Powder for injection 500mg, 1 g
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 or pharmacist. This includes any possible side effects not listed in this leaflet.
- If you have any further questions, ask your doctor or pharmacist.t
it is used f
Afaxon® is used to treat infections caused by bacteria.
These include infections of the:
Lower Respiratory Tract Infections, Skin and Skin Structure Infections, Complicated and Uncomplicated Urinary Tract Infections, Pelvic Inflammatory Disease, Bacterial Septicemia, Bone and Joint Infections, Intra-abdominal Infections, Meningitis, and Surgical Prophylaxis.
Before use this drug, ask your doctor:
- If you are allergic to ceftriaxone or other cephalosporin class antibacterials, penicillins, or other beta-lactam antibacterials.
- Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.
- If you are allergic to lidocaine and you are to be given Ceftriaxone for injection as an injection into a muscle.
Ceftriaxone for injection must not be given to babies if:
- 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.
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 or pharmacist for advice before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Ceftriaxone for injection if:
- An allergic reaction Include anaphylaxis and serious skin reactions occur discontinue the drug.
- You have recently received or are about to receive products that contain calcium. Do not administer simultaneously with calcium-containing IV solutions.
- 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.
- You have gall stones or kidney stones.
- You have other illnesses, such as hemolytic anemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).
- You are given Ceftriaxone for injection for a long time; you may need to have regular blood tests. Ceftriaxone for injection can affect the results of urine tests for sugar and a blood test.
- You are on a low sodium diet. (The sodium content of each gram of ceftriaxone is approximately 3.6 mEq Sodium ion)
- 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).
Driving and using machines
Ceftriaxone for injection may cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience these symptoms.
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.
Method of administration
- Intramuscular administration
1g ceftriaxone should be dissolved in 3.5ml of 1% lidocaine Injection.
2g ceftriaxone should be dissolved in 7.0ml of 1% lidocaine Injection.
The solution should be administered by deep intramuscular injection.
Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1g should be injected at one site.
Dosages greater than 1g should be divided and injected at more than one site.
As the solvent used is lidocaine, the resulting solution should never be administered intravenously.
- Intravenous administration
Ceftriaxone 1g powder for solution for injection
For IV injection 1g ceftriaxone is dissolved in 10 ml of water for injections.
The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.
- For i.v. infusion
500 mg and 1 g ceftriaxone is dissolved in 4.8 ml and 9.6 mL of sterile water then diluted with one of the following calcium-free infusion solutions: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxy ethyl starch 6- 10%, water for injections (up to 50 or 100 mL).
The infusion should be given over at least 30 minutes.
Do not use diluents containing calcium, such as Ringer’s solution.
The recommended dose
The medicine should be taken for the prescribed number of days.
Your doctor will decide the correct dose of Ceftriaxone for injection 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 for injection 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 2g 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 4g once a day). If your daily dose is higher than 2g, 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 4g once a day. If your daily dose is higher than 2g, 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.
People with liver and kidney problems
You may be given a different dose to the usual dose. Your doctor will decide how much Ceftriaxone for injection you will need and will check you closely depending on the severity of the liver and kidney disease.
If you are given more Ceftriaxone for injection 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 for injection
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 for injection
Do not stop taking Ceftriaxone for injection unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 rashes (not known, frequency cannot be estimated from the available data)
If you get a severe skin rash, 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.
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
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 (anemia), 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 along the vein where Ceftriaxone for injection has been given, pain where the injection was given, 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 ( 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, edema (fluid build-up), shivering.
Special precautions for storage
- 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 label. The expiry date refers to the last day of that month.
- The vials and bottles should not be stored above 25°C.
- Keep the vial or bottle in the outer carton in order to protect from light.
- For a microbiological point of view, the product should be used immediately. In use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. Once reconstituted, any unused portion of solution should be discarded.
- Do not throw away any medicines via wastewater or household waste.
Each vial contains:
Ceftriaxone (as sodium) 500mg, 1g
Manufacture by Afa chemi pharmaceutical co. Tehran-Iran.