Cefoject® ( Cefotaxime ) 500mg

Cefoject®

Cefotaxime

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.

• Keep this leaflet. You may need to read it again while you are receiving your treatment.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.it is used f

Cefoject® Injection is an antibiotic belonging to a group called “cephalosporins”. It is generally effective to fight a range of micro-organism. It is used for the treatment of a range of serious bacterial infections of:

• the lungs (pneumonia)
• the urinary tract
• the membranes covering the brain (meningitis)
• the abdomen
• the skin and soft tissue
• the genitals with gonococci
• preoperative prophylaxis in colorectal surgery

 

Before use this drug, ask your doctor:

• if you are allergic (hypersensitive) to Cefotaxime or any other Cephalosporins
• if you previously had acute and/or severe allergic reactions to penicillin or any other beta-lactam antibiotic
• to infants under 30 months
• if you are allergic (hypersensitive) to Lidocaine or other local Anaesthetics of the amide type
• if you have irregular heartbeat
• if you have heart problems which can cause shortness of breath or ankle swelling
• if you are receiving Cefotaxime Injection intravenously (directly into your bloodstream)
• if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• other antibiotics (such as Penicillins, Aminoglycosides, Tetracyclines, Erythromycin and Chloramphenicol)
• Diuretics (e.g. furosemide)
• Probenecid (for the treatment of gout and arthritis) may increase or decrease the effect of Cefotaxime Injection. Inform your doctor if you are in treatment with these medicines

 

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant or are planning to become pregnant, your doctor has to determine if a treatment with Cefotaxime Injection is suitable for you. Cefotaxime Injection excretes in breast milk in low concentrations. Therefore it should not be used during breast-feeding.

 

Warnings and precautions

Tell your doctor or healthcare professional if:

• you have ever had an allergic or hypersensitive reaction to penicillin or other medicines from the penicillin family (beta-lactam-antibiotics)
• experience skin reactions. Contact your doctor immediately
• you suffer from severe allergies or asthma
• you develop severe persistent (bloody) diarrhoea. You may have an inflammation of the large intestine caused by the use of Cefotaxime. In that case, the use of Cefotaxime Injection must be stopped immediately. Do not take medicines that reduce bowel movements
• you have kidney problems
• you are on a low-sodium (low salt) diet. This medicinal product contains 48 mg sodium per gram.

 

Driving and using machines

The effect of Cefotaxime on the ability to drive and use machines has not been investigated. However, this medicine may cause impairment of consciousness, abnormal movements and dizziness in some patients. If this happens, do not drive or use machines.

 

Medical Tests

This medicine can alter the results of some blood and urine tests. If you are having blood tests (such as Coombs’ test) or urinary sugar tests (the Fehling’s type which test for reducing sugars) tell your doctor you are taking this medicine as this medicine may cause false positive results.

 

Method of administration

• Intramuscular administration

500mg Cefotaxime should be dissolved in 2ml of water for injection.

1g Cefotaxime should be dissolved in 3ml of water for injection.

Afterwards the injection should take place deep into the gluteal muscle.

• Intravenous administration

For IV injection 1g Cefotaxime or 500mg Cefotaxime is dissolved in 10 ml of water for injections.

Subsequently injected directly into the vein over 3 to 5 minutes

• For i.v. infusion

500 mg and 1 g Cefotaxime is dissolved in 50-100ml of sodium chloride 0.9% or dextrose 5%, dextrose.

Subsequently IV infused over 20 to 30 minutes.

 

The recommended dose

The medicine should be taken for the prescribed number of days.

Your doctor will decide the correct dose of Cefotaxime 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 Cefotaxime for injection depends on what sort of infection you have.

Adults and adolescents (12 to 16-18 years):

• will usually be given 1 g every 12 hours. In severe infections, this may be increased up to 12 g per day, given in 3-4 doses. For infections caused by sensitive Pseudomonas species, daily doses of greater than 6 g will usually be required.

Children:

• The dose will depend on the size of your body; the usual dose is 50-100 mg/kg/day in 2-4 divided doses. In very severe infections, doses of up to 200 mg/kg/day may be required.

Babies (0-27 days):

• The recommended dosage is 50 mg/ kg/day in 2-4 divided doses. In severe infections, doses of up to 150-200 mg/kg/day may be required.

 

People with liver and kidney problems

If the condition of the kidneys is very poor (creatinine clearance of ≤ 5 ml/min), your doctor will reduce the dosage by half after you have received an initial normal dose.

 

If you are given more Cefotaxime for injection than you should

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call a poison control center right away. Symptoms of overdose may include: seizures.

 

If you forget to use Cefotaxime for injection

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

 

If you stop using Cefotaxime for injection

Do not stop taking Cefotaxime 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.

 

Adverse reactions

Like all medicines, Cefotaxime Injection can cause side effects, although not everybody gets them.

Very common side effects (affects more than 1 user in 10):

• transient pain at the injection site

Uncommon side effects (affects 1 to 10 users in 1,000):

• reduced amount of white blood cells or of blood platelets
• reactions called “Jarisch-Herxhemier” which includes fever, shivering, headache and joint pain
• convulsions
• diarrhoea
• changes in liver values
• rash, itching and special skin rash named urticaria
• impaired kidney function
• fever
• inflammation at the injection site and of your veins (thrombophlebitis)

Not known (frequency cannot be estimated from the available data):

• infections with unsusceptible organisms (“Superinfections”)
• decrease in the number of a type of white blood cells (neutropenia)
• serious condition in which white blood cells decrease in number or disappear altogether (Agranulocytosis)
• low levels of red blood cells (anaemia)
• anaphylactoid reactions (that may range from mild to severe, including a sudden, generalised allergic reaction that may lead to a life-threatening “anaphylactic” shock [e.g. difficulty in breathing, drop of blood pressure, fast pulse])
• severe allergic reactions as swelling of the face, throat, and lips (angiooedema)
• bronchial spasms
• headache and dizziness
• brain disorders (e.g. impairment of consciousness, abnormal movements)
• irregular heartbeat
• feeling sick, vomiting
• pain in the abdomen
• a serious bacterial infection of your gut known as pseudomembranous colitis (including severe, persistent or bloody diarrhoea associated with abdominal pain or fever)
• hepatitis, sometimes with jaundice
• serious skin conditions such as Steven-Johnsons syndrome, erythema multiforme and toxic epidermal necrolysis
• reversible inflammation of the kidneys
• reactions to lidocaine if Cefotaxime Injection is given as a injection into a muscle

 

Special precautions for storage

• Keep this medicine out of the sight and reach of children.
• Do not use Cefotaxime Injection after the expiry date which is stated on the vial and carton after EXP.
• The expiry date refers to the last day of that month. Store the unopened vial below 25°C. Keep container in the outer carton.
• Once the powder has been dissolved, the solution should be used immediately or stored at 2-8°C and discarded after 24 hours.
• 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.

Cefoject®

Each vial contains:

Cefotaxime (as sodium) 500mg, 1g

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.