CLOXACILLIN-ELSaad 500

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CLOXACILLIN-ELSaad 500

Chemical Name:

Cloxacillin (Sodium)
Therapeutic Category:

Antimicrobial
Pharmacologic Category:

Antibiotic, Penicillin
Pharmaceutical Form:

Vial
Composition:

Cloxacillin (Sodium) 500mg

Leaflet

CLOXACILLIN ELSaad

For Injection (Vial)

Cloxacillin (Sodium)

1-CLINICAL PHARMACOLOGY:

CLOXACILLIN is a semi-synthetic penicillin which is stable to beta-lactamase and highly active against staphylococci, irrespective of their sensitivity to other penicillins. It is also active against streptococci and pneumococci.

CLOXACILLIN is bactericidal against Gram-positive organisms, particularly staphylococci, (irrespective of their ability to produce beta-lactamase ) streptococci, and pneumococci.

Susceptible organisms include: staphylococcus aureus, staphylococcus pneumonia, streptococcus viridans, streptococcus pyogenus, corynebaterium diphtheria, and clostridium species.

CLOXACILLIN is acid-stable and well absorbed, producing high serum levels, which are maintained for up to four hours. It is excreted by glomerular filtration and renal tubular secretion in a similar manner to other penicllins. The concurrent administration of Probenicid enables serum levels to be raised and minimum inhibitory concentrations (MIC) to be maintained for up to 6 hours. Probenicid should not be given in cases of renal insufficiency.

2-INDICATIONS:

Gram-positive infections including those caused by penicillin-resistant staphylococci.

Typical infections include:

Skin and soft tissue infections:

Boils/carbuncles, abscesses, cellulitis, infected wounds, infected burns, protection for skin grafts, infected skin conditions associated with ulcers and eczema.

Respiratory tract, ear, nose and throat infections:

Pneumonia, lung abscesses, empyema, sinusitis, pharyngitis, otitis media, tonsillitis, quinsy.

Other infections:

Osteomyelitis, staphylococcal, enterocolitis, septic arthritis, endocarditis, meningitis, septicaemia, urinary tract infections.

3-CONTRAINDICATIONS:

CLOXACILLIN should not be administered to subjects with a known hypersensitivity to pencillins or used in the eye either subconjunctivally or locally.

4-PRECAUTIONS:

-Avoid high dose in cases of renal and heart impairment and in cases of concomitantly administration of K-sparing diuretic.

-CLOXACILLIN should not be administered to patients with a history of sensitivity to any pencillin.

-Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion of the physician, the condition being treated is life threatening and amenable only to penicillin therapy.

-Prolonged use may cause fungal infection.

5-SIDE EFFECTS:

CLOXACILLIN produces few side effects. If experienced they are usually confined to transient diarrhoea or indigestion and occasional rashes.

6-DRUG INTERACTIONS:

-Concurrent use of Tetracycline and CLOXACILLIN should be avoided.

-Concurrent administration of Probenicid with CLOXACILLIN enables serum levels to be raised and MIC (minimum inhibitory concentrations) to be maintained.

-Concomitantly administration with anticoagulants may increase bleeding time.

7-DOSAGE & ADMINISTRATION:

Adults Dosage:

ROUTE	DOSAGE	ADMINISTRATION
ORAL	250 – 500 mg every 6 hours	Administer ½ -1 hour before meals.
I.M. INJECTION	250 / 500 mg every 4-6 hours	Dissolve contents of each vial in 1.5 ml of Water for Injection.
I.V. INJECTION / INFUSION	500 mg / 1 Gr. every 4-6 hours (in severe infections up to 8 g daily)	Dissolve 500 mg in 10 ml or 1 g. In 20 ml of Water for Injections and inject slowly over 3-4 minutes. Cloxacillin may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of 3-4 minutes.

Pediatric Dosage:

Up to 2 years : ¼ Adult dose

2 – 10 years: ½ Adult dose

Dosage in children based on body weight is 25 – 50 mg /kg / day given in divided doses. In severe infections oral and parenteral dosages may be safely increased.

-Stability and Compatibility:

-Injectable Solutions: solutions should be used immediately upon reconstitution.

-Intravenous Infusion: CLOXACILLIN is compatible with commonly used intravenous fluids but should not, however, be mixed with blood products or proteinaceous fluids such as protein hydrolysates nor with lipid emulsions.

The periods of stability at room temperature are shown in the following table:

INTRAVENOUS FLUID	STABILITY PERIOD AT 23 ˚C
Sodium Chloride 0.9%	24 hours
Dextrose 5%	24 hours
Sodium Chloride 0.18% & Dextrose 4%	24 hours
Sodium Lactate M/6	6 hours
Compound Sodium Chloride injection ( Ringer’s Solution )	24 hours
Sodium Bicarbonate 1.4%	6 hours
Dextran 40 10 % in Sodium Chloride 0.9%	24 hours
Dextran 40 10% in Dextrose 5%	ours