Fuzidanat^® (Powder) Instructions for Use

Marketing Authorization Holder

Abolmed, LLC (Russia)

ATC Code

J01XC01 (Fusidic acid)

Active Substance

Fusidic acid (Rec.INN registered by WHO)

Dosage Form

Fuzidanat®

Powder for solution for infusion 500 mg: vial in set with buffer solution (citrate)

Dosage Form, Packaging, and Composition

Buffer solution citrate.

500 mg – vials (1) in set with solvent (vial) – cardboard packs.
500 mg – vials (1) in set with solvent (vial) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic

Pharmacotherapeutic Group

Polycyclic structure antibiotic

Pharmacological Action

Antibiotic. It has a bacteriostatic or bactericidal effect. The mechanism of action is associated with the suppression of protein synthesis due to the inhibition of the factor necessary for the translocation of protein subunits and elongation of the peptide chain, which subsequently leads to the death of the pathogen.

It is highly active against Staphylococcus spp., especially Staphylococcus aureus and Staphylococcus epidermidis (including methicillin-resistant strains), Nocardia asteroides, Clostridium spp.

It is less active against Streptococcus spp., Enterococcus spp., Neisseria spp., Bacteroides spp., Mycobacterium tuberculosis, Mycobacterium leprae.

Fusidic acid is active against some protozoa, including Giardia lamblia, Plasmodium falciparum.

Pharmacokinetics

After oral administration, it is widely distributed in the body. Fusidic acid accumulates in pus, sputum, bone tissue, synovial fluid, sequestra, burn scabs, and brain abscesses in concentrations exceeding the MIC for Staphylococcus aureus (0.03-0.16 µg/ml). It is metabolized in the liver. It is excreted in bile, a small amount – in urine.

When applied topically, Fusidic acid penetrates well through both damaged and healthy skin, while systemic absorption is low.

When applied locally, it penetrates well into the intraocular fluid. Therapeutic concentrations are maintained in the tear and intraocular fluid for at least 12 hours.

Indications

Infectious and inflammatory diseases caused mainly by Staphylococcus spp.: for oral administration – brain abscess, bone and joint infections, endocarditis, eye infections, septicemia, pneumonia, skin and soft tissue infections, infectious and inflammatory complications in cystic fibrosis, wound infection; for external use – impetigo, carbuncles, furuncles, infected wounds, hidradenitis, folliculitis, paronychia, sycosis barbae, erythrasma, acne vulgaris; for local use in ophthalmology – conjunctivitis, blepharitis, hordeolum, dacryocystitis, keratitis, infections associated with the removal of a foreign body from the conjunctiva and cornea.

ICD codes

Dosage Regimen

Orally for adults: a single dose is usually 500 mg, the daily dose is 1.5 g (in 3 doses with 8-hour intervals). For severe infections – in the first 2 days up to 2-3 g/day, then the dose is reduced to 1.5 g/day. The average duration of treatment is 7-14 days, for osteomyelitis – 2-3 weeks or more.

Orally for 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 doses. The duration of treatment is 7-10 days, for the treatment of osteomyelitis – 2-3 weeks or more.

For external use, fusidic acid is applied in a thin layer to the affected areas of the skin 2-3 times/day for 7 days. For the treatment of acne vulgaris, longer courses of therapy are required.

Locally for eye diseases, apply 2 times/day. Treatment should be continued for 2 days after the disappearance of clinical symptoms of the disease.

Adverse Reactions

From the digestive system: abdominal pain, nausea, belching, vomiting, diarrhea.

From the immune system: allergic phenomena – redness of the mucous membrane of the oral cavity and pharynx, pain when swallowing and skin rash, eosinophilia.

From the organ of vision: periorbital edema.

From the skin and subcutaneous tissues: infrequently – rash (erythematous, maculopapular, pustular), skin irritation, including pain, burning sensation, tingling sensation on the skin, itching, dry skin, contact dermatitis; rarely – eczema, erythema.

Contraindications

Hypersensitivity to fusidic acid.

Use in Pregnancy and Lactation

If it is necessary to use during pregnancy and breastfeeding, the expected benefit for the mother and the potential risk to the fetus or infant should be assessed.

In experimental studies, it was found that Fusidic acid does not have a teratogenic effect.

Fusidic acid penetrates the placental barrier. In in vitro experiments, it was found that Fusidic acid displaces bilirubin from its binding to albumin. Therefore, the use of fusidic acid in the third trimester of pregnancy should be avoided due to the possible development of kernicterus in newborns. This fact should be taken into account when it is necessary to use in newborns (including premature) infants with jaundice and acidosis.

Fusidic acid is excreted in breast milk in very low concentrations.

Use in Renal Impairment

It should be taken into account that fusidic acid can be used in cases of renal impairment and in cases where the use of other antibiotics is contraindicated.

Pediatric Use

Use is possible according to the dosage regimen.

Special Precautions

It should be taken into account that fusidic acid can be used in cases of renal impairment and in cases where the use of other antibiotics is contraindicated.

No cross-hypersensitivity to other antibiotics has been noted.

In severe infections, as well as in cases where long-term treatment is necessary, fusidic acid should be combined with other antibiotics active against staphylococci in order to reduce the risk of resistance development.

Drug Interactions

With simultaneous use with cholestyramine, insoluble complexes are formed, which leads to a decrease in the concentration of fusidic acid in the blood plasma.

With simultaneous use of fusidic acid with penicillins resistant to penicillinase, cephalosporins, erythromycin, rifampicin, lincomycin, an additive effect or synergism is observed.

Pharmaceutical interaction

Infusion solutions containing fusidic acid are incompatible with kanamycin, gentamicin, vancomycin, cephaloridine, carbenicillin, amino acid solutions, blood substitutes and calcium-containing drugs. Precipitation of fusidic acid may occur in infusion solutions at pH below 7.4.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.