Gentamicin Injection (gentamicin) Drug / Medicine Information

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

gentamicin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Gentamicin Injection. It does not
contain all the available information. It does not take the place of talking to your
healthcare professional.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking
Gentamicin Injection against the benefits this medicine is expected to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If
possible, please read this leaflet carefully before this medicine is given to you.
In some cases this leaflet may be given to you after the medicine has been used.

If you have any concerns about taking this medicine, ask your healthcare professional.

Keep this leaflet.

You may need to read it again.

What Gentamicin Injection is used for

Gentamicin is used to treat serious bacterial infections. It is an antibiotic that
belongs to a group of medicines called aminoglycoside antibiotics. It works by killing
bacteria or preventing their growth.

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

Your doctor may have prescribed gentamicin for another reason.

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

Before you are given Gentamicin Injection

When you must not be given it

You must not be given Gentamicin Injection if you have an allergy to:

any medicine containing gentamicin

any of the ingredients listed at the end of this leaflet

any other similar medicines such as aminoglycoside antibiotics such as tobramycin,
streptomycin, amikacin, netilmicin, or neomycin.

Some of the symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin.

If you are not sure whether any of these apply to you, talk to your healthcare professional.

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

If you are not sure whether you should be given DBL Gentamicin Injection BP, talk
to your healthcare professional.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

kidney disease or any kidney problems

hearing problems, or if you or your family have a mitochondrial mutation disease,
or loss of hearing due to antibiotic medicines; certain mitochondrial mutations may
increase your risk of hearing loss with this product

muscle disorders (e. g. myasthenia gravis, Parkinson’s disease (a disease affecting
movement)).

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start
being given Gentamicin Injection.

Taking other medicines

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

Some medicines and gentamicin may interfere with each other. These include:

antibiotics to treat infection such as colistin, vancomycin, clindamycin, cephalosporins
and penicillins

water tablets (diuretics) e.g. frusemide, etacrynic acid, bumetanide)

cisplatin, a medicine used to treat cancer

amphotericin, an anti-fungal medicine

anaesthetics (e. g. halothane)

vitamin K

muscle relaxants (e.g. suxamethonium.

These medicines may be affected by gentamicin or may affect how well it works. You
may need different amounts of your medicines, or you may need to take different medicines.

Your healthcare professional will advise you about continuing to take other medicines
while you are receiving gentamicin.

How Gentamicin Injection is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your age, weight, and kidney function.

How it is given

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

If you are given too much (overdose)

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

Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Emergency at the nearest hospital, if you think that you
or anyone else may have taken too much DBL Gentamicin Injection BP. Do this even
if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of a gentamicin overdose may include the side effects listed below in the
‘Side Effects’ section, but are usually of a more severe nature.

While you are being given Gentamicin Injection

Things you must do

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

Things you must 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.

Side effects

Tell your healthcare professional as soon as possible if you do not feel well while
you are being given gentamicin or after the injection.

This medicine helps most people with certain infections, but it may have unwanted
side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Ask your healthcare professional to answer any questions that you may have.

Tell your healthcare professional if you notice any of the following and they worry
you:

fever, severe chills, sore throat, mouth ulcers

nausea or vomiting

headache

unusual bleeding or bruising under the skin

weight loss, loss of appetite

weakness or tiredness

increased salivation

joint pain

hair loss

confusion

depression

pain at the injection site

These side effects are usually mild.

If any of the following happen, tell your healthcare professional immediately or go
to Emergency at the nearest hospital:

signs of an allergic reaction, such as rash, itching or hives on the skin; swelling
of the face, lips, tongue or other parts of the body; shortness of breath, wheezing
or difficulty breathing

severe headache

dizziness

hearing problems or ringing in the ears

problems with your balance

decrease in urination

skin tingling, numbness, or muscle twitching

fits (convulsion).

The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation.

Tell your healthcare professional if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some patients.

Some of these side effects can only be found when your healthcare professional does
tests from time to time to check your progress.

After being given Gentamicin Injection

Storage

Gentamicin Injection will usually be stored in the pharmacy or ward. It is kept in
a cool, dry place, protected from light, where the temperature stays below 25°C.

Product Description

What it looks like

Gentamicin Injection is a clear solution in a plastic ampoule.

Ingredients

Active ingredients:

• Each 2 mL of Gentamicin Injection contains gentamicin (as sulfate) 80 mg.

Other ingredients:

• disodium edetate
• water for injections
• sodium hydroxide.
• sulfuric acid.

It does not contain preservatives.

Sponsor

Gentamicin Injection is supplied in Australia by:

Pfizer Australia Pty Ltd

Sydney NSW

Toll Free Number: 1800 675 229

www.pfizermedinfo.com.au

© Copyright

Gentamicin Injection is available in the following strength and pack sizes:

80 mg/2 mL x 10 ampoules

80 mg/2 mL x 50 ampoules.

AUST R 11376

This leaflet was prepared in September 2022.

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Gentamicin (Systemic: Pediatric Medication | Memorial Sloan Kettering Cancer Center

Pediatric Medication

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Warning

• This drug may cause kidney, nerve, and hearing problems (like long-lasting hearing loss), even at normal doses. The risk may be higher if your child already has kidney or hearing problems, gets higher doses, or uses this drug for a long time. The risk may be higher in older people, infants, or with dehydration. Hearing loss can happen even after this drug is stopped. If your child already has kidney problems or hearing problems, tell the doctor. Your child may need to have hearing and kidney tests.
• Do not give this drug to your child if your child is taking or has recently taken any drugs that can cause nerve, kidney, or hearing problems. This may be drugs like amphotericin B, bacitracin, cephaloridine, cisplatin, colistin, cyclosporine, ethacrynic acid, furosemide, paromomycin, polymyxin B, vancomycin, viomycin, or other drugs like this one. There are many other drugs that can do this. Ask the doctor or pharmacist if you are not sure.
• Muscle problems (muscle weakness) and severe breathing problems have happened with drugs like this one. The risk is higher in people who already have nerve or muscle problems like myasthenia gravis. The risk is also higher in people who are getting other drugs like those that are used to put you to sleep or to relax muscles. If you have questions, talk with the doctor.

If your child is pregnant:

• This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.

What is this drug used for?

• It is used to treat bacterial infections.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.

This drug may interact with other drugs or health problems.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

• Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
• If your child is allergic to sulfites, talk with your child’s doctor. Some products have sulfites in them.
• Have your child’s blood work, hearing, and other lab tests checked as you have been told by the doctor.
• Do not give to your child longer than you have been told. A second infection may happen.

If your child is breast-feeding a baby:

• Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Dizziness or passing out.
• Change in balance.
• Ringing in the ears, hearing loss, or any other changes in hearing.
• Muscle weakness.
• Trouble breathing that is new or worse.
• A burning, numbness, or tingling feeling that is not normal.
• Twitching.
• Seizures.
• Feeling confused.
• Feeling very tired or weak.
• Depression.
• Change in eyesight.
• Fever.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Decreased appetite.
• Weight loss.
• Headache.
• Upset stomach or throwing up.
• More saliva.
• Mouth irritation or mouth sores.
• Hair loss.
• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or as an infusion into a vein over a period of time.
• Have your child drink lots of noncaffeine liquids unless told to drink less liquid by your child’s doctor.

What do I do if my child misses a dose?

• Call your child’s doctor to find out what to do.

How do I store and/or throw out this drug?

• If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.

General drug facts

• If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
• Do not share your child’s drug with others and do not give anyone else’s drug to your child.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last Reviewed Date

2023-03-22

Copyright

© 2023 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Last Updated

Monday, December 12, 2022

Gentamicin instructions for use: indications, contraindications, side effects – description Gentamicin solution for intravenous and intramuscular administration 80 mg/2 ml: amp. 10 pieces. (17716)

💊 Composition of the preparation Gentamicin ✅ Use of the preparation Gentamicin Keep for yourself Search for analogues Interaction ⚠️ The state registration of this drug has been canceled Description of the active ingredients of the preparation Gentamicin (Gentamicin) The scientific information provided is general and cannot be used to make decisions. decisions about the use of a particular drug. Update date: 2020.05.21 Marketing authorization holder: NPO MICROGEN, JSC (Russia) Manufactured: VIRION NPO (Russia) ATX code: J01GB03 (Gentamicin) Active substance: gentamicin (gentamicin) Rec.INN registered by WHO Dosage form Gentamicin Solution for intravenous and intramuscular administration 80 mg/2 ml: amp. 10 pieces. reg. No.: R N000108/01 from 22.01.08 – Cancel State. registration Release form, packaging and composition drug Gentamicin 2 ml – ampoules (10) – packs of cardboard. 2 ml – ampoules (10) / with knife ampoule or scarif. as required./ – packs of cardboard pasted over with a parcel post. 2 ml – ampoules (10) – cardboard packs pasted over with a parcel post. Clinical and pharmacological group: Aminoglycoside antibiotic Pharmacotherapeutic group: Aminoglycoside antibiotic Pharmacological action Aminoglycoside antibiotic with a wide spectrum of action. It has a bactericidal effect. Actively penetrating through the cell membrane of bacteria, it irreversibly binds to the 30S subunit of bacterial ribosomes and, thereby, inhibits protein synthesis of the pathogen. Highly active against aerobic Gram-negative bacteria: Escherichia coli, Shigella spp., Salmonella spp., Enterobacter spp., Klebsiella spp., Serratia spp., Proteus spp., Pseudomonas aeruginosa, Acinetobacter spp. Also active against aerobic Gram-positive cocci: Staphylococcus spp. (including resistant to penicillins and other antibiotics), some strains of Streptococcus spp. Neisseria meningitidis, Treponema pallidum, some strains of Streptococcus spp., anaerobic bacteria are resistant to gentamicin. Pharmacokinetics After intramuscular administration, it is rapidly absorbed from the injection site. C max is achieved 30-60 minutes after i / m administration. Plasma protein binding is low (0-10%). It is distributed in the extracellular fluid, in all tissues of the body. Penetrates through the placental barrier. Not metabolized. T 1/2 2-4 hours 70-95% excreted in urine, small amount in bile. Indications of the active substances of the drug Gentamicin Infectious and inflammatory diseases caused by microorganisms sensitive to gentamicin: infections of the upper and lower respiratory tract (including bronchitis, pneumonia, pleural empyema), complicated urogenital infections (pyelonephritis, cystitis, urethritis, prostatitis, gonorrhea, endometritis), bone and joint infections (including osteomyelitis), abdominal infections (peritonitis, pelvioperitonitis), central nervous system infections (meningitis), purulent infections of the skin and soft tissues, wound infection, burn infection. Open list of ICD-10 codes A54 Gonococcal infection G00 Bacterial meningitis, not elsewhere classified J15 Bacterial pneumonia, not elsewhere classified J20 Acute bronchitis J42 Chronic bronchitis, unspecified J86 Pyothorax (pleural empyema) K65. 0 Acute peritonitis (including abscess) K81.0 Acute cholecystitis K83.0 Cholangitis L01 Impetigo L02 Skin abscess, furuncle and carbuncle L03 Phlegmon L08.0 Pyoderma L08.8 Other specified local skin and subcutaneous tissue infections M00 Pyogenic arthritis M86 Osteomyelitis N10 Acute tubulointerstitial nephritis (acute pyelonephritis) N11 Chronic tubulointerstitial nephritis (chronic pyelonephritis) N30 Cystitis N34 Urethritis and urethral syndrome N37. 0 Urethritis in diseases classified elsewhere N41 Inflammatory diseases of the prostate N71 Inflammatory disease of the uterus other than the cervix (including endometritis, myometritis, metritis, pyometra, uterine abscess) N72 Inflammatory disease of the cervix (including cervicitis, endocervicitis, exocervicitis) N73.5 Female pelvic peritonitis, unspecified N74.3 Gonococcal inflammatory diseases of the female pelvic organs T30 Thermal and chemical burns, unspecified T79. 3 Post-traumatic wound infection, not elsewhere classified Dosing regimen The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed. Installed individually, taking into account the severity of the course and localization of the infection, the sensitivity of the pathogen. When administered intravenously or intramuscularly for adults, a single dose is 1-1.7 mg/kg, a daily dose is 3-5 mg/kg; frequency of administration – 2-4 times / day. The course of treatment is 7-10 days. Depending on the etiology of the disease, it is possible to use a dose of 120-160 mg 1 time / day for 7-10 days or 240-280 mg once. IV infusion is carried out over 1-2 hours. For children older than 2 years, the daily dose of gentamicin is 3-5 mg/kg; frequency of administration – 3 times / day. Premature and newborn children are prescribed in a daily dose of 2-5 mg / kg; frequency of administration – 2 times / day; children under 2 years of age are prescribed the same dose at a frequency of administration 3 times / day. Patients with impaired renal excretory function require adjustment of the dosing regimen depending on the CC values. Maximum daily doses: for adults and children when administered intravenously or intramuscularly – 5 mg/kg. Side effects On the part of the digestive system: nausea, vomiting, increased activity of hepatic transaminases, hyperbilirubinemia. From the hematopoietic system: anemia, leukopenia, granulocytopenia, thrombocytopenia. From the urinary system: oliguria, proteinuria, microhematuria, renal failure, tubular necrosis. From the nervous system: muscle twitching, paresthesia, numbness, epileptic seizures, headache, drowsiness, in children – psychosis. From the senses: tinnitus, hearing loss, vestibular and labyrinth disorders, irreversible deafness. Allergic reactions: skin rash, pruritus, urticaria, fever; rarely – Quincke’s edema. Other: fever, development of superinfection. Contraindications for use Hypersensitivity to gentamicin and other antibiotics of the aminoglycoside group, neuritis of the auditory nerve, severe chronic renal failure with azotemia and uremia, pregnancy, lactation (breastfeeding), newborns (up to 1 month), incl. premature babies (due to the high risk of developing ototoxic and nephrotoxic effects). Precautions Myasthenia gravis, parkinsonism, botulism (aminoglycosides can cause impaired neuromuscular transmission, leading to further weakening of skeletal muscles), dehydration, renal failure, advanced age. Use in pregnancy and lactation Gentamicin is contraindicated in pregnancy. If necessary, use during lactation should stop breastfeeding. Renal dysfunction Contraindicated in severe renal impairment, uremia. With caution in violation of kidney function. When using gentamicin, kidney function should be monitored. Patients with impaired renal excretory function require adjustment of the dosing regimen depending on the CC values. In patients with chronic renal insufficiency, it is necessary to take into account the possibility of resorptive action of gentamicin when applied externally for a long time on large skin surfaces. Use in children Use with caution in newborns (up to 1 month), incl. premature babies. Use in elderly patients In elderly patients, use according to the state of renal function. Special instructions When using gentamicin, the functions of the kidneys, auditory and vestibular apparatus should be monitored. Patients with infectious and inflammatory diseases of the urinary tract should drink plenty of fluids during the treatment period. Drug interactions Enhances the muscle relaxant effect of curare-like drugs. Reduces the effectiveness of drugs for the treatment of myasthenia gravis. Methoxyflurane, parenteral polymyxins and other drugs that block neuromuscular transmission (halogenated hydrocarbons as inhalation anesthetics, narcotic analgesics, large transfusions with citrate preservatives) increase the risk of nephrotoxicity and respiratory depression (due to increased neuromuscular blockade). With the simultaneous use of gentamicin and “loop” diuretics (furosemide, ethacrynic acid), the concentration in the blood of gentamicin increases, and therefore the risk of developing toxic side reactions increases. Toxicity is enhanced by concomitant use with cisplatin and other ototoxic and nephrotoxic agents. Antibiotics of the penicillin series (ampicillin, carbenicillin) enhance the antimicrobial effect by expanding the spectrum of activity. Parenteral administration of indomethacin increases the risk of developing toxic effects of aminoglycosides. Pharmaceutically incompatible with other drugs. Keep If you want to place a link to the description of this drug – use this code Gentamicin . Description of the drug in the reference book Vidal.

Gentamycin sulfate: instructions, price, analogues | solution for injection Galichpharm

• Pharmacological properties
• Indications Gentamicin sulfate
• Application of Gentamicin sulfate
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

pharmacodynamics. Gentamicin is a broad-spectrum aminoglycoside antibiotic. The mechanism of action is associated with the inhibition of 30S ribosomal subunits. Tests in vitro confirm its activity against different types of gram-positive and gram-negative microorganisms: Escherichia coli, Proteus spp. (indole positive and indole negative), Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., Citrobacter spp., Salmonella spp., Shigella spp. and Staphylococcus spp. . (including penicillin- and methicillin-resistant strains).

The following organisms are generally resistant to gentamicin: Streptococcus pneumoniae , most other streptococci, enterococci, Neisseria meningitides, Treponema pallidum and anaerobic organisms such as Bacteroides spp . or Clostridium spp .

Pharmacokinetics . Gentamicin is easily absorbed, reaching C _max in blood plasma 30–60 minutes after intramuscular administration.

Therapeutic concentrations in the blood persist for 6-8 hours.

With intravenous drip, the concentration of the antibiotic in the blood plasma during the first hours exceeds the concentration that is achieved after the intramuscular administration of the drug. Plasma protein binding is 0-10%.

In therapeutic concentrations, it is determined in the tissue of the kidneys, lungs, in pleural and peritoneal exudates. Normally, parenteral administration of gentamicin poorly penetrates the BBB, but with meningitis, the concentration in the CSF increases. The drug passes into breast milk.

Approximately 70% of gentamicin is excreted unchanged into the urine during the day by glomerular filtration. T _½ from blood plasma is about 2 hours. If the excretory function of the kidneys is impaired, the concentration increases significantly and T _½ of gentamicin increases.

Considering the limits of therapeutic efficacy of gentamicin, it should be used in cases where microorganisms are resistant to other antibiotics. Gentamicin sulfate is indicated for the treatment of infections caused by pathogens susceptible to it, including:

• sepsis;
• urinary tract infections;
• infectious diseases of the lower respiratory tract;
• infectious diseases of the skin, bones, soft tissues;
• infected burn wounds;
• infectious diseases of the central nervous system (meningitis) in combination with β-lactam antibiotics;
• infections of the abdominal cavity (peritonitis).

gentamicin sulfate can be used IM or IV.

Dose, route of administration and intervals between doses depend on the site, severity of disease, age of the patient and renal function. The dose regimen is determined based on the patient’s body weight. With the improvement of the clinical condition or with the development of side effects, the dose is reduced.

Adults and children over 14 years of age . The usual daily dose of the drug for patients with moderate and severe infections is 3 mg/kg body weight IM or IV in 2-3 injections. The maximum daily dose for adults is 5 mg / kg of body weight in 3-4 injections.

The usual duration of the drug for all patients is 7-10 days.

If necessary, in case of severe and complicated infections, the course of therapy can be extended. In such cases, it is recommended to monitor the function of the kidneys, the auditory and vestibular apparatus, since the toxic effect of the drug appears after its use for > 10 days.

Dose based on body weight

Dose is calculated based on actual body weight (BW) if the patient is not overweight (i.e. no more than 20% additional to ideal body weight (BMI)). If the patient is noted to be overweight, the dose is calculated for the required body weight (DMT) according to the formula:

DMT \u003d BMI + 0.4 (FMT – BMI) .

In case of impaired renal function it is necessary to change the dosing regimen of the drug so that it guarantees therapeutic adequacy of the treatment. It is necessary to control the concentration of gentamicin in the blood plasma. 30–60 minutes after i / m administration, the concentration of the drug in the blood plasma should be 5–10 mcg / ml.

Before prescribing gentamicin, creatinine clearance must be determined. The initial single dose for patients with stable chronic renal failure is 1-1.5 mg / kg, in the future, the dose and interval between doses are determined depending on creatinine clearance.

Adult patients with a bacterial infection requiring dialysis are given gentamicin 1–1. 5 mg per kg of body weight at the end of each dialysis.

For adult peritoneal dialysis, add 1 mg of gentamicin to 2 liters of dialysis solution.

Children . For children under 3 years of age, gentamicin sulfate is prescribed exclusively for health reasons.

Daily doses are: newborns and children under 1 year old – 2-5 mg / kg of body weight, children from 1 year to 5 years old – 1.5-3 mg / kg of body weight, 6-14 years old – 3 mg / kg body weight. The maximum daily dose for children of all age groups is 5 mg/kg of body weight. The drug is administered 2-3 times a day for 7-10 days.

For intravenous administration, a single dose of the drug is diluted with a solvent. The usual volume of solvent (sterile 0.9% sodium chloride solution or 5% glucose solution) for adults is 50-300 ml; for children, the volume of the solvent must be reduced accordingly. The concentration of gentamicin in the solution should not exceed 1 mg / ml (0.1%). Duration of intravenous infusion – 1-2 hours; injected at a rate of 60-80 drops / min. In / infusion spend 2-3 days, then switch to the / m administration.

hypersensitivity to the components of the drug/antibiotics of the aminoglycoside group, CRF with azotemia and uremia, acoustic neuritis, myasthenia gravis, parkinsonism, botulism (gentamicin can cause a violation of the neuromuscular transmission, which can lead to further weakening of the skeletal muscles), old age, prior treatment with ototoxic drugs. Restriction to the use of the drug is OPN.

ototoxicity (damage to the VIII pair of cranial nerves): may develop hearing loss, initially high tones (so impaired speech recognition, which is low-frequency, is not the first sign of ototoxicity), and damage to the vestibular apparatus (with a symmetrical lesion of the vestibular apparatus, these violations in some cases in the early stages may even go unnoticed). Manifested by dizziness or vertigo. Tinnitus, hearing loss. A special risk may cause an extended course of treatment with gentamicin – 2-3 weeks.

Nephrotoxicity: the frequency and severity of kidney damage depend on the single dose, duration of treatment and individual characteristics of the patient, the quality of therapy control and the simultaneous use of other nephrotoxic drugs. Kidney damage is manifested by renal failure, usually mild, acute tubular necrosis, interstitial nephritis, decreased glomerular filtration rate (occurs after several days of treatment or after discontinuation of therapy), proteinuria, azotemia, less often oliguria and, as a rule, is reversible.

In addition to high plasma concentrations, which particularly increase the risk of ototoxicity and nephrotoxicity, there are many other risk factors (see SPECIAL INSTRUCTIONS).

Electrolyte disorders: hypomagnesemia, hypocalcemia and hypokalemia.

From the digestive tract: stomatitis, nausea, vomiting, increased salivation, loss of appetite, weight loss, pseudomembranous colitis.

From the immune system: allergic reactions, including skin rashes, urticaria, pruritus, fever, purpura. Anaphylactic reactions and endotoxic shock. Shortness of breath, Quincke’s edema.

The preparation contains sodium metabisulphite (E223), which can rarely cause hypersensitivity reactions and bronchospasm.

From the blood system: thrombocytopenia, granulocytopenia, anemia, leukopenia.

Changes in laboratory parameters: increase in the level of transaminases in blood plasma (ALAT, AST), bilirubin, reticulocytes.

From the side of the central nervous system: headache, drowsiness, neurotoxicity (encephalopathy, confusion, lethargy, hallucinations, convulsions and depression), peripheral neuropathy.

From the side of the cardiovascular system: arterial hypotension.

Others: neuromuscular blockade and respiratory depression, joint pain, muscle pain, general weakness.

Changes at the injection site: at the injection site – hyperemia, soreness, induration at the injection site, atrophy or necrosis of the subcutaneous tissue, with intravenous administration – the development of phlebitis and periphlebitis.

due to its wide spectrum of action, gentamicin is often prescribed for mixed infections, as well as in cases where the pathogen is not identified, usually in combination with semi-synthetic penicillins (ampicillin, carbenicillin).

In patients with kidney disease, it is necessary to regularly monitor the concentration of gentamicin in the blood plasma and the function of the kidneys, as well as the auditory and vestibular apparatus.

If symptoms of impaired renal function or damage to the auditory or vestibular apparatus appear, urgent discontinuation of gentamicin therapy or, in exceptional cases, dose adjustment is necessary.

Gentamicin sulfate should be used with caution in patients with dehydration, botulism, parkinsonism, hypocalcemia, diabetes mellitus, obesity, otitis media (including history), as well as in elderly patients who have previously taken ototoxic drugs. During treatment, a sufficient amount of liquid should be consumed.

Rapid infusion is not recommended.

Patients with kidney disease, hearing loss, dizziness or tinnitus are especially sensitive to gentamicin.

Due to limited clinical experience, administration of the entire daily dose of gentamicin sulfate is not recommended for conditions such as burns >20% of body surface area; cystofibrosis; ascites; endocarditis; CKD with hemodialysis; sepsis.

With prolonged use or use of gentamicin in high doses, the dose of the drug should ensure that the concentration of gentamicin in the blood does not exceed the maximum allowable. To do this, in patients at risk, during the period of treatment, it is necessary to control the concentration of gentamicin in the blood. Regularly (1 or 2 times a week, and in patients using high doses, or those who are on treatment for more than 10 days – daily), kidney function should be monitored. In order to avoid the development of hearing loss, it is recommended to conduct regular (1 or 2 times a week) studies of vestibular function or the determination of hearing loss at high frequencies.

In some cases, hearing impairment may occur after the end of treatment.

Tell your doctor if you have the following symptoms: any hearing loss, ringing or tinnitus, dizziness, incoordination, numbness, skin tingling, muscle twitches, convulsions at any time during treatment. This may indicate the development of neurological side effects.

Among the antibiotics of the aminoglycoside group, cross-hypersensitivity is possible.

Microbial resistance may develop during treatment. In such cases, it is necessary to cancel the drug and conduct a study of the sensitivity of microorganisms to the antibiotic.

Pregnancy and lactation. Due to the fact that gentamicin sulfate crosses the placenta and may have a nephrotoxic effect on the fetus, the drug is contraindicated during pregnancy.

The drug passes into breast milk, so you should either stop breastfeeding or stop using the drug.

Children . For children under 3 years of age, gentamicin sulfate is prescribed exclusively for health reasons.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms . Data on the effect of gentamicin on the ability to drive a car or operate other mechanisms are not available. However, in some patients, the drug in high doses can cause imbalance, which is accompanied by nausea and dizziness, therefore, during treatment, it is recommended to refrain from engaging in potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions (including driving vehicles and other mechanisms).

simultaneous appointment with potent diuretics (furosemide, ethacrynic acid) should be avoided, since the latter can enhance the ototoxic and nephrotoxic effect. Respiratory dysfunction may occur due to neuromuscular blockade in patients who are simultaneously prescribed muscle relaxants (succinylcholine, tubocurarine, decamethonium), anesthetics, or have a history of a previous massive blood transfusion using a citrate anticoagulant. The use of calcium salts and anticholinesterase agents can eliminate the effects of neuromuscular blockade.

Simultaneous and/or sequential systemic or local use of other neuro- and/or nephrotoxic agents such as cisplatin, cephaloridine, aminoglycoside antibiotics, polymyxin B, colistin, vancomycin should be avoided.

The risk of impaired renal function increases with the simultaneous use of indomethacin, phenylbutazone and other NSAIDs with gentamicin, as well as quinidine, cyclophosphamide, cephalosporins (monitoring of kidney function is recommended), ganglioblockers, verapamil, polyglucin. Gentamicin increases the toxicity of digoxin.

With the simultaneous administration of aminoglycosides and penicillins, T _½ decreases and their content in blood plasma decreases.

Decrease in T _½ is noted in patients with severe renal impairment with the combined use of carbenicillin with gentamicin.

When combined with bisphosphonates, the risk of hypocalcemia increases, with botulinum toxin, the risk of toxicity increases due to increased neuromuscular blockade.

Simultaneous use with oral anticoagulants may increase the hypothrombinemic effect.

Antagonism is possible with simultaneous administration of gentamicin with neostigmine or pyridostigmine.

Incompatible . Pharmaceutically incompatible in the same syringe or in the same infusion system with other drugs (especially β-lactam antibiotics, heparin, amphotericin).

symptoms: dizziness, nausea, vomiting, nephrotoxicity, ototoxicity, neuromuscular blockade with respiratory failure.

Treatment: i.v. neostigmine plus 10% calcium chloride or 5% calcium gluconate. Before the introduction of neostigmine, atropine is administered intravenously at a dose of 0.5–0.7 mg, an increase in heart rate is expected, and after 1.5–2 minutes, 1.5 mg of neostigmine is administered intravenously. If the effect of this dose was insufficient, the same dose of neostigmine is re-introduced (if bradycardia appears, an additional injection of atropine is administered).