FUCIDIN Sodium Fusidate 20mg / g Ointment 5g
NONRXDRUG-DR-1170-5
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Features
Brand
Fucidin
Full Details
Dosage Strength
20mg / g
Drug Ingredients
- Fusidate
Drug Packaging
Ointment 5g
Generic Name
Sodium Fusidate
Dosage Form
Ointment
Registration Number
DR-1170
Drug Classification
Over-The-Counter (OTC)
Description
Indications/Uses
Cream: This medicine works by killing germs (bacteria) that cause infections.
It is used to treat skin infections such as those caused by bacteria called Staphylococcus aureus.
Ointment: Fusidate sodium (Fucidin) ointment is indicated for treatment of skin infections caused by staphylococci, streptococci, Corynebacterium minutissimum and other organisms sensitive to sodium fusidate; the most important indications being: Impetigo; Boils; Hidradenitis; Infected wounds; Sycosis barbae; Paronychia; Folliculitis; Carbuncles; Erythrasma.
It is used to treat skin infections such as those caused by bacteria called Staphylococcus aureus.
Ointment: Fusidate sodium (Fucidin) ointment is indicated for treatment of skin infections caused by staphylococci, streptococci, Corynebacterium minutissimum and other organisms sensitive to sodium fusidate; the most important indications being: Impetigo; Boils; Hidradenitis; Infected wounds; Sycosis barbae; Paronychia; Folliculitis; Carbuncles; Erythrasma.
Dosage/Direction for Use
Cream: The doctor will tell how much Fusidic acid (Fucidin) cream to use.
The usual treatment time is up to two weeks. Ask the doctor before using this medicine for any longer.
Put the cream on the affected area of the skin, usually patient will need to do this three or four times a day, but less often if patient covered the area with a plaster or bandage.
The patient should notice skin improvement after just a few days of using the cream. If there is no improvement after seven days the patient should stop using the cream and go back to the doctor.
Missed Dose: If the patient forgets to use this medicine, use it as soon as remembered. Then next use this medicine at the usual time.
Ointment: Fusidate sodium (Fucidin) ointment is applied to the affected area 2–3 times daily, generally for a period of 7 days. It can be used with or without a covering dressing.
Caution should be observed when applying Fusidate sodium (Fucidin) ointment in the eye region as this preparation may cause irritation if it gets into the eye.
The usual treatment time is up to two weeks. Ask the doctor before using this medicine for any longer.
Put the cream on the affected area of the skin, usually patient will need to do this three or four times a day, but less often if patient covered the area with a plaster or bandage.
The patient should notice skin improvement after just a few days of using the cream. If there is no improvement after seven days the patient should stop using the cream and go back to the doctor.
Missed Dose: If the patient forgets to use this medicine, use it as soon as remembered. Then next use this medicine at the usual time.
Ointment: Fusidate sodium (Fucidin) ointment is applied to the affected area 2–3 times daily, generally for a period of 7 days. It can be used with or without a covering dressing.
Caution should be observed when applying Fusidate sodium (Fucidin) ointment in the eye region as this preparation may cause irritation if it gets into the eye.
Overdosage
Overdose is unlikely to occur.
Contraindications
Cream: If the patient is allergic to fusidic acid or any of the other ingredients of this medicine (listed under DESCRIPTION).
Ointment: Hypersensitivity to the active substance or to any of the excipients.
Ointment: Hypersensitivity to the active substance or to any of the excipients.
Special Precautions
Cream: Take the medicine exactly as the doctor has told the patient.
Tell the doctor immediately if the patient becomes pregnant while taking this medication. Fusidic acid (Fucidin) Cream is a ready-for-use preparation and should, therefore, not be mixed with other ingredients or preparations.
Avoid getting the cream in the eyes (e.g. accidentally from the hands or by using it too close to the eyes) as it could irritate (sting) them.
Consult the doctor: Talk to the doctor, pharmacist or nurse before using Fusidic acid (Fucidin) cream.
Do not use Fusidic acid (Fucidin) cream for a long time as the germs (bacteria) may no longer be killed by the antibiotic.
Driving and using machines: This medicine should not have any effect on the ability to drive or use machinery. Check with the doctor if the patient feels any side effect that may stop him/her from driving or using machinery.
Ointment: Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical Fucidin. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.
Fucidin ointment contains cetyl alcohol and hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
When Fucidin ointment is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.
Effects on the ability to drive and use machines: Fucidin administered topically has no or negligible influence on the ability to drive or to use machines.
Tell the doctor immediately if the patient becomes pregnant while taking this medication. Fusidic acid (Fucidin) Cream is a ready-for-use preparation and should, therefore, not be mixed with other ingredients or preparations.
Avoid getting the cream in the eyes (e.g. accidentally from the hands or by using it too close to the eyes) as it could irritate (sting) them.
Consult the doctor: Talk to the doctor, pharmacist or nurse before using Fusidic acid (Fucidin) cream.
Do not use Fusidic acid (Fucidin) cream for a long time as the germs (bacteria) may no longer be killed by the antibiotic.
Driving and using machines: This medicine should not have any effect on the ability to drive or use machinery. Check with the doctor if the patient feels any side effect that may stop him/her from driving or using machinery.
Ointment: Bacterial resistance among Staphylococcus aureus has been reported to occur with the use of topical Fucidin. As with all antibiotics, extended or recurrent use of fusidic acid may increase the risk of developing antibiotic resistance.
Fucidin ointment contains cetyl alcohol and hydrous lanolin. These excipients may cause local skin reactions (e.g. contact dermatitis). Fucidin ointment contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
When Fucidin ointment is used on the face; care should be taken to avoid the eyes as the excipients in the ointment may cause conjunctival irritation.
Effects on the ability to drive and use machines: Fucidin administered topically has no or negligible influence on the ability to drive or to use machines.
Use In Pregnancy & Lactation
Cream: Tell the doctor immediately if patient becomes pregnant while taking this medication.
Pregnancy and breast-feeding: If the patient is pregnant or breast-feeding, thinks that she might be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before using this medicine.
If the patient is pregnant or thinks that she might be pregnant; Fusidic acid (Fucidin) cream may be used during pregnancy.
If the patient is breast-feeding; Fusidic acid (Fucidin) cream may be used by women who are breast-feeding but the cream should not be applied to the breast.
Ointment: Fertility: There are no clinical studies with topical Fucidin regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically applied fusidic acid/sodium fusidate is negligible.
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical Fucidin can be used during pregnancy.
Breast-feeding: No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Fucidin can be used during breast-feeding but it is recommended to avoid applying topical Fucidin on the breast.
Pregnancy and breast-feeding: If the patient is pregnant or breast-feeding, thinks that she might be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before using this medicine.
If the patient is pregnant or thinks that she might be pregnant; Fusidic acid (Fucidin) cream may be used during pregnancy.
If the patient is breast-feeding; Fusidic acid (Fucidin) cream may be used by women who are breast-feeding but the cream should not be applied to the breast.
Ointment: Fertility: There are no clinical studies with topical Fucidin regarding fertility. No effects in women of childbearing potential are anticipated, since systemic exposure following topically applied fusidic acid/sodium fusidate is negligible.
Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical Fucidin can be used during pregnancy.
Breast-feeding: No effects on the breastfed new-born/infant are anticipated since the systemic exposure of topically applied fusidic acid/sodium fusidate to the breast-feeding woman is negligible. Topical Fucidin can be used during breast-feeding but it is recommended to avoid applying topical Fucidin on the breast.
Adverse Reactions
Cream: Like all medicines, this medicine can cause side effects, although not everybody gets them. In clinical trials, approximately 2 out of every 100 patients got a side effect. The most frequent side effects are non-serious skin problems where the cream is used and these occur in approximately 1 out of every 100 patients.
Important side effects to look out for: The patient must get urgent medical help straight away if he/she has any of the following symptoms: The patient may be having an allergic reaction. This is rare (may affect up to 1 in 1000 people).
The patient has difficulty breathing.
Lips and mouth start to tingle or swell.
Face or throat swell.
Skin develops a severe rash.
Other possible side effects which are less serious can also occur. The patient should tell the doctor about these as soon as possible.
Uncommon (may affect up to 1 in 100 people): Rash or itch; Redness of the skin; Itchy red rash with heat and swelling in the area where the cream is used (contact dermatitis or eczema); Pain, irritation (stinging) or burning in the area where the cream is used.
Rare (may affect up to 1 in 1000 people): The eye might get very itchy and have a watery discharge; Swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing; Hives or blisters.
These side effects may also occur in children who use the product.
Ointment: The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
Based on pooled data from clinical studies including 4724 patients who received Fucidin cream or Fucidin ointment, the frequency of undesirable effects is 2.3%.
The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients.
Hypersensitivity and angioedema have been reported.
Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000. (See table.)
Important side effects to look out for: The patient must get urgent medical help straight away if he/she has any of the following symptoms: The patient may be having an allergic reaction. This is rare (may affect up to 1 in 1000 people).
The patient has difficulty breathing.
Lips and mouth start to tingle or swell.
Face or throat swell.
Skin develops a severe rash.
Other possible side effects which are less serious can also occur. The patient should tell the doctor about these as soon as possible.
Uncommon (may affect up to 1 in 100 people): Rash or itch; Redness of the skin; Itchy red rash with heat and swelling in the area where the cream is used (contact dermatitis or eczema); Pain, irritation (stinging) or burning in the area where the cream is used.
Rare (may affect up to 1 in 1000 people): The eye might get very itchy and have a watery discharge; Swelling of the face, lips, mouth, throat or tongue which may cause difficulty in swallowing or breathing; Hives or blisters.
These side effects may also occur in children who use the product.
Ointment: The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
Based on pooled data from clinical studies including 4724 patients who received Fucidin cream or Fucidin ointment, the frequency of undesirable effects is 2.3%.
The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by various application site conditions such as pain and irritation, which all occurred in less than 1% of patients.
Hypersensitivity and angioedema have been reported.
Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000. (See table.)
Paediatric population: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Caution For Usage
FOR EXTERNAL USE ONLY.
Storage
Cream: Do not store above 30°C.
The tube should be discarded 28 days after first opening. Write the date the tube was first opened in the space provided on the carton.
Ointment: Store at temperatures not exceeding 30°C.
The tube should be discarded 28 days after first opening. Write the date the tube was first opened in the space provided on the carton.
Ointment: Store at temperatures not exceeding 30°C.
Action
Ointment: Pharmacology: Pharmacodynamics: Fucidin ointment 2% contains Sodium Fusidate, a potent topical antibacterial. Fusidic acid and its salts exhibit fat and water solubility properties with strong surface activity, and show unusual ability to penetrate intact skin. However, they are poorly systemically absorbed after topical administration.
Concentrations of 0.03 - 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus. Topical Fucidin is also active against Streptococci, Corynebacteria, Neisseria and certain Clostridia.
Pharmacokinetics: There are no data which define the pharmacokinetics of Fucidin Ointment, following topical administration in man.
However, in-vitro studies show that fusidic acid and its salts can penetrate intact human skin in concentrations well above the MIC value of susceptible organisms.
The degree of penetration depends on factors such as the duration of exposure to fusidic acid (or its salts) and the condition of the skin. Fusidic acid and its salts are excreted mainly in the bile with little excreted in the urine.
Concentrations of 0.03 - 0.12 mcg/ml inhibit nearly all strains of Staphylococcus aureus. Topical Fucidin is also active against Streptococci, Corynebacteria, Neisseria and certain Clostridia.
Pharmacokinetics: There are no data which define the pharmacokinetics of Fucidin Ointment, following topical administration in man.
However, in-vitro studies show that fusidic acid and its salts can penetrate intact human skin in concentrations well above the MIC value of susceptible organisms.
The degree of penetration depends on factors such as the duration of exposure to fusidic acid (or its salts) and the condition of the skin. Fusidic acid and its salts are excreted mainly in the bile with little excreted in the urine.
MedsGo Class
Topical Antibiotics
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