PENSTAPHO

Patient Information Leaflet

PENSTAPHO

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Patient Information Leaflet

PENSTAPHO

1 g/5 ml powder and solvent for injectable solution
Sodium oxacillin monohydrate
Please read this leaflet carefully before taking/giving this medicine to your child because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and/or your child only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you and/or your child experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Penstapho is and what it is used for
2. What you need to know before taking/giving Penstapho to your child
3. How to take/give Penstapho to your child
4. Possible side effects
5. How to store Penstapho
6. Package contents and other information

1. What Penstapho is and what it is used for

Penstapho contains sodium oxacillin and belongs to the group of systemic antimicrobial agents (medicines capable of killing bacteria or inhibiting their growth), meaning they act throughout all organs of the body.
As with all antibiotics, your doctor will instruct you to take Penstapho only after obtaining the results of a sensitivity test to determine whether your bacteria are susceptible to this antibiotic.
Penstapho is indicated in adults and children for the treatment of:

• respiratory tract infections (lungs, bronchi, ear, nose and throat)
• skin and soft tissue infections:
  • furunculosis (appearance of red, painful skin nodules)
  • septic ulcers (slow-healing skin lesions infected with germs)
  • wound infections
  • cellulitis (inflammation of fatty tissue caused by infection)
  • abscesses (collections of pus formed within a tissue)
• osteomyelitis (infections and inflammations affecting both bone and the bone marrow cavity)
• genital and urinary tract infections
• bacteremia (presence of bacteria in the blood)
• staphylococcal enterocolitis (inflammations of the small intestine and colon caused by Staphylococcus bacteria).

2. What you should know before taking/giving Penstapho to your child

Do not take/give Penstapho to your child

• If you and/or your child are allergic to sodium oxacillin.
• If your child is a newborn. 2/8

1 g/5 ml powder and solvent for injectable solution
Sodium oxacillin monohydrate
Read this leaflet carefully before taking/giving this medicine to your child because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and/or your child only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you and/or your child experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Penstapho is and what it is used for
2. What you should know before taking/giving Penstapho to your child
3. How to take/give Penstapho to your child
4. Possible side effects
5. How to store Penstapho
6. Package contents and other information

1. What Penstapho is and what it is used for

Penstapho contains sodium oxacillin and belongs to the group of systemic antimicrobial agents (medicines capable of killing bacteria or inhibiting their growth) intended for systemic use (i.e. affecting all organs of the body).
As with all antibiotics, your doctor will instruct you to take Penstapho after obtaining the results of a test to determine whether your bacteria are sensitive to this antibiotic (sensitivity test).
Penstapho is indicated in adults and children for the treatment of:

• respiratory tract infections (lungs, bronchi, ear, nose and throat)
• skin and soft tissue infections:
  • furunculosis (appearance of red, painful skin nodules)
  • septic ulcers (slow-healing skin lesions infected with microorganisms)
  • wound infections
  • cellulitis (inflammation of adipose tissue caused by infection)
  • abscesses (collections of pus formed within a tissue)
• osteomyelitis (infections and inflammations affecting both bone and the medullary cavity)
• genital and urinary tract infections
• bacteremia (presence of bacteria in the blood)
• staphylococcal enterocolitis (inflammations affecting the small intestine and colon caused by Staphylococcus bacteria).

2. What you should know before taking/giving Penstapho to your child

Do not take/give Penstapho to your child

• If you and/or your child are allergic to sodium oxacillin.
• If your child is a newborn.
• If you are pregnant or breastfeeding.

Warnings and precautions
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Consult your doctor or pharmacist before taking/giving Penstapho.
Inform your doctor if:

• you have previously experienced an allergic reaction to other beta-lactam antibiotics (medicines similar to Penstapho such as penicillins, cephalosporins), to other antibiotics (such as cephemins, carbapenems, 1-oxacillin-beta-lactams) or to other allergens, as your doctor will administer Penstapho with caution. If you experience an allergic reaction during treatment, your doctor will instruct you to stop the medicine and will initiate appropriate therapy (see section 4).

The use of beta-lactam antibiotics, including oxacillin, may cause encephalopathy (e.g. confusion,
impaired consciousness, epilepsy, movement disorders); particularly in patients with renal
impairment and when high doses are administered.
With the use of almost all antibiotics, including Penstapho, Clostridium difficile-associated
diarrhoea (a bacterium normally present in the digestive system) has been reported, which may vary in severity from mild diarrhoea to fatal colitis. The onset of C. difficile-associated diarrhoea may occur up to two months after Penstapho treatment. In case of suspected or confirmed C. difficile infection, your doctor may decide to discontinue antibiotic therapy.

Possible consequences of prolonged use of Penstapho
Like other antibiotics, Penstapho may cause uncontrolled growth of organisms (bacteria not sensitive to this antibiotic and fungi). If you and/or your child develop a new infection in addition to the existing one, your doctor will take appropriate measures.

What to do before starting treatment and during treatment:
Before starting treatment with Penstapho and at least once a week during treatment, the following are recommended:

• blood cultures (tests to isolate and identify any microorganisms present in the blood)
• white blood cell count
• differential white blood cell count (leukocyte formula). During treatment, the following tests are recommended:
• periodic urine examination
• blood urea nitrogen (BUN): nitrogen concentration in the blood
• serum creatinine: creatinine concentration in the blood, an indicator of kidney function
• serum aspartate aminotransferase (AST, a protein particularly present in muscles, liver and heart), which may primarily indicate liver and heart problems
• serum alanine aminotransferase (ALT, a protein particularly present in the liver), which may indicate liver problems. If these values rise, your doctor will evaluate whether dosage adjustments are needed. During prolonged Penstapho therapy, periodic monitoring of kidney, liver and haematopoietic system (the system responsible for producing blood cells) function is recommended.

Children and adolescents
For children over 1 month of age and adolescents, the doctor must carefully evaluate the dose based on age, weight, severity and type of infection, and kidney function.

Other medicines and Penstapho
Inform your doctor or pharmacist if you and/or your child are taking, have recently taken, or might take any other medicines.
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Consult your doctor if you are taking:

• probenecid, a medicine used to increase uric acid excretion in urine;
• aminoglycosides (antibiotics);
• oral contraceptives (medicines used to prevent pregnancy).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Penstapho should be used during pregnancy only if clearly needed and under strict medical supervision. Therefore, your doctor will carefully evaluate the benefits of treatment against potential risks to the fetus.
Breastfeeding
Inform your doctor if you are breastfeeding or about to start breastfeeding. Your doctor will evaluate whether to discontinue breastfeeding or Penstapho treatment.
This medicine should only be taken if clearly necessary and under strict medical supervision.

Driving and using machines
This medicine may affect the ability to drive vehicles and operate machinery in case of encephalopathy.

3. How to take/give Penstapho to your child

Take/give this medicine exactly as directed by the doctor. If you have any doubts, consult your doctor or pharmacist. The dose will be determined by the doctor based on the type of bacteria, the severity of the infection, kidney function, and your general condition.
Penstapho will be administered into a vein in your body (intravenous use) by a doctor or healthcare professional.
Use in children and adolescents
The doctor will determine the recommended dose based on the child's age, weight, severity and type of infection, and kidney function.
The doctor will carefully evaluate whether to administer the medicine to your newborn, closely monitoring the dose and drug levels in the blood, and monitoring for possible adverse effects.
Duration of treatment
The doctor will determine the duration of treatment based on age, weight, severity and type of infection, and kidney function of you/your child.
If you take/give your child more Penstapho than you should
If you and/or your child accidentally take an excessive dose of Penstapho, contact your doctor or the nearest hospital immediately.
The use of beta-lactam antibiotics, including oxacillin, may cause encephalopathy (e.g. confusion, impaired consciousness, epilepsy, movement disorders); particularly in patients with renal impairment and in cases of high-dose administration.
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If you forget to take/give your child Penstapho
Do not take a double dose to make up for the missed dose.
If you stop treatment with Penstapho
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects while taking Penstapho, consult your doctor immediately, who will STOP treatment with this medicine:

• Allergic reactions that may even lead to death and may present as:
  ➢ Within 20 minutes to 48 hours after administration: urticaria (appearance on the skin of red or white welts of various sizes) and itching or fever or angioedema (swelling of the face, tongue or throat) or laryngeal edema or laryngospasm (contraction of laryngeal muscles) or bronchospasm (reduction in bronchial diameter) or hypotension (lowering of blood pressure) or vascular collapse (severe reduction in blood perfusion to body tissues) or death;
  ➢ Between 48 hours and up to 2–4 weeks after administration: fever or fatigue or urticaria or myalgia (localized pain in one or more muscles) or arthralgia (joint pain and pain in surrounding tissues) or abdominal pain or various skin rashes (e.g., purpura: appearance of purple-colored skin patches of varying sizes).

Additionally, the following side effects may occur, although their frequency is unknown:
Effects affecting the mouth, stomach, and intestine

• nausea
• vomiting
• diarrhoea
• stomatitis (inflammation of the mucous membrane of the mouth)
• black hairy tongue (appearance of a dark, hair-like patch in the center of the tongue)
• irritation of the stomach and intestine
• pseudomembranous colitis (inflammation of the colon associated with antibiotic use)

Effects affecting the nervous system

• persistent drowsiness (lethargy)
• confusion
• spasms (sudden, involuntary muscle contractions)
• multifocal myoclonus (brief spasms of one or more muscles affecting the entire body)
• epileptiform seizures (involuntary contractions of certain muscles)
• amblyopia (weakening of vision in one eye)
• neuropathies (diseases affecting the peripheral nervous system)
• encephalopathy (disease affecting the brain), which may manifest as confusion, altered consciousness, epilepsy, and movement disorders

Effects affecting the kidneys and urinary tract (infrequently associated with oxacillin)

• damage to renal tubules
• interstitial nephritis (kidney inflammation caused by various pathogens, primarily involving the renal interstitium), manifesting as: skin rash, fever (elevated body temperature), eosinophilia (increased concentration in blood of eosinophils, a type of white blood cell)
• presence of blood in urine (haematuria)
• presence of protein in urine (proteinuria)
• reduced kidney function (renal insufficiency)

Effects affecting the blood

• increased concentration in blood of eosinophils, a type of white blood cell (eosinophilia)
• reduced number of platelets in blood (thrombocytopenia)
• reduced haemoglobin levels in blood (haemolytic anaemia)
• severe reduction in the number of granulocytes in blood, a type of white blood cell (agranulocytosis)
• reduced number of neutrophils in blood, a type of white blood cell (neutropenia)
• reduced number of white blood cells in blood (leucopenia)
• reduced number of granulocytes in blood, including eosinophils and basophils (granulocytopenia)
• reduced number of certain blood cells due to bone marrow failure (bone marrow suppression)

Effects affecting the liver and bile

• liver toxicity (hepatotoxicity), presenting as: fever (elevated body temperature), nausea and vomiting
• asymptomatic and transient increase in alanine aminotransferase (ALT, a protein particularly present in the liver), which may indicate liver problems
• asymptomatic and transient increase in aspartate aminotransferase (AST, a protein particularly present in muscles, liver, and heart), which may primarily indicate liver or heart problems
• asymptomatic and transient increase in alkaline phosphatase levels in blood (a protein mainly present in the liver, biliary tract, and bones), which may indicate skeletal or liver diseases

Effects affecting the skin and subcutaneous tissues

• bullous dermatitis

Reporting of side effects
If you or your child experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazione-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Penstapho

Keep this medicine out of sight and reach of children.
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This medicine does not require any special storage conditions. Use immediately after reconstitution.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Penstapho Contains
Vial:

• The active substance is sodium oxacillin monohydrate 1.1 g, equivalent to 1 g of oxacillin.

Solvent vial:
Each solvent vial contains water for injections.

Description of the Appearance of Penstapho and Contents of the Package
Powder and solvent for injectable solution for intravenous use.
One package contains 1 vial of 1 g and 1 solvent vial of 5 ml.
One package contains 25 vials of 1 g and 25 solvent vials of 5 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
LABORATOIRES DELBERT sas
49 rue Rouelle
75015 Paris – France

Manufacturer
Haupt Pharma Latina
Strada Statale 156 dei Monti Lepini,
04100 Borgo San Michele (LT), Italy

The following information is intended exclusively for physicians or healthcare professionals:
Dosage and Method of Administration
Bacteriological studies should be performed to identify the causative organisms and their susceptibility to penicillinase-resistant penicillins.
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The duration of therapy varies depending on the type and severity of infection, as well as the patient's general condition. Therefore, it should be determined based on the patient's clinical and bacteriological response.
Treatment should continue for at least 48 hours after the patient becomes afebrile, asymptomatic, and cultures are negative.
In severe staphylococcal infections, therapy with penicillinase-resistant penicillins should continue for at least 14 days.
Treatment of endocarditis and osteomyelitis may require a longer duration. Infections caused by beta-hemolytic streptococci should be treated for at least 10 days to prevent the onset of rheumatic fever or glomerulonephritis.
PENSTAPHO must be administered exclusively by slow intravenous injection or, preferably, by intravenous infusion.

For mild to moderate upper respiratory tract infections or localized skin and soft tissue infections:
Adults or children weighing ≥40 kg: 250 to 500 mg every 4–6 hours.
Children weighing less than 40 kg: 50 mg/kg/day divided into equal doses every 6 hours.

For more severe infections such as lower respiratory tract infections or disseminated infections:
Adults or children weighing ≥40 kg: 1 g or more, as determined by the physician, every 4–6 hours.
Children weighing less than 40 kg: 100 mg/kg/day divided into equal doses every 4–6 hours.

Special populations: Renal impairment
Generally, dosage adjustment is not required in patients with renal impairment; however, in patients with creatinine clearance below 10 ml/min, the lowest dose within the usual dosage range may be indicated.

Instructions for Preparation and Use of the Injectable Solution
Intravenous administration (into a vein of the body): Add to the vial water for injections or physiological solution in the following proportions: 5 ml to the 1 g vial. Inject slowly into a vein over 10 minutes. Particular caution should be exercised in elderly patients due to the possibility of thrombophlebitis (inflammation of superficial veins leading to vessel occlusion).
WARNING: Rapid administration may cause convulsions (involuntary muscle contractions).

Intravenous infusion administration: The reconstituted solution (as described above for intravenous injection) should be further diluted in an infusion solution. Under these conditions, the antibiotic remains stable for at least 6 hours.

Compatible Solutions

• Sodium chloride 0.9% solution (physiological saline)
• 5% dextrose solution in water
• 5% dextrose in sodium chloride solution
• 10% fructose solution in water
• 10% fructose in sodium chloride solution
• Ringer-lactate solution
• Lactate-potassium saline solution
• 10% invert sugar solution in water
• 10% invert sugar solution in sodium chloride solution
• 10% invert sugar solution plus 0.3% potassium chloride in water

Only the solutions listed above should be used for intravenous infusion of Penstapho. The antibiotic concentration should be between 0.5 and 2 mg/ml. The drug concentration, infusion rate, and volume must be adjusted so that the total dose of oxacillin is administered before the solution loses its stability.
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After opening and reconstitution: the product should be used immediately.

After reconstitution and dilution:
The chemical and physical stability of various reconstituted and diluted solutions in different solvents has been evaluated as follows:

The chemical and physical stability of solutions reconstituted with water for injection and diluted in 0.9% sodium chloride solution has been demonstrated for 8 hours between 18 and 25 °C.
The chemical and physical stability of solutions reconstituted with water for injection and diluted in 5% glucose solution has been demonstrated for 8 hours between 18 and 25 °C for solution (A) and solution (B).
The chemical and physical stability of solutions reconstituted with water for injection and diluted in 5% glucose solution has been demonstrated for 6 hours between 18 and 25 °C for solution (C).
However, from a microbiological standpoint, Penstapho 1 g/5 ml, powder and solvent for solution for injection, should be used immediately.
Only the solutions mentioned above should be used for intravenous infusion of Penstapho. The drug concentration, infusion rate, and infusion volume must be adjusted so that the total dose of oxacillin is administered before the solution loses its stability.
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