PACKAGE LEAFLET

PIPERACILLIN K24 PHARMACEUTICALS

Sodium piperacillin
COMPOSITION
PIPERACILLIN K24 PHARMACEUTICALS 1g/2ml
One vial contains:
Active substance:
Sodium piperacillin g 1.04 (equivalent to piperacillin g 1.00).
The solvent vial (for intramuscular use only) contains:
Lidocaine hydrochloride and Water for injections.
PIPERACILLIN K24 PHARMACEUTICALS 2g/4ml
One vial contains:
Active substance:
Sodium piperacillin g 2.08 (equivalent to piperacillin g 2.00).
The solvent vial (for intramuscular use only) contains:
Lidocaine hydrochloride and Water for injections.
PIPERACILLIN K24 PHARMACEUTICALS 4g
One vial contains:
Active substance:
Sodium piperacillin g 4.17 (equivalent to piperacillin g 4.00).
PHARMACEUTICAL FORM AND CONTENT
Powder and solvent for injectable solution for IM use
PIPERACILLIN K24 PHARMACEUTICALS 1g/2ml
1 vial of 1g powder + 2 ml solvent vial (0.5% lidocaine hydrochloride solution).
PIPERACILLIN K24 PHARMACEUTICALS 2g/4ml
1 vial of 2g powder + 4 ml solvent vial (0.5% lidocaine hydrochloride solution).
PIPERACILLIN K24 PHARMACEUTICALS 4g
1 vial of powder for injectable solution
THERAPEUTIC CATEGORY
Beta-lactam antibiotic.
MARKETING AUTHORISATION HOLDER
K24 Pharmaceuticals S.r.l. – Via Generale Orsini, 46 80132 Napoli.
LOT RELEASE RESPONSIBLE MANUFACTURER:
Biopharma S.r.l. – Via delle Gerbere, S. Palomba (ROME)
THERAPEUTIC INDICATIONS
Gram-Negative Bacteria
Piperacillin is indicated for the treatment of the following infections caused by pathogens
susceptible to piperacillin, particularly Pseudomonas, indole-positive and indole-negative Proteus,
Citrobacter, Klebsiella, Enterobacter, Serratia, E. coli, H. influenzae, N. meningitidis, Neisseria
gonorrhoeae:

Complicated and uncomplicated infections of the kidney and genitourinary tract.
Piperacillin has proven particularly effective due to the high concentrations of active drug achieved in urine, both after intramuscular and intravenous administration.
Acute and chronic respiratory tract infections.
Severe systemic infections and septicemia.
Skin and soft tissue infections.
Piperacillin shows synergistic action when used in combination with aminoglycoside antibiotics. This characteristic can be advantageously exploited in clinical practice for infections caused by Gram-negative pathogenic microorganisms.
Anaerobic Bacteria
Piperacillin is indicated for the treatment of the following infections caused by anaerobic bacteria, particularly Bacteroides (including B. fragilis), Clostridium, Peptococcus and Peptostreptococcus:
Pleuro-pulmonary infections such as empyema, pneumonia and lung abscess.
Intra-abdominal infections such as peritonitis and abscess (typically arising from anaerobic microorganisms, normal inhabitants of the gastro-enteric system).
Gynecological infections such as endometritis, pelvic inflammatory disease, pelvic abscess and salpingitis.
Skin and soft tissue infections.
Septicemia.
Perioperative prophylaxis.
Gram-Positive and Mixed Bacteria
Piperacillin is indicated for the treatment of infections, as previously listed, caused by Gram-positive bacteria including streptococci, pneumococci, non-penicillinase-producing staphylococci and enterococci.
Piperacillin is effective in the treatment of mixed infections: Gram-positive, Gram-negative, aerobic/anaerobic.
CONTRAINDICATIONS
Known hypersensitivity to penicillins and cephalosporins.
Hypersensitivity to lidocaine (intramuscular solvent).
PRECAUTIONS FOR USE
Piperacillin offers no particular advantage in infections caused by organisms sensitive to penicillin G, nor is it active against penicillinase-producing staphylococci, which are poorly sensitive to penicillin.
Prolonged use of penicillins, as with other antibiotics, may promote the growth of non-susceptible microorganisms, including fungi, requiring appropriate therapeutic measures.
During prolonged treatments with high doses, periodic monitoring of hematological parameters and hepatic and renal function is recommended.
In pregnant women and very young infants, the product should be administered only when clearly needed and under direct medical supervision.
Do not use injectable sodium piperacillin solutions for topical ophthalmic use.
Hemophagocytic lymphohistiocytosis
Cases of a disease in which the immune system produces an abnormally high number of white blood cells called histiocytes and lymphocytes, leading to inflammation (hemophagocytic lymphohistiocytosis), have been reported. This condition can be life-threatening if not diagnosed and treated early.
If you develop various symptoms such as fever, swollen lymph nodes, weakness, mental confusion, shortness of breath, bruising or skin rash, contact your doctor immediately.
PIPERACILLIN K24 PHARMACEUTICALS 1g/2ml contains 44.4 mg of sodium (main component of table salt) per vial of powder. This corresponds to 2.22% of the maximum recommended daily dietary intake for an adult.
PIPERACILLIN K24 PHARMACEUTICALS 2g/4ml contains 88.8 mg of sodium (main component of table salt) per vial of powder. This corresponds to 4.44% of the maximum recommended daily dietary intake for an adult.
PIPERACILLIN K24 PHARMACEUTICALS 4g contains 177 mg of sodium (main component of table salt) per vial of powder. This corresponds to 8.85% of the maximum recommended daily dietary intake for an adult.
INTERACTIONS
In vitro, piperacillin shows synergy with aminoglycosides.
If the patient suffers from other diseases or is taking other medications, he/she should consult his/her physician for necessary information.
SPECIAL WARNINGS
Hypersensitivity and anaphylactic reactions have mostly been reported following parenteral administration of penicillin, very rarely after oral administration.
Such reactions occur more frequently in patients with a history of hypersensitivity to multiple allergens, asthma, hay fever, or urticaria. Cross-allergy with penicillin G, semisynthetic penicillins, and cephalosporins is possible.
An accurate patient history is therefore necessary before starting therapy with a penicillin.
In case of an allergic reaction, treatment must be discontinued and appropriate therapy initiated (vasopressor amines, antihistamines, corticosteroids), or, in case of anaphylaxis, immediate treatment with adrenaline or other appropriate emergency measures.
KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Intramuscular administration
The following dosage regimen may be used as a guide:

Age	Single dose	Frequency of administration
Adults	2g (1 vial)	2 times daily
Children
Over 6 years of age	1g (1 vial)	2 times daily
Under 6 years of age	0.5g (1/2 vial)	2 times daily

Intravenous administration
Piperacillin may be administered either by direct injection or by intravenous infusion.
The following dosage recommendations are advised for adults, depending on the condition being treated:

Septicemia, respiratory tract infections, abdominal and pelvic infections, skin and soft tissue infections: 200–300 mg/kg/day (up to 24 g within 24 hours), divided into multiple doses; these dosages are made possible by the high therapeutic index of the drug.
Complicated urinary tract infections: 150–200 mg/kg/day, divided into multiple doses. The following dosage recommendations are advised for children, depending on the condition being treated:
Urinary tract infections: 100–200 mg/kg/day, divided into multiple doses.
Respiratory tract infections (pneumonia, bronchitis, bronchopneumonia, empyema), skin and soft tissue infections, hepatobiliary infections: 100–300 mg/kg/day, divided into multiple doses.
Severe infectious conditions (septicemia, central nervous system infections): 300 mg/kg/day, divided into multiple doses.

INSTRUCTIONS FOR USE
Piperacillin may be administered either by intramuscular or intravenous route, either directly or by infusion.
The vial of solvent containing lidocaine supplied with the package must be used only for
intramuscular administration.
For direct intravenous injection (administered over a period of 3–5 minutes), sterile water for injection must be used: at least 4 ml for the 1-gram piperacillin vial, 8 ml for the 2-gram piperacillin vial, and 16 ml for the 4-gram piperacillin vial.
After adding the appropriate solvent, shake the vial until complete dissolution of the contents is achieved.
When administering by intravenous infusion (duration 30 minutes), prepare the product as for direct intravenous administration and add it to at least 50 ml of the infusion solution.

OVERDOSAGE
In case of overdosage, it is recommended to consult the treating physician.

UNDESIRABLE EFFECTS
Adverse reactions due to sodium piperacillin are rare and usually mild or moderate in severity. The most frequently reported symptoms are urticaria and skin rash, generally transient in nature and rarely requiring discontinuation of therapy. Nausea, diarrhea, chills, headache, and dizziness occur infrequently.
Anaphylactoid reactions to piperacillin and other severe allergic phenomena, as with other penicillins, may occur.
Transaminase level changes have been reported rarely and with uncertain clinical significance. Likewise infrequent are anemia, thrombocytopenia, purpura, eosinophilia, leukopenia, and agranulocytosis, which are usually reversible upon discontinuation of therapy and are also considered manifestations of hypersensitivity.
ADHERENCE TO THE INSTRUCTIONS CONTAINED IN THIS LEAFLET REDUCES THE RISK OF UNDESIRABLE EFFECTS. IT IS IMPORTANT TO INFORM YOUR PHYSICIAN OR PHARMACIST OF THE OCCURRENCE OF ANY ADVERSE EFFECT, EVEN IF NOT DESCRIBED IN THIS LEAFLET.

STORAGE AND STABILITY
Store in a cool place at a temperature below 25°C and protect from light.
For the expiration date, refer to the date indicated on the packaging.
The shelf life applies to the product in its original, unopened packaging stored under recommended conditions.
After reconstitution, intramuscular solutions should be used immediately.
Caution: do not use the medicinal product after the expiration date stated on the packaging.

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