Flucloxin 250

Generic

Flucloxacillin Sodium

 

Indications

Flucloxacillin is suitable for treating infections caused by gram-positive bacteria, including infections caused by penicillinase-producing staphylococci. These indications include:

Skin and soft tissue infections: boils, abscesses, carbuncles, infected skin conditions (such as ulcers, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, middle ears and external otitis, impetigo).

Respiratory tract infection: pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, Quincy disease.

Is also used to treat other infections, such as osteomyelitis, enteritis, endocarditis, urinary tract infections, meningitis, and sepsis caused by bacteria sensitive to flucloxacillin.

Is used as a preventive agent in appropriate major surgical operations; for example, cardiothoracic surgery 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 isoxacillin, 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 staphylococci that produce penicillinase. Flucloxacillin destroys the bacterial cell wall and interferes with the synthesis of peptidoglycan. Peptidoglycan is a heteromeric structure that provides mechanical stability to the cell wall. The last step of peptidoglycan synthesis involves the completion of cross-linking with the terminal glycine residue of the pentaglycine bridge that binds 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.
• Oral doses should be administered 1 hour before meal.

 

Interaction

Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.

 

Contraindications

Flucloxacillin is contraindicated in penicillin hypersensitive patients.

 

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.

 

Pregnancy & Lactation

Flucloxacillin is classified as a pregnancy category B by the US Food and Drug Administration. In pregnant women, there are no sufficient and well-controlled trials. Because animal reproduction studies do not always predict human response, this medication should only be used during pregnancy if absolutely necessary. Human milk has been found to contain flucloxacillin. When Flucloxacillin is given to a nursing woman, vigilance should be observed.

 

Precautions & Warnings

In patients with hepatic impairment, flucloxacillin should be taken with caution. In the treatment of patients with allergic diathesis, caution is also advised.

 

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.