Ampicillin Sulbactam Tzf

Leaflet attached to the packaging: patient information

Ampicillin Sulbactam TZF , 500 mg + 250 mg, powder for solution for injection and infusion
and infusion
Ampicillin Sulbactam TZF , 1 g + 500 mg, powder for solution for injection and
infusion
Ampicillin Sulbactam TZF , 2 g + 1 g, powder for solution for injection and infusion
Ampicillin + Sulbactam

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor.
• 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 side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Ampicillin Sulbactam TZF and what is it used for
• 2. Important information before using Ampicillin Sulbactam TZF
• 3. How to use Ampicillin Sulbactam TZF
• 4. Possible side effects
• 5. How to store Ampicillin Sulbactam TZF
• 6. Contents of the packaging and other information

1. What is Ampicillin Sulbactam TZF and what is it used for

Ampicillin Sulbactam TZF is an antibiotic that works bactericidally on bacteria that cause infections. It contains two different medicines: ampicillin and sulbactam. Ampicillin belongs to a group of medicines called "penicillins", which can sometimes be inactivated. The second active ingredient (sulbactam) counteracts this inactivation.
Ampicillin Sulbactam TZF is indicated for the treatment of the following infections caused by microorganisms sensitive to ampicillin with sulbactam:

• upper respiratory tract infections, including sinusitis, otitis media, and pharyngitis;
• lower respiratory tract infections, including bacterial pneumonia and bronchitis;
• urinary tract infections and pyelonephritis;
• skin and soft tissue infections;
• gonococcal infections.

Ampicillin Sulbactam TZF may also be administered during the perioperative period to reduce the frequency of postoperative wound infections in patients undergoing abdominal or pelvic surgery, who may be at risk of peritonitis.
Ampicillin Sulbactam TZF is recommended for the treatment of respiratory pneumonia and bacteremia (presence of bacteria in the blood) caused by Acinetobacter baumanii.
Ampicillin Sulbactam TZF may be used prophylactically after childbirth or cesarean section to reduce the risk of postoperative sepsis.

2. Important information before using Ampicillin Sulbactam TZF

When not to use Ampicillin Sulbactam TZF

If the patient is allergic (hypersensitive) to ampicillin or sulbactam.
If the patient has a history of hypersensitivity to penicillins.

Warnings and precautions

• If the patient has a history of allergic reactions to penicillins or other beta-lactam antibiotics, they should inform their doctor before starting treatment with the medicine.
• If the patient experiences an allergic reaction, characterized by sudden onset of wheezing, difficulty breathing, swelling of the eyelids, face, or lips, rash, or itching, they should discontinue the medicine and seek medical attention immediately.
• If the patient experiences diarrhea after taking an antibiotic, they should consult their doctor.
• If the following side effects occur: abdominal pain, itching, dark urine, yellowing of the skin or eyes, nausea (vomiting) or general malaise, the patient should inform their doctor immediately. These symptoms may indicate liver damage caused by the use of ampicillin with sulbactam.

The patient should also inform their doctor if:

• they have infectious mononucleosis (viral disease); in patients with mononucleosis, a skin rash may occur after taking ampicillin;
• they have kidney disease and (or) need to control their sodium intake;
• they experience a new infection (e.g., thrush) while taking Ampicillin Sulbactam TZF; the doctor may then decide to discontinue treatment with the medicine.

During long-term therapy, periodic tests of the internal organs, kidneys, liver, and hematopoietic system are recommended. This is especially important in newborns (especially premature babies) and infants.

Ampicillin Sulbactam TZF and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking:
allopurinol (used to treat gout - a disease characterized by recurring joint inflammation): the frequency of skin rash increases;
aminoglycoside antibiotics (e.g., streptomycin, tobramycin, gentamicin);
anticoagulant medicines (medicines that prevent blood clots), such as warfarin: the risk of bleeding may increase;
probenecid (used to treat gout, with increased uric acid levels in the blood) administered simultaneously with amoxicillin may increase the concentration of the antibiotic in the blood serum;
chloramphenicol, erythromycin, sulfonamides (antibiotics): concurrent administration of Ampicillin Sulbactam TZF with any of these medicines may reduce the effectiveness of the medicine;
oral contraceptives containing estrogens: there is a risk that the effectiveness of the contraceptive may decrease; to avoid unplanned pregnancy, a non-hormonal method of contraception should be used;
methotrexate (a medicine used, for example, in rheumatoid arthritis, cancer): ampicillin may increase its toxicity;
salicylic acid, indomethacin, phenylbutazone: may prolong the elimination of penicillins from the body.
Effect on laboratory test results
In patients treated with ampicillin, glucose tests in urine may be falsely positive and therefore, if such a test is necessary, it is recommended to use enzymatic tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Ampicillin Sulbactam TZF should be avoided during pregnancy, unless the doctor considers it necessary.
During treatment with Ampicillin Sulbactam TZF, breastfeeding is not recommended.

Driving and operating machinery

The effect of the medicine on the ability to drive and operate machinery is unknown.

Ampicillin Sulbactam TZF contains sodium

Ampicillin Sulbactam TZF, 500 mg + 250 mg, contains 59.15 mg of sodium (the main component of table salt) per vial. This corresponds to 2.957% of the maximum recommended daily intake of sodium in the diet for adults.
Ampicillin Sulbactam TZF, 1 g + 500 mg, contains 112.435 mg of sodium (the main component of table salt) per vial. This corresponds to 5.622% of the maximum recommended daily intake of sodium in the diet for adults.
Ampicillin Sulbactam TZF, 2 g + 1 g, contains 223.75 mg of sodium (the main component of table salt) per vial. This corresponds to 11.187% of the maximum recommended daily intake of sodium in the diet for adults.
The sodium content from the solvent should be taken into account when calculating the total sodium content in the prepared dilution of the product (see "Instructions for preparing the medicine for use and method of administration").
This should be considered in patients with impaired renal function and in patients controlling their sodium intake.

3. How to use Ampicillin Sulbactam TZF

The patient does not use this medicine on their own.
The medicine will be administered to the patient by a qualified person, i.e., a doctor or nurse.
Ampicillin Sulbactam TZF can be administered by intramuscular or intravenous injection or by intravenous infusion.
Recommended dose

Adults

Usually, 1.5 g to 12 g is administered per day in divided doses every 6-8 hours.
The daily dose of Ampicillin Sulbactam TZF should not exceed 12 g (4 g of sulbactam).
Infections with a milder course can be treated by administering the medicine every 12 hours.

Dosing in the treatment of respiratory pneumonia and bacteremia due to Acinetobacter baumanii.
The recommended daily dose is 18 g (12 g + 6 g) in 6 divided doses.
Higher daily doses have been reported in the medical literature for this indication.
In the prevention of surgical infections, 1.5 g to 3 g of Ampicillin Sulbactam TZF should be administered during anesthesia, ensuring an adequate period to achieve therapeutic levels of the medicine in the blood serum and tissues during the procedure. The dose can be repeated every 6-8 hours; administration of the medicine is completed 24 hours after the end of most surgical procedures, unless another therapeutic cycle with Ampicillin Sulbactam TZF is indicated.
In the treatment of uncomplicated gonorrhea, Ampicillin Sulbactam TZF can be administered as a single dose of 1.5 g. To increase the concentration and prolong the action of ampicillin and sulbactam in the blood serum, 1.0 g of probenecid should be administered orally.

Children, infants, and newborns

The dose of Ampicillin Sulbactam TZF in the treatment of most infections in children, infants, and newborns is 150 mg/kg body weight per day (corresponding to a dose of 100 mg/kg body weight per day of ampicillin and 50 mg/kg body weight per day of sulbactam).
Children, infants, and newborns should be administered Ampicillin Sulbactam TZF every 6-8 hours, according to the usual dosing of ampicillin.
In newborns in the first week of life (especially premature babies), the recommended dose is 75 mg/kg body weight per day (corresponding to a dose of 50 mg/kg body weight per day of ampicillin and 25 mg/kg body weight per day of sulbactam) in divided doses every 12 hours.
In children with a body weight of less than 40 kg, the recommended dose is 300 mg (200 mg of ampicillin + 100 mg of sulbactam)/kg body weight per day in divided doses every 6 hours.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Duration of treatment

The duration of treatment will be determined by the doctor, depending on the severity and type of infection. The patient should follow the doctor's recommendations.

Method of administration and preparation of solutions

Detailed information is provided at the end of the leaflet in the section intended for medical personnel - "Information intended exclusively for medical professionals".

Use of a higher than recommended dose of Ampicillin Sulbactam TZF

Administration of a dose higher than recommended is unlikely. If the patient believes they have been given a dose higher than recommended, they should contact their doctor, pharmacist, or nurse as soon as possible. Overdose of the medicine may lead to an increase in side effects, including central nervous system irritation and seizures.
In case of doubts about the method of administration of the medicine, the patient should consult their doctor, pharmacist, or nurse.

Missing a dose of Ampicillin Sulbactam TZF

If a dose is missed at a fixed, specified time, the medicine should be administered as soon as possible, provided that the time to the next dose is long enough, or regular administration of the medicine should be continued. A double dose should not be used to make up for a missed dose.

Discontinuation of Ampicillin Sulbactam TZF

It is important to use the medicine according to the recommended treatment cycle. The patient should not discontinue treatment just because they feel better. If the treatment cycle is discontinued too early, the infection may recur.

4. Possible side effects

Like all medicines, this medicine can cause the following side effects, although not everybody gets them.

Severe side effects

Rare (occurring in 1 to 10 out of 10,000 patients):

• widespread rash on the skin, within which blisters and skin peeling may occur, especially around the mouth, nose, eyes, and genitals;
• severe diarrhea, persistent, containing blood, accompanied by abdominal pain and fever; it may be a sign of severe colitis (pseudomembranous colitis), which can occur after antibiotic use.

Frequency not known (frequency cannot be estimated from available data):

• sudden wheezing, swelling of the lips, face, or body, rash, fainting, or difficulty swallowing, anaphylactic shock, angioedema (severe allergic reaction);
• swelling of the face, lips, tongue, and (or) throat with difficulty swallowing or breathing (angioedema), skin rash (erythema), blisters, redness, or discoloration of the skin (urticaria).

➢ If any of these symptoms occur, the patient should discontinue the medicine immediately and inform their doctor or go to the emergency room of the nearest hospital.
Other side effects that the patient should inform their doctor about if they occur
Very common (occurring in more than 1 in 10 patients):

• diarrhea

Common (occurring in 1 to 10 out of 100 patients):

• nausea, abdominal pain

Uncommon (occurring in 1 to 10 out of 1,000 patients):

• thrombocytopenia (low platelet count, which affects blood clotting)
• headache, drowsiness
• fatigue
• vomiting, glossitis
• hyperbilirubinemia (increased bilirubin levels)

Rare (occurring in 1 to 10 out of 10,000 patients):

• pseudomembranous colitis
• seizures, dizziness
• colitis
• interstitial nephritis
• toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis (severe skin reactions, with peeling or exfoliation of the skin)

Frequency not known (frequency cannot be estimated from available data):

• candidiasis (fungal infection), decreased susceptibility of pathogenic bacteria to the antibiotic used
• changes in blood cell count: pancytopenia (deficiency of all normal morphological elements of blood: red blood cells, white blood cells, and platelets), prolonged blood clotting time, significant decrease in granulocyte count, decrease in leukocyte count, decrease in neutrophil count, anemia, including hemolytic anemia (decrease in red blood cell count, including due to red blood cell breakdown), eosinophilia, thrombocytopenic purpura
• anorexia
• symptoms of nervous system damage (including mood changes, excitement, insomnia, depression, psychosis, seizures, vision disturbances, tinnitus)
• allergic vasculitis
• dyspnea
• hematemesis, gastrointestinal bleeding, oral mucositis, dry mouth, abdominal pain, taste disturbances, bloating, black hairy tongue
• cholestasis, liver dysfunction, jaundice, increased liver enzyme activity
• arthralgia
• stomatitis
• rash, pruritus, skin reactions, urticaria
• platelet aggregation disorder

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Ampicillin Sulbactam TZF

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Ampicillin Sulbactam TZF contains

The active substance of the medicine is ampicillin (in the form of ampicillin sodium) and sulbactam (in the form of sulbactam sodium).
Ampicillin Sulbactam TZF, 500 mg + 250 mg: 1 vial contains 500 mg of ampicillin and 250 mg of sulbactam.
Ampicillin Sulbactam TZF, 1 g + 500 mg: 1 vial contains 1 g of ampicillin and 500 mg of sulbactam.
Ampicillin Sulbactam TZF, 2 g + 1 g: 1 vial contains 2 g of ampicillin and 1 g of sulbactam.
The medicine does not contain other ingredients.

What Ampicillin Sulbactam TZF looks like and what the packaging contains

White or almost white powder.
Packaging:one vial in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone: 22-811-18-14
In order to obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder.

Date of last revision of the leaflet: May 2022

Information intended exclusively for medical professionals