F-CILLIN (dry powder)
-
Chemical Name:
Flucloxacillin (Sodium) -
Therapeutic Category:
Antimicrobial -
Pharmacologic Category:
Antibiotic, Penicillin -
Pharmaceutical Form:
Dry powder for suspension -
Composition:
Flucloxacillin (Sodium) 250mg/5ml
F-CILLIN
Capsules, Dry Powder for Oral Suspension, for Injection (Vial)
Flucloxacillin
1-PHARMACOLOGICAL EFFECTS :
F-CILLIN is an isoxazolylpenicillin resistant to penicillinase produced by staphylococci.
It is active therefore against penicillinase - producing and non–penicillinase- producing staphylococci, with minimum inhibitory concentrations in the range of 0,25 to 0.5 µg/mL.
It also stable to gastric acid and is given by mouth or by injection.
2-PHARMACOKINETICS:
F-CILLIN is twice as well absorbed from the gastro – intestinal tract as Cloxacillin Sodium, absorption is reduced by the presence of food in the stomach.
After an oral dose of 250 mg to 1 gr, peak plasma concentrations in about 1 hour are in the range of 5 to 15 µg/ml.
Following the instramuscular injection, peak concentrations are achieved in about 30 minutes.
About 95% of Flucloxacillin in the circulation is bound to plasma proteins.
Flucloxacillin and metabolites are excreted in the urine.
About 50 % of an oral dose and up to 90 % of an intramuscular dose is excreted in the urine within 6 hours.
Small amounts are excreted in the bile.
3-INDICATIONS:
Treatment of infections due to staphylococci resistant to benzylpenicillin:
-Bone and joint infections
-Endocarditis
-Peritonitis
-Pneumonia
-Skin infections (including soft – tissue)
-(Prophylaxis) in surgical infection
4-CONTRAINDICATIONS:
Hypersensitivity to the drug.
5-PRECAUTIONS:
Care should be taken in older patients and those receiving Flucloxacillin for more than
2 weeks as hepatitis and cholestatic jaundice have been reported occasionally.
The drug should be used with caution in patients with impaired renal or heptic function.
6-DRUG INTERACTIONS:
Flucloxacillin may decrease the efficacy of estrogen – containing oral contraceptives.
Plasma concentrations are enhanced if probenecid is given concomitantly.
7-SIDE EFFECTS:
It may rarely cause: Gastrointestinal disturbances including nausea-diarrhea,
allergic manifestations; fever, urticaria, anaphylactic shock in exceptional cases .
Occasionally: cholestatic jaundice.
Phlebitis has rarely followed intravenous infusion.
8-PREGNANCY AND NURSING MOTHERS:
Only when clearly needed.
9-DOSAGE & ADMINISTRATION:
Usual dose: 250 mg to 1gr four times daily depending on the severity of the infection.
Oral dose: should be taken at least 30 minutes before meals.
Intravenous dose: should be administered by slow injection over 3 to 4 minutes or by intravenous infusion.
Endocarditis or osteomyelitis:
Doses could be up to 8 gr daily .
Flucloxacillin has been administered by other routes in conjunction with systemic therapy:
Intra articular injection: 250 to 500 mg daily, dissolved if necessary in a 0,5% solution of lignocaine hydrochloride.
Intrapleural injection: 250 mg daily.
Children up to 2 years : ¼ adult dosage.
Children 2 – 10 years : ½ adult dosage.
10-RECONSTITUTION:
Intramuscular injection: 500 mg vial is dissolved in 2 mL water for injection.
Intravenous: 500 mg is dissolved in 5 – 10 mL water for injection. And 1 gr vial is dissolved in 15 – 20 mL water for injection. The injection is slowly during 3 – 4 min.
Intra articular injection: 500 mg vial is dissolved in 5 mL water for injection.
Intrapleural injection: every 250 mg is dissolved in 5 – 10 mL water for injection.
11-PACKAGING & COMPOSITION:
-F-CILLIN - Capsules: A pack of 20 capsules. Each capsule contains Flucloxacillin Sodium equivalent to Flucloxacillin 500 mg.
-F-CILLIN - Dry Powder for Oral Suspension: A pack of glass bottle of 100 mL. Each 5 mL of suspension contains Flucloxacillin Magnesium equivalent to Flucloxacillin 250 mg.
-F-CILLIN 500 - for Injection: A pack of 1 vial. Each vial contains Flucloxacillin Sodium equivalent to Flucloxacillin 500 mg.
-F-CILLIN 1000 - for Injection: A pack of 1 vial. Each vial contains Flucloxacillin Sodium equivalent to Flucloxacillin 1000 mg.
12-STORAGE CONDITIONS:
Store F-CILLIN – Capsules, Dry Powder for Oral Suspension and for Injection at temperature below 25°C.
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