BAGENTA is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is indicated to
treat severe infections caused by bacteria susceptible to BAGENTA such as, but not limited to:
x Urinary tract infections
x Respiratory tract infections
x Intra-abdominal infections
x CNS infections
x Severe neonatal infections
It is usually active against most strains of the following organisms: Escherichia coli, Klebsiella spp.,
Proteus spp. (indole positive and indole negative), Pseudomonas aeruginosa, Staphylococci, Enterobacter
spp., Citrobacter spp. and Providencia spp. Consideration should be given to official local guidance on
the appropriate use of antibacterial agents.
 

Posology
Adults
Serious infections: If renal function is not impaired, 5 mg/kg/daily in divided doses at six or eight hourly
intervals. The total daily dose may be subsequently increased or decreased as clinically indicated.
Systemic infections: If renal function is not impaired, 3 – 5 mg/kg/day in divided doses according to
severity of infection, adjusting according to clinical response and body weight. Urinary tract infections: As
“Systemic infections”. Or, if renal function is not impaired, 160 mg once daily may be used.
Elderly
There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether
secondary to previous auditory/vestibular impairment or borderline renal dysfunction. Accordingly,
therapy should be closely monitored by frequent determination of gentamicin serum levels, assessment of
renal function and signs of ototoxicity.
Renal impairment
In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal
function. Gentamicin is excreted by simple glomerular filtration and therefore reduced dosage is necessary
where renal function is impaired. Nomograms are available for the calculation of dose, which depends on
the patient's age, weight and renal function. The following table may be useful when treating adults.

*60 mg if body weight < 60 kg. Frequency of dosage in hours may also be approximated as serum
creatinine (mg%) x eight or in SI units, as serum creatinine (μmol/l) divided by 11. If these dosage guides
are used peak serum levels must be measured. Peak levels of gentamicin occur approximately one hour
after intra muscular injection and intravenous injection. Trough levels are measured just prior to the next
injection. Assay of peak serum levels gives confirmation of adequacy of dosage and also serves to detect
levels above 10 mg/l, at which the possibility of ototoxicity should be considered. One hour
concentrations of gentamicin should not exceed 10 mg/l (but should reach 4 mg/l), while the pre dose
trough concentration should be less than 2 mg/l.
Paediatric population
The daily dose recommended in children aged 1 year and above and adolescents with normal renal
function, is 3 – 6 mg/kg body weight per day as one single dose (preferred) or two divided doses.
The daily dose in infants after the first month of life is 4.5 – 7.5 mg/kg body weight per day as one single
dose (preferred) or two divided doses. The daily dose in neonates and pre-term infants (aged 0 – 4 weeks
old) is 4 – 7 mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily
dose in one single dose.
Method of administration
The recommended dose and precautions for intramuscular and intravenous administration are identical.
BAGENTA when given intravenously should be injected directly into a vein or into the drip set tubing
over no less than three minutes. If administered by infusion, this should be over no longer than 20 minutes
and in no greater volume of fluid than 100 ml.
Monitoring advice
Serum concentration monitoring of BAGENTA is recommended, especially in elderly, in newborns and in
patients with impaired renal function. Samples are taken at the end of a dosing interval (trough level).
Trough levels should not exceed 2 μg/ml administering BAGENTA twice daily and 1 μg/ml for a once
daily dose (see section 4.4).

To avoid adverse events, continuous monitoring (before, during and after) of renal function (serum
creatinine, creatinine clearance), control of function of vestibule and cochlea as well as hepatic and
laboratory parameters is recommended.
Ototoxicity has been recorded following the use of BAGENTA. Groups at special risk include patients
with impaired renal function, infants and possibly the elderly. Consequently, renal, auditory and vestibular
functions should be monitored in these patients and serum levels determined so as to avoid peak
concentrations above 10 mg/l and troughs above 2 mg/l when administering BAGENTA twice daily and 1
mg/l for a once daily dose. As there is some evidence that risk of both ototoxicity and nephrotoxicity is
related to the level of total exposure, duration of therapy should be the shortest possible compatible with
clinical recovery. In some patients with impaired renal function there has been a transient rise in
bloodurea-nitrogen which has usually reverted to normal during or following cessation of therapy. It is
important to adjust the frequency of dosage according to the degree of renal function.
BAGENTA should only be used in pregnancy if considered essential by the physician (see section 4.6).
BAGENTA should be used with care in conditions characterised by muscular weakness. In cases of
significant obesity BAGENTA serum concentrations should be closely monitored and a reduction in dose
should be considered.

Concurrent administration of BAGENTA and other potentially ototoxic or nephrotoxic drugs should be
avoided. Potent diuretics such as etacrynic acid and furosemide are believed to enhance the risk of
ototoxicity whilst amphotericin B, cisplatin and ciclosporin are potential enhancers of nephrotoxicity.
Any potential nephrotoxicity of cephalosporins, and in particular cephaloridine, may also be increased in
the presence of BAGENTA. Consequently, if this combination is used monitoring of kidney function is
advised.
Neuromuscular blockade and respiratory paralysis have been reported from administration of
aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.
Indometacin possibly increases plasma concentrations of gentamicin in neonates. Concurrent use with oral
anticoagulants may increase the hypothrombinanaemic effect. Concurrent use of bisphosphonates may
increase the risk of hypocalcaemia. Concurrent use of the Botulinum Toxin and BAGENTA may increase
the risk of toxicity due to enhanced neuromuscular block.
Antagonism of effect may occur with concomitant administration of BAGENTA with either neostigmine
or pyridostigmine.
 

Pregnancy
There are no proven cases of intrauterine damage caused by BAGENTA. However, in common with most
drugs known to cross the placenta, usage in pregnancy should only be considered in life threatening
situations where expected benefits outweigh possible risks.
Breast-feeding
In the absence of gastro-intestinal inflammation, the amount of BAGENTA ingested from the milk is
unlikely to result in significant blood levels in breast-fed infants.
 

Not known.
 

Side-effects include vestibular damage or hearing loss, particularly after exposure to ototoxic drugs or in
the presence of renal dysfunction. Nephrotoxicity (usually reversible) and occasionally acute renal failure,
anaemia, blood dycrasias, purpura, stomatitis, convulsions and effects on liver function occur
occasionally.
Rarely hypomagnesia on prolonged therapy and antibiotic-associated colitis have been reported.
Nausea, vomiting and rash have also been reported.
Immune system disorders:
Not known: hypersensitivity, anaphylaxis/anaphylactic reaction (including anaphylactic shock)
Nervous system disorders:
Central neurotoxicity, including encephalopathy, confusion, lethargy, mental depression and
hallucinations, has been reported in association with BAGENTA therapy but this is extremely rare.
Not known: peripheral neuropathy

To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance Centre (NPC):
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa/
 

Other GCC States:
Please contact the relevant competent authority.
 

Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more
efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused
by BAGENTA.
 

Pharmacotherapeutic group: Antibacterials for systemic use,
BAGENTA is a mixture of antibiotic substances produced by the growth of micromonospora purpurea. It
is bactericidal with greater antibacterial activity than streptomycin, neomycin or kanamycin.
BAGENTA exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma
membrane and the metabolism of RNA, but its most important effects is inhibition of protein synthesis at
the level of the 30s ribosomal subunit.
 

BAGENTA is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70 – 85% bound to
plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its
elimination in normal patients is 2 – 3 hours.
• Effective plasma concentration is 4 – 8 μg/ml.
• The volume of distribution (vd) is 0.3 l/kg.
• The elimination rate constant is:
1. 0.02 hr-1 for anuric patients*
2. 0.30 hr-1 normal
* Therefore in those with anuria care must be exercised following the usual initial dose, any subsequent
administration being reduced in-line with plasma concentrations of gentamicin.
Paediatric population (premature infants and neonates)
 

Distribution
The distribution volume of gentamicin is about equivalent to the volume of extracellular water. In the
newborn water makes up 70 – 75% of bodyweight, compared with 50 – 55% in adults. The extracellular
water compartment is larger (40% of body weight compared with 25% of body weight in adults).
Therefore, the volume of distribution of gentamicin per kg bodyweight is affected and decreases with
increasing age from 0.5 – 0.7 l/kg for a premature newborn to 0.25 l/kg for an adolescent. The larger
volume of distribution per kg bodyweight means that for adequate peak blood concentration a higher dose
per kg bodyweight needs to be administered.

Elimination
Gentamicin is not metabolized in the body but is excreted unchanged in microbiologically active form
predominantly via the kidneys. In patients with normal renal function the elimination half-life is about 2 –
3 hours. In neonates elimination rate is reduced due to immature renal function.
Elimination half-life averages approximately 8 hours in neonates at a gestational age of 26 – 34 weeks
compared with about 6.7 hours in neonates at a gestational age of 35 – 37 weeks.
Correspondingly, clearance values increase from about 0.05 l/h in neonates at a gestational age of 27 – 0.2
l/h in neonates at a gestational age of 40 weeks.
 

NA

Sodium metabisulphite , methylparaben , propylparaben , disodium edetate , water for injection.

In general, BAGENTA injection should not be mixed.
In particular the following are incompatible in mixed solution with BAGENTA injection: - penicillins
- cephalosporins
- erythromycin
- heparins
- sodium bicarbonate
*Dilution in the body will obviate the danger of physical and chemical incompatibility and enable
BAGENTA to be given concurrently with the drugs listed above either as a bolus injection into the drip
tubing, with adequate flushing, or at separate sites. In the case of carbenicillin, administration should only
be at a separate site.
*Carbon dioxide may be liberated on addition of the two solutions. Normally this will dissolve in the
solution but under some circumstances small bubbles may form.
 

Store below 30°C.
Keep out of the reach and sight of children.
Do not use BAGENTAAmpoules after the expiry date printed on the label and carton. The expiry date
refers to the last day of that month.
 

A clear, colourless to slightly yellow solution in a 2 ml ampoule.
BAGENTA 80 mg Ampoules: Pack of 5 ampoules of 2ml each, packed in plastic tray along with printed
leaflet inside the unit carton.
 

No special requirements.