Flucloxin 500

Generic

Flucloxacillin Sodium.

 

Indications

Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by penicillinase producing staphylococci. These indications include:

1. Skin and soft tissue infections: Boils, abscess, carbuncles, infected skin conditions (e.g. ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, otitis media and externa, impetigo).
2. Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.
3. It is also used for the treatment of other infections i.e. osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia caused by Flucloxacillin-sensitive organisms.
4. As a prophylactic agent, it is used during major surgical procedures where appropriate; for example, cardiothoracic and orthopedic surgery.

 

Pharmacology

Flucloxacillin is active against Gram-positive bacteria, including strains that produce penicillinase. It has little activity against Gram-negative bacilli. Flucloxacillin works by inhibiting the formation of bacterial cell walls. Flucloxacillin is isoxazole penicillin, which combines the properties of resistance to penicillin enzymatic hydrolysis, gastric acid stability and anti-Gram-positive bacteria activity. Flucloxacillin is a bactericidal antibiotic that is particularly useful for Staphylococcus that produces penicillinase. Flucloxacillin destroys the bacterial cell wall, which interferes with peptidoglycan synthesis. Peptidoglycan is a heteromeric structure that provides mechanical stability to the cell wall. The final step of peptidoglycan synthesis involves completion of crosslinking with the terminal glycine residue of the pentaglycine bridge connected to the fourth pentapeptide residue (Dalanin). The transpeptidase that performs this step is inhibited by flucloxacillin. As a result, the bacterial cell wall weakens, the cell swells, and then breaks down. The effect of flucloxacillin against bacterial penicillinase may be due to the steric hindrance caused by the acyl side chain preventing the opening of the β-lactam ring.

 

Dosage & Administration

Oral administration:

• Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm. daily is used in 6-8 hourly divided doses.
• Children (2-10 years): 1/2 of adult dose.
• Children (Under 2 years): 1/4 of adult dose.

Parenteral administration:
Adult or Elderly:

• Intramuscular Injection: 250 mg four times daily.
• Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
• All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.

Children:

• 2-10 years: half of the adult dose.
• Under 2 years: a quarter of the adult dose.

 

Interaction

Concurrent Flucloxacillin use may result in an elevated Flucloxacillin level in the blood for an extended length of time.

 

Contraindications

Flucloxacillin is contraindicated in patients allergic to penicillin.

 

Side Effects

Nausea, vomiting, diarrhoea, dyspepsia, and other minor gastrointestinal problems are some of the most prevalent gastrointestinal side effects. Urticaria, purpura, fever, interstitial nephritis, hepatitis, and cholestatic jaundice have all been documented in addition to these rashes.

 

Precautions & Warnings

US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.

 

Therapeutic Class

Penicillinase-resistant penicillins

 

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.

 

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.