ORBENIL 2 G

Israel - English - Ministry of Health

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Active ingredient:
CLOXACILLIN AS SODIUM
Available from:
SALOMON,LEVIN & ELSTEIN LTD
ATC code:
J01CF02
Pharmaceutical form:
POWDER FOR SOLUTION FOR INJECTION
Composition:
CLOXACILLIN AS SODIUM 2 G/VIAL
Administration route:
I.M, I.V
Prescription type:
Required
Manufactured by:
SANDOZ GmbH, AUSTRIA
Therapeutic group:
CLOXACILLIN
Therapeutic area:
CLOXACILLIN
Therapeutic indications:
For the treatment of infections caused by penicillinase-producing staphylococci. Because of the high incidence of staphylococcal isolates resistant to penicillin G both within and outside the hospiral environment . Orbenil is recommended as initial therapy in patients with suspected staphylococcal infections. Orebenil is also effective in the treatment of other commonly encountered Gram-positive coccal infections.Typical indications include: - respiratory tract infections such as pneumonia and sinusitis - infected wounds and burns - osteomyelitis and septic arthritis - other infections due to staphylococci (including penicillin-resistant strains) such as septicemia endocarditis enterocolitis and urinary tract infections.
Authorization number:
102 73 27338 00
Authorization date:
2011-11-30

Orbenil Injection , 13. 3. 2011 , RH

"

ע עבקנ הז ןולע טמרופ

"

רשואו קדבנ ונכותו תואירבה דרשמ י

."

רשואמ ןולע

ץרמ

2011

“This leaflet format has been determined by the Ministry of Health and the content thereof has been

checked and approved.” Date of approval: March 2011.

אפורל ןולע

Physician's Package Insert

=========================================================================

לינברוא

ORBENIL

---------------------------------------------------------------------------------------------------------------------------

הקרזהל

INJECTION

Composition

Each vial contains:

Active Ingredient

Cloxacillin (as sodium salt) 500 mg or 2 g

Sodium content:

Orbenil 500 mg: 27.5 mg per vial

Orbenil 2 g: 110 mg per vial

Mechanism of Action

Cloxacillin is an isoxazolyl semisynthetic penicillin which is markedly resistant to

cleavage by penicillinase. It is a potent inhibitor of the growth of most penicillinase-

producing staphylococci.

Cloxacillin is effective both by the oral and parenteral routes. However, in serious

life-threatening staphylococcal infections, initiation of therapy with Orbenil injection is

recommended.

Indications

Orbenil is indicated primarily for the treatment of infections caused by penicillinase-

producing staphylococci. Because of the high incidence of staphylococcal isolates

resistant to penicillin G, both within and outside the hospital environment, Orbenil is

recommended as initial therapy in patients with suspected staphylococcal infections.

Orbenil is also effective in the treatment of other commonly encountered Gram-

positive coccal infections.

Typical indications include:

respiratory tract infections, such as pneumonia and sinusitis

infected wounds and burns

osteomyelitis and septic arthritis

other infections due to staphylococci (including penicillin-resistant strains) such

as septicemia, endocarditis, enterocolitis and urinary tract infections.

Contraindications

Known hypersensitivity to a penicillin-type drug.

This drug should not be administered to babies born to mothers with a history of

hypersensitivity to a penicillin-type drug.

Warnings

Serious and occasionally even fatal hypersensitivity (anaphylactoid) reactions due

to penicillin therapy have been reported. Although anaphylaxis is more frequent

following parenteral therapy, it has occurred in patients receiving oral penicillins.

Such reactions are more likely to occur in individuals with a history of hypersensitivity

to penicillins and/or a history of sensitivity to multiple allergens. There have also been

reports of individuals with a history of penicillin hypersensitivity experiencing severe

reactions when treated with cephalosporins.

Orbenil Injection , 13. 3. 2011 , RH

Therefore before initiating therapy with this drug, careful inquiry should be made

concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other

allergens, because of the risk of anaphylactoid reactions.

If an allergic reaction occurs, the drug should be discontinued and appropriate

therapy instituted.

Serious

anaphylactoid

reactions

require

immediate

emergency

treatment

with

adrenaline.

Oxygen,

intravenous

steroids

airway

management

including

intubation, should also be administered as indicated.

Use in Pregnancy

Safety for use in pregnancy has not been established.

Use in Breastfeeding

Since penicillins are excreted in breast milk, administration of this drug to nursing

mothers may lead to sensitization, diarrhea, candidiasis and skin rash in infants.

Therefore, having taken into account the importance of the drug to the mother, either

discontinue nursing or discontinue the drug.

Use in Pediatrics

Penicillins are excreted largely unchanged by the kidney. Because renal function is

incompletely developed in infants, the rate of elimination of the drug tends to be slow.

Penicillin-type drugs should therefore be administered with caution, particularly in

neonates, and organ system function should be evaluated frequently.

Adverse Reactions

As with other penicillins, it may be expected that untoward reactions will be

essentially limited to sensitivity phenomena. These reactions are more likely to occur

in individuals who have previously demonstrated hypersensitivity to pencillins and in

those with a history of allergy, asthma, hay fever, or urticaria.

In common with other

-lactam antibiotics, angioedema and anaphylaxis may

occur.

The following adverse reactions have been reported as being associated with the

use of penicillins.

Hypersensitivity

Anaphylaxis is the most serious potential adverse reaction to a penicillin drug. It is

usually associated with the administration of parenteral rather than oral dosage

forms. Serious anaphylactoid reactions require immediate emergency treatment with

adrenaline.

Oxygen,

intravenous

steroids

airway

management

including

intubation, should also be administered as indicated (see Warnings).

Erythematous maculopapular rashes, urticaria, and occasional cases of exfoliative

dermatitis,

erythema

multiforme

Stevens-Johnson

syndrome

have

been

reported. Laryngeal edema and serum sickness-like reactions including chills, fever,

serum sickness, edema and arthralgia have also been reported. Such reactions may

controlled

with

antihistamines

and,

necessary,

systemic

corticosteroids.

Whenever such reactions occur, the drug should be discontinued unless, in the

opinion of the physician, the condition being treated is life-threatening and amenable

only to penicillin therapy.

Gastrointestinal

Glossitis, stomatitis, glossitis, black "hairy" tongue, nausea, vomiting, enterocolitis,

pseudomembranous colitis and diarrhea have been observed.

Orbenil Injection , 13. 3. 2011 , RH

Hepatic

A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) and/or serum

glutamic pyruvic transaminase (SGPT) has been noted, particularly in infants, but the

significance

this

finding

unknown.

Rare

cases

transient

hepatitis

cholestatic jaundice have been reported.

Renal

Interstitial nephritis (rare).

Hematological

Hematological

reactions

including

hemolytic

anemia,

transient

neutropenia,

thrombocytopenia,

thrombocytopenic

purpura,

eosinophilia,

leukopenia,

agranulocytosis have been observed. These are believed to be hypersensitivity

phenomena and are usually reversible upon discontinuation of therapy.

Central Nervous System

Rare cases of reversible hyperactivity, agitation, anxiety, insomnia, confusion,

behavioral changes, and/or dizziness have been reported.

Precautions

In the treatment of group A

-hemolytic streptococcal infections, therapy with this

drug should be continued for at least 10 days to help prevent the occurrence of acute

rheumatic fever or glomerulonephritis.

Following completion of treatment, cultures should be taken to determine whether

streptococci have been eradicated.

As with any potent drug, periodic assessment of renal, hepatic and hematopoietic

functions should be made during prolonged therapy. This is particularly important in

infants including prematures and neonates.

The possibility of superinfection with mycotic or bacterial pathogens should be kept

in mind during therapy. If superinfection occurs, appropriate therapy should be

instituted.

Drug Interactions

Cloxacillin/Fusidic Acid:

May diminish the therapeutic effect of cloxacillin. Therefore,

administer cloxacillin at least 2 hours before fusidic acid.

Cloxacillin/Methotrexate

Serum

methotrexate

concentrations

elevated,

increasing the risk of toxicity. Thus, monitor for methotrexate toxicity. Measure

methotrexate concentrations twice a week for at least the first 2 weeks in patients

receiving

low-dose

oral

methotrexate.

need

dosage

adjustment

methotrexate during therapy with cloxacillin. Avoid cloxacillin immediately before and

during IV methotrexate treatment.

Cloxacillin/Warfarin

: Effects of warfarin may be increased, resulting in an increased

risk of bleeding; therefore UNR should be closely monitored upon addition and

withdrawal of cloxacillin. UNR should also be reassessed periodically during therapy

since an adjustment in the warfarin dose may be necessary to maintain an effective

level of anticoagulation.

Penicillins/Aminoglycosides:

Concurrent

therapy

with

penicillins

resulted

inactivation of aminoglycosides. Therefore, do not mix parenteral aminoglycosides

and penicillins in the same IV solution. Monitor aminoglycoside serum concentrations

and renal function and adjust dose accordingly. Penicillins and aminoglycosides are

often used together to achieve synergistic action.

Penicillins/Live

Typhoid

Vaccine:

Penicillins

interfere

with

immunologic

response to the vaccine. Therefore, administer oral live typhoid vaccine at least 24

hours from the last dose of the antibiotic.

Orbenil Injection , 13. 3. 2011 , RH

Penicillins/Oral Contraceptives

: Antibacterial agents may suppress intestinal flora that

provide hydrolytic enzymes essential for enterohepatic recirculation of estrogens

resulting

decreased

contraceptive

effectiveness.

There

possibility

contraceptive failure. Concurrent use may therefore warrant an additional form of

birth control to avoid slight increased risk of pregnancy.

Penicillins/Chloramphenicol/Erythromycin/Tetracyclines/Sulfonamides

: Pharmacologic and

therapeutic action of penicillins could be reduced. Since bacteriostatic drugs may

interfere with the bactericidal effect of penicillins in the treatment of meningitis or

other conditions where a rapid bactericidal effect is necessary, it is best to avoid

concurrent therapy.

Penicillins/Probenecid

: Probenecid may decrease renal tubular secretion of penicillin-

type drugs, resulting in increased blood levels of cloxacillin . Thus there may be an

increase in the effect of cloxacillin; this effect has been utilized clinically to prolong

the excretion and enhance the efficacy of penicillins.

Drug/Food Interactions (for oral cloxacillin

): Food decreases the extent of absorption

of cloxacillin and therefore may reduce its antimicrobial effectiveness. Administer

cloxacillin on an empty stomach 1 hour before or 2 hours after meals to enhance its

absorption.

Diagnostic Interference

Treatment with penicillins may result in false positive reactions when testing for the

presence of glucose in urine using Clinitest, Benedict's Solution or Fehling's Solution.

Tests based on enzymatic glucose oxidase reactions such as Clinistix or Tes-Tape

are not affected.

Dosage and Administration

Parenteral drug products should be inspected visually for particulate matter and

discoloration, prior to administration, whenever solution and container permit.

Orbenil injection is intended for intramuscular, intravenous, intrapleural and intra-

articular use.

The recommended dosages are given below. In severe, stubborn infections, a

higher dosage may be administered.

Adults

Intramuscular Use

250 mg every 4-6 hours.

Intravenous Use

500 mg every 4-6 hours, administered into a vein either directly or via a drip-tube

over a period of 3-4 min. More rapid administration may result in convulsive seizures.

Intrapleural Use

500 mg administered once daily as a single injection.

Intra-articular Use

500 mg administered once daily as a single injection.

Infants and Children

In infants up to 2 years of age, one-quarter of the adult dosage.

In children 2-10 years of age, half the adult dosage.

Orbenil Injection , 13. 3. 2011 , RH

Overdosage

Overdosage

penicillin

drugs

cause

neuromuscular

hyperirritability

convulsive seizures.

Discontinue medication, treat symptomatically, and institute supportive measures

as required. In patients with renal function impairment, the antibiotic may be removed

from the circulation by hemodialysis, not by peritoneal dialysis.

Preparation of the Solution

Prior to reconstitution, Orbenil vials should be stored in a cool dry place. Solutions

for injections should be freshly prepared.

If Orbenil is prescribed concurrently with an aminoglycoside, the two antibiotics

should not be mixed in the same syringe, intravenous fluid container or giving set

because loss of activity of the aminoglycoside can occur under these conditions.

Orbenil injection should not be mixed with proteinaceous fluids such as protein

hydrolysates, blood or plasma, or with intravenous lipid emulsions.

Reconstitution

Intramuscular Use

To reconstitute the 500 mg vial, add 1.6 ml Water for Injection to provide a

concentration of 250 mg/ml.

To reconstitute the 2g vial, add 6.4 ml Water for Injection to provide a concentration

of 250 mg/ml.

Intravenous Use

To reconstitute the 500 mg vial, add 10 ml Water for Injection.

Intrapleural Use

To reconstitute the 500 mg vial, add 5-10 ml Water for Injection.

Intra-articular Use

To reconstitute the 500 mg vial, add 5 ml Water for Injection or 5 ml 0.5% Lidocaine

HCl Solution.

Stability of the Reconstituted Solutions:

Orbenil injection is unstable in concentrated solutions and, when prepared for

intramuscular or direct intravenous injection, should be used immediately.

Further dilution:

Reconstituted solution of Orbenil can be further diluted with Dextrose 5% or Sodium

Chloride 0.9% to concentrations between 1-20 mg/ml.

The solutions are physically stable at 25

C for 24 hours when diluted with Sodium

Chloride 0.9%, and for 12 hours when diluted with Dextrose 5%.

From a microbiological point of view, the product should be used immediately. If not

used

immediately,

in-use

storage

times

conditions

prior

responsibility of the user. Reconstitution/Dilution should take place in controlled and

validated aseptic conditions.

Orbenil Injection , 13. 3. 2011 , RH

Drug Reg. Nos. :

500 mg: 052 57 24630 00

2 g:

102 73 27338 00

Storage

Store below 25

Manufacturer

Sandoz GmbH

Kundl, Austria

Licence Holder

Salomon Levin & Elstein Ltd

P.O. Box: 3696, Petach-Tikva

Teva Group.

Marketed by:

Teva Pharmaceutical Industries Ltd.,

P.O.Box 3190, Petach-Tikva

ןרצי

:

זודנס עב

לדנוק

הירטסוא

םושירה לעב

:

ןומולס

עב ןייטשלאו ןיול

"

8077

הינתנ

42504

עבט תצובקמ

ע קוושמ

"

י

:

עב תויטבצמרפ תוישעת עבט

"

3190

הוקת חתפ

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