Consumer medicine information

Gentamicin Noridem

Gentamicin

BRAND INFORMATION

Brand name

Gentamicin Noridem

Active ingredient

Gentamicin

Schedule

SUMMARY CMI

GENTAMICIN NORIDEM*

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using GENTAMICIN NORIDEM?

GENTAMICIN NORIDEM contains the active ingredient Gentamicin sulfate. GENTAMICIN NORIDEM is used to treat serious bacterial infections.

For more information, see Section 1. Why am I using GENTAMICIN NORIDEM? in the full CMI.

2. WHAT SHOULD I KNOW BEFORE I USE GENTAMICIN NORIDEM

Do not use if you have ever had an allergic reaction to GENTAMICIN NORIDEM or other aminoglycoside antibiotics such as amikacin, tobramycin or neomycin or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use GENTAMICIN NORIDEM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with GENTAMICIN NORIDEM and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. HOW DO I USE GENTAMICIN NORIDEM?

Gentamicin is given as an injection into a muscle or as a slow injection into a vein (intravenously). This medicine should only be given by a doctor, nurse or other trained person

More instructions can be found in Section 4. How do I use GENTAMICIN NORIDEM? in the full CMI.

5. WHAT SHOULD I KNOW WHILE USING GENTAMICIN NORIDEM?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using GENTAMICIN NORIDEM. Tell your doctor or pharmacist if you think you may be pregnant
Things you should not do	Do not take any other medicines, whether they are prescription or over-the-counter medicines, unless they have been approved or recommended by a doctor or pharmacist who knows you are being given gentamicin. Gentamicin should not be taken while you are pregnant
Looking after your medicine	GENTAMICIN NORIDEM will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

For more information, see Section 5. What should I know while using GENTAMICIN NORIDEM? in the full CMI.

6. Are there any side effects?

Some common side effects are pain at the injection site, nausea or vomiting, headache. More serious side effects that may occur include allergic reaction characterized by swelling of limbs, face, lips, mouth or throat, shortness of breath or breathing difficulties, rash, itching or sever skin reaction. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

GENTAMICIN NORIDEM*

Active ingredient(s): Gentamicin sulfate

Consumer Medicine Information (CMI)

This leaflet provides important information about using GENTAMICIN NORIDEM. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using GENTAMICIN NORIDEM.

Where to find information in this leaflet:

1. Why am I using GENTAMICIN NORIDEM?
2. What should I know before I use GENTAMICIN NORIDEM?
3. What if I am taking other medicines?
4. How do I use GENTAMICIN NORIDEM?
5. What should I know while using GENTAMICIN NORIDEM?
6. Are there any side effects?
7. Product details

1. Why am I using GENTAMICIN NORIDEM?

GENTAMICIN NORIDEM contains the active ingredient Gentamicin sulfate. GENTAMICIN NORIDEM is an antibiotic that belongs to a group of medicines called aminoglycosides (pronounced a-my-noe-GLY-koe-sides).

GENTAMICIN NORIDEM is used to treat serious bacterial infections. Gentamicin works by killing bacteria or preventing their growth. It is used for the treatment of serious infections, including:

septicaemia (infection of the blood)
respiratory tract infections
infected wounds
bone or tissue infections
infected burns
urinary tract infections.

Your doctor may have prescribed gentamicin for another reason.

Ask your doctor if you have any questions about why gentamicin has been prescribed for you.

This medicine is available only with a doctor's prescription

2. WHAT SHOULD I KNOW BEFORE I USE GENTAMICIN NORIDEM?

Warnings

Do not use GENTAMICIN NORIDEM if:

if you have an allergy to gentamicin or other aminoglycoside antibiotics such as

Amikacin
Tobramycin
Neomycin
or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.

You must not be given GENTAMICIN NORIDEM if you have experienced serious reactions (such as hearing loss or kidney problems) to gentamicin, amikacin, tobramycin, or neomycin in the past.

Check with your doctor if you:

have any medical conditions especially the following:-

kidney problems
muscular disorders (eg myasthenia gravis, Parkinson's disease)
hearing problems.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Like most aminoglycoside antibiotics, gentamicin is not recommended for use during pregnancy. If there is a need for you to be given gentamicin, your doctor or pharmacist will discuss with you the benefits and risks of using it during your pregnancy.

Gentamicin may affect your developing baby if you take it during pregnancy. If it is necessary for you to be given Gentamicin Injection, your doctor will discuss with you the benefits and risks of using it during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

If there is a need for you to be given gentamicin, your doctor or pharmacist will discuss the possible risks and benefits of using it during breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with GENTAMICIN NORIDEM and affect how it works.

These include:

fluid tablets (eg frusemide, ethacrynic acid, bumetanide)
cisplatin, a medicine used to treat cancer
antibiotics to treat infection such as colistin, vancomycin, clindamycin, cephalosporins and penicillins
amphotericin, an antifungal medicine
anaesthetics (eg halothane)
muscle relaxants (eg succinylcholine).

These medicines may be affected by gentamicin, or may affect how well it works. You may need different amounts of your medicine, or you may need to take/use different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while receiving gentamicin

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect GENTAMICIN NORIDEM.

4. How do I use GENTAMICIN NORIDEM?

How much to take / use

Gentamicin is given as an injection into a muscle or as a slow injection into a vein (intravenously). This medicine should only be given by a doctor, nurse or other trained person.
Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight and kidney function

If you forget to use GENTAMICIN NORIDEM

As GENTAMICIN NORIDEM is usually given to you in hospital under the supervision of your doctor, it is very unlikely that you will be in a situation where a dose is forgotten.

If you use too much GENTAMICIN NORIDEM

As GENTAMICIN NORIDEM is usually given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive an overdose.

If you think that you have used too much GENTAMICIN NORIDEM, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using GENTAMICIN NORIDEM?

Things you should do

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given gentamicin.

Call your doctor straight away if you notice any of the following:

swelling of the limbs, face, lips, mouth or throat
shortness of breath or breathing difficulties
rash, itching, hives or severe skin reaction

These symptoms are signs of an allergic reaction to gentamicin.

If any of these symptoms happen, tell your doctor or nurse immediately

Remind any doctor, dentist or pharmacist you visit that you are using GENTAMICIN NORIDEM.

Things you should not do

Do not take any other medicines, whether they are prescription or over-the-counter medicines, unless they have been approved or recommended by a doctor or pharmacist who knows you are being given gentamicin.

Looking after your medicine

GENTAMICIN NORIDEM will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

Keep it where young children cannot reach it.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Gastrointestinal/Digestive

Nausea and vomiting
decreased appetite

Neurological

confusion,
depression
tiredness or weakness
headache

Mouth

increased salivation
sore mouth and gums

Hair

Hair loss

Muscles & Joints

Joint pain

General body

fever
bruising
weight loss

Injection Site

pain at injection site

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Genito-urinary tract

Decreased urination

Neurological

severe headache,
dizziness
problems with your balance
Fits -Convulsions
numbness

Ears

hearing loss
Ringing in the ears

Muscles & Joints

Muscle twitching.

Skin

Skin tingling

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What GENTAMICIN NORIDEM contains

Active ingredient (main ingredient)	Gentamicin
Other ingredients (inactive ingredients)	Disodium edetate Sodium metabisulfite Water for injections Sodium Hydroxide Sulfuric acid
Potential allergens	Sulfites as sodium metabisulfite

Do not take this medicine if you are allergic to any of these ingredients.

GENTAMICIN NORIDEM injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

GENTAMICIN NORIDEM does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

What GENTAMICIN NORIDEM looks like

GENTAMICIN NORIDEM is a clear, colourless liquid and comes in glass ampoules.

GENTAMICIN NORIDEM is available in the following strength and pack:

80mg/2mL ampoule AUST R 391250

Packs of 50 ampoules

Who distributes GENTAMICIN NORIDEM

InterPharma Pty Ltd.
Suite 103, 39 East Esplanade
MANLY NSW 2095 AUSTRALIA.
Ph.: 029976 6876.

This leaflet was prepared in April 2023.

Published by MIMS February 2024

BRAND INFORMATION

Brand name

Gentamicin Noridem

Active ingredient

Gentamicin

Schedule

1 Name of Medicine

Gentamicin sulfate.

2 Qualitative and Quantitative Composition

Gentamicin Noridem is a sterile, preservative-free solution containing gentamicin (as sulfate) 80 mg/2 mL.

Excipients with known effect.

Contains sulfites. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection. Clear and colourless solution.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of infections due to one or more susceptible strains of bacteria, including Pseudomonas aeruginosa, Proteus species (indole positive and indole negative), Escherichia coli, Klebsiella, Enterobacter and Serratia species and Staphylococcus (including strains resistant to other antibiotics).
Gentamicin may also be used for the treatment of the following conditions when caused by susceptible organisms: bacteraemia, respiratory tract infections, urinary tract infections, skin and skin structure infections, bone infections, peritonitis, septic abortion and burns complicated by sepsis. Aminoglycosides, including gentamicin are generally not indicated in uncomplicated initial episodes of urinary tract infection unless the causative organisms are not susceptible to less toxic antibiotics.
In suspected or documented Gram-negative sepsis, gentamicin should be considered for initial antimicrobial therapy. Therapy may be instituted before obtaining results of susceptibility tests. The decision to continue therapy is based on results of the susceptibility tests, the severity of the infection and risk of toxicity. If anaerobic organisms are suspected, antimicrobial therapy in addition to the gentamicin regimen should be considered.

4.2 Dose and Method of Administration

Each ampoule is for use in a single patient on one occasion only.
Gentamicin is normally given by intramuscular injection. Intravenous administration may be used for particular indications when the intramuscular route is not appropriate. The dosage is the same for either route of administration. It is desirable to measure both peak and trough serum levels during treatment.
Prior to administration, the patient's bodyweight should be measured for the correct calculation of dosage. In obese patients, the appropriate dose can be calculated by assuming the bodyweight is the patient's estimated lean bodyweight plus 40% of the excess.
Blood specimens for the determination of peak gentamicin concentrations should be obtained approximately one hour following IM administration and 30 minutes after completion of a 30-minute infusion. Blood specimens for the trough gentamicin concentration should be obtained immediately prior to the next IM or IV dose.

Intravenous administration.

For IV administration, the prescribed dose of gentamicin may be diluted in 100-200 mL of sterile normal saline or 5% glucose in water. The concentration of gentamicin in the solution should not exceed 1 mg/mL. Infusion periods of 30 minutes to 2 hours have been advocated.
To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, the diluted product can be stored for up to 24 hours at either 2-8°C or 25°C. See Section 6.4 Special Precautions for Storage. Administration of the dose by bolus injection produces serum levels which are initially in excess of what is regarded as being safe from toxic side effects. The high serum level does however rapidly fall, and the potential danger or safety of this method is yet to be established.
Gentamicin injection must not be mixed with other drugs, but should be administered by separate infusion (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Adults (dosage in patients with normal renal function).

For serious infections (systemic and urinary tract infections).

3 mg/kg/day in three doses given every eight hours.

Life threatening infections.

Up to 5 mg/kg/day in 3 or 4 equal doses with reduction to 3 mg/kg/day as soon as clinically indicated. Doses should never exceed 5 mg/kg/day unless serum levels are monitored. Table 1 should be used as a guide.

Paediatrics.

Table 2 should be used as a guide.

Dosage in patients with impaired renal function.

Dosage should be adjusted to minimise the risk of toxicity. The first dose should be as normal e.g. 80 mg (bodyweight > 60 kg) and subsequent doses should be given less frequently, depending on the degree of renal impairment.
Table 3 should be used as a guide.

When only a serum urea concentration is available, this value may be utilised initially, however, it should be supplemented with a serum creatinine level or creatinine clearance rate whenever possible.

Note.

The standard dose of 80 mg three times a day may be inappropriate, and a more appropriate dose can be calculated using a nomogram which takes into account the patient's serum creatinine levels, bodyweight and age. This dose can be adjusted if necessary following determination of serum creatinine levels. Desirable serum levels of gentamicin are 5-8 microgram/mL as a peak and 1-2 microgram/mL as a trough.

Note.

In children with impaired renal function serum levels should be monitored and frequency of dosage reduced if indicated.
In adults with renal failure undergoing haemodialysis, the amount of gentamicin removed from the blood may vary depending upon several factors including the dialysis method used. An eight-hour haemodialysis may reduce serum concentrations of gentamicin by approximately 50%. The recommended dosage at the end of each dialysis period is 1 to 1.7 mg/kg depending upon the severity of infection.

4.3 Contraindications

Known hypersensitivity to gentamicin, any of the excipients, or patients who have experienced previous toxic reactions (ototoxicity, nephrotoxicity) resulting from aminoglycoside therapy.

4.4 Special Warnings and Precautions for Use

Nephrotoxicity and ototoxicity.

As for other aminoglycosides, patients being treated with gentamicin should be under close clinical observation during treatment because of the potential toxicity associated with their use. Gentamicin, as with other aminoglycosides, is potentially nephrotoxic and ototoxic.
Ototoxicity may be manifested by both vestibular and auditory ototoxicity. These auditory changes are generally irreversible, usually bilateral and may be partial or total. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions. The risk of this toxicity is higher in patients receiving high doses, prolonged treatment, or with impaired renal function. Gentamicin should therefore be used with caution in patients with impaired renal function. In such patients the frequency of administration should be reduced and renal function should be monitored. Prolonged concentrations above 10 microgram/mL should be avoided and trough concentrations should not exceed 2 microgram/mL. In neonates, infants and children, dosage reductions may also be necessary to avoid toxicity.
Patients with mitochondrial DNA mutations, particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene may be at higher risk for ototoxicity, even if the patient's aminoglycoside serum levels were within the recommended range. In case of family history of aminoglycoside induced deafness or known mitochondrial DNA mutations in the 12S rRNA gene, alternative treatments other than aminoglycosides should be considered.
Peak and trough blood levels should be constantly monitored as should renal and eighth cranial nerve function, especially in patients with known or suspected reduced renal function at onset of therapy and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Where possible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug. As with the other aminoglycosides, on rare occasions changes in renal and eighth cranial nerve function may not become manifest until soon after completion of therapy. Treatment period should not normally exceed 10-14 days.
Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions) should be avoided. This includes concurrent use with potent diuretics, cephalosporins or other aminoglycosides. Other factors which may increase the risk of toxicity are dehydration and advancing age. Patients should be well hydrated during therapy.
Recent evidence suggests that neurotoxic and nephrotoxic antibiotics may be absorbed in significant quantities from body surfaces after local irrigation or application. The potential toxic effect of antibiotics administered in this fashion should be considered and inadvertent contact with the skin should be removed with water.

Neuromuscular disorders.

Aminoglycosides should be used cautiously in patients with neuromuscular disorders such as myasthenia gravis or parkinsonism. In such cases, gentamicin may aggravate muscle weakness because of its curare-like effect on neuro-muscular function.

Use during anaesthesia.

The possibility of prolonged or secondary apnoea should be considered if the drug is administered to anaesthetised patients who are concurrently receiving neuromuscular blocking agents such as suxamethonium (succinylcholine), tubocurarine or decamethonium. This also applies to patients who are receiving massive transfusions of citrated blood. If neuromuscular blockade occurs, it may be reversed by the administration of calcium salts.

Superinfection.

Treatment with gentamicin may lead to an over-growth of non-susceptible organisms. If overgrowth of non-susceptible organisms occurs, appropriate therapy should be initiated.

Allergic reactions.

May occur after administration of gentamicin. Cross allergenicity among aminoglycosides has also been known to occur.
Gentamicin Noridem injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

Use in the elderly.

Because of its toxicity, gentamicin should be used with caution in elderly patients only after less toxic alternatives have been considered and/or found ineffective. Elderly patients are more likely to have an age-related decrease in renal function which may not be evident in the results of routine screening test such as serum urea or serum creatinine. A creatinine clearance determination may be more useful. Recommended doses should not be exceeded, and the patient's renal function should be carefully monitored during therapy. Elderly patients may require smaller daily doses of gentamicin in accordance with their increased age, decreased renal function, and possibly, decreased weight. In addition, loss of hearing may result even in patients with normal renal function.

Paediatric use.

Gentamicin should be used with caution in premature and neonatal infants because their renal immaturity may result in the prolongation of the serum half-life of the drug and subsequent gentamicin induced toxicity.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Neuromuscular blocking agents.

Respiratory paralysis and prolongation of neuromuscular blockade may occur if a neuromuscular blocking agent such as suxamethonium (succinylcholine), tubocurarine, decamethonium, halogenated hydrocarbon inhalation anaesthetics, opioid analgesics or massive transfusions with citrated anticoagulated blood are administered to a patient receiving gentamicin.

Other neurotoxic and/or nephrotoxic agents.

Since the ototoxic or nephrotoxic effects of gentamicin may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic antibiotics, including other aminoglycosides, polymyxin B, colistin, cisplatin, vancomycin, amphotericin, clindamycin and cephalosporins.

Diuretics.

Potent diuretics such as ethacrynic acid or frusemide may potentiate the ototoxic effects of gentamicin.

Penicillins.

Gentamicin is inactivated by solutions containing beta-lactam antibiotics (penicillins and cephalosporins) so the two drugs should not be administered simultaneously nor should they be combined in the intravenous fluid. The inactivation of gentamicin by penicillins may occur in vivo, especially in patients with renal failure who maintain a higher level of the penicillin for a longer period of time. Therefore, when gentamicin and penicillins are used together in patients with renal failure, the time of administration of each drug should be staggered so that several hours separate each infusion.

Vitamin K.

Gentamicin may inhibit the action of intravenous vitamin K upon the synthesis of clotting factors.

Potential interactions.

In vitro synergism and antagonism have been found between various antineoplastic agents and aminoglycosides.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus.
Small amounts of gentamicin have been detected in breast milk. Because of the potential risk to the newborn, it is recommended that breastfeeding be discontinued during therapy unless the expected benefits outweigh any potential risk.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Serious or life-threatening reactions.

Otic (see Section 4.4 Special Warnings and Precautions for Use).

Serious adverse effects on both vestibular and auditory branches of the eighth cranial nerves have been reported, primarily in patients with renal impairment (especially if dialysis is required), and in patients on high doses and/or prolonged therapy. Symptoms reported include dizziness, vertigo, tinnitus, roaring in the ears and hearing loss may be irreversible. Hearing loss is usually manifested initially by diminution of high tone acuity. Other factors that may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs.

Renal (see Section 4.4 Special Warnings and Precautions for Use).

Adverse renal effects have been reported, and are demonstrated by the presence of casts, cells or protein in the urine or by rising serum urea, NPN, serum creatinine or oliguria. They occur more frequently in patients with a history of renal impairment and in patients who have been treated for longer periods or with larger dosage than recommended.

More common reactions.

Neurological.

Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions and a myasthenia gravis-like syndrome, have also been reported.

Dermatological and hypersensitivity.

Rash, itching, urticaria, purpura, generalised burning, anaphylactoid reactions may occur.

Pulmonary.

Respiratory depression, laryngeal oedema, pulmonary fibrosis may occur.

Gastrointestinal.

Nausea, vomiting, increased salivation and stomatitis may also occur.

Other adverse reactions.

Lethargy, confusion, depression, visual disturbances, decreased appetite, weight loss, hypotension and hypertension; fever and headache, pseudotumor cerebri, acute organic brain syndrome, alopecia, joint pain, transient hepatomegaly, and splenomegaly.
While local tolerance of gentamicin injection is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.

Laboratory tests.

Laboratory abnormalities possibly related to gentamicin include: increased levels of serum transaminase (ALT, AST), serum LDH and bilirubin; decreased serum calcium, magnesium, sodium and potassium; anaemia, leucopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts, and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesaemia, hypocalcaemia and hypokalaemia.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

As the drug is almost entirely eliminated by the kidneys, fluid loading may hasten its elimination following overdosage. Peritoneal dialysis or haemodialysis will also aid in the drug's removal.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Class.

Aminoglycoside antibiotic.

Microbiology.

Gentamicin is bactericidal and acts by inhibiting protein synthesis in susceptible bacteria. Cell death results. It is active against a wide range of pathogenic Gram-negative organisms including Escherichia coli, Pseudomonas aeruginosa, Proteus sp. (both indole positive and indole negative), Klebsiella, Enterobacter and Serratia species. It is also active against some Gram-positive organisms, e.g. Staphylococcus sp. (including methicillin and penicillin resistant strains). In vitro, gentamicin is also active against Salmonella and Shigella. Some species have demonstrated resistance to aminoglycosides including Streptococcus pneumoniae and anaerobic organisms such as Bacteroides or Clostridium species.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Gentamicin is rapidly absorbed after intramuscular injection and peak serum levels are usually achieved within 30 to 90 minutes and are measurable for 6-8 hours. Following parenteral administration gentamicin can be detected in tissues and body fluids. Following absorption, gentamicin is widely distributed into body fluid including ascitic, pericardial, pleural, synovial and abscess fluids. Concentration in bile is low.
Gentamicin is excreted almost entirely by renal glomerular filtration, hence the half-life of the drug is prolonged in the presence of renal failure. Adjustments in the frequency of administration of gentamicin are necessary to allow for the degree of renal failure (see Section 4.2 Dose and Method of Administration). The serum half-life of gentamicin is approximately 2-3 hours in adults with normal renal function. It is prolonged in patients with impaired renal function and in premature or newborn infants.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Disodium edetate, sodium metabisulfite, water for injections, sodium hydroxide, sulfuric acid.

6.2 Incompatibilities

When gentamicin is used in combination with any other drug, mixing the drugs before administration should be avoided at all costs.

6.3 Shelf Life

After first opening, the product should be used immediately.
To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2-8°C for not more than 24 hours.
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Single use only. Discard unused portion.

Diluted solution.

To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2-8°C for not more than 24 hours.

6.5 Nature and Contents of Container

AUST R 391250 Gentamicin Noridem 80 mg in 2 mL in clear glass ampoules in packs of 50 ampoules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Gentamicin sulfate is a mixture of the sulfates of antimicrobial substances produced by Micromonospora purpurea. The potency is not less than 590 I.U. per milligram, calculated with reference to the anhydrous substance. It is a white or almost white powder, freely soluble in water, practically insoluble in alcohol and in ether.

Chemical structure.

The structural formula is represented below.

CAS number.

1405-41-0.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine - S4.

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Gentamicin Noridem

Gentamicin

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BRAND INFORMATION