Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Fusidic acid belongs to the pharmacological class of Steroid antibacterials.
Fusidic acid has been approved to relieve symptoms and also for the treatment and maintenance of Ophthalmic infections and conjunctivitis, Skin infections.
Fusidic acid is a gel formulation containing a 1% microcrystalline suspension of fusidic acid in a carbomer gel. This sustained release formulation ensures prolonged contact with the eye. Pharmacokinetic studies conducted in humans have shown that one hour after a single drop of Fusidic acid is administered into the fornix of the eye, the concentrations of fusidic acid in the lacrimal fluid range from 15.7 to 40 mcg/mL. After 12 hours, the concentrations range from 1.4 to 5.6 mcg/mL. The median antibiotic levels of 0.3 mcg/mL are maintained in the aqueous humor for 12 hours. Due to the achievement of high concentrations of fusidic acid in the eye after the topical application of Fusidic-acid, standardized susceptibility tests may not accurately predict its clinical effectiveness.
The common side effects involved in using Fusidic acid are Skin irritation: Redness, itching, or rash at the application site, Nausea, vomiting, diarrhea, or abdominal pain, Headache, Metallic taste in the mouth.
Fusidic acid is available in the form of Ointment , Cream, Eye drops.
Fusidic acid is approved in Germany, Japan, Malaysia, India, the U.K., the U.S., and China.
Fusidic acid belongs to the pharmacological class of Steroid antibacterials.
The antibacterial effect of fusidic acid is achieved by interfering with the transfer of amino acids from aminoacyl-tRNA to protein on the ribosomes. Depending on the initial number of bacteria present, fusidic acid can either halt their growth (bacteriostatic) or cause their death (bactericidal). In vitro studies have shown that bacterial cells cease dividing shortly after contact with the antibiotic, but DNA and RNA synthesis continue for a period of 45 minutes and 1-2 hours, respectively. Despite having a steroid-like structure, fusidic acid does not possess any steroid-like pharmacological activities such as hormonal or anti-inflammatory effects.
Fusidic acid has been approved to relieve symptoms and also for the treatment and maintenance of Ophthalmic infections and conjunctivitis, Skin infections.
Fusidic acid is found to be available in the form of Ointment, Cream, Eye drops.
Fusidic acid can be used in the following treatment:
- Ophthalmic infections and conjunctivitis
- Skin infections
Fusidic acid can help to relieve symptoms and also for the treatment and maintenance of Ophthalmic infections and conjunctivitis, Skin infections.
Fusidic acid is approved for use in the following clinical indications:
- Ophthalmic infections and conjunctivitis
Indication: For ophthalmic infections or conjunctivitis
Dosage: Ophthalmic
- Administration: Instill 1 drop into the conjunctival sac of each eye every 12 hours.
- Duration: Continue treatment for a period of 7 days.
- Reassessment: If the infection has not resolved after 7 days of treatment, further evaluation is advised.
Indication: Skin infections
Dosage: Topical
- Application: Apply a small amount of the medication to the affected area.
- Frequency: Apply 2 to 3 times daily.
- Duration: Continue treatment for a period of 7 to 14 days.
- Dressing: If a gauze dressing is used, the frequency of application may be reduced to once or twice daily.
Ointment: Typically available in strengths of 2% fusidic acid.
Cream: Usually available in strengths of 2% fusidic acid.
Eye drops: Available in strengths of 1% fusidic acid for ophthalmic use.
Ointment, Cream, Eye drops.
- Dosage Adjustments in Pediatric Patients:
For ophthalmic infections or conjunctivitis, the use of fusidic acid is suitable for children aged 2 years and older, as well as adolescents.
For the treatment of skin infections, topical application of fusidic acid is recommended. Apply a small amount of the medication to the affected area 2 to 3 times daily for a duration of 7 to 14 days suitable for children aged 2 years and older, as well as adolescents.
Fusidic acid does not have specific dietary restrictions.
Fusidic acid may be contraindicated under the following conditions:
- Fusidic acid is contraindicated in patients who have demonstrated hypersensitivity to the drug.
General:
- For the treatment of severe or refractory skin lesions, the use of a systemic antibacterial agent should be considered in addition to topical treatment. Overgrowth of non-susceptible organisms may occasionally occur with the use of topical antibiotics. In such cases, or if irritation or sensitization develops, treatment with Fusidic acid should be discontinued, and appropriate therapy should be initiated.
Susceptibility/Resistance:
- Development of Drug-Resistant Bacteria
- Prescribing Fusidic acid Ointment and creams without a confirmed or strongly suspected bacterial infection is unlikely to benefit the patient and poses the risk of developing resistant organisms.
- Potential for Microbial Overgrowth
- The use of topical Fusidic acid has been associated with bacterial resistance in Staphylococcus aureus. Like all antibiotics, prolonged or recurrent use of fusidic acid may increase the risk of antibiotic resistance. To minimize this risk, therapy with topical fusidic acid should be limited to a maximum of 14 days at a time.
Fertility:
- There are no clinical studies on fertility with topical Fusidic-acid. As systemic exposure to topically applied fusidic acid/sodium fusidate is negligible, no effects on women of childbearing potential are expected.
Skin:
- Fusidic acid cream contains butyl hydroxy anisole, cetyl alcohol, and potassium sorbate. These ingredients may cause local skin reactions, such as contact dermatitis. Butyl hydroxyanisole may also cause irritation to the eyes and mucous membranes. Therefore, caution should be exercised when applying Fusidic acid cream near the eyes.
- Fusidic acid ointment contains cetyl alcohol and hydrous lanolin, which may cause local skin reactions, including contact dermatitis. Additionally, Fusidic acid ointment contains butylhydroxytoluene (E321), which may cause local skin reactions or irritation to the eyes and mucous membranes. When using Fusidic acid ointment on the face, care should be taken to avoid contact with the eyes as the ointment's ingredients may cause conjunctival irritation.
Alcohol Warning
- It is important to exercise caution and avoid consuming alcohol while taking fosfomycin. Alcohol may interact with fosfomycin and potentially lead to adverse effects or reduce the effectiveness of the medication.
- Drinking alcohol while on fosfomycin treatment can increase the risk of side effects such as nausea, vomiting, dizziness, and gastrointestinal disturbances. Additionally, alcohol consumption can impair liver function, which may impact the body's ability to metabolize and eliminate fosfomycin effectively.
Breast Feeding Warning
After the systemic administration of fusidic acid, it has been observed to appear in the breast milk of nursing mothers. Therefore, when using Fusidic acid while breastfeeding, it is essential to carefully consider the benefits in relation to the potential risks to the nursing infant.
Pregnancy Warning
Pregnancy:
Teratogenic Effects - Category B
The available data from studies in pregnant women are insufficient and do not provide well-controlled results. As a result, when considering the use of Fusidic acid during pregnancy, it is necessary to carefully assess the advantages against the potential risks to the fetus. It has been observed that fusidic acid can cross the placental barrier in humans after systemic administration. However, animal studies have not shown any evidence of fusidic acid causing birth defects (teratogenicity).
Food Warning
The adverse reactions related to Fusidic acid can be categorized as follows:
Common:
● Skin irritation: Redness, itching, or rash at the application site.
● Gastrointestinal effects: Nausea, vomiting, diarrhea, or abdominal pain.
● Headache
● Changes in taste: Metallic taste in the mouth.
Less Common:
● Decreased appetite
● Nausea
● Abdominal or stomach pain
● Increased frequency of bowel movements
● Loose stools
Rare:
● Unusual fatigue or weakness
● Yellowing of the eyes or skin
No studies investigating interactions have been conducted. The potential for interactions with systemically administered medications is considered minimal due to the negligible systemic absorption of topical Fusidic acid.
The following are the side effects involving Fusidic acid:
● Decreased appetite
● Nausea
● Abdominal or stomach pain
● Increased frequency of bowel movements
● Loose stools
Pregnancy:
Teratogenic Effects - Category B
The available data from studies in pregnant women are insufficient and do not provide well-controlled results. As a result, when considering the use of Fusidic acid during pregnancy, it is necessary to carefully assess the advantages against the potential risks to the fetus. It has been observed that fusidic acid can cross the placental barrier in humans after systemic administration. However, animal studies have not shown any evidence of fusidic acid causing birth defects (teratogenicity).
Lactation:
After the systemic administration of fusidic acid, it has been observed to appear in the breast milk of nursing mothers. Therefore, when using Fusidic acid while breastfeeding, it is essential to carefully consider the benefits in relation to the potential risks to the nursing infant.
Pediatric:
There have been no quantitative bacteriology studies conducted in children under the age of 2, so the effectiveness of Fusidic acid has not been established for this age group. However, the incidence and range of adverse reactions in children under 2 years old are similar to those in children aged 2 and older.
Physicians should be knowledgeable as well as vigilant about the treatment and identification of overdosage of Fusidic-acid.
- There is no available information regarding potential symptoms and signs caused by an overdose of topically applied fusidic acid.
- The likelihood of experiencing systemic consequences from an accidental oral intake of an overdose of the active substance is low. The amount of fusidic acid contained in one tube of Fusidic acid does not surpass the oral daily dose used in systemic treatment.
Pharmacodynamics:
Fusidic acid acts as a bacteriostatic antibiotic, inhibiting the growth of bacteria and supporting the immune system in eliminating the infection.
Pharmacokinetics:
Absorption:
● Sodium fusidic acid tablets exhibit a 91% oral bioavailability.
● Film-coated tablets are completely absorbed when compared to a solution, although oral absorption may vary.
● Oral fusidic acid hemihydrate (suspension) achieves a 22.5% bioavailability in pediatric patients when administered at a dose of 20 milligrams/kilogram.
Volume of distribution:
● Information Not Available.
Protein binding:
● Fusidic acid has a high protein binding capacity, ranging from 97% to 99%.
Metabolism:
● Metabolites of fusidic acid include dicarboxylic ester/acid, 3-keto fusidic acid, hydroxy fusidic acid, glucuronide fusidic acid, and a glycol metabolite.
- Fusidic acid (fusidic acid) [product monograph]. Thornhill, Ontario, Canada: LEO Pharma Inc; July 2017.
- Livingstone V, Stringer LJ. The treatment of Staphylococcus aureus infected sore nipples: a randomized comparative study [published correction appears in: J Hum Lact 2000;16(2):179.]. J Hum Lact. 1999;15(3):241-246. doi: 10.1177/089033449901500315. [PubMed 10578803]
- Park MR, Kim DS, Kim J, Ahn K. Anaphylaxis to topically applied sodium fusidate [published online November 2, 2012]. Allergy Asthma Immunol Res. 2013;5(2):110-112. [PubMed 23450038]
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