Ampicillin/sulbactam Baush Health

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Ampicillin/Sulbactam Bausch Health, 1 g + 0.5 g, powder for solution for injection/infusion

for injection/infusion

Ampicillin/Sulbactam Bausch Health, 2 g + 1 g, powder for solution for injection/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.
• In case of any doubts, consult a doctor 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Ampicillin/Sulbactam Bausch Health and what is it used for

Ampicillin/Sulbactam Bausch Health is a broad-spectrum antibiotic. It treats infections caused by bacteria sensitive to ampicillin and sulbactam.
Ampicillin belongs to a group of medicines called "penicillins" (a type of beta-lactam antibiotic).
Its action involves inhibiting the formation of the bacterial cell wall during bacterial multiplication (biosynthesis).
Sulbactam has effective antibacterial action against bacterial strains insensitive to ampicillin.
The doctor may administer Ampicillin/Sulbactam Bausch Health to the patient by injection to treat the following bacterial infections:

• upper respiratory tract infections, including sinusitis, otitis media, or laryngitis (epiglottitis);
• lower respiratory tract infections, including pneumonia;
• urinary tract infections, including kidney inflammation (pyelonephritis);
• gastrointestinal tract infections, including abdominal cavity infections (peritonitis), cholecystitis;
• bone and joint infections;
• skin and soft tissue infections;
• sexually transmitted infections, including gonorrhea;
• female genital tract infections, including endometritis, pelvic inflammatory disease;
• after abortion or cesarean section to reduce the risk of postoperative infections;
• septicemia (bacterial infection spreading through the blood);
• preoperative and postoperative use: to prevent surgical wound infections after abdominal or pelvic surgery.

2. Important information before using Ampicillin/Sulbactam Bausch Health

When not to use Ampicillin/Sulbactam Bausch Health:

• if the patient is allergic (hypersensitive) to ampicillin or sulbactam.
• if the patient has been diagnosed with an allergy (hypersensitivity) to any type of penicillin (beta-lactam antibiotics).

Warnings and precautions

Before starting treatment with Ampicillin/Sulbactam Bausch Health, the patient should discuss it with their doctor, pharmacist, or nurse if:

• the patient has experienced allergic reactions to penicillins or other antibiotics (cephalosporins) in the past or if the patient has been diagnosed with hypersensitivity to allergenic chemicals;
• the patient has liver, kidney, or blood formation problems;
• the patient is taking oral contraceptives (ampicillin may reduce their effectiveness). The patient should consult their doctor for advice on using an alternative or additional safe and effective contraceptive method during treatment with Ampicillin/Sulbactam Bausch Health.

As with any long-term therapy, during treatment with Ampicillin/Sulbactam Bausch Health, periodic tests for kidney, liver, and blood system disorders are recommended, especially in premature infants, newborns, and infants.
The patient should immediately inform their doctor if they experience abdominal pain, itching, dark urine, yellowing of the eyes or skin, or if they feel nauseous or weak. These may be symptoms of liver function impairment caused by the use of ampicillin with sulbactam.
Since infectious mononucleosis is a viral disease, Ampicillin/Sulbactam Bausch Health should not be used to treat it. Many patients with mononucleosis who received ampicillin developed a skin rash.

During treatment with Ampicillin/Sulbactam Bausch Health, the patient should immediately inform their doctor if they experience:

• severe skin reactions (redness, rash). The doctor will decide whether to discontinue treatment.
• allergic reactions. In such cases, the administration of Ampicillin/Sulbactam Bausch Health should be discontinued, and the doctor will start appropriate therapy. Severe hypersensitivity reactions will be treated urgently.
• persistent and severe diarrhea (with blood and mucus). The patient should immediately consult their doctor, as these symptoms may indicate a life-threatening condition. As with other antibiotics, during long-term treatment, there may be an "overgrowth" of microorganisms resistant to Ampicillin/Sulbactam Bausch Health, including fungi. In such cases, appropriate treatment should be started, according to the doctor's recommendations, depending on the patient's condition. The patient should not take anti-diarrheal medications without consulting their doctor.

Ampicillin/Sulbactam Bausch Health and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may change the effectiveness of Ampicillin/Sulbactam Bausch Health, and Ampicillin/Sulbactam Bausch Health may also affect the effectiveness of other medicines.
The patient should inform their doctor if they are taking any of the following medicines:

• concomitant use of a medicine used to treat gout (allopurinol, probenecid) increases the risk of rash
• aminoglycoside antibiotics
• blood clot prevention medicines
• bacterial anti-infective medicines (chloramphenicol, erythromycin, sulfonamide, and tetracycline)
• oral contraceptives containing estrogens
• methotrexate (a medicine used to treat cancer or rheumatic diseases)

Effect on laboratory test results
The results of glucose tests in urine and some hormone level tests in pregnant women may be falsely positive.

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 or pharmacist before using this medicine.
During pregnancy, the doctor will carefully determine whether the patient should use Ampicillin/Sulbactam Bausch Health, considering the benefit-to-risk ratio, as there is no evidence that the use of this medicine in pregnant women is safe.
Ampicillin and sulbactam are excreted in small amounts into human milk. Use in breastfeeding mothers may cause side effects in infants such as diarrhea.
Ampicillin/Sulbactam Bausch Health should be used during breastfeeding only if the expected benefits outweigh the potential risk.
Before using this medicine during breastfeeding, the patient should consult their doctor, pharmacist, or nurse.

Driving and operating machinery

It is not known whether Ampicillin/Sulbactam Bausch Health may affect the ability to drive and operate machinery; however, due to side effects, the patient's reaction ability may be impaired. In such cases, the patient should not drive vehicles.

Ampicillin/Sulbactam Bausch Health contains sodium

Ampicillin/Sulbactam Bausch Health, 1 g + 0.5 g, powder for solution for injection/infusion, contains 115.1 mg of sodium (the main component of common salt) per vial.
This corresponds to 5.8% of the maximum recommended daily sodium intake in the diet for adults.
The patient should discuss this with their doctor or pharmacist if they need to take 4 or more vials per day for an extended period, especially if they have been advised to follow a low-sodium diet (low salt content).
Ampicillin/Sulbactam Bausch Health, 2 g + 1 g, powder for solution for injection/infusion, contains 230.2 mg of sodium (the main component of common salt) per vial.
This corresponds to 11.5% of the maximum recommended daily sodium intake in the diet for adults.
The patient should discuss this with their doctor or pharmacist if they need to take 2 or more vials per day for an extended period, especially if they have been advised to follow a low-sodium diet (low salt content).

3. How to use Ampicillin/Sulbactam Bausch Health

This medicine can be administered intramuscularly or intravenously and will always be prepared and administered by a doctor, pharmacist, or nurse.
Adults
The doctor will determine the dose of the medicine based on the severity of the infection and the patient's condition.
The dosage range of Ampicillin/Sulbactam Bausch Health is from 1.5 g to 12 g per day in divided doses.
The total dose of sulbactam should not exceed 4 grams per day.
The frequency of dosing may be determined based on the severity of the disease and kidney function.
In the case of less severe infections, injections can be performed 3 to 4 times a day (every 6 to 8 hours) or twice a day (every 12 hours).
The total dose of sulbactam should not exceed 4 grams per day.
Less severe infections can be treated according to a 12-hour dosing schedule.
Treatment is usually continued for 48 hours after the fever and other abnormal symptoms have subsided.
Treatment is usually carried out for 5-14 days, but in severely ill patients, additional ampicillin may be administered.

Surgical infection prophylaxis

1.5 g to 3 g of Ampicillin/Sulbactam Bausch Health should be administered during anesthesia induction.
The dose can be repeated every 6-8 hours.
Administration of the medicine is discontinued after 24 hours from the end of most surgical procedures, unless another therapeutic cycle of Ampicillin/Sulbactam Bausch Health is indicated.

Treatment of uncomplicated gonorrhea

Ampicillin/Sulbactam Bausch Health can be administered as a single dose of 1.5 g.
The doctor may start concomitant administration of probenecid at a dose of 1.0 g orally.

Newborns, infants, and children

The dose for the treatment of most infections in children, infants, and newborns is 150 mg/kg body weight per day (which corresponds to a dose of 50 mg/kg body weight of sulbactam per day and 100 mg/kg body weight of ampicillin per day), usually every 6 or 8 hours.
In newborns in the first week of life and in premature infants, the recommended dose is 75 mg/kg body weight per day (which corresponds to 25 mg/kg body weight of sulbactam per day and 50 mg/kg body weight of ampicillin per day) in divided doses every 12 hours.

Patients with renal impairment

In these patients, Ampicillin/Sulbactam Bausch Health should be administered less frequently.

Use of a higher than recommended dose of Ampicillin/Sulbactam Bausch Health

It is unlikely that a doctor or a member of the medical staff - usually in a hospital - would administer a higher dose of the medicine to the patient.
Expected symptoms of overdose may mainly be an intensification of side effects reported after administration of the medicine.
It is known that high concentrations of beta-lactam antibiotics in cerebrospinal fluid can cause neurological effects, such as seizures.
Since ampicillin and sulbactam are removed from the circulation by hemodialysis, these procedures may increase the elimination of the medicine from the body in case of overdose in patients with renal impairment.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Severe side effects

The patient should immediately inform their doctor if they experience any of the following severe side effects, as urgent medical attention may be necessary.

The frequency of the following side effects is unknown (cannot be determined from available data):

• sudden onset of allergic reactions (anaphylactoid) and anaphylactic shock (circulatory collapse);
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome;
• severe diarrhea due to colitis (bacterial pseudomembranous colitis);
• severe skin diseases with blisters, peeling, and necrotic changes (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, acute generalized exanthematous pustulosis);
• kidney inflammation.

The following side effects are listed according to their frequency of occurrence:
Common(may occur in 1 in 10 patients):

• decrease in red blood cell count (anemia) and platelet count (thrombocytopenia), increase in the number of a certain type of white blood cell (eosinophilia). These reactions usually resolve after treatment is discontinued.
• vein inflammation
• diarrhea
• transient increase in liver enzyme activity (ASAT, ALAT) and bilirubin levels due to abnormal liver function
• pain at the injection site

Uncommon(may occur in 1 in 100 patients):

• decrease in white blood cell count (usually returns to normal after treatment)
• headaches
• change in blood cell count (decrease in the number of so-called neutrophil granulocytes)
• vomiting
• rash, itching
• fatigue
• malaise

Rare(may occur in 1 in 1000 patients):

• nausea
• inflammation of the tongue
• abdominal pain

Frequency not known(cannot be determined from available data):

• anemia due to excessive breakdown of red blood cells (hemolytic anemia)
• change in blood cell count (decrease in the number of so-called granulocytes)
• bleeding spots, red spots caused by a decrease in platelet count
• anaphylactic reaction, anaphylactoid shock, hypersensitivity
• drowsiness
• seizures
• dizziness
• breathing difficulties
• inflammation of the small and large intestine (so-called enterocolitis)
• black, tarry stools
• inflammation of the mouth
• discoloration of the tongue
• widespread skin reactions (red, swollen, pus-filled blisters)
• exfoliative dermatitis
• abnormal liver function, jaundice, bile stasis, hepatitis with bile stasis
• local reaction at the injection site
• facial swelling, lip swelling, tongue swelling, and (or) throat swelling with difficulty swallowing and breathing (angioedema), with skin rash (erythema), blisters, redness of the skin, or bruising
• inflammation of the kidney tissue (interstitial nephritis)

Other side effects may also occur during treatment, which are characteristic of ampicillin.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
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 Bausch Health

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
Do not use this medicine after the expiry date (EXP) stated on the packaging and vial.
The expiry date refers to the last day of the given 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 Bausch Health contains

• The active substances are:

Ampicillin/Sulbactam Bausch Health, 1 g + 0.5 g, powder for solution for injection/infusion
Each vial contains 1.0 g of ampicillin (which corresponds to 1.063 g of ampicillin sodium) and 0.5 g of sulbactam (which corresponds to 0.547 g of sulbactam sodium).
Ampicillin/Sulbactam Bausch Health, 2 g + 1 g, powder for solution for injection/infusion
Each vial contains 2.0 g of ampicillin (which corresponds to 2.126 g of ampicillin sodium) and 1 g of sulbactam (which corresponds to 1.094 g of sulbactam sodium).

• Other ingredients: none

What Ampicillin/Sulbactam Bausch Health looks like and what the packaging contains

Powder for solution for injection/infusion.
White or almost white sterile powder, free from foreign particles.
Ampicillin/Sulbactam Bausch Health, 1 g + 0.5 g, powder for solution for injection/infusion
Vials made of colorless glass type I, closed with bromobutyl rubber stoppers type I and blue aluminum seals and PP caps, type flip-off, in a cardboard box.
Ampicillin/Sulbactam Bausch Health, 2 g + 1 g, powder for solution for injection/infusion
Vials made of colorless glass type I, closed with bromobutyl rubber stoppers type I and orange aluminum seals and PP caps, type flip-off, in a cardboard box.
The packaging contains 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer

Acs Dobfar S.p.A
San Nicolo A Tordino
Nucleo Industriale S Atto
64100 Teramo
Italy

Date of last revision of the leaflet: 20.03.2025

This medicine is authorized for use in the Member States of the European Economic Area under the following names:

Poland: Ampicillin/Sulbactam Bausch Health
Estonia: Ampicillin/Sulbactam Bausch Health
Slovakia: Ampicillin/Sulbactam Bausch Health 2g/1g