Sulperazon 1 g
Ask a doctor about a prescription for Sulperazon 1 g
How to use Sulperazon 1 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.
- In case of any doubts, you should consult a doctor, pharmacist, or nurse.
- This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any side effects, including any 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 using Sulperazon
- 3. How to use 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 sensitive 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 using Sulperazon
When not to use Sulperazon:
Warnings and precautions
Before starting treatment with Sulperazon, you should discuss it with your doctor or pharmacist.
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 you are currently taking or have recently taken, as well as any medicines 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
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 data 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.
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.
3. How to use Sulperazon
The medicine is administered under close medical supervision by medical personnel. In case of doubts, you should consult a doctor or nurse.
Sulperazon contains cefoperazone and sulbactam in a 1:1 ratio.
Use 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).
Use 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.
Use in newborns
In newborns under the first week of life, Sulperazon should be used 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). 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. 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. Intravenous and intramuscular administration. Detailed instructions are provided at the end of the leaflet, in the section intended for healthcare professionals. After 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. 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. Like all medicines, this medicine can cause side effects, although not everybody gets them. Common(may affect up to 1 in 10 people): Uncommon(may affect up to 1 in 100 people): Frequency not known(cannot be estimated from the available data)Use in patients with hepatic impairment
Use in patients with renal impairment
Method of administration
Use of a higher than recommended dose of Sulperazon
Cefoperazone and sulbactam are removed from the body during hemodialysis, so this procedure may accelerate the elimination of the medicine components from the body in case of overdose in patients with renal impairment.Missing a dose of Sulperazon
Stopping treatment with Sulperazon
4. Possible side effects
Very common(may affect more than 1 in 10 people):Reporting side effects
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 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 what the pack contains
A vial made of colorless glass, sealed with a silicone, gray, bromobutyl, teflon-coated or EFTE plug, closed with an aluminum cap with a plastic flip-off lid.
A cardboard box containing 1 vial with 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, you should 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 for healthcare professionals only
Incompatibilities
Aminoglycosides
Due to physical incompatibility, the solution of Sulperazon should not be mixed with aminoglycosides. If combination therapy is considered, it can be performed 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 administered during the day be spaced out as much as possible between the administration of Sulperazon and aminoglycosides.
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, after initial dissolution of the powder in water for injection (as described 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
Due to the possibility of incompatibility, 2% lidocaine hydrochloride solution should not be used for initial dissolution of the medicine. However, in a two-stage dissolution process, after initial dissolution of the powder in water for injection (as described above), the solution can be diluted with 2% lidocaine hydrochloride solution to achieve concentrations of up to 250 mg of cefoperazone and 125 mg of sulbactam per 1 ml of lidocaine hydrochloride solution at a concentration of approximately 0.5%.
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 at concentrations in the range of 10-250 mg/ml of solvent. Sulbactam is compatible at concentrations in the range of 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 described 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 described 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 of lidocaine hydrochloride solution at a concentration of approximately 0.5%.
| Total dose [g] | Dose of cefoperazone and sulbactam [g] | Volume of solvent [ml] | Maximum final concentration [mg/ml] |
| 1.0 | 0.5 + 0.5 | 3.4 | 125 + 125 |
| 2.0 | 1.0 + 1.0 | 6.7 | 125 + 125 |
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 injections, 2% lidocaine hydrochloride solution can be used as a diluent, but it should not be used for initial dissolution of the medicine.
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- ImporterHaupt Pharma Latina S.r.l.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to Sulperazon 1 gDosage form: Powder, 1000 mg + 1000 mgActive substance: cefoperazone and beta-lactamase inhibitorManufacturer: Haupt Pharma Latina S.r.l.Prescription not requiredDosage form: Powder, 1 gActive substance: cefotaximeManufacturer: Zakłady Farmaceutyczne POLPHARMA S.A. Zakłady Farmaceutyczne POLPHARMA S.A. Oddział Produkcyjny w DuchnicachPrescription not requiredDosage form: Powder, 2 gActive substance: cefotaximeManufacturer: Zakłady Farmaceutyczne POLPHARMA S.A. Zakłady Farmaceutyczne POLPHARMA S.A. Oddział Produkcyjny w DuchnicachPrescription not required
Alternatives to Sulperazon 1 g in other countries
The best alternatives with the same active ingredient and therapeutic effect.
Alternative to Sulperazon 1 g in Ukraine
Alternative to Sulperazon 1 g in Spain
Online doctors for Sulperazon 1 g
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for Sulperazon 1 g – subject to medical assessment and local rules.
Get updates and exclusive offers
Be the first to know about new services, marketplace updates, and subscriber-only promos.
