Patient leaflet - Ceftriaxone 1 g powder for solution for injection/infusion
1. What is Ceftriaxone and what it is used for
Ceftriaxone is is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone is used to treat infections of:
- the brain (meningitis).
- the lungs.
- the middle ear.
the abdomen and abdominal wall
(peritonitis).
- the urinary tract and kidneys.
- bones and joints.
- the skin or soft tissues.
- the blood.
- the heart.
It can be given:
to treat specific sexually transmitted
infections (gonorrhoea and syphilis).
to treat patients with low white blood
cell counts (neutropenia) who have fever due to bacterial infection.
to treat infections of the chest in adults
with chronic bronchitis.
to treat Lyme disease (caused by tick
bites) in adults and children including newborn babies from 15 days of age.
- to prevent infections during surgery.
2. What you need to know before you are given Ceftriaxone
The nurse or doctor giving you this medicine will ask some questions about you. They need the following information before you have this medicine for the first time.
You must not be given Ceftriaxone:
If you are allergic to ceftriaxone or
any of the other ingredients of this medicine (listed in section 6).
If you have had a sudden or severe
allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). If the signs include sudden swelling of the throat or face which might make it difficult to breath or swallow, sudden swelling of the hands, feet and ankles, chest pain and a severe rash that develops quickly.
If you are allergic to lidocaine and
you are to be given Ceftriaxone as an injection into a muscle.
Ceftriaxone must not be given to babies:
- If the baby is premature.
If the baby is newborn (up to 28
days of age) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is to be given a product that contains calcium into their vein.
Warnings and precautions
Talk to your doctor or nurse before you are given Ceftriaxone if:
You have recently received or are
about to receive products that contain calcium.
You have recently had diarrhoea after
having an antibiotic medicine. You have ever had problems with your gut, in particular colitis (inflammation of the bowel).
You have liver or kidney problems (see
- You have gall stones or kidney stones
You have other illnesses, such as
haemolytic anaemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).
- You are on a low sodium diet.
You experience or have previously
experienced a combination of any of the following symptoms: rash, red skin, blistering of the lips eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).
If you need a blood or urine test
If you are given Ceftriaxone for a long time, you may need to have regular blood tests. Ceftriaxone can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:
- Tell the person taking the sample that you have been given Ceftriaxone.
If you are diabetic or need to have your blood glucose level monitored you should not use certain blood glucose monitoring systems which may estimate blood glucose incorrectly while you are receiving ceftriaxone. If you use such systems check the instructions for use and tell your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.
Children
Talk to your doctor or pharmacist or nurse before your child is administered Ceftriaxone if:
- He/She has recently been given or is to be given a product that contains calcium into their vein.
Other medicines and Ceftriaxone
Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
A type of antibiotic called an
aminoglycoside.
An antibiotic called chloramphenicol
(used to treat infections, particularly of the eyes).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The doctor will consider the benefit of treating you with Ceftriaxone against the risk to your baby.
Driving and using machines
Ceftriaxone can cause dizziness. If you feel dizzy, do not
drive or use any tools or machines. Talk to your doctor
if you experience these symptoms.
Ceftriaxone contains sodium
If you are on a low sodium diet, it is important to know how much sodium is in your medicine.
Each gramme of this medicine contains approximately 3.6mmol (millimoles) of sodium.
3. How Ceftriaxone is given
Ceftriaxone is usually given by a doctor or nurse. It can be given as
- a drip (intravenous infusion) or as an injection directly into a vein or
- into a muscle.
Ceftriaxone is made up by the doctor, pharmacist or nurse and will not be mixed with or given to you at the same time as calcium-containing injections.
The usual dose
Your doctor will decide the correct dose of Ceftriaxone for you. The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working. The number of days or weeks that
you are given Ceftriaxone depends on what sort of infection you have.
Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):
- 1 to 2 g once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.
Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg:
- 50-80 mg Ceftriaxone for each kg of the child’s body weight once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose up to 100 mg for each kg of body weight to a maximum of 4 g once a day. If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.
- Children with a body weight of 50 kg or more should be given the usual adult dose.
Newborn babies (0-14 days):
- 20 – 50 mg Ceftriaxone for each kg of the child’s body weight once a day depending on the severity and type of infection.
- The maximum daily dose is not to be more than 50 mg for each kg of the baby’s weight.
Patients with liver and kidney problems:
You may be given a different dose to the usual dose. Your doctor will decide how much Ceftriaxone you will need and will check you closely depending on the severity of the liver and kidney disease.
If you are given more Ceftriaxone than you should
If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.
If you forget to use Ceftriaxone
If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a missed dose.
If you stop using Ceftriaxone
Do not stop taking Ceftriaxone unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse. Arial 9pt 160x840mm
Instructions for use and handling
Single use only, whereby any unused solution should be discarded.
The use of freshly prepared solutions is recommended. Τhese maintain potency for at least 6 hours at or below 25o C, or 24 hours at 2-8οC (see section 6.3). Protect from light.
The reconstituted solution should be clear. Do not use if particles are present. Ceftriaxone when reconstituted with Water for Injections is a light to dark yellow solution. Variations in the intensity of the colour will not affect the potency of the drug.
Ceftriaxone should not be mixed in the same syringe with any drug other than 1.06% Lidocaine Hydrochloride BP Solution (for intramuscular injection only).
Solutions containing ceftriaxone should not be mixed with or added to solutions containing other agents than listed below (see section 6.6). In particular diluents containing calcium, (e.g. Ringer’s
solution, Hartmann’s solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions
The reconstituted solution should be shaken for approximately 90 seconds to ensure complete dissolution of the ceftriaxone.
The user should then allow the solution to stand in order to ensure that there are no bubbles in the solution.
Intramuscular injection:
250mg Ceftriaxone should be dissolved in 1ml of 1.06% Lidocaine Hydrochloride BP solution or 1 g in 3.5 ml of 1.06% Lidocaine Hydrochloride BP. The solution should be administered by deep intramuscular injection. Dosages greater than 1g should be divided and injected at more than one site.
Solutions in Lidocaine should not be administered intravenously.
4. Possible side-effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may happen with this medicine:
Treatment with ceftriaxone, particularly in elderly patients with serious kidney or nervous system problems may rarely cause decreased consciousness, abnormal movements, agitation and convulsions.
Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have a severe allergic reaction, tell a doctor straight away.
The signs may include:
Sudden swelling of the face, throat,
lips or mouth. This can make it difficult to breathe or swallow.
Sudden swelling of the hands, feet and
ankles.
Chest pain in the context of allergic
reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome).
Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you get a severe skin reaction, tell a doctor straight away.
The signs may include:
A severe rash that develops quickly,
with blisters or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis which are also known as SJS and TEN).
A combination of any of the following
symptoms: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Jarisch-Herxheimer reaction which
causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting Ceftriaxone treatment for infections with spirochete such as Lyme disease.
Other possible side effects:
Common (may affect up to 1 in 10 people)
Abnormalities with your white
blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).
- Loose stools or diarrhoea.
Changes in the results of blood tests
for liver functions.
- Rash.
Uncommon (may affect up to 1 in 100 people)
Fungal infections (for example, thrush
or genital fungal infections).
A decrease in the number of white
blood cells (granulocytopenia).
Reduction in number of red blood cells
(anaemia).
Problems with the way your blood
clots. The signs may include bruising easily and pain and swelling of your joints.
- Headache.
- Dizziness.
- Feeling sick or being sick.
- Pruritis (itching).
Pain or a burning feeling where
Ceftriaxone has been given. Blisters, bruising, deep redness or rash, irritation, itching, hardening of the skin or swelling at the injection site.
- A high temperature (fever).
Abnormal kidney function test (blood
creatinine increased).
Rare (may affect up to 1 in 1,000 people)
Inflammation of the large bowel
(colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and fever.
- Difficulty in breathing (bronchospasm).
A lumpy rash (hives) that may cover a
lot of your
- body, feeling itchy and swelling.
- Blood or sugar in your urine.
- Oedema (fluid build-up).
- Shivering.
- Infection at the site of injection.
Not known (Frequency cannot be estimated from the available data)
A secondary infection that may not
respond to the antibiotic previously prescribed.
Form of anaemia where red blood cells
are destroyed (haemolytic anaemia).
Severe decrease in white blood cells
(agranulocytosis).
- Convulsions.
- Vertigo (spinning sensation).
Inflammation of the pancreas
(pancreatitis). The signs include severe pain in the stomach which spreads to your back.
Inflammation of the mucus lining of the
mouth (stomatitis).
Inflammation of the tongue (glossitis).
The signs include swelling, redness and soreness of the tongue.
Problems with your gallbladder and/or
liver which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay coloured stools.
A neurological condition that may
occur in neonates with severe jaundice (kernicterus).
Kidney problems caused by deposits
of calcium ceftriaxone. There may be pain when passing water (urine) or low output of urine.
A false positive result in a Coombs’
test (a test for some blood problems).
A false positive result for
galactosaemia (an abnormal build up of the sugar galactose).
Ceftriaxone may interfere with some
types of blood glucose tests - please check with your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist 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, Website:
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.
5. How to store Ceftriaxone
Your doctor, nurse or pharmacist will usually store your medicine for you. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the label on the glass container (vial) after EXP. The expiry date refers to the last day of the month. Store below 25ºC. Always keep the glass container in the outer carton. Protect from light. Once the powder has been made into a liquid solution, it should be used immediately or within 24 hours if it is kept in the fridge, i.e. 2-8 oC or 6 hours if it is kept at or below 25oC. Protect from light. Only use the solution if it is clear and contains no particles or specks of powder. Give any leftover medicine to your doctor, nurse or pharmacist. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Ceftriaxone contains
The active substance is Ceftriaxone. There are no other ingredients in your medicine. Each glass container will contain either 250 mg, 1 g or 2 g of Ceftriaxone powder.
What Ceftriaxone looks like and contents of the pack
Ceftriaxone is a white to pale yellow powder for solution for injection or infusion. This means liquid must be added to make a solution before it can be given to you as an injection. In some cases, more liquid may be added to make a weaker solution which can then be given to you as an infusion (a drip).
Normally your doctor, nurse or pharmacist will prepare your medicine before it is given to you.
Contents of the pack
250mg, 1g: Each pack contains 1, 5, 10, 20 or 50 vials (glass containers). 2g: Each pack contains 1, 5, 10, 20 or 50 vials (glass containers). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Noridem Enterprises Ltd.,
Evagorou & Makariou,
Mitsi Building 3, Office 115,
1065 Nicosia, Cyprus.
Manufacturer:
Demo S.A. PHARMACEUTICAL INDUSTRY, 21st Km National Road Athens-Lamia,
14568 Krioneri, Attiki, Greece,
T: +30 210 8161802,
F: +30 210 8161587.
This leaflet was last revised in 05/2026.
Intravenous injection:
250mg Ceftriaxone should be dissolved in 5ml or 1 g Ceftriaxone should be dissolved in 10ml of Water for Injections BP. The injection should be administered over at least 2-4 minutes, directly into the vein or via the tubing of an intravenous infusion.
Intravenous infusion:
2g Ceftriaxone should be dissolved in 40ml of one of the following calcium-free solutions: Dextrose injection BP 5% or 10%, Sodium Chloride Injection BP, Sodium Chloride and Dextrose Injection BP (0.45% Sodium Chloride and 2.5% Dextrose), Dextran 6% in Dextrose Injection BP 5%, hydroxyethyl starch 6-10% infusions. First, the powder is reconstituted in 20 mL of compatible diluent. The reconstituted solution is further diluted with 20 mL of compatible diluent to a concentration of 48 mg/ mL using an appropriate administration device (e.g. infusion pump, infusion bag). The infusion should be administered over at least 30 minutes.
The displacement value of 250mg of Ceftriaxone is 0.194ml.
Please refer to the Summary of Product Characteristics for full information.