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EPIGENT

Composition

Each ampoule contains:

Gentamicin (as sulphate) 20 or 80 mg

Properties and Mode of Action

EPIGENT is an aminoglycoside bactericidal antibiotic acting through inhibition of bacterial protein synthesis.

EPIGENT is active against a broad spectrum of G-ve and G+ve organisms including E.coli, Klebsiella sp., Proteus sp.,

Providencia sp., Pseudomonas aeruginosa, Salmonella sp., Shigella sp., Serratia sp., Citrobacter sp., Enterobacter sp.,

Yersinia (Pasteurella) pestis, Staphylococci including Staph. aureus (penicillinase - producing and nonpenicillinase -

producing), Streptococcus faecalis (usually concomitantly with other anti-infectives).

Indications

Treatment of infections due to susceptible organisms:

Bacterial septicemia, bacterial neonatal sepsis, serious bacterial infections of the C.N.S. (meningitis, ventriculitis), urinarytract, respiratory tract, biliary tract, skin and soft tissue (including burn wound), bone and joint and intra-abdominal

infections (including peritonitis).

Dosage and Administration

I.M. or I.V..

Adults:

Serious infections : 3 mg/kg/day in 3 equal doses every 8 hours.

Life-threatening infections: 5 mg/kg/day in 3 or 4 equal doses.

Reduce dosage to 3 mg/kg/day as soon as clinically indicated.Doses up to 15 mg/kg/day have been used in the treatment of intraocular infections.

Children:

6 - 7.5 mg/kg/day (2 - 2.5 mg/kg every 8 hours).

Infants and Neonates:

7.5 mg/kg/day (2.5 mg/kg every 8 hours) .Premature or Full-term Neonates (1 week of age):

5 mg/kg/day (2.5 mg/kg every 12 hours).

Duration of therapy is usually 7 - 10 days.

In difficult and complicated infections, a longer course of therapy may be necessary, in which case, renal, auditory and

vestibular functions should be monitored, since toxicity is more apt to occur with treatment extended beyond 10 days.

Reduce dosage if clinically indicated.

Prevention of Bacterial Endocarditis:

In Dental, Oral or Upper Respiratory Tract Procedures (Alternate Regimen):

1 - 2 g (50 mg/kg for children) ampicillin plus 1.5 mg/kg (2 mg/kg for children) EPIGENT, not to exceed 80 mg, both I.M.

or I.V. one-half hour prior to procedure followed by 1.5 g (25 mg/kg for children) amoxycillin orally 6 hours after initial

dose or repeat parenteral dose 8 hours after initial dose.

http://www.eipico.com.eg/PRODUCT.ASP?id1=4&id2=

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GU or Gl Procedures (Standard Regimen):

2 g (50 mg/kg for children) ampicillin plus 1.5 mg/kg (2 mg/kg for children) EPIGENT, not to exceed 80 mg, both I.M. or

I.V. one-half hour prior to procedure followed by 1.5 g (25 mg/kg for children) amoxicillin 6 hours after initial dose.

Renal Function Impairment:

Adjust dosage; whenever possible, monitor serum concentrations ofEPIGENT.

One method of dosage adjustment is to increase the interval between the doses administered.

Approximate the interval between doses (in hours) by multiplying the serum creatinine level (mg/dl) by 8.

In patients with serious systemic infections and renal impairment, administer the antibiotic more frequently, but in reduced

dosage. After the usual initial dose, a rough guide for determining reduced dosage at 8 hour intervals is to divide the

normally recommended dose by the serum creatinine level.The above dosage schedules are not rigid recommendations, but are provided as rough guides to dosage when the

measurement ofEPIGENT serum levels is not feasible.

Hemodialysis:

1 - 1.7 mg/kg, at the end of each dialysis period, depending on the severity of infection.

In children, administer a dose of 2 - 2.5 mg/kg.

I.V.: The dose for IV and IM administration is identical; IV administration may be preferred for patients with bacterial

septicemia or those in shock, some patients with CHF, hematologic disorders, severe burns or reduced muscle mass .

A 1 - 2 mg/kg loading dose may be used, followed by a maintenance dose.

Precautions

Aminoglycosides may cause nephrotoxicity with risk factors including the elderly patients with a history of renal impairment

who are treated for longer periods or with higher doses than those recommended, a recent course of aminoglycosides

(within 6 weeks), concurrent use of other nephrotoxic agents, frequent dosing, potassium depletion and decreased

intravascular volume.

Aminoglycosides may cause ototoxicity with risk factors including renal impairment (especially if dialysis is required),

excessive dosage, dehydration, concomitant administration of ethacrynic acid or furosemide, or previous exposure to

other ototoxic drugs.

Evidence of renal impairment or otoxicity requires discontinuation of the drug or appropriate dosage adjustments. When

feasible, monitor drug serum concentrations. Avoid concomitant use with other ototoxic, neurotoxic or nephrotoxic drugs.

Aminoglycosides should be cautiously used in patients with neuromuscular disorders as they may aggravate muscle

weakness because of a potential curare-like effect on the neuromuscular junction.

Use with caution in newborns of mothers receiving magnesium sulfate.

In pregnancy, risk/benefit must be carefully considered when gentamicin is required in life-threatening situations or in

serious diseases for which other medications cannot be used or are ineffective.

Aminoglycosides are excreted in breast milk in small but variable amounts. However they are poorly absorbed from the

gastrointestinal tract and problems in nursing infants have not been documented.

Use with caution in premature infants and neonates because of their renal immaturity, and in elderly.Cross-allergenicity among aminoglycosides has been demonstrated.

Drug Interactions

Aminoglycosides nephrotoxicity may be increased with concomitant vancomycin, enflurane, methoxyflurane or

cephalosporins administration .

Aminoglycosides auditory toxicity appears to be increased during concomitant use with loop diuretics.

Neuromuscular blocking effects of neuromuscular blocking agents (depolarizing and nondepolarizing) are enhanced by

aminoglycosides.

Concurrent use of polypeptide antibiotics with aminoglycosides may increase the risk of respiratory paralysis and renal

dysfunction .

Contra_indications

Previous reactions to aminoglycosides, long - term therapy.

This product contains sodium metabisulphite and must not be used in asthmatic patients.

Side effects

Decreased appetite, hypersalivation, stomatitis, weight loss; depression, respiratory depression; transient

agranulocytosis, increased or decreased reticulocyte count, hypersensitivity e.g. generalized burning, purpura;

hypertension, joint pain, splenomegaly; leg cramps, transient hepatomegaly; arachnoiditis or burning at injection site after

intrathecal administration may occur.

Presentation

EPIGENT 20 mg Ampoules : Box of 3 ampoules of 2 ml each.

EPIGENT 80 mg Ampoules : Box of 3 ampoules of 2 ml each.


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3/2/2011

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