Sab-Cefotaxime 1 g Injection

SAB-CEFOTAXIME contains cefotaxime. Cefotaxime belongs to a group of medicines known as cephalosporin antibiotics. Cefotaxime is an antibiotic used to treat infections in different parts of the body caused by bacteria.

SAB-CEFOTAXIME is used for the treatment of the following common infections:

• Genito-urinary tract [infection of bladder, kidney and reproductive tract (gonorrhoea)]
• Skin and soft tissue (infections of the skin like sellulitis, impetigo, furunculosis, abscess)
• Respiratory tract (infection of lungs and airways such as sinusitis, pneumonia, pharyngitis, follicular tonsillitis, scarlet fever, bronchitis, septic sore throat)
• Ear (otitis media)
• Gastro-intestinal tract (infections of stomach and bowel such as enteritis, dysentery)
• Meningitis in children (infections around the brain or spinal cord)
• Sepsis (whole-body inflammation caused by severe infection)

Cefotaxime works by killing bacteria that are causing your infection.

SAB-CEFOTAXIME should not be administered to you if:

• If you are hypersensitive (allergic) to cefotaxime or to any cephalosporin antiobiotics or to any of the other ingredients of SAB-CEFOTAXIME (listed in section 6). The symptoms of an allergic reaction include rash, itching, swelling of face, lip/hands/feet or breathing difficulties.
• If you have had a severe allergic reaction to penicillin and other beta-lactam antiobiotics.

Do not take SAB-CEFOTAXIME if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• if you are allergic or sensitive to pencillin
• if you have a history of allergy
• if you have kidney problems
• if you are going to take certain blood/urine tests
• if you develop any other infection while on treatment with cefotaxime
• if you develop severe diarrhoea while on treatment with cefotaxime. Treatment should be discontinued if severe diarrhoea develops.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking SAB-CEFOTAXIME.

Do not share medicines prescribed for you with any other person.

For prevention of infections the minimum effective dose will be 1 g SAB-CEFOTAXIME 30 – 90 minutes prior to surgery.

For the treatment of infections:

Adults

The usual dose will depend on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need. The usual dose is 2 g dose per day in divided doses. Your doctor may increase the dose to 3 to 4 g per day in divided doses depending on the severity of your illness.

Paediatrics

Use in infants and children: The usual dose for children of 50- 100 mg/kg body mass per day in divided doses. Your doctor may increase the dose up to 200 mg/kg body mass per day in divided doses depending on severity of your illness.

Neonates: The recommended dosage regimen for neonates is as follows: 0 -7 days (1 week) of age: 50 mg/kg IV at 12 hour intervals. 7-28 days (1-4 weeks) of age: 50 mg/kg IV at 8 hour intervals. The dosages above are applicable to both premature and full term infants.

Patients with kidney problems: Your doctor will decide the appropriate dose for you. Your doctor will tell you how long your treatment with SAB-CEFOTAXIME will last. Do not stop treatment early. If you have the impression that the effect of SAB-CEFOTAXIME is too strong or too weak, tell your doctor or pharmacist.

You will not be expected to give yourself SAB-CEFOTAXIME. It will be given to you by a person who is qualified to do so.

SAB-CEFOTAXIME can have side effects. Not all side effects reported for SAB-CEFOTAXIME are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SAB-CEFOTAXIME, please consult your health care provider for advice.

If any of the following happens, you should not be given SAB-CEFOTAXIME and you should tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, shortness of breath;
• rash or itching;
• Extremely serious allergic skin reaction (Steven-Johnsons Syndrome).
• chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome).
• drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving cefotaxime. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after drug intake). Further symptoms could comprise abdominal pain, lethargy, diarrhoea, and low blood pressure.
• rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease).

These are very serious side effects. If you have them, you may have had a serious allergic reaction to SAB-CEFOTAXIME. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequent infections such as fever, severe chills, sore throat or mouth ulcers (neutropenia)
• Bleeding or bruising more easily than normal (thrombocytopenia)
• Bleeding complications related to blood disorder leading to an increased physiological risk for bleeding (hypoprothrombinaemia) and/or dysfunction of blood cells which help blood to clot may occur.
• Fever, rash, enlarged kidneys, low back pain, painful urination, abnormal urination frequency (acute interstitial nephritis, renal tubular necrosis, nephrotoxicity)
• Nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine, inflammation of liver (hepatitis, cholestatic jaundice)
• Fits (convulsions)
• Severe diarrhoea, usually with blood and mucus, stomach pain, fever (pseudomembranous colitis)
• Pain at the site of injection, skin redness or inflammation, swelling (oedema) of the extremities (ankle and foot), palpable cord-like veins (thrombophlebitis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Tenderness and pain with redness and/or swelling at the site of injection

Less frequent side effects:

• Diarrhoea
• Headache
• Decreased number of red blood cells
• Tendency to bleed/bruise easily
• Thrush
• Infection in gut (colitis)
• Lack of awareness, loss of consciousness
• Inability to control movements.

Side effects occurring with an unknown frequency:

• Nausea and vomiting
• Dehydration
• Fever
• Loss of appetite
• Sores in the mouth and throat
• Increased heart rate
• Trouble breathing
• Joint pain
• Yellowing of skin and eyes
• Fatigue
• Burning sensation with urination
• Dizziness;
• Confusion and anxiety
• Sweating
• Bloody, watery diarrhoea
• Stomach cramps or pain
• Vaginal itching or soreness
• Sensitivity to light and blurred vision

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to:

• The Pharmacovigilance Unit at Innovata: +27 869 990 912 (tel), or
• SAHPRA via the “6.04 Adverse Medicine Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

By reporting side effects, you can help provide more information on the safety of SAB-CEFOTAXIME.

• Store all medicines out of reach of children.
• Before reconstitution dry powder should be stored at or below 25 °C, protected from light.
• The vial must be stored in the carton until required for use.
• Reconstituted solution to be stored in original vial.
• After reconstitution do not freeze.
• Any unused portion must be discarded.
• Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).