Gentamycin Injection

Gentamycin Injection

Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

  • Keep this leaflet. You may need to read it again before, during or after use of this medicine. 
  • If you have any further questions, ask your health care provider. 
  • This medicine has been prescribed for you only. Do not pass it on to others. It may  harm them, even if their symptoms are the same as yours. 
  • If any of the side effects become serious, or if you notice any side effects not listed in  this leaflet, please inform your health care provider. 

In this leaflet: 

  1. What Gentamycin Injection is and what it is used for 
  2. What you need to know before you are given Gentamycin injection  3. How to take Gentamycin Injection  
  3. Possible side effects 
  4. How to store Gentamycin Injection 
  5. Contents of the pack and other information 

 

  1. WHAT GENTAMYCIN INJECTION IS AND WHAT IT IS USED FOR Gentamycin Injection contains the active substance Gentamycin. It belongs to a group of antibiotics called aminoglycosides. This medicine is used to treat severe infections caused by bacteria. This includes: 
  • infections of the urinary tract (including kidneys or bladder)
  • infections in the chest (including lungs), such as hospital-acquired and ventilator associated pneumonia (HAP and VAP).
  • bacterial inflammation of the heart lining (endocarditis).
  • infections of the abdomen.
  • infections of the brain and spinal cord (meningitis caused by bacteria) • infections of the bones and joints (osteomyelitis and bacterial arthritis) • management of neutropenic patients with fever that is suspected to be due to a bacterial infection  
  • infections of the whole body due to the presence of Listeria monocytogenes in the blood • severe infection in newborn babies
  • infections of the blood (bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above)
  1. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GENTAMYCIN INJECTION 

You must not be given Gentamycin Injection 

  • if you are allergic to Gentamycin or any of the other ingredients of this medicine. • subcutaneously (beneath the skin), as it is not effective via this route and necrosis (death  of body tissue) may occur at the injection site

Warnings and precautions: Talk to your doctor, pharmacist, or nurse before you are given  Gentamycin:  

  • if you have problems with your kidneys 
  • if you have liver problems  
  • if you have diabetes  
  • if you suffer from deafness or have a hearing or balance disorder, a history of ear  infections or if you have been treated with medicines that affect hearing in the past. In  these cases, you will be given Gentamycin only if your doctor regards this treatment as  essential to treat your illness. Your doctor will take special care to adjust your  Gentamycin injection dose. Your doctor will be particularly vigilant if you have a disease  affecting your nerve and muscle functions, such as Parkinson’s disease or myasthenia  gravis, or if you are given a muscle relaxant during surgery, because Gentamycin may  have a blocking effect on your nerve and muscle functions

Taking other medicines with Gentamycin Injection  

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other  medicines. 

Medicines that may damage the kidneys and hearing. 

Tell your doctor if you are receiving or about to receive treatment with medicines that may  potentially damage the kidneys or hearing, as there is an increased risk of side effects. These  medicines include:  

  • Amphotericin B (used to treat fungal infections)  
  • Polymyxin B (antibiotic) 
  • Ciclosporin (used in organ transplants or for severe skin problems)  • Cisplatin and other organoplatinum compounds (used to treat cancer) • Other antibiotics of aminoglycoside group, such as tobramycin, streptomycin • Water tablets or injections (diuretics), such as furosemide  
  • Tacrolimus (used after organ transplants)  
  • Cephalothin (antibiotic of cephalosporins group)  
  • Methoxyflurane (an anaesthetic gas)  
  • Indomethacin (one of a group of medicines called nonsteroidal anti-inflammatory agents,  used to treat pain and inflammations)  
  • Anticoagulants (used to thin the blood), such as warfarin and phenindione • Biphosphonates (used to treat osteoporosis)  
  • Iodinated contrast media (agent used to facilitate radiographic imaging), antiviral agents  (such as the ciclovir group, foscarnet), methotrexate, pentamidine  
  • Antibiotics of the glycopeptide group, such as vancomycin and teicoplanin  • Neostigmine or pyridostigmine (used to treat muscle weakness)  
  • Digoxin (used to treat various heart conditions) 

Medicines whose effect may be increased by Gentamycin Injection Also tell your doctor if you are taking the following medicines, as their effect may be increased  when used together with Gentamycin:  

  • Botulinum toxin (used to lower the activity of overactive muscles) 
  • Curare medicines (muscle relaxants) 

Pregnancy and Breast-feeding  

Pregnancy 

Gentamycin should only be used during pregnancy for life-threatening indications and when  no safer treatment alternatives are available due to the potential danger for the unborn baby.  This medicine is not recommended for use in pregnancy unless considered appropriate by  your doctor. 

Breast-feeding 

Do not breast-feed during your treatment with Gentamycin. Small amounts of Gentamycin are  excreted in human milk and low concentrations have been found in the serum of breastfed  infants. A decision must be made whether to stop breastfeeding or whether to discontinue or  not to give Gentamycin. The breast-fed infant may suffer from diarrhea and thrush in the  mouth (fungal infection) whilst the mother is being treated with this medicine 

Driving and using machines 

Do not drive or operate machinery as Gentamycin may reduce mental alertness. 

  1. HOW TO TAKE GENTAMYCIN INJECTION 

Your doctor will decide how much to give you, depending on your weight. The correct dose  also depends on the type of infection and any other illnesses you may have. Blood samples  will be taken by your doctor or nurse to check the dose is right for you. The amount of  Gentamycin in your blood will be measured regularly to check that the correct blood levels  have been achieved. Treatment with Gentamycin may cause damage to hearing and also to  kidney function. Your doctor will decide, depending on your condition, how long you should  receive Gentamycin. In some cases, your doctor may carry out blood tests to check your  kidney function before and during treatment with Gentamycin. Occasionally you may also be  asked to take a hearing test to check the medicine is not affecting your hearing. 

Dosage  

The recommended daily dose for children, adolescents and adults with normal kidney function  is 3 to 6 mg / kg body weight per day and should preferably be given as a single dose, or else  divided into 2 separate doses. 

Use in infants  

  • The daily dose recommended in children aged 1 year and above with normal renal  function, is 3 – 6 mg / kg / day as one single dose (preferred) or two divided doses. The recommended daily dose for infants after the first month of life is 4.5 – 7.5 mg / kg  body weight per day and should be preferably given as a single dose, or else divided into  2 separate doses.  
  • The recommended daily dose for newborn infants is 4 – 7 mg / kg body weight per day.  Due to the longer half-life, newborn infants are given the required dose as a single dose.

Use in patients with kidney problems 

If you have kidney problems your daily recommended dose should be reduced and adjusted  to kidney function. 

Method of administration  

This medicine is injected into a muscle (intramuscularly) or into a vein (intravenously) after  dilution. 

Duration of use  

The duration of use is decided by your doctor. For common bacterial infectious diseases, the  duration of treatment depends on the progression of the disease. Normally, a treatment period  of 7 to 14 days is sufficient. The duration of therapy should preferably not exceed 10 to 14  days. A course of treatment with Gentamycin immediately after a previous course of  aminoglycoside treatment should be avoided. You should wait 7 to 14 days before starting  treatment with Gentamycin. Please talk to your doctor if you have the impression that the  effect of Gentamycin is too strong or too weak. 

If you miss a dose of Gentamycin Injection 

Your doctor has instructions about when to give you your medicine. It is most unlikely that  you will not be given the medicine as it has been prescribed. If you think that you may  have missed a dose, then talk to your doctor. 

If you receive more Gentamycin Injection than you should 

It is unlikely that your doctor will give you too much medicine. Your doctor will monitor your  progress and check the medicine you are given. Always ask your doctor if you are not sure  why you are getting a dose of medicine. 

  1. POSSIBLE SIDE EFFECTS 

Like all medicines, this medicine can cause side effects, although not everybody gets them.  Tell your doctor straight away if you notice any signs of an allergic reaction, including  anaphylactic shock (life threatening allergic reaction), such as:  

  • itching or skin rashes 
  • swelling of the face, lips or throat  
  • difficulty in breathing or wheeziness 

Other possible side effects  

Common: may affect up to 1 in 10 people  

  • problems with kidney function  

Uncommon: may affect up to 1 in 100 people 

  • problems with blood clotting  
  • intense skin redness without papules or blisters  

Rare: may affect up to 1 in 1,000 people 

  • low blood levels of potassium, calcium and magnesium 
  • increased levels of aldosterone in the blood  
  • loss of appetite  
  • weight loss  
  • damage of peripheral nerves  
  • loss of feeling  
  • feeling or being sick 
  • increased liver enzymes and urea in the blood (all reversible) 
  • increased production of saliva  
  • inflammation of the mouth lining  
  • skin reddening  
  • muscle pain  
  • increased body temperature 
  • increased serum bilirubin level in the blood  

Very rare: may affect up to 1 in 10,000 people  

  • superinfection (with Gentamycin-resistant germs) 
  • very severe inflammation of the colon  
  • blood disorders affecting certain blood components and generally detected by blood tests • decrease in the number of phosphates in the blood  
  • confusion, hallucinations, depression 
  • a collection of brain problems 
  • seizures (fits)  
  • neuromuscular block  
  • dizziness, vertigo, balance disorders, headache  
  • visual disturbances  
  • loss of hearing 
  • inner ear problems, tinnitus 
  • low blood pressure  
  • high blood pressure  
  • serious allergic reaction of the skin and mucous membranes with blistering and redness of  the skin (erythema multiforme) which can, in very severe cases, affect the internal organs  and become life-threatening (Steven-Johnson’s Syndrome, toxic epidermal necrolysis),  skin detachment (Toxic epidermal necrolysis, or Lyell’s syndrome)  
  • hair loss  
  • muscle wasting (decrease in the mass of the muscle)  
  • acute kidney failure, raised phosphate levels in the urine and amino acids (known as  fanconi syndrome, associated with high doses administered over a long period of time)  • pain at the injection site. 

Reporting of side effects 

If you get any side effects, talk to your healthcare provider. This includes any possible side  effects not listed in this leaflet. By reporting side effects, you can help provide more  information on the safety of this medicine.

  1. HOW TO STORE GENTAMYCIN INJECTION 
  • Keep all medicines out of the reach of children.  
  • Store below 30oC. 
  • Do not use this medicine after the expiry date ‘Exp. Date’ which is stated on the label. The  expiry date refers to the last day of the month.  

Do not throw away any medicines via wastewater or household waste. Ask your nurse or  pharmacist how to throw away medicines you no longer use. These measures will help protect  the environment. 

  1. FURTHERINFORMATION 

What Gentamycin Injection contains  

The active substance of Gentamycin Injection is Gentamycin 80mg/2ml. 

What Gentamycin Injection looks like and contents of the pack 

Gentamycin injection is packed as 10x2ml ampoule injection, placed in a carton with patient  information leaflet. 

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