CEFTRIAXONE 2 G POWDER FOR SOLUTION FOR INJECTION/INFUSION - patient leaflet, side effects, dosage

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Package leaflet: Information for the Patient

Ceftriaxone 1 g powder for solution for injection/infusion

Ceftriaxone 2 g powder for solution for injection/infusion

Ceftriaxone (as Ceftriaxone Sodium)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Ceftriaxone is and what it is used for

• 2. What you need to know before you are given Ceftriaxone

• 3. How Ceftriaxone is given

• 4. Possible side effects

• 5. How to store Ceftriaxone

• 6. Contents of the pack and other information

1. what ceftriaxone is and what it is used for

Ceftriaxone 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.

You must talk to a doctor if you do not feel better or if you feel worse.

2. what you need to know before you are given ceftriaxone

You must not be given Ceftriaxone if:

• You are allergic to ceftriaxone.
• You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). 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, and a severe rash that develops quickly.
• You are allergic to lidocaine and you are to be given ceftriaxone as an injection into a muscle.
• The baby is premature.
• 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 pharmacist 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 section 4).
• 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 being 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 or pharmacist 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, breast-feeding and fertility

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 receiving 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

1g vial: This medicine contains 82.8 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 4.14% of the recommended maximum daily dietary intake of sodium for an adult.

2g vial: This medicine contains 165.6 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 8.28% of the recommended maximum daily dietary intake of sodium for an adult.

• 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 prepared 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 recommended 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, elderly 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 recommended adult dose.
• 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.

People with liver and kidney problems

You may be given a different dose to the recommended 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.

The following information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

Ceftriaxone 1 g powder for solution for injection/infusion

Ceftriaxone 2 g powder for solution for injection/infusion

Ceftriaxone (as Ceftriaxone Sodium)

Please refer to the Summary of Product Characteristics for full prescribing information.

Method of Administration Intramuscular administration Ceftriaxone can be administered by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site.

As the solvent used is lidocaine, the resulting solution should never be administered intravenously. The information in the Summary of Product Characteristics of lidocaine should be considered.

Intravenous administration Ceftriaxone can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy. Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g intravenous administration should be used.

Ceftriaxone is contraindicated in neonates (< 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium.

Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s so­lution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously.

For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30–90 minutes prior to surgery.

Instructions for use

Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C and for 24 hours at 2–8°C.

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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 miss a dose of Ceftriaxone If you miss your dose of this medicine, you should receive it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. You must not receive a double dose (two injections at the same time) to make up for a missed dose.

If you stop receiving Ceftriaxone Do not stop receiving ceftriaxone unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

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.

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 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).
• 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.
• Pruritus (itching).
• Pain or a burning feeling on the spot or along the vein where this medicine has been given. Pain where the injection was given.
• 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.
• Treatment with ceftriaxone, particularly in elderly patients with serious kidney or nervous system problems may rarely cause decreased consciousness, abnormal movements, agitation and convulsions.

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, which may cause pain, feeling sick and being sick.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

Website: 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 or pharmacist is responsible for storing ceftriaxone. They are also responsible for disposing of any unused ceftriaxone correctly.
• 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 or vial. The expiry date refers to the last day of that month.
• Do not store above 25°C, keep vial in the outer carton in order to protect from light.

Chemical and physical in-use stability has been demonstrated for 6 hours at 25°C and for 24 hours at 2–8°C.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not throw away any medicines via wastewater. Ask your pharmacist 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 in ceftriaxone powder for solution for injection or infusion is ceftriaxone.

• 1 g: Each vial contains ceftriaxone sodium equivalent to 1 g ceftriaxone.

• 2 g: Each vial contains ceftriaxone sodium equivalent to 2 g ceftriaxone.

Each gram of ceftriaxone sodium contains approximately 3.6 mmol (82.8 mg) sodium.

There are no other ingredients in ceftriaxone.

What Ceftriaxone looks like and contents of the pack

• Ceftriaxone is a powder for solution for injection/infusion. It is almost white or yellowish crystalline powder in colour. It is supplied in a glass vial. The solution after reconstitution is pale-yellow to yellow coloured, depending on the length of storage, concentration and diluent used but this does not affect the efficacy of the active substance. Only clear solution free from particles should be used.
• Before it is given to the patient, ceftriaxone is made into a solution by adding sterile liquid to the vial. The correct dose is then taken out of the vial. It can be given to the patient either as an injection or added to a bag of infusion solution which is given through a small tube into one of your veins.
• Ceftriaxone is supplied in packs of 1, 10 and 100 vials. Not all pack sizes may be marketed.