1 g powder and solvent for solution for injection ceftriaxone
(as ceftriaxone sodium), lidocaine (as lidocaine hydrochloride)
What Rocephalin with lidocaine is and what it is used for
Rocephalin with lidocaine is an antibiotic given to adults and children (including newborns). It works by killing bacteria that cause you an infection. It belongs to a group of medicines called cephalosporins. Rocephalin with lidocaine is given as an injection into the muscle in a solution containing lidocaine, which reduces the pain that an injection can cause.
Rocephalin with lidocaine is used to treat infections in:
- the brain ( meningitis ).
- the lungs.
- middle ear.
- the abdomen or abdominal wall (peritonitis).
- the urinary tract and kidneys.
- legs and joints.
- the skin or soft tissues.
- the blood.
- the heart.
It can be given:
- to treat certain sexually transmitted diseases ( gonorrhea and syphilis ).
- to treat patients with low white blood cell count ( neutropenia ) who have a fever caused by a bacterial infection.
- to treat your chest infection in adults with chronic bronchitis.
- to treat Lyme disease (caused by tick bites) in adults and children including newborns from 15 days of age.
- to prevent infection during surgery.
What you need to know before you are treated with Rocephalin with lidocaine
You should not be treated with Rocephalin with lidocaine if:
- You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
- You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Symptoms include sudden swelling of the throat or face which may make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, and severe rashes that develop rapidly.
- You are allergic to lidocaine and you should receive Rocephalin with lidocaine as an injection into a muscle.
- You suffer from abnormal conduction of impulses in the heart that causes lowered blood pressure, and slow heart rate (complete heart block).
- You have a low blood volume ( hypovolemia ).
Rocephalin with lidocaine should not be given to infants if:
- The baby is born prematurely.
- The child is a newborn (up to 28 days of age) and has certain types of blood problems or jaundice (yellowing of the skin or whites of the eyes) or if the child is to be given a product that contains calcium in a vein.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before you are treated with Rocephalin with lidocaine if:
- You have recently received or will receive products that contain calcium.
- You have recently had diarrhea after taking an antibiotic. Have you ever had problems with your stomach, especially colitis ( inflammation of the intestines)?
- You have liver or kidney problems (see section 4).
- You have gallstones or kidney stones.
- You have had other diseases, such as hemolytic anemia (a decrease in your red blood cells that can make your skin pale yellow and cause weakness or shortness of breath).
- You have been prescribed a low-salt diet.
- You suffer from loss of muscle function and weakness ( myasthenia gravis ).
- You suffer from seizures ( epilepsy ).
- You suffer from a heart problem, especially if it affects your heart rate.
- You have problems with your breathing.
- You have porphyria (an unusual inherited disease that affects the skin and nervous system).
- You experience or have previously experienced a combination of some of the following symptoms: skin rash, redness, blisters on lips, eyes, and mouth, scaly skin, high fever, flu-like symptoms, increased levels of liver enzyme seen in blood tests, and an increase in a type of white blood cells ( eosinophilia ) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).
If you need a blood or urine sample
If you are being treated with Rocephalin with lidocaine for a long time, you may need to have regular blood tests. Rocephalin with lidocaine can affect the results of tests for sugar in the urine and a blood test called the Coombs test. If you are going to take a test:
- Tell the person taking the test that you are being treated with Rocephalin with lidocaine.
If you are diabetic or need to monitor your blood sugar level, do not use certain types of blood glucose meters as these may calculate your blood sugar incorrectly while you are receiving ceftriaxone. If you use such meters, read the instructions for use and talk to your doctor, pharmacist, or nurse. Alternative test methods should be used if necessary.
Children and young people
Talk to your doctor, pharmacist, or nurse before treating your child with Rocephalin with lidocaine if:
- He/she has recently received or will receive, a product that contains calcium in a vein.
Other medicines and Rocephalin with lidocaine
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, as they may interact with ceftriaxone:
- A type of antibiotic is called an aminoglycoside.
- An antibiotic called chloramphenicol (used to treat infections, especially in the eyes).
A large number of drugs can interact with lidocaine and their effect can be affected. These medicines include:
- drugs used to treat infections (clarithromycin, erythromycin).
- medicines used to treat stomach ulcers (eg cimetidine).
- strong painkillers such as codeine and pethidine.
- drugs used to treat irregular heart rhythms (eg mexiletine, cocaine).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will weigh the benefits of treating you with Rocephalin with lidocaine against the risk to your child.
Driving and using machines
Rocephalin with lidocaine may cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience any of these symptoms.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How Rocephalin with lidocaine is given
Rocephalin with lidocaine is usually given by a doctor or nurse. It is given as an injection directly into a muscle. Rocephalin with lidocaine is prepared by your doctor, pharmacist, or nurse and will not be mixed with or given at the same time as calcium-containing injections.
The usual dose is one
Your doctor will determine the correct dose of Rocephalin with lidocaine for you. Dose one depends 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 you receive Rocephalin with lidocaine depends on the type of infection you have.
Adults, the elderly, and children 12 years or older and weighing 50 kilograms (kg) or more:
- 1 to 2 g once a day depending on the severity and type of infection. If you have a serious 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 can get it as a single dose once a day or as two separate doses.
Newborns and children from 15 days to 12 years of age with a body weight of less than 50 kg:
- 50-80 mg Rocephalin with lidocaine for every kg of the child’s body weight once daily depending on the severity and type of infection. If you have a serious infection, your doctor will give you a higher dose up to 100 mg per kg body weight up to a maximum of 4 g once daily. If your daily dose is higher than 2 g, you can get 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 Rocephalin with lidocaine for every kg of the baby’s body weight once daily depending on the severity and type of infection.
- The maximum daily dose should not exceed 50 mg for each kg of body weight of the child.
People with liver and kidney problems
You may be given a different dose than the standard dose. Your doctor will decide how much Rocephalin with lidocaine you need and will monitor you carefully depending on how severe your liver or kidney disease is.
If you have been given more Rocephalin with lidocaine than you should
If you accidentally get more than one prescribed dose, contact your doctor or nearest hospital immediately.
If you forget to use Rocephalin with lidocaine
If you miss an injection, get it as soon as possible. However, if it is soon time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to compensate for a missed dose.
If you stop using Rocephalin with lidocaine
Do not stop taking Rocephalin with lidocaine unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor or nurse.
Rocephalin with lidocaine contains sodium
This medicine contains 85.4 mg sodium (the main ingredient in table salt/table salt) per 1 g vial. This corresponds to 4.3% of the highest recommended daily intake of sodium for adults.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Treatment with ceftriaxone, especially in elderly patients with severe kidney or nervous system problems, may in rare cases cause decreased consciousness, abnormal movements, agitation, and seizures.
Severe allergic reactions (not known frequency, can not be calculated from the available data)
If you get a severe allergic reaction, tell your doctor immediately.
Symptoms may include:
- Sudden swelling of the face, neck, lips, or mouth. This may make it difficult to breathe or swallow.
- Sudden swelling of hands, feet, or ankles.
Severe skin reactions (not known frequency, can not be calculated from the available data)
If you get severe skin reactions, tell your doctor immediately.
Symptoms may include:
- Severe rash that develops suddenly, with blisters or scaling of the skin and possibly blisters in the mouth (Steven-Johnson syndrome and toxic epidermal necrolysis also known as SJS and TEN).
- A combination of some of the following symptoms: scattered skin rash, high body temperature, elevated liver enzyme levels, abnormal blood levels ( eosinophilia ), enlarged lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms also known as DRESS or hypersensitivity syndrome).
- Jarisch-Herxheimer reaction causes fever, chills, headache, muscle aches, and a rash which is usually transient. This occurs shortly after starting treatment with Rocephalin with lidocaine for spirochete infections such as Lyme disease.
Other possible side effects:
Common (may affect up to 1 in 10 people)
- Abnormalities in your white blood cells (such as a decrease in leukocytes and an increase in eosinophils ) and platelets (decrease in platelets ).
- Loose stools or diarrhea.
- Changes in the results of blood tests for liver function.
Uncommon (may affect up to 1 in 100 people)
- Fungal infections (eg cod).
- A decrease in the number of white blood cells ( granulocytopenia ).
- A decrease in the number of red blood cells ( anemia ).
- Problems with how your blood clots. Symptoms may include bruising and pain and swelling in the joints.
- Nausea or vomiting.
- Pruritus ( itching ).
- Pain or a burning sensation along the vein in which Rocephalin with lidocaine was given. Pain where the injection was given.
- High body temperature (fever).
- Abnormal kidney function test (increased blood creatinine).
Rare (may affect up to 1 in a thousand people)
- Inflammation of the colon ( colon ). Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.
- Difficulty breathing.
- Elevated rash ( hives ) that can cover large parts of your body, an itchy feeling, and swelling.
- Blood or sugar in your urine.
- Edema (fluid accumulation).
No known frequency (can not be calculated from the available data)
- A secondary infection that may not respond to the antibiotics previously prescribed.
- A type of anemia in which red blood cells are destroyed ( hemolytic anemia ).
- Severe decrease in white blood cells ( agranulocytosis ).
- Dizziness (a tingling sensation).
- Inflammation of the pancreas ( pancreatitis ). Symptoms include severe abdominal pain that spreads to your back.
- Inflammation of the mucous membrane of the mouth ( stomatitis ).
- Inflammation of the tongue ( glossitis ). Symptoms include swelling, redness, and soreness of the tongue.
- Problems with the gallbladder and/or liver can cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-colored stools.
- A neurological condition that can occur in newborns with severe jaundice (kernicterus).
- Kidney problems caused by precipitation of calcium ceftriaxone. Pain may occur when urinating or with low urine output.
- A false-positive result for the Coombs test (a test for certain blood problems).
- A false-positive test for galactosemia (an abnormal accumulation of the galactose sugar).
- Rocephalin with lidocaine can interfere with certain types of blood glucose tests – ask your doctor.
Other side effects may occur after accidental injection of lidocaine into a blood vessel when administered in a muscle together with Rocephalin with lidocaine. Such side effects may include:
No known frequency (can not be calculated from the available data)
- Changes in heart rate and velocity
- Low blood pressure
- Slow heartbeat (less than 60 beats/minute)
- Disruption of normal blood circulation due to cardiac arrest and loss of blood flow
- Loss of balance, tingling and tingling around the mouth, numbness in the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears ( tinnitus ), dizziness or dizziness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epileptic seizures, deep unconsciousness ( coma ).
- Blurred vision, double vision, or temporary loss of vision
- Nausea or vomiting
- Breathing difficulties
- Decreased respiratory rate or cessation of breathing
- Feeling of abnormal drowsiness or tiredness during the day or fainting
How to store Rocephalin with lidocaine
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 of the vial after the abbreviation EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Keep the vial in the outer carton. Sensitive to light.
The chemical and physical in-use stability of the reconstituted solution is 6 hours if stored at 25 ° C or lower and 24 hours if stored in a refrigerator (2 ° C-8 ° C).
From a microbiological point of view, medicine should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user and would normally not be longer than that indicated above for the chemical and physical in-use stability of the reconstituted solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
The active substances are ceftriaxone and lidocaine
One vial contains 1 g of ceftriaxone as ceftriaxone sodium.
One ampoule contains 35 mg of lidocaine hydrochloride in 3.5 ml.
The displacement volume of 1g Rocephalin is 0.71 ml in 1% lidocaine hydrochloride solution. When 3.5 ml of 1% lidocaine hydrochloride solution is added, the final concentration of the reconstituted solution is 237.53 mg/ml.
Rocephalin with lidocaine should not be mixed in the same syringe with any medicine.
What the medicine looks like and the contents of the pack
Rocephalin with lidocaine consists of powder and solvent for solution for injection.
The powder is white to yellow-orange. The solution is clear and colorless.
Rocephalin with lidocaine is available in packs of 1 or 5 vials and 1 or 5 ampoules.
Not all pack sizes may be marketed
Marketing Authorisation Holder
171 23 Solna
This medicinal product is authorized under the European Economic Area under the names:
Belgium, Luxembourg: Rocephine IM + Lidocaine
Finland, Sweden: Rocephalin with lidocaine
Netherlands, UK: Rocephin IM