Fusidine-sodium (Fusidin-Sodium)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFusidic acidFusidic acid
Dosage form: & nbspenteric coated tablets
Composition:
1 tablet contains the active substance: Fusidate-sodium (Fusidin-sodium) (in terms of the active substance) - 125 mg or 250 mg.
Excipients: calcium stearate, povidone (low molecular weight polyvinylpyrrolidone 12600 ± 2700), lactose (milk sugar).
Sheath composition: cellacephate (acetylphthalylcellulose), titanium dioxide, polysorbate-80 (tween-80), paraffin liquid, dye azorubin.

Description:The tablets covered with a cover of dark pink color, round, biconcave.
Pharmacotherapeutic group:antibiotic of polycyclic structure
ATX: & nbsp

D.09.A.A.02   Fusidic acid

Pharmacodynamics:
Fusidine-sodium has a high antibacterial activity against staphylococci, especially against Staphylococcus spp., Staphylococcus aureus and Staphylococcus epidermidis (including methicillin-resistant strains), Nocardia asteroides, Clostridia spp., Neisseria meningitides, Neisseria gonorrhoeae, is less active against Streptococcus spp ., including Streptococcus pneumoniae.Effective against Staphylococcus (resistant to penicillins, streptomycin, chloramphenicol, erythromycin); Neisseria spp., Haemophilus spp., Moraxella spp. and Corynebacterium spp. The drug is inactive against E. coli, Salmonella, Proteus and other gram-negative bacteria, as well as fungi and protozoa. The drug has a bacteriostatic effect.

Pharmacokinetics:
When administered orally, the drug is well absorbed and reaches high concentrations in the blood. Fusidine-sodium penetrates the skin, subcutaneous fat, lungs, hepatic tissue, bones, pleural exudate, cartilage and connective tissue, penetrates the placental barrier and is excreted in breast milk. It is excreted from the body mainly with bile and, to a lesser extent, kidneys.

Indications:
Septicemia, pneumonia, otitis media, lung abscess, phlegmon, furunculosis, infected
Burns and wounds, infections of soft tissue, osteomyelitis, gonorrhea caused by
benzylpenicillin strains of the gonococcus, increased sensitivity of the patient to the penicillins.

Contraindications:
Hypersensitivity to the drug, giperprotrombinemiya, children's age to 3 years.

Carefully:
Chronic renal failure.

Pregnancy and lactation:
Fusidine-sodium displaces bilirubin from binding to plasma proteins, thereby increasing the risk of developing nuclear jaundice. Therefore, when it is necessary to use in pregnancy, the estimated benefit to the mother and the potential risk to the fetus should be assessed.

Dosing and Administration:
Inside after eating.
Adults: single dose is usually 0.5 g, daily - 1.5 g (in 3 divided doses at intervals of 8 hours). In severe infections, it is prescribed in the first 2 days to 2-3 grams per day, then the dose is reduced (to 1.5 g per day). The average duration of the course of treatment is 7 to 14 days, with osteomyelitis 2 to 3 weeks or more.
Children: from 3 to 4 years - 40 - 60 mg / kg / day, 4 years and older - 20 - 40 mg / kg / day, the daily dose is divided into 3 divided doses. Duration of treatment - 7 - 10 days, in the treatment of osteomyelitis - 2 - 3 weeks or more.

Side effects:
Abdominal pain, nausea, eructation, vomiting, diarrhea, allergic phenomena (reddening of the oral mucosa and pharynx, pain during swallowing and skin rash), eosinophilia.

Interaction:
The interaction is not well understood and the data is ambiguous.
Antacids slow down absorption.
Kolestiramin reduces the concentration in the plasma.
Reduces (mutually) or does not change the effect of rifampicin, some beta-lactams against a number of strains.
Glycopeptides, fluoroquinolones reduce (mutually) the effect.
With benzylpenicillin, it gives a synergistic effect on penicillinase-forming staphylococci and additive for benzylpenicillin susceptible. When combined with macrolides, a pronounced synergistic effect is also observed; with tetracycline, streptomycin and chloramphenicol most often - additive effect.

Special instructions:
In severe disease and the need for prolonged treatment, a combination of Fusidine-sodium with semisynthetic penicillins or tetracyclines is recommended, which increases the effectiveness and prevents the emergence of resistant microorganisms. Dyspeptic phenomena are due to the local irritant effect of the drug on the mucosa of the gastrointestinal tract. To prevent and reduce them, the drug is taken with liquid food.
With the development of allergic phenomena, the drug is canceled and desensitizing therapy is administered.
Antibiotic reserve for infections caused by strains of staphylococcus, resistant to penicillin and other antibiotics.

Form release / dosage:
Tablets, coated with enteric coating, 125 mg and 250 mg.

Packaging:
For 20 tablets in cans of orange glass or in cans of polymeric.
For 10 tablets in a contour mesh box made of polyvinylchloride film and foil of aluminum printed lacquered or paper with a polymer coating.
One jar or two contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:
List B. In a dry, the dark place at a temperature of no higher than 25 ° C.
In a place inaccessible to children.

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

Terms of leave from pharmacies:On prescription
Registration number:LSR-004912/08
Date of registration:25.06.2008
The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
Manufacturer: & nbsp
Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
Information update date: & nbsp27.09.2015
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