DR.HYTHAM KADOUR

هذا المنتدى هو للتعارف و تبادل العلوم و الثقافات المختلفة
 
الرئيسيةبحـثالتسجيلالأعضاءدخول

شاطر | 
 

 جديد الفوسيغون ( ظهور اليرقان فقط في الجرعات الوريدية و ليس الفموية)

استعرض الموضوع السابق استعرض الموضوع التالي اذهب الى الأسفل 
كاتب الموضوعرسالة
د هيثم قدور
Admin
avatar

ذكر
عدد الرسائل : 85
العمر : 48
الموقع : http://naji1969.montadarabi.com
العمل/الترفيه : dentist
تاريخ التسجيل : 23/02/2008

مُساهمةموضوع: جديد الفوسيغون ( ظهور اليرقان فقط في الجرعات الوريدية و ليس الفموية)   الأحد مارس 02, 2008 12:35 am

Leo Laboratories Limited

Longwick Road
Princes Risborough
Bucks.
HP27 9RR



Telephone: +44 (0)1844 347 333
Facsimile: +44 (0)1844 342 278
Medical Information e-mail: medical-info.uk@leo-pharma.com


Document last updated on the eMC: Wed 18 February 2004

Fucidin Tablets
Table of Contents

1. NAME OF THE MEDICINAL PRODUCT

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

3. PHARMACEUTICAL FORM

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handling

7. MARKETING AUTHORISATION HOLDER

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

LEGAL CATEGORY








1. NAME OF THE MEDICINAL PRODUCT

Fucidin® Tablets




2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Sodium Fusidate Ph.Eur.250mg




3. PHARMACEUTICAL FORM

Tablet.




4. CLINICAL PARTICULARS





4.1 Therapeutic indications

Fucidin® is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: cutaneous infections, osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.

Fucidin® should be administered intravenously whenever oral therapy is inappropriate, which includes cases where absorption from the gastro-intestinal tract is unpredictable.





4.2 Posology and method of administration

For staphylococcal cutaneous infections:

Adults:
Standard Dose: 250mg (one tablet) sodium fusidate (equivalent to 240mg fusidic acid) twice daily for 5-10 days.



For staphylococcal infections such as osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.

Adults:
Standard dose: 500mg (two tablets) sodium fusidate (equivalent to 480mg fusidic acid) three times daily.



In severe cases of fulminating infections, the dosage may be doubled or

appropriate combined therapy may be used.

Elderly: No dosage alterations are necessary in the elderly.

Since Fucidin® is excreted in the bile, no dosage modifications are needed in renal impairment.

The dosage in patients undergoing haemodialysis needs no adjustment as Fucidin® is not significantly dialysed.





4.3 Contraindications

Contra-indicated in patients with known hypersensitivity to fusidic acid and its salts.





4.4 Special warnings and precautions for use

Caution should be exercised with other antibiotics which have similar biliary excretion pathways e.g. lincomycin and rifampicin. Periodic liver function tests should be carried out when high oral doses are used, when the drug is given for prolonged periods and in patients with liver dysfunction.

Fucidin® displaces bilirubin from its albumin binding site in vitro. The clinical significance of this finding is uncertain and kernicterus has not been observed in neonates receiving Fucidin®. However, this observation should be borne in mind when the drug is given to pre-term, jaundiced, acidotic or seriously ill neonates.

The use of Fucidin® in combination with drugs that are CYP-3A4 biotransformed should be avoided. See Section 4.5

Patients given Fucidin® systemically in combination with HMG-CoA reductase inhibitors should be closely clinically monitored. See Section 4.5





4.5 Interaction with other medicinal products and other forms of interaction

Specific pathways of Fucidin® metabolism in the liver are not known, however, an interaction between Fucidin® and drugs being CYP-3A4 biotransformed can be suspected. The mechanism of this interaction is presumed to be a mutual inhibition of metabolism. There is insufficient data to characterise the effect of

fusidic acid on CYPs in-vitro. The use of Fucidin® systemically should be avoided in patients treated with CYP-3A4 biotransformed drugs.

Fucidin® administered systemically and concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions may increase the plasma concentration of these agents enhancing the anticoagulant effect. Anticoagulation should be closely monitored and a decrease of the oral anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation. Similarly, discontinuation of Fucidin® may require the maintenance dose of anticoagulant to be re-assessed. The mechanism of this suspected interaction remains unknown.

Co-administration of Fucidin® systemically and HMG-CoA reductase inhibitors such as statins may cause increased plasma concentrations of both agents and rare cases of rhabdomyolysis have been reported for this combination. Patients on this combination should be closely clinically monitored.

Co-administration of Fucidin® systemically and ciclosporin has been reported to cause increased plasma concentration of ciclosporin.





4.6 Pregnancy and lactation

There is inadequate evidence of safety in human pregnancy. Animal studies and many years of clinical experience suggest that fusidic acid is devoid of teratogenic effects. There is evidence to suggest that when given systemically, fusidic acid can cross the placental barrier. If the administration of Fucidin® to pregnant patients is considered essential, its use requires that the potential benefits be weighed against the possible hazards to the foetus.

Safety in nursing mothers has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in the breast milk. Caution is therefore required when Fucidin® is used in mothers who wish to breast feed.





4.7 Effects on ability to drive and use machines

None known.





4.8 Undesirable effects

In some patients, given Fucidin®, particularly in the young and elderly, a reversible jaundice has been reported. Jaundice has been seen most frequently in patients receiving intravenous Fucidin® in high dosage, or where the drug has been infused too rapidly or at too high a concentration in the infusion fluid. In some instances instituting oral therapy may be beneficial. If the jaundice persists Fucidin® should be withdrawn, following which the serum bilirubin will invariably return to normal. Reported reactions are gastro-intestinal upsets and, rarely, skin rashes and other allergic reactions including anaphylaxis. Isolated cases of haematological abnormalities which can affect the 3 blood cell lines but mainly white blood cells e.g. bone marrow depression, neutropenia, granulocytopenia, agranulocytosis and pancytopenia have been reported. Reported less often is a depressive effect on the platelets and red blood cells with reports of thrombocytopenia and various anaemias. These abnormalities have been observed especially with treatment of more than 15 days. Acute renal failure has been described in patients with jaundice, particularly in the presence of other factors predisposing to renal failure.





4.9 Overdose

There has been no experience of overdosage with Fucidin®. Treatment should be restricted to symptomatic and supportive measures. Dialysis is of no benefit, since the drug is not significantly dialysed.




5. PHARMACOLOGICAL PROPERTIES





5.1 Pharmacodynamic properties

Fusidic acid and its salts are potent anti-staphylococcal agents with unusual ability to penetrate tissue. Bactericidal levels have been assayed in bone and necrotic tissue. Concentrations of 0.03 - 0.12 micrograms/ml inhibit nearly all strains of Staphylococcus aureus. Fusidic acid is active against Staphylococcus epidermidis and methicillin resistant staphylococci.





5.2 Pharmacokinetic properties

Blood levels are cumulative, reaching concentrations of 20-35 micrograms/ml after oral administration of 250mg twice daily for seven days and 50-100 micrograms/ml after oral administration of 500mg three times daily for three to four days.

Fucidin® is excreted mainly in the bile, little or none being excreted in the urine.

In severe or deep-seated infections and when prolonged therapy may be required, Fucidin® should generally be given concurrently with other anti-staphylococcal antibiotic therapy.





5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.




6. PHARMACEUTICAL PARTICULARS





6.1 List of excipients

Cellulose microcrystalline, crospovidone, gelatin, hydroxypropylmethylcellulose, lactose, magnesium stearate, polyvinylpyrolidone, silicon dioxide, talc, titanium dioxide.





6.2 Incompatibilities

None.





6.3 Shelf life

3 years.





6.4 Special precautions for storage

Do not store above 25°C.





6.5 Nature and contents of container

Blister packs of 10 and 10 x 10 tablets.





6.6 Special precautions for disposal and other handling

None.




7. MARKETING AUTHORISATION HOLDER

LEO Laboratories Limited, Longwick Road, Princes Risborough, Bucks. HP27 9RR.




8. MARKETING AUTHORISATION NUMBER(S)

0043/5000R




9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

4.6.87 (after review).




10. DATE OF REVISION OF THE TEXT

January 2004.





LEGAL CATEGORY

POM


file:///C:/Documents and Settings/syphco pharma/سطح المكتب/Fucidin Tablets , SPC from the eMC.htm



SUPPORTING INFORMATION

Patient Information Leaflet:
Fucidin Tablets
Medicine Guide:
Fucidin tablets (new window)

هذه الدراسة معدة من قبل مندوبتنا في حلب ص ميساء
الرجوع الى أعلى الصفحة اذهب الى الأسفل
معاينة صفحة البيانات الشخصي للعضو http://naji1969.montadarabi.com
 
جديد الفوسيغون ( ظهور اليرقان فقط في الجرعات الوريدية و ليس الفموية)
استعرض الموضوع السابق استعرض الموضوع التالي الرجوع الى أعلى الصفحة 
صفحة 1 من اصل 1

صلاحيات هذا المنتدى:لاتستطيع الرد على المواضيع في هذا المنتدى
DR.HYTHAM KADOUR :: الطب و الصحة :: منشورات و ردود خاصة-
انتقل الى: