions

Instructions

Wilprafen® solutab® (Wilprafen® solutab®)