Fucidin® (Fucidin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFusidic acidFusidic acid
Dosage form: & nbspcream for external use
Composition:

In 1 g of cream contains:

Active substance: fusidic acid

hemihydrate 20.4 mg (in terms of acid

anhydrous - 20.0 mg).

Excipients: cetyl

alcohol 111 mg; glycerol 85% - 111 mg;

paraffin liquid * - 111 mg; paraffin soft

white * - 56 mg; polysorbate 60 - 56 mg;

hydrochloric acid q.s. up to pH 5;

potassium sorbate - 2.7 mg; butylhydroxyanisole

- 0.04 mg; water approx. 531 mg.

* Contains about 10 ppm alpha-tocopherol

Description:
Homogenous cream from white to almost white.

Pharmacotherapeutic group:antibiotic of polycyclic structure
ATX: & nbsp

D.09.A.A.02   Fusidic acid

Pharmacodynamics:
Bacteriostatic antibiotic.
Fusidic acid belongs to the group of fusidins, antimicrobial compounds, the mechanism of their action is associated with a violation of protein synthesis in the bacterial cell.
By fusidic acid sensitive Gram-positive bacteria and gram negative cocci, e.g., Staphylococcus aureus, Staphylococcus epidermidis (including metitsillin- resistant strains), Nocardia asteroids, Coiynebacterium minutissimum, Streptococcus pyogenes, Pseudomonas spp, Clostridium spp., Neisseria meningitidis, Neisseria gonorrhoeae, Inactive Escherichia coli, Salmonella spp., Proteus spp. and other gram-negative bacteria, as well as protozoa and fungi.

Pharmacokinetics:
With external use, systemic absorption of fusidic acid is low. In the systemic blood stream does not fall.

Indications:
Skin infections caused by bacteria sensitive to fusidic acid.
Contraindications:

Hypersensitivity to the components of the drug.

Carefully:: pregnancy, lactation period
Dosing and Administration:
Outwardly.
In adults and children from birth to 18 years, the cream is applied to the affected areas of the skin with a thin layer 3-4 times a day.
When using gauze bandages, the frequency of application can be reduced to 1 to 2 times a day.
The duration of treatment depends on the form and severity of the disease and on average is 7-14 days.

Side effects:
The incidence of side effects is very rare - side effects may be expected in about 5% of patients.
The following are data on adverse adverse reactions, depending on the
frequency of occurrence
Very often> 1/10
Often> 1/100 and <1/10
Infrequently> 1/1000 and <1/100
Rarely> 1/10000 and <1/1000
Very rarely <1/10000
Disturbances 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:
urticaria, angioedema, eczema, periorbital edema, erythema. Immune system disorders:
Rarely:
Allergic reactions.
Disorders from the side of the organ of vision:
Rarely:
Irritation of the conjunctiva.
If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:Overdose is unlikely.
Interaction:not identified
Special instructions:
Do not apply Fucidine® cream to the skin in the eye area, because fusidic acid, in contact with the eyes, causes irritation of the conjunctiva.
Fucidin® cream contains butyl hydroxy anisole, cetyl alcohol and potassium sorbate, which can cause local allergic skin reactions (eg, contact dermatitis).
Butylhydroxyanisole can also cause irritation of the eyes and mucous membranes.
When using fusidic acid, bacterial resistance may develop. As with other antibiotics, prolonged or recurring use may increase the risk of developing resistance to antibiotics.

Effect on the ability to drive transp. cf. and fur:
Influence on ability to drive vehicles and complex mechanisms is not revealed.

Form release / dosage:
Cream for external use 2%.

Packaging:
15 g of the drug in an aluminum tube, lacquered from the inside with a screwed polyethylene lid.
1 tuba together with instructions for use in a cardboard box.

Storage conditions:
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children.

Shelf life:
3 years. ,
Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:П N011114 / 03
Date of registration:01.06.2010
The owner of the registration certificate:Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark
Manufacturer: & nbsp
Representation: & nbspLEO Pharmaceutical Products Ltd.LEO Pharmaceutical Products Ltd.
Information update date: & nbsp27.09.2015
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