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Cloxacillin
 

DESCRIPTION

CLOXACILLIN CAPSULE 250MG contains: Cloxacillin Sodium equivalent to Cloxacillin 250 mg.

Capsule Colour: Orange/Black

Capsule Size: #2

Granules Colour: White

 

CLOXACILLIN CAPSULE 500MG contains: Cloxacillin Sodium equivalent to Cloxacillin 500 mg.

Capsule Colour: Amethyst/Black

Capsule Size: #0

Granules Colour: White

Marking: "DYNA" & Company Logo

PHARMACODYNAMICS
Cloxacillin is a bactericidal antibiotic which inhibits bacterial cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited and lysis of susceptible bacteria frequently occurs. Rapidly dividing bacteria are most susceptible to penicillin group of antibiotics. Cloxacillin is resistant to staphylococcal penicillinase. It has an antibacterial spectrum similar to that of methicillin.

PHARMACOKINETICS
Cloxacillin sodium is incompletely absorbed from the gastrointestinal tract after oral administration, and absorption is further reduced by the presence of food in the stomach. After an oral dose of 500 mg, a peak plasma concentration of 7 to 14 g per ml is obtained in fasting subjects in 1 to 2 hours. Absorption is more complete when given by intramuscular injection and peak plasma concentrations of about 15 g per ml have been observed 30 minutes after a dose of 500 mg. Doubling the dose can double the plasma concentration. About 94% of cloxacillin in the circulation are bound to plasma proteins. Cloxacillin has been reported to have a plasma half-life of approximately 0.5 hours in healthy subjects. The half-life is prolonged in neonates. Cloxacillin diffuses across the placenta into the foetal circulation and is excreted in breast milk. There is little diffusion into the CFS except when the meninges are inflamed. Therapeutic concentrations can be achieved in pleural and synovial fluids and in bone. Cloxacillin is metabolised to a limited extent, and the unchanged drug and metabolites are excreted in the urine by glomelurar filtration and renal tubular secretion. About 35% of an oral dose are excreted in the urine and up to 10% in the bile. Serum concentrations are enhanced if probenecid is given concomitantly.

INDICATION
Infections caused by staphylococci resistant to benzylpenicillin, including infections of the skin and soft tissues, bones and joints, respiratory tract and urinary tract; otitis media, endocarditis, septicaemia and meningitis. It is also used for mixed streptococcal and staphylococcal infections when the staphylococci are penicillin-resistant. It is also used for the prophylaxis of staphylococcal infections during major surgical procedures, particularly in cardiothoracic and orthopaedic surgery.

RECOMMENDED DOSE
Adults 250 - 500 mg every 6 hours daily.
Children 50 - 100 mg per kg body-weight daily in divided doses.

Note:

* Patient should continue medicine for full course of treatment.

* Take medicine on empty stomach.
* Reduced dosage is required in patients with impaired renal function.


CONTRAINDICATIONS
Patients hypersensitive to cloxacillin or a history of allergic to penicillin group of drugs.


WARNING AND PRECAUTIONS
Patients hypersensitive to other penicillin or cephalosporins or penicillamine may be hypersensitive to cloxacillin. If a skin rash occurs, treatment should be discontinued.

DRUG INTERACTIONS
Probenecid impairs renal excretion. Reduces anticoagulant effect.

PREGNANCY AND LACTATION
Risk-benefit must be considered when given to pregnant women and during breast-feeding.

SIDE EFFECTS/ADVERSE REACTIONS
Side effects such as diarrhoea, nausea and heartburn may occur following administration by mouth. Sensitivity reactions may occur to patients hypersensitive to the drug. The most common side effects are allergic reaction and of these, skin rashes occur most frequently.

SYMPTOMS AND TREATMENT OF OVERDOSE
Overdosage may cause GIT disturbances, reversible impairment of liver function and diarrhoea. Treatment include stop antibiotic treatment, treat GIT distress by giving milk every 3 hours alternating with bismuth subcarbonate 5 g every 3 hours.


Problems of overdosage are unlikely to be encountered. Gross overdosage will produce very high urinary concentration, more so after parenteral administration. Problems are unlikely if adequate fluid intake and urinary output are maintained; however crystalluria is a possibility. More specific measures may be necessary in patients with impaired renal function; the antibiotic is removed by haemodialysis.

PACKING/PACK SIZES
CLOXACILLIN CAPSULE 250MG
- Plastic containers of 20's and 1000's (For EXPORT/TENDER Only).

- Blister packs of 50 x 10's and 100 x 10's.


CLOXACILLIN CAPSULE 500MG
- Plastic container of 500's (For EXPORT/TENDER Only).

- Blister packs of 10 x 10's and 50 x 10's.

SHELF LIFE
3 years from the date of manufacture.


STORAGE CONDITIONS
KEEP OUT OF REACH OF CHILDREN

Keep Container Tightly Closed

Store In A Dry Place Below 25C

Protect From Light

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