Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Gentamicin Intrathecal 5mg/ml
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Gentamicin sulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of this medicine is Gentamicin Intrathecal 5mg/ml Solution for Injection (called gentamicin in this leaflet). It contains a medicine called gentamicin sulphate. This belongs to a group of antibiotics called 'aminoglycosides'. Gentamicin is used to treat infections caused by bacteria. This includes infections in your:
- brain – including meningitis
- spinal cord
What you need to know before you take it
e gentamicin Do not have gentamicin if you:
- are allergic (hypersensitive) to gentamicin sulphate, any other antibiotics or to any of the other ingredients of this medicine (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue.
- have myasthenia gravis or a related condition. This is a disease that causes muscle weakness. Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before having gentamicin. Warnings and precautions Talk to your doctor or nurse before having gentamicin if you:
- are pregnant, think you may be pregnant or are planning to have a baby.
- are breast-feeding or are planning to breast-feed.
- have any muscle weakness problems.
- are extremely overweight (obese).
- have kidney problems.
- have cystic fibrosis.
- are elderly (over 65 years of age) or the patient is less than 1 year old.
- have, or have a maternal history of mitochondrial mutation disease (a genetic condition) or loss of hearing due to antibiotic medicines, you are advised to inform your doctor, pharmacist or nurse before you take or are given an aminoglycoside; certain mitochondrial mutations may increase your risk of hearing loss with this product. Your doctor may recommend genetic testing before administration of gentamicin. Your doctor will need to monitor you before, during and shortly after your treatment. Your doctor may check your 11503803-09
hearing, balance, how your kidneys are working and the amount of gentamicin in your blood. This is to prevent damage to your ears and/or kidneys and is particularly important if you have kidney problems, are obese, suffer from cystic fibrosis or are over 65 years of age, or the patient is less than 1 year old. If you are not sure if any of the above applies to you, talk to your doctor or nurse before having gentamicin. Talk to your doctor or nurse if you experience severe diarrhoea. Other medicines and gentamicin Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because gentamicin can affect the way some other medicines work. Also, some medicines can affect the way gentamicin works. In particular tell your doctor if you are taking any of the following:
- Medicines used to thin the blood such as warfarin.
- Water tablets or injections (diuretics) such as furosemide or etacrynic acid.
- Amphotericin B (used to treat fungal infections).
- Cephalosporin antibiotics such as cephaloridine.
- Ciclosporin (used in organ transplants or for severe skin problems).
- Neostigmine or pyridostigmine (used to treat myasthenia gravis).
- Muscle relaxants – sometimes used during operations which need an anaesthetic.
- Indometacin (used to treat pain or swelling).
- Bisphosphonates (used to treat osteoporosis).
- Cisplatin (used to treat some cancers).
- Botulinum toxin – used to lower the activity of overactive muscles. This is also sometimes used in cosmetic procedures. These medicines may increase the chances of getting certain side effects. If you are unsure about any of the above, consult your doctor or nurse. Pregnancy and breast-feeding Ask your doctor or nurse for advice before having this medicine if you are:
- pregnant, think you may be pregnant are planning to have a baby. Gentamicin should not normally be used during pregnancy.
- breast-feeding or planning to breastfeed. Important information about the ingredients of Gentamicin This medicine contains less than 1 mmol sodium (23 mg) per 1 ml ampoule, that is to say essentially 'sodium-free'. 3.How to have gentamicin Gentamicin is always given to you by a doctor or nurse. This is because it is given as an injection. Having this medicine 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, in particular diseases of the kidney. Tests Blood samples will be taken by your doctor or nurse to check the dose is right for you. You should not receive gentamicin if these blood tests cannot be performed. You may also need tests to check your hearing and balance. Elderly or obese people, newborns, people with impaired kidney function and those with cystic fibrosis should be particularly closely monitored when having this medicine.
How to take it
Adults and children
- The usual starting dose is 1mg a day given into the brain or spine (intraventrically or intrathecally).
- This dose may be increased or decreased by your doctor depending on your illness
- A separate injection into a muscle is given every 8 hours. This dose will be decided by your doctor depending on your bodyweight. If you have more gentamicin than prescribed It is most unlikely that you will be given too much medicine by the doctor or nurse. Your doctor or nurse will be checking your progress and checking the medicine that you are given. Ask if you are not sure why you are getting a dose of medicine. If you miss a dose of gentamicin Gentamicin will be given to you by a doctor or nurse. 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 nurse or doctor. If you stop having gentamicin It is important that the course of treatment your doctor has prescribed is finished. You may start to feel better but it is important to continue your treatment until the doctor advises. If you stop, your infection may get worse again. 4.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 of the following serious side effects – you may need urgent medical treatment: Not known (frequency cannot be estimated from available data) Allergic reactions (including serious allergic reactions such as anaphylaxis), which may include:
- An itchy, lumpy rash (hives) or nettle rash (urticaria)
- Swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing
- Fainting, dizziness, feeling lightheaded (low blood pressure)
- Severe allergic reaction of the skin and mucous membranes accompanied by blistering and reddening of the skin which might in very severe cases affect inner organs and might be life threatening (Stevens-Johnson syndrome, toxic epidermal necrosis) Tell your doctor or nurse as soon as possible if any of the following side effects happen: Very rare side effects (may affect less than 1 in 10,000 people)
- Acute kidney failure, which may cause you to pass less urine than is normal for you, fluid retention, breathlessness or fatigue/tiredness Not known (frequency cannot be estimated from available data)
- Temporary or irreversible hearing loss or deafness
- Unusual difficulty in moving which has not happened before
- Numbness, weakness and pain in the arms and legs (peripheral neuropathy)
- Blood in the urine
- Diarrhoea, with or without blood and/ or stomach cramps Tell your doctor or nurse if any of the following side effects gets serious or last longer than a few days. Also tell them if you notice any side effects not listed in this leaflet Very common side effects (may affect more than 1 in 10 people)
- Being sick (vomiting) Not known (frequency cannot be estimated from available data)
- Feeling sick (nausea)
- Inflammation of the gut (lower intestine) and mouth ulcers, associated with antibiotic use
- Rash, itching or a purplish or reddishbrown skin colouring 11503803-09
- Depression
- Seeing or hearing things that are not real (hallucinations)
- Feeling confused, tired or weak
- Fits
- Infection with other gentamicinresistant germs Other possible side effects: Very rare side effects (may affect less than 1 in 10,000 people)
- High levels of phosphate and amino acids (so-called Fanconi-like syndrome, associated with high doses given over a long time) Not known (frequency cannot be estimated from available data)
- Changes in the number of blood cells (including anaemia) – shown up in the results of blood tests
- Changes in the amount of liver enzymes – shown up in the results of blood tests
- A decrease in the level of magnesium in the blood, associated with prolonged therapy Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
gentamicin
- This medicine will be kept by your doctor or nurse in a safe place out of the sight and reach of children
- You will not be asked to store your medicine. It will be brought to you ready to be given straight away.
- Store below 25oC, do not refrigerate or freeze.
- Do not have this medicine after the expiry date. This is stated in month and year on the carton and on the label after "EXP". The expiry date refers to the last day of that month. If you are not sure when this is, check with your doctor or nurse.
- Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What gentamicin contains The active substance is gentamicin sulphate. Each ampoule contains the equivalent of 5mg of gentamicin. The other ingredients are sodium chloride and water for injections. What gentamicin looks like and content of the pack Gentamicin is available in packs of 5 ampoules. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom The Manufacturer is: Famar Health Care Services Madrid, S.A.U, Avda Leganes 62, Alcoron 28923, Madrid, Spain This leaflet was last revised in March 2024
1065040923
Frequently asked questions about Gentamicin Intrathecal 5mg/ml
What is the active substance in Gentamicin Intrathecal 5mg/ml?
The active substance in Gentamicin Intrathecal 5mg/ml is gentamicin sulfate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Gentamicin Intrathecal 5mg/ml, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Gentamicin Intrathecal 5mg/ml without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: gentamicin sulfate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. 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.
Gentamicin Intrathecal Injection is indicated as a supplement to systemic therapy in bacterial meningitis, ventriculitis and other bacterial infections of the central nervous system.
Consideration should be given to official local guidance on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
Bacterial meningitis and ventriculitis:
The starting dose of Gentamicin Intrathecal Injection for both children and adults is 1 mg daily, intrathecally or intraventricularly, together with 1 mg/kg every eight hours intramuscularly.
The MIC of the infecting organism in the C.S.F. should be assessed and, if necessary, the intrathecal/intraventricular dose increased to 5 mg daily, whilst keeping the intramuscular dose at 1 mg/kg eight-hourly.Treatment should be continued for at least 7 days but longer if necessary.Periodic serum and C.S.F. gentamicin assays should be carried out to ensure that adequate antibiotic levels are maintained and that serum and C.S.F. levels do not exceed 10 mg/l.
Method of administration
Intrathecal or intraventricular.
4.3. Contraindications
• Known hypersensitivity to the active substance (gentamicin), other aminoglycosides or any of the excipients listed in section 6.1.
• Myasthenia gravis and related conditions (evidence exists that gentamicin may cause neuromuscular blockade).
4.4. Special warnings and precautions for use
Ototoxicity and nephrotoxicity
Ototoxicity has been reported following the use of aminoglycosides, including gentamicin. Symptoms include loss of balance and hearing loss, which may be irreversible (see section 4.8). Important risk factors include renal impairment, high doses, prolonged duration of treatment and age (neonates/infants and possibly the elderly). Due to the potential for ototoxicity and nephrotoxicity, monitoring of vestibule, cochlea and renal function is recommended before, during and shortly after treatment (see section 4.8). Serum levels are determined so as to avoid peak concentrations above 10 mg/l and troughs above 1 mg/l when administrating gentamicin once daily and 2 mg/l when administering gentamicin twice daily.
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 blood-urea-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.
There is an increased risk of ototoxicity in patients with mitochondrial DNA mutations, (particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene), even if aminoglycoside serum levels are within the recommended range during treatment. Alternative treatment options should be considered in such patients. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
To avoid adverse events, continuous monitoring (before, during and after treatment) of hepatic and laboratory parameters is also recommended.
In patients with a maternal history of relevant mutations or aminoglycoside induced deafness, alternative treatments or genetic testing prior to administration should be considered.
Drug-resistant microorganisms
Treatment with gentamicin may produce an excessive growth of drug-resistant microorganisms. If this happens, an appropriate treatment should be initiated.
Clostridium difficile infection
Diarrhoea and pseudomembranous colitis have been observed when gentamicin is combined with other antibiotics. These diagnoses should be considered in every patient that develops diarrhoea during or immediately after treatment. Gentamicin should be discontinued if the patient suffers severe diarrhoea and/or bloody diarrhoea during treatment and an appropriate treatment should be initiated. Drugs that inhibit peristalsis should not be administered (see section 4.8).
Pregnancy
Gentamicin should only be used in pregnancy if considered essential by the physician (see section 4.6).
Conditions characterised by muscular weakness.
Gentamicin should be used with care in conditions characterised by muscular weakness.
Obesity
In cases of significant obesity gentamicin serum concentrations should be closely monitored and a reduction in dose should be considered
Important information about the ingredients of Gentamicin
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent administration of gentamicin 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 gentamicin. 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.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no proven cases of intrauterine damage caused by gentamicin. 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 gentamicin ingested from the milk is unlikely to result in significant blood levels in breast-fed infants.
4.7. Effects on ability to drive and use machines
Not known.
4.8. Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common (≥ 1/10); common (≥ 1/100 to ≤ 1/10); uncommon (≥ 1/1,000 to ≤ 1/100); rare (≥ 1/10,000 to ≤ 1/1,000); very rare (≤ 1/10,000); not known (cannot be estimated from the available data).
Infections and infestations:
Not known: antibiotic-associated colitis, pseudomembranous colitis, Superinfection (caused by gentamicin-resistant bacteria)
Blood and lymphatic system disorders:
Not known: anaemia, blood dyscrasia
Immune system disorders:
Not known: hypersensitivity, anaphylaxis/anaphylactic reaction (including anaphylactic shock)
Metabolism and nutrition disorders:
Not known: hypomagnesaemia on prolonged therapy
Psychiatric disorders:
Not known: depression, hallucinations, confusion
Nervous system disorders:
Not known: central neuropathy (including convulsions, lethargy, encephalopathy), peripheral neuropathy
Ear and labyrinth disorders:
Not known: transitory hearing loss, irreversible hearing loss, deafness, particularly after exposure to ototoxic drugs or in the presence of renal dysfunction (see section 4.4).
Gastrointestinal disorders:
Not known: stomatitis, nausea, vomiting
Hepatobiliary disorders:
Not known: abnormal liver function, transaminases increased
Skin and subcutaneous tissue disorders:
Not known: rash, purpura, urticaria, pruritus, Steven Johnson syndrome, toxic epidermal necrosis
Renal and urinary disorders:
Very rare: acute renal failure, Fanconi-like syndrome in patients treated with a prolonged course of high-dose
Not known: nephrotoxicity (usually reversible) has been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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 gentamicin
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- GENTAMICINA NORIDEM 20 mg/ml prescriptionGENTAMICINUM · injection / infusion
- GENTAMICINA NORIDEM 40 mg/ml prescriptionGENTAMICINUM · injection / infusion
- GENTAMICINA NORIDEM 80 mg/ml prescriptionGENTAMICINUM · injection / infusion
- GENTAMICIN KRKA 40 mg/1 ml prescriptionGENTAMICINUM · injection / infusion
- GENTAMICIN KRKA 80 mg/2 ml prescriptionGENTAMICINUM · injection / infusion
- GENTAMICINA SULFAT EIPICO 3 mg/ml prescriptionGENTAMICINUM · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- GaramycinGentamicini sulfas
- Gentamycin KRKAGentamicinum · injection / infusion
- Gentamicin WZF 0,3%Gentamicinum · eye / ear / nose
- Gentamicin WZF 0.3 % - vetGentamicinum · eye / ear / nose
- Gentamicin B.BraunGentamicinum · injection / infusion
- BiometrigenGentamicini sulfas · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Gentamicin Intrathecal 5mg/ml. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Gentamicin sulfate
- Cidomycin 80mg/2ml Solution for Injection
- Gentamicin 1 mg/ml solution for infusion
- Gentamicin 10mg/ml Solution for Injection or Infusion
- Gentamicin 3 mg/ml solution for infusion
- Gentamicin 40mg/ml Solution for Injection or Infusion
- Gentamicin 40mg/ml Solution for Injection/Infusion
- Gentamicin Eye/Ear Drops 0.3% w/v
- Gentamicin Paediatric 20mg/2ml Solution for Injection
- Genticin (Gentamicin 0.3% w/v) Eye/Ear Drops
- Genticin (Gentamicin) 40mg/ml Injectable