Ampicillin sulbactam inpharm

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Ampicillin Sulbactam Inpharm
2 g + 1 g, powder for solution for injection and infusion
Ampicillinum + Sulbactamum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor. See section 4.

Table of contents of the leaflet

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

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

Ampicillin Sulbactam Inpharm is an antibiotic with bactericidal activity against bacteria causing infections. It contains two different active substances: ampicillin and sulbactam. Ampicillin belongs to a group of medicines called "penicillins," whose activity may sometimes be inhibited (inactivated). The second active component (sulbactam) counteracts this inactivation.
Ampicillin Sulbactam Inpharm 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 tonsillitis;
• lower respiratory tract infections, including bacterial pneumonia and bronchitis;
• urinary tract infections and pyelonephritis;
• skin and soft tissue infections;
• gonococcal infections.

Ampicillin Sulbactam Inpharm may also be administered in the perioperative period to reduce the incidence of postoperative wound infections in patients undergoing abdominal or pelvic surgery where peritoneal infection may occur.
Ampicillin Sulbactam Inpharm is recommended for the treatment of ventilator-associated pneumonia and bacteremia (presence of bacteria in the blood) caused by Acinetobacter baumannii.
Ampicillin Sulbactam Inpharm may be used prophylactically after childbirth or caesarean section to reduce the risk of postoperative sepsis.

2. Important information before using Ampicillin Sulbactam Inpharm

When not to use Ampicillin Sulbactam Inpharm
If the patient is allergic (hypersensitive) to ampicillin or sulbactam.
If the patient has previously experienced hypersensitivity to penicillins.

Warnings and precautions

• If the patient has previously experienced an allergic reaction to penicillins or other beta-lactam antibiotics, it is essential to inform the doctor before starting treatment with this medicine.
• If the patient experiences an allergic reaction, characterized by sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, administration of the medicine must be stopped immediately and medical advice sought without delay.
• If diarrhoea occurs after taking the antibiotic, the patient should consult a doctor.
• If any of the following adverse effects occur: abdominal pain, itching, darkening of the urine, yellowing of the skin or eyes, nausea (feeling sick) or general malaise, the patient must inform the doctor immediately. These symptoms may indicate liver damage caused by treatment with ampicillin and sulbactam.

The doctor should also be informed if:

• the patient has infectious mononucleosis (a viral disease); skin rash may occur in patients with mononucleosis after taking ampicillin;
• the patient has kidney disease and (or) needs to monitor sodium intake in the diet;
• a new infection (e.g. fungal infection) occurs during treatment with Ampicillin Sulbactam Inpharm; the doctor may then decide to discontinue treatment;
• severe skin reactions (redness, rash) occur. The doctor will make decisions regarding further treatment (see section 4).

During prolonged therapy, periodic monitoring of kidney, liver and haematopoietic system function is recommended. This is particularly important in newborns (especially premature infants) and infants.

Ampicillin Sulbactam Inpharm and other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

In particular, inform the doctor if the patient is taking:

• allopurinol (used in the treatment of gout – a disease characterized by recurrent joint inflammation): the frequency of skin rash increases;
• aminoglycoside antibiotics (e.g. streptomycin, tobramycin, gentamicin);
• anticoagulant medicines (medicines preventing blood clots), such as warfarin: the tendency to bleed may increase;
• probenecid (used in the treatment of gout, in cases of elevated uric acid levels in blood) – when administered concomitantly with amoxicillin, may increase antibiotic concentration in blood serum;
• chloramphenicol, erythromycin, sulfonamides (antibiotics): concomitant administration of Ampicillin Sulbactam Inpharm with any of these drugs may reduce the effectiveness of the medicine;
• oral contraceptives containing estrogens: there is a risk that contraceptive effectiveness may decrease; to avoid unintended pregnancy, an additional non-hormonal contraceptive method should be used;
• methotrexate (a medicine used e.g. in rheumatoid arthritis, in oncological diseases): ampicillin may increase its toxicity;
• salicylic acid, indometacin, phenylbutazone: may prolong elimination of penicillins from the body.

Effect on laboratory test results
In patients treated with ampicillin, urine glucose tests may yield false-positive results; therefore, if such testing is necessary, enzymatic tests are recommended.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Ampicillin Sulbactam Inpharm should be avoided during pregnancy unless the doctor considers its use necessary.

Breastfeeding is not recommended during treatment with Ampicillin Sulbactam Inpharm.

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

Ampicillin Sulbactam Inpharm contains sodium
This medicine contains 230.2 mg (10.01 mmol) of sodium (main component of table salt) per vial.
This corresponds to 11.5% of the maximum recommended daily sodium intake in the diet of adults.
The sodium content originating from the solvent should be taken into account when calculating the total sodium content in the prepared dilution of the product (see section "Instructions for preparation of the medicine for use and method of administration").

This should be considered in patients with impaired kidney function and in patients monitoring sodium intake in the diet.

3. How to use Ampicillin Sulbactam Inpharm

The patient must not use this medicine on their own.
The medicine will be administered by a qualified healthcare professional, i.e. a doctor or nurse.
Ampicillin Sulbactam Inpharm can be given by intramuscular or intravenous injection or by intravenous infusion.

Recommended dose
Adults
The usual dose is 1.5 g to 12 g per day, given in divided doses every 6–8 hours.
The daily dose of Ampicillin Sulbactam Inpharm must not exceed 12 g (4 g of sulbactam).
Milder infections may be treated by administering the drug every 12 hours.

Dosage for the treatment of respiratory tract infections and bacteremia caused by Acinetobacter baumannii
The recommended daily dose is 18 g (12 g + 6 g) administered in 6 divided doses.
Higher daily doses have been described in medical literature for this indication.
For surgical infection prophylaxis, 1.5 g to 3 g of Ampicillin Sulbactam Inpharm should be administered during anesthesia, ensuring adequate time to achieve therapeutic drug concentrations in serum and tissues during the procedure. The dose may be repeated every 6–8 hours; administration of the drug ends 24 hours after completion of most surgical procedures, unless another cycle of therapy with Ampicillin Sulbactam Inpharm is indicated.
For treatment of uncomplicated gonorrhea, Ampicillin Sulbactam Inpharm may be administered as a single dose of 1.5 g. To increase serum concentrations and prolong the action of ampicillin and sulbactam, 1.0 g of probenecid should be administered orally.

Children, infants, and newborns
The dose of Ampicillin Sulbactam Inpharm for treatment of most infections in children, infants, and newborns is 150 mg/kg body weight per day (corresponding to 100 mg/kg body weight per day of ampicillin and 50 mg/kg body weight per day of sulbactam).
Ampicillin Sulbactam Inpharm should be administered to children, infants, and newborns every 6–8 hours, in accordance with general ampicillin dosing guidelines.
In newborns during the first week of life (especially premature infants), the recommended dose is 75 mg/kg body weight per day (corresponding to 50 mg/kg body weight per day of ampicillin and 25 mg/kg body weight per day of sulbactam), given in divided doses every 12 hours.
In children with body weight < 40 kg, the recommended dose is 300 mg (200 mg ampicillin + 100 mg sulbactam)/kg body weight per day, given in divided doses every 6 hours.

If during treatment the patient feels that the effect of the drug is too strong or too weak, they should consult their physician.

Duration of treatment
The duration of treatment will be determined by the physician depending on the severity and type of infection. The physician's instructions must be followed.

Method of administration and preparation of solutions
Detailed information is provided at the end of this leaflet in the section intended for healthcare professionals – "Information intended exclusively for healthcare professionals".

Administration of a higher than recommended dose of Ampicillin Sulbactam Inpharm
Administration of a dose higher than recommended is unlikely. If the patient believes they have received a higher than recommended dose, they should contact their physician, pharmacist, or nurse as soon as possible. Overdose may lead to intensification of adverse effects, including central nervous system irritation and seizures.

In case of any doubts regarding the method of administration, consult a physician, pharmacist, or nurse.

Missed dose of Ampicillin Sulbactam Inpharm
If a dose is missed at the usual scheduled time, the drug should be administered as soon as possible, provided that sufficient time remains before the next scheduled dose, or regular dosing should be continued. A double dose should not be administered to make up for the missed dose.

Discontinuation of Ampicillin Sulbactam Inpharm
It is important to take the drug according to the recommended treatment regimen. Do not discontinue treatment just because the patient feels better. If treatment is stopped too early, the infection may recur.

4. Possible adverse reactions

Like any medicine, this medicine can cause the following adverse reactions, although they do not occur in everyone.
Serious adverse reactions
Rare (occur in 1 to 10 out of 10,000 patients):

• Red, non-elevated, target-shaped or round spots on the trunk, often with centrally located blisters, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis);
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• Severe diarrhoea, persisting for a prolonged period or containing blood, accompanied by abdominal pain and fever; this may indicate a serious intestinal inflammation (called pseudomembranous colitis), which may occur after antibiotic use;
• Severe skin reactions with blisters, skin peeling and necrotic changes (erythema multiforme, exfoliative dermatitis).

Frequency unknown (frequency cannot be estimated from available data):

• Sudden wheezing, swelling of 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 cyanosis of the skin (urticaria);
• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
  If any of these symptoms occur, the medicine must be discontinued immediately and the doctor must be informed immediately or the nearest hospital emergency department must be visited without delay.

Other adverse reactions that should be reported to a doctor if they occur
Very common (occur in more than 1 in 10 patients):

• Diarrhoea.

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

• Nausea, abdominal pain.

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

• Thrombocytopenia (low platelet count, affecting blood clotting)
• Headache, drowsiness
• Feeling of fatigue
• Vomiting, glossitis

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

• Seizures, dizziness
• Colitis
• Tubulointerstitial nephritis.

Frequency unknown (frequency cannot be estimated from available data):

• Candidiasis (yeast infection), reduced susceptibility of pathogenic bacteria to the antibiotic used
• Changes in the number of different types of blood cells: pancytopenia (deficiency of all normal blood cells: red blood cells, white blood cells and platelets), prolonged blood clotting time, marked decrease in granulocyte count, decreased leukocyte count, decreased neutrophil count, anaemia, including haemolytic anaemia (reduced number of red blood cells, including due to red blood cell destruction), eosinophilia, thrombocytopenic purpura
• Loss of appetite
• Symptoms of nervous system damage (e.g. mood changes, agitation, insomnia, depression, psychosis, seizures, visual disturbances, tinnitus)
• Allergic vasculitis
• Shortness of breath
• Haematemesis, bleeding from the small intestine and (or) colon, oral mucositis, dry mouth, epigastric pain, taste disturbances, bloating, black hairy tongue
• Bile stasis (cholestasis), liver function disorders, jaundice, increased liver enzyme activity
• Joint pain
• Mucositis
• Rash, itching, skin reactions, urticaria
• Impaired platelet aggregation.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ampicillin Sulbactam Inpharm

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ampicillin Sulbactam Inpharm contains
The active substances are ampicillin (in the form of sodium ampicillin) and sulbactam (in the form of sodium sulbactam).
One vial contains 2 g of ampicillin and 1 g of sulbactam.
The medicine does not contain any other ingredients.

What Ampicillin Sulbactam Inpharm looks like and contents of the pack
White or almost white powder.
Packaging: one vial in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Responsible party in Greece, country of export:
Pfizer Hellas A.E.
A. Mesogeion 243
154 51 Neo Psichiko
Greece

Manufacturer:
Haupt Pharma Latina S.r.l.
Strada Statale 156 Km 47,600
04100 Borgo San Michele
Italy

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorization number in Greece, country of export: 42506/14-10-2008
Parallel import authorization number: 3/26

Information intended solely for professional medical personnel

Instructions for preparation of the medicinal product for use and method of administration
Any unused product or waste material should be disposed of in accordance with local regulations.
Pharmaceutical incompatibilities
Ampicillin Sulbactam Inpharm and aminoglycosides must be prepared and administered separately due to the in vitro inactivation of aminoglycosides by all aminopenicillins.
Preparation of solutions
Intramuscular injection
Dissolve Ampicillin Sulbactam Inpharm in 3.2 mL of sterile water for injections or another compatible diluent (e.g. isotonic sodium chloride solution, 5% aqueous glucose solution). To reduce injection pain, 0.5% sterile solution of lidocaine hydrochloride anhydrous may be used for reconstitution.
Intravenous injection
Dissolve Ampicillin Sulbactam Inpharm in at least 3.2 mL of sterile water for injections or another compatible diluent (e.g. isotonic sodium chloride solution, 5% aqueous glucose solution) and administer slowly (over at least 3 minutes).
Intravenous infusion
Dissolve Ampicillin Sulbactam Inpharm in at least 3.2 mL of sterile water for injections or another compatible diluent (e.g. isotonic sodium chloride solution, 5% aqueous glucose solution). The final volume for infusion should be achieved by adding an appropriate diluent (do not use sterile water for injections). Administer intravenously as an infusion over 15–30 minutes.
To ensure complete dissolution of the drug, wait several minutes until the active substances are fully dissolved and the foam has dissipated.
Sodium sulbactam is compatible with most intravenous diluents; however, sodium ampicillin, and thus the medicinal product Ampicillin Sulbactam Inpharm, is less stable in solutions containing glucose or other carbohydrates. Therefore, it should not be mixed with blood products or protein hydrolysates.
Ampicillin, and thus the medicinal product Ampicillin Sulbactam Inpharm, is incompatible with aminoglycosides and should not be mixed in the same container.
The concentrated solution for intramuscular injections should be used within 1 hour after preparation.
Solutions intended for intravenous injections and infusions retain stability depending on the diluent used and storage temperature.