PERK

CLOXIL Capsules & Injections

Ampicillin and Cloxacillin 250mg, 500mg Capsules &

250mg, 500mg & DS (1gm) I.M. & I.V. Injection

 

 Composition:

 (a) Oral Capsules:
Ampicillin
trihydrate I.P. and Cloxacillin sodium I.P. available as:

CLOXIL 250

:

Gelatin capsules containing the equivalent of 125 mg ampicillin and 125 mg cloxacillin.

CLOXIL 500

:

Gelatin capsules containing the equivalent of 250 mg ampicillin and 250 mg cloxacillin.

  (b) Parenteral Injections:
Ampicillin sodium
I P. and Cloxacillin sodium I.P. available as:

CLOXIL 250 Inj.

:

Sterile powder for preparing the equivalent of 125 mg ampicillin and 125 mg cloxacillin per vial.

CLOXIL 500 Inj.

:

Sterile powder for preparing the equivalent of 250 mg ampicillin and 250 mg cloxacillin per vial.

CLOXIL DS Inj.

:

Sterile powder for preparing the equivalent of 500 mg ampicillin and 500 mg cloxacillin per vial.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.2 Penicillins
PHARMACOLOGICAL ACTION:
(a) Bacteriology:
CLOXIL
exhibits in vivo and in vitro bactericidal activity against Gram-positive and Gram-negative organisms.
In vitro sensitivity does not necessarily imply in vivo activity.
(b) Absorption:
Both ampicillin and cloxacillin are acid stable and well absorbed orally, giving peak serum levels about two hours after dosing. As there is a linear dose/response in peak serum level after oral administration of both components, doubling the dose virtually doubles the peak serum levels.
(c) Excretion:
Both components are excreted primarily by the kidneys by glomerular filtration and tubular secretion.
Bile: Bile concentrations of CLOXIL vary from 3 –48 times the serum concentration, according to the condition of the biliary tract.
(d) Probenecid:
Higher CLOXIL serum levels can be achieved in patients with normal renal function by the concurrent administration of a renal blocking agent such as probenecid. In adults, a dose of 500 mg of probenecid q.d.s. will result in 1,5 –2 fold increase in CLOXIL serum levels.

INDICATIONS:
The use of this antibiotic may lead to the appearance of resistant strains of organisms and sensitivity resting should, therefore, be carried out wherever possible, to ensure the appropriateness of the therapy.
Infections caused by susceptible organisms where a mixed infection is present and includes penicillin-resistant staphylococci.
CONTRA-INDICATIONS:
Known allergy to penicillin or cephalosporins. Cases of cross sensitivity have been reported.
Babies born of hypersensitive mothers in the neonatal period.
The oral dosage forms are not recommended for chronic, severe, or deep-seated infections such as subacute bacterial endocarditis, meningitis or syphilis. CLOXIL should not be administered by sub-conjunctival injection or used as an eye drop as it contains cloxacillin.

WARNINGS:
When administered to a patient with penicillin allergy anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis. Use with caution in patients with a known history of allergy.
Because of the variability in intestinal absorption of cloxacillin containing products, oral administration is not a suitable substitute for the parenteral route in treatment of severe infections.

DOSAGE AND DIRECTIONS FOR USE:
The average adult dose for CLOXIL is 2 –4g per day. In severe infections, dosages may be safely increased.
(i) ORAL:

Adults and children over 10

:

500 mg –1 g (1 –2 x 500 mg capsules) every 6 hours.

Children 2 –10 years

:

250 –500 mg (1-2 x 250 mg capsules) every 6 hours.

Children up to 2 years

:

250 mg (1 x 250 mg Capsule) every 6 hours.

Neonates

:

90 mg (1/4 to ˝ x 250mg Capsule) every 4 hours.

Note: Best results are obtained if dosages are administered half to one hour prior to meals or at least two hours after meals.

(ii) PARENTERAL

Adults and children over 10

:

500 mg –1 g intravenously or intramuscularly every 4 – 6 hours or as dictated by the severity of the infection.

Children 2 –10 years*

:

Half the adult dose.

Children up to 2 years*

:

Quarter the adult dose.

Neonates*

:

75 mg every 8 hours.

* These dosages should correspond to a daily dosage of 50 –150 mg/kg.
Note: Patients with renal insufficiency may require a reduced dosage.

DIRECTIONS FOR USE:
Intramuscular injection:

250 mg vial

add 1,5-2 mL of Water for Injections I.P. (supplied) and shake vigorously.

500 mg vial

add 1,5-2 mL of Water for Injections I.P. (supplied) and shake vigorously.

1 gm vial

add 3 mL of Water for Injections I.P. (supplied) and shake vigorously.

Intravenous injection:
Normally given by slow intravenous injection.

250 mg vial

dissolve in 5 mL of Water for Injections I.P. (supplied) by first dissolving the contents of the vial in approximately 3 mL of the Water for Injections B.P. and then withdrawing the dissolved contents into a 10 mL syringe containing the remaining Water for Injections B.P.

500 mg vial

dissolve in 5-10 mL of Water for Injections I.P. (supplied 5ml) by first dissolving the contents of the vial in approximately 3 mL of the Water for Injections B.P. and then withdrawing the dissolved contents into a 10 mL syringe containing the remaining Water for Injections B.P.

1 gm vial

dissolve in 5-10 mL of Water for Injections I.P. (supplied 5ml) by first dissolving the contents of the vial in approximately 3 mL of the Water for Injections B.P. and then withdrawing the dissolved contents into a 10 mL syringe containing the remaining Water for Injections B.P.

Intravenous infusion:
Vial contents should be dissolved in a suitable volume of fluid and given as a rapid intravenous infusion over 30 minutes or suitably diluted into the drip tubing. Solutions must be used within 30 minutes of preparation.
Compatibility:
CLOXIL
injectable is compatible with commonly used intravenous fluids including: normal saline, 5% dextrose, dextrose saline, M/6 sodium lactate, Ringer's solution, 1,4% sodium bicarbonate, Dextran 40 injection in normal saline.
Incompatibility:
CLOXIL
should not be added to infusion bottles containing Dextran 40 injection in 5% dextrose, but may be injected into the drip tubing of such an infusion. Cloxacillin has been reported to be incompatible with aminoglycosides, tetracyclines, and other antimicrobial agents including erythromycin and polymyxin B sulphate.
Should not be mixed with blood products or other proteinaceous fluids.

Warnings & Precautions:
 

Pregnancy
Cloxil
can be given during pregnancy. However, the drug should be used with caution.

Lactation
Although the drug can be safely given to nursing mothers, there is some risk to the baby of sensitisation, skin rash and diar­rhoea in case of capsules.

Paediatric use
Because of incompletely developed renal function in new-borns, penicillinase-resistant penicillins may not be completely excreted, resulting in high levels of the drug

 

 

 

 

 

Side Effects
As with all penicillins, side effects are generally those related to allergic res­ponse.

 PRESENTATION:

(a)

CLOXIL 250 Capsules

:

10X10 Blister Strips.

(b)

CLOXIL 500 Capsules

:

10X10 Blister Strips.

(c)

CLOXIL 250 Injection

:

Glass vials in combi-pack with Water for Injection I.P.

(d)

CLOXIL 500 Injection

:

Glass vials in combi-pack with Water for Injection I.P.

(e)

CLOXIL DS Injection

:

Glass vials in combi-pack with Water for Injection I.P.

STORAGE INSTRUCTIONS:
Containers of CLOXIL Capsules should be kept tightly closed in a cool (below 25°C), dry place.
CLOXIL 250/500/DS Injections preparations should be stored in a cool (below 25°C), dry place.
Once prepared, CLOXIL Injections must be used immediately.
KEEP OUT OF REACH OF CHILDREN.
 

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