Sulperazon 2 g

Leaflet attached to the packaging: information for the user

Sulperazon 1 g,

500 mg + 500 mg, powder for solution for injection and infusion

Sulperazon 2 g,

1000 mg + 1000 mg, powder for solution for injection and infusion

Cefoperazone+ Sulbactam

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sulperazon and what is it used for
• 2. Important information before taking Sulperazon
• 3. How to take Sulperazon
• 4. Possible side effects
• 5. How to store Sulperazon
• 6. Contents of the packaging and other information

1. What is Sulperazon and what is it used for

Sulperazon is a combination medicine (containing cefoperazone and sulbactam) in the form of a dry powder, which is dissolved to prepare a solution for injection and infusion. Cefoperazone in combination with sulbactam acts on microorganisms sensitive to cefoperazone. Sulperazon is indicated for the treatment of the following infections caused by susceptible microorganisms:

• respiratory tract infections (upper and lower),
• urinary tract infections (upper and lower),
• peritonitis, cholecystitis, cholangitis, and other intra-abdominal infections,
• septicemia,
• skin and soft tissue infections,
• bone and joint infections,
• inflammatory conditions in the pelvic area, endometritis, gonorrhea, and other genital tract infections.

Combination therapy
Due to the broad spectrum of antibacterial activity of cefoperazone and sulbactam, many infections can be treated with this medicine alone. However, the doctor may recommend using Sulperazon in combination with other antibiotics if such combination therapy is indicated. If the patient is also taking aminoglycosides, the doctor may recommend monitoring kidney function during treatment.

2. Important information before taking Sulperazon

When not to use Sulperazon:

Warnings and precautions

Before starting treatment with Sulperazon, you should discuss it with your doctor or pharmacist.

• If the patient has a history of hypersensitivity reactions to beta-lactam antibiotics, cephalosporins, penicillins, or other antibiotics (see section: When not to use Sulperazon). The risk of such reactions is higher in people with a history of hypersensitivity to various allergens.
• If the patient experiences severe skin reactions, such as toxic epidermal necrolysis, Stevens-Johnson syndrome (a disease characterized by the formation of numerous skin blisters) and exfoliative dermatitis (a disease characterized by redness and peeling of the skin), they should stop taking Sulperazon and consult a doctor.
• If the patient is taking anticoagulant medicines (medicines that inhibit blood clotting).
• In patients with liver function disorders and/or biliary obstruction. In such cases, it may be necessary to monitor the concentration of the medicine in the blood serum and adjust the dose of the medicine, especially if there are also kidney function disorders.
• If the patient is on a low-calorie diet, is being fed parenterally for a long time, or has impaired nutrient absorption. Cefoperazone, one of the active substances of Sulperazon, may inhibit blood clotting. Serious bleeding, sometimes leading to death, has been reported with the use of Sulperazon. If symptoms of bleeding occur, you should contact your doctor immediately.
• If the patient experiences diarrhea, they should consult a doctor to determine further therapy. Diarrhea may be a symptom of pseudomembranous colitis, a rare complication that can occur with antibiotic treatment. It may be necessary to discontinue the medicine, and in severe cases, oral metronidazole or vancomycin may be administered. It is contraindicated to take medicines that inhibit peristalsis. Pseudomembranous colitis has been reported to occur even after more than two months after the administration of antibacterial medicines.
• If the medicine is used for a long time, an overgrowth of non-susceptible microorganisms may occur. Therefore, during treatment with Sulperazon, the patient will be under close supervision. The doctor may recommend periodic testing of the function of individual systems and organs. This applies especially to the kidneys, liver, and hematopoietic system. The effect of the medicine should be particularly monitored in newborns, especially premature infants, and in infants and young children.

Children
Before starting treatment with Sulperazon in premature infants and newborns, the doctor will weigh the potential benefits of administering the medicine against the risk associated with its use.
Elderly patients
There is no need to change the dosage in elderly patients.
Patients with renal impairment
The doctor will adjust the dose of the medicine in patients with kidney function disorders.
Patients with hepatic impairment
The doctor will adjust the dose of the medicine in patients with liver function disorders or biliary obstruction.

Sulperazon and other medicines

You should tell your doctor or pharmacist about all medicines that you are currently taking or have recently taken, as well as any medicines that you plan to take.
Changes in laboratory test results -false-positive results of glucose tests in urine using the Benedict or Fehling method may occur.

Sulperazon and alcohol

In patients who consumed alcohol during treatment with Sulperazon or within 5 days of the last administration of the medicine, a disulfiram-like reaction was observed: facial flushing, sweating, and headaches and tachycardia (heart rate exceeding 120 beats per minute). You should not consume alcohol during treatment with Sulperazon.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor.
Sulperazon can be used during pregnancy only if the doctor considers that the expected benefit to the mother outweighs the risk to the fetus.
Sulperazon should not be used during breastfeeding, unless the doctor recommends otherwise.
In preclinical studies in rats, no fertility disorders were found. Sulperazon crosses the placental barrier. Clinical trial results on fertility in men and women are not available.

Driving and using machines

It is unlikely that Sulperazon will affect your ability to drive or use machines.

Sulperazon contains sodium

Sulperazon 1g, 500 mg + 500 mg, powder for solution for injection and infusion contains 67.1 mg of sodium (the main component of common salt) per vial. This corresponds to 3.4% of the maximum recommended daily intake of sodium in the diet for adults.
The maximum recommended daily dose of this medicine contains 536.8 mg of sodium (present in common salt). This corresponds to 26.8% of the maximum recommended daily intake of sodium in the diet for adults.
If you take 6 or more vials per day for a long time, patients, especially those controlling their sodium intake, should consult their doctor or pharmacist.
Sulperazon 2 g, 1,000 mg + 1,000 mg, powder for solution for injection and infusion contains 134.2 mg of sodium (the main component of common salt) per vial. This corresponds to 6.7% of the maximum recommended daily intake of sodium in the diet for adults.
The maximum recommended daily dose of this medicine contains 536.8 mg of sodium (present in common salt). This corresponds to 26.8% of the maximum recommended daily intake of sodium in the diet for adults.
If you take 3 or more vials per day for a long time, patients, especially those controlling their sodium intake, should consult their doctor or pharmacist.
This medicine can be prepared for administration using solutions containing sodium (see section "Information intended exclusively for healthcare professionals"). This should be taken into account when calculating the total sodium content, especially when it is administered to patients on a low-sodium diet.

3. How to take Sulperazon

The medicine is administered under close medical supervision by medical personnel. If you have any doubts, you should consult a doctor or nurse.
Sulperazon contains cefoperazone and sulbactam in a 1:1 ratio.

Administration in adults

The recommended dose of Sulperazon for adults is 2 g to 4 g (1 g to 2 g of cefoperazone per day) administered intravenously or intramuscularly in divided doses, every 12 hours.
In severe or resistant infections, the doctor may recommend increasing the dose of Sulperazon to 8 g per day, administered intravenously in divided doses, every 12 hours. The recommended maximum daily dose of sulbactam is 4 g (8 g of Sulperazon).

Administration in children

Children should be given Sulperazon in doses of 40 to 80 mg/kg body weight per day, i.e., 20 to 40 mg/kg body weight per day of cefoperazone and 20 to 40 mg/kg body weight per day of sulbactam. The medicine is administered every 6 to 12 hours, in 2 or 4 divided doses.
In severe or resistant infections, the doctor may recommend increasing the dose to 160 mg/kg body weight per day (i.e., 80 mg/kg body weight per day of cefoperazone). The medicine is administered in 2 to 4 divided doses.

Administration in newborns

In newborns under the first week of life, Sulperazon should be administered every 12 hours. The maximum daily dose of sulbactam that can be used in newborns should not exceed 80 mg/kg body weight per day (160 mg/kg body weight per day of Sulperazon).
If it is necessary to use a dose of cefoperazone greater than 80 mg/kg body weight per day, cefoperazone should be administered separately.

Administration in patients with hepatic impairment

In patients with severe biliary obstruction, severe liver disease, and other liver function disorders, and if the patient also has kidney function disorders, the doctor may decide to change the dosage of the medicine. In such cases, the dose of the medicine will not exceed 2 g of cefoperazone per day.

Administration in patients with renal impairment

In patients with significant kidney function disorders, the doctor may decide to change the dosage of the medicine. In cases of severe infections, it may be necessary to administer additional cefoperazone.

Method of administration

Intravenous and intramuscular administration. Detailed instructions are provided at the end of the leaflet, in the section intended for healthcare professionals.

Use of a higher than recommended dose of Sulperazon

After an overdose, neurological symptoms, including seizures, may occur. Since the medicine will be administered under close medical supervision, the use of a higher than recommended dose of the medicine seems unlikely. If a higher than recommended dose of the medicine is taken, you should always inform your doctor.
Cefoperazone and sulbactam are removed from the body during hemodialysis, so this procedure may accelerate the elimination of the medicine's components from the body in case of an overdose in patients with kidney function disorders.

Missing a dose of Sulperazon

Since the medicine will be administered under close medical supervision, missing a dose seems unlikely. However, if you suspect that you have missed a dose of the medicine, you should always inform your doctor or nurse. You should not take a double dose to make up for a missed dose.

Stopping treatment with Sulperazon

If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people):

• neutropenia (decrease in the number of neutrophils), leukopenia (decrease in the number of white blood cells), positive direct Coombs test, decrease in hemoglobin, decrease in hematocrit, thrombocytopenia (decrease in the number of platelets)
• increase in the activity of enzymes: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase

Common(may affect up to 1 in 10 people):

• coagulopathy (blood clotting disorders)
• eosinophilia (increase in the number of eosinophils)
• diarrhea, nausea, vomiting
• increase in bilirubin levels in the blood

Uncommon(may affect up to 1 in 100 people):

• headache
• itching, urticaria
• phlebitis at the injection site, pain at the injection site, fever, chills

Frequency not known(cannot be estimated from the available data)

• hypoprothrombinemia (prothrombin deficiency - a protein involved in the blood clotting process)
• anaphylactic shock, anaphylactic reactions, anaphylactoid reactions, including shock (a severe condition characterized by a sudden drop in blood pressure, posing a threat to life), hypersensitivity reactions
• bleeding, vasculitis, hypotension
• pseudomembranous colitis (see section 2. Warnings and precautions)
• jaundice
• toxic epidermal necrolysis, Stevens-Johnson syndrome (a severe skin reaction, characterized by the formation of numerous blisters, mainly in the mouth and genital areas, with possible fever and joint pain), exfoliative dermatitis (a disease characterized by redness and peeling of the skin), maculopapular rash
• hematuria

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Sulperazon

The medicine should be stored out of the sight and reach of children.
Store in a temperature below 25°C.
The prepared solution can be stored for 24 hours after reconstitution.
Do not use this medicine after the expiry date stated on the carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sulperazon contains

Sulperazon 1 g
The active substances of the medicine are cefoperazone and sulbactam.
Each vial contains 500 mg of cefoperazone in the form of cefoperazone sodium (517 mg) and 500 mg of sulbactam in the form of sulbactam sodium (547 mg).
Sulperazon 2 g

• The active substances of the medicine are cefoperazone and sulbactam. Each vial contains 1000 mg of cefoperazone in the form of cefoperazone sodium (1034 mg) and 1000 mg of sulbactam in the form of sulbactam sodium (1094 mg).

The medicine does not contain any other ingredients.

What Sulperazon looks like and contents of the pack

A vial made of colorless glass, protected by a silicone, gray bromobutyl, teflon-coated or EFTE plug, closed with an aluminum cap with a plastic flip-off lid.
A carton contains 1 vial containing 500 mg of cefoperazone and 500 mg of sulbactam (Sulperazon 1 g) or 1000 mg of cefoperazone and 1000 mg of sulbactam (Sulperazon 2 g).

Marketing authorization holder:

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Manufacturer:

Haupt Pharma Latina S.r.l., Latina (LT), Strada Statale 156 Km 47,600, 04100 Borgo San Michele, Italy

For more information about this medicine, please contact the marketing authorization holder:

Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals

Incompatibilities

Aminoglycosides
Due to physical incompatibility, the solution of Sulperazon should not be mixed with aminoglycosides. If combination therapy is considered, it can be carried out in consecutive, short-term intravenous infusions using two intravenous catheters, which should be flushed with a suitable diluent between the administration of the medicines (Sulperazon and aminoglycosides). It is also recommended that the doses of Sulperazon be distributed throughout the day so that the time interval between the administration of this medicine and the administration of aminoglycosides is as long as possible.
Ringer's lactate solution
Due to the possibility of incompatibility, Ringer's lactate solution should not be used for initial dissolution of the medicine. However, in a two-stage dissolution process, if the medicine is initially dissolved in water for injection, and then diluted with Ringer's lactate solution, incompatibility does not occur.
Lidocaine
Due to the possibility of incompatibility, 2% lidocaine hydrochloride solution should not be used for initial dissolution of the medicine. However, if the medicine is initially dissolved in water for injection, and then diluted with 2% lidocaine hydrochloride solution, incompatibility does not occur.

Preparation of the medicine for administration

The medicine containing cefoperazone and sulbactam is available in vials containing 1.0 g or 2.0 g of the medicine.
It has been shown that Sulperazon, which contains cefoperazone and sulbactam, is compatible with the following solvents: water for injection, 5% glucose solution, 0.9% sodium chloride solution, 5% glucose solution in 0.225% sodium chloride solution, and 5% glucose solution in 0.9% sodium chloride solution.
Cefoperazone is compatible in concentrations ranging from 10-250 mg/ml of solvent. Sulbactam is compatible in concentrations ranging from 5-125 mg/ml of solvent.
Ringer's lactate solution
For initial dissolution of the medicine, water for injection should be used. In a two-stage dissolution process, after dissolving the medicine in water for injection (as shown in the table above), the solution can be diluted with Ringer's lactate solution to achieve a sulbactam concentration of 5 mg/ml (2 ml of solution after initial dissolution in water for injection in 50 ml or 4 ml of solution after initial dissolution in water for injection in 100 ml of Ringer's lactate solution).
Lidocaine
For initial dissolution of the medicine, water for injection should be used. To achieve a cefoperazone concentration of 250 mg/ml or higher in a two-stage dissolution process, after dissolving the medicine in water for injection (as shown in the table above), the solution can be diluted with 2% lidocaine hydrochloride solution to achieve solutions containing up to 250 mg of cefoperazone and 125 mg of sulbactam per 1 ml in a 0.5% lidocaine hydrochloride solution.

Method of administration

Intravenous administration
For short-term intravenous infusions, the contents of each vial of Sulperazon should be dissolved in an appropriate volume of 5% glucose solution, 0.9% sodium chloride solution, or sterile water for injection, and then diluted with the same solution to a volume of 20 ml. The infusion should last from 15 to 60 minutes.
Ringer's lactate solution can be used for intravenous administration, but it should not be used for initial dissolution of the medicine. However, it can be used for intravenous infusion as a diluent for the previously dissolved Sulperazon powder.
For intravenous injections, the contents of each vial should be dissolved as described above. The medicine should be administered over at least 3 minutes.
Intramuscular administration
For intramuscular injection, 2% lidocaine hydrochloride solution can be used as a diluent, but it should not be used for initial dissolution of the medicine.