Sandoz Flucloxacillin

Uses

Sandoz Flucloxacillin is used for the treatment of infections due to Gram-positive organisms, including infections caused by β-lactamase producing staphylococci.

Skin and Soft Tissue Infections: Boils, abscesses, carbuncles, furunculosis,infected wounds, infected burns, protection of skin grafts, otitis media and externa, impetigo.

Infected Skin Conditions: Ulcer, eczema and acne.

Respiratory Tract Infections: Pneumonia, lung abscess, empyema, sinusitis,pharyngitis, tonsillitis, quinsy.

Other infections caused by Sandoz Flucloxacillin-sensitive organisms such as osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia.

Sandoz Flucloxacillin is also used for use as a prophylactic agent during major surgical procedures where appropriate, for example, cardiothoracic and orthopaedic surgery

Sandoz Flucloxacillin is also used to associated treatment for these conditions: Susceptible infections

How Sandoz Flucloxacillin works

By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, flucloxacillin inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that flucloxacillin interferes with an autolysin inhibitor.

Dosage

Sandoz Flucloxacillin dosage

Oral administration:

Adult or Elderly:

• Usual dosage: 250 mg four times daily. In severe infections, dosage should be doubled.
• In osteomyelitis and endocarditis: up to 8 gm daily, in divided doses 6 to 8 hourly.
• In case of secondary bacterial infection in chicken pox: Sandoz Flucloxacillin 500 mg six hourly should be prescribed.

Children:

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

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

Doses should be administered half an hour before meals.

Sandoz Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.

Side Effects

There have been some common side effects of GIT such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported

Precaution

Patient with spirochaete infections (e.g. syphilis, leptospirosis), history of hypersensitivity to β-lactam antibiotics. Newborn infants. Hepatic or renal impairment. Pregnancy and lactation.

Interaction

The administration of probenecid with Sandoz Flucloxacillin results in higher serum peak concentrations and prolongs the time that therapeutic concentrations of Sandoz Flucloxacillin are achieved in serum. Physical incompatibility and/or loss of activity of Sandoz Flucloxacillin in solution has been reported when given with gentamycin sulphate, streptomycin sulphate, vitamin mixtures. Sandoz Flucloxacillin should not be added to intravenous lipids, blood products and protein hydrolysates or other proteinaceous fluids.

Food Interaction

• Take on an empty stomach.

Elimination Route

Bioavailability is 50–70% following oral administration.

Half Life

0.75–1 hour

Pregnancy & Breastfeeding use

The use of Sandoz Flucloxacillin in pregnancy should be reserved for cases considered essential by the clinician. Use of the drug in the second and third trimesters may result in the sensitisation of the fetus. During lactation, trace quantities of penicillins can be detected in breast milk.

Contraindication

Sandoz Flucloxacillin is contraindicated for those who have hypersensitivity to penicillins.

Special Warning

Dose adjustment in renal impairment : As common with other penicillins, Sandoz Flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or an extension of dose interval should be considered. Sandoz Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosages need to be administered either during or at the end of the dialysis period.

Acute Overdose

Symptoms: Neurotoxicity (e.g. convulsions, encephalopathy), GI effects (e.g. nausea, vomiting, diarrhoea), blood disorders (e.g. neutropenia, haemolytic anaemia, prolongation of bleeding time, defective platelet function), electrolyte disturbances.

Management: Symptomatic treatment.

Storage Condition

Store below 25° C. Reconstituted solution: Store between 2-8°C.

Innovators Monograph

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