Sintarpen

Leaflet attached to the packaging: patient information

Syntarpen, 1 g, powder for solution for injection

Cloxacillin

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 a doctor, pharmacist, 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Syntarpen is and what it is used for

Syntarpen contains the active substance cloxacillin, which is a semi-synthetic penicillin antibiotic. Cloxacillin works against various strains of Gram-positive and Gram-negative bacteria, but it is most commonly used to treat infections caused by staphylococci. Cloxacillin is used to treat infections caused by staphylococci, such as:

• skin and soft tissue infections (cellulitis);
• endocarditis, central nervous system infections;
• lower respiratory tract infections;
• purulent post-burn and post-operative complications;
• bone and joint infections, mainly post-traumatic - in the later stage of treatment, oral form is administered;
• septicaemia.

2. Important information before using Syntarpen

Before starting treatment, the doctor may order a test (antibiogram) to determine the effectiveness of Syntarpen against the bacteria causing the infection. Treatment may be started before the test results are available. After receiving the antibiogram results, the doctor may change the antibiotic.

When not to use Syntarpen

If the patient is allergic to cloxacillin, penicillins, or cephalosporins.

Warnings and precautions

Before starting Syntarpen, discuss it with your doctor.
➢ If the patient has a history of allergic reactions to any antibiotic or other allergic reactions, they should inform their doctor before using Syntarpen.
Reactions to cloxacillin may occur more frequently in people with a tendency to allergic reactions to many different substances and in patients with asthma. These reactions can have various symptoms and severity – from skin changes to anaphylactic shock (severe allergic reaction; see section 4 "Possible side effects"). Therefore, if skin changes (e.g., hives, itching) or other symptoms indicating an allergy occur during Syntarpen use, the medicine should be discontinued, and the patient should consult their doctor as soon as possible.
➢ If the patient needs to take Syntarpen for a longer period, the doctor will usually order periodic monitoring of kidney and liver function, as well as peripheral blood morphology.
➢ Prolonged use of antibiotics may lead to the overgrowth of insensitive bacteria or fungi. If symptoms of new infections occur during Syntarpen treatment, the medicine should be discontinued, and the patient should consult their doctor.
➢ If the patient experiences diarrhea during Syntarpen treatment or after its completion, they should inform their doctor. This may be a sign of pseudomembranous colitis – a complication associated with antibiotic use. It is then necessary to discontinue the medicine and sometimes administer appropriate treatment. Anti-peristaltic drugs or other constipating agents should not be given.
➢ Kidney and urinary tract disorders occur most frequently in patients receiving high doses of the medicine and (or) with existing kidney function disorders and subside after the medicine is discontinued. Therefore, during prolonged use of cloxacillin, kidney function, liver function, and peripheral blood morphology should be periodically monitored. In case of renal failure associated with liver function disorders, cloxacillin serum levels should be regularly monitored.
➢ If the patient has cystic fibrosis, it is recommended to monitor cloxacillin levels in the blood and consider increasing the dose.
In case of doubts, consult a doctor or pharmacist.

Syntarpen and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking:
probenecid (used to treat gout) administered simultaneously with Syntarpen may increase the antibiotic level in the blood;
anticoagulant medicines (medicines that prevent blood clot formation), such as warfarin, used with Syntarpen may increase the risk of bleeding and lead to hemorrhage;
methotrexate (used to treat arthritis): Syntarpen used with methotrexate may increase its toxicity;
oral contraceptives: Syntarpen used with oral contraceptives may reduce the effectiveness of contraception. The doctor will recommend using additional non-hormonal contraceptive methods.
ampicillin, fusidic acid (antibiotics) used simultaneously with Syntarpen have an enhanced effect;
erythromycin, tetracyclines, chloramphenicol (antibiotics): simultaneous administration of Syntarpen with any of these medicines may weaken the effect of Syntarpen;
aminoglycoside antibiotics (e.g., streptomycin, gentamicin, neomycin) and Syntarpen are physicochemically incompatible, and their simultaneous use should be avoided;
proguanil (a medicine used to treat malaria) may cause a decrease in cloxacillin levels in the blood and reduce the effectiveness of treatment.
Patients allergic to cephalosporins may also be allergic to cloxacillin (so-called cross-allergy).
Effect on laboratory test results
In patients taking Syntarpen, glucose test results in urine using certain methods may be falsely positive, so if such a test is necessary, it is recommended to use enzymatic tests.
Syntarpen may also affect the results of urine steroid 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.
For safety reasons, Syntarpen should be used during pregnancy only if the doctor believes that the potential benefits outweigh the possible risks.
The medicine passes into breast milk in small amounts. Therefore, breastfeeding may need to be discontinued if the infant experiences gastrointestinal disturbances (diarrhea, thrush, or skin rash).
There is limited data on the use of cloxacillin in humans. Animal studies on reproductive toxicity are insufficient.

Driving and using machines

There is no data on the effect of Syntarpen on the ability to drive and use machines. Therefore, if the patient experiences symptoms that disrupt concentration (e.g., headache, drowsiness; see section 4 "Possible side effects"), they should not drive or operate machines.

Syntarpen contains sodium

Each gram of Syntarpen contains 55.01 mg of sodium (the main component of common salt). This corresponds to 2.75% of the maximum recommended daily sodium intake in the diet for adults.
Considering the dosing regimen presented in section 3, the maximum amount of sodium that can be administered to the patient in a single dose is 110.02 mg. This corresponds to 5.5% of the maximum recommended daily sodium intake in the diet for adults.
Considering the dosing regimen presented in section 3, the amount of sodium that can be administered to the patient in a daily dose is 660.11 mg. This corresponds to 33% of the maximum recommended daily sodium intake in the diet for adults.
This should be taken into account in patients controlling their sodium intake.
When using sodium-containing solvents (see "Information intended exclusively for healthcare professionals"), the amount of sodium from the solvent should be included in the calculation of the total sodium amount in the prepared solution. To do this, consult the leaflet of the solvent used.

3. How to use Syntarpen

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Recommended dose

Adults

Depending on the type and severity of the infection, 1-2 g is administered intramuscularly or intravenously every 4-6 hours.
The maximum daily dose is 12 g.

Children

Usually, 100-200 mg/kg body weight per day is administered intravenously or intramuscularly in 4 divided doses (every 6 hours). In severe infections, the dose can be increased to 100-300 mg/kg body weight per day in 4-6 divided doses.
Staphylococcal pneumonia
Adults: 1-2 g intravenously or intramuscularly every 6 hours for 10-14 days.
Children over 5 years: 50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 6 hours for 10-14 days.
Children from 2 months to 5 years: 25-50 mg/kg body weight (maximum 2 g) intravenously every 6 hours, in combination with gentamicin at a dose of 7.5 mg/kg body weight administered intravenously in 1-3 divided doses for at least 3 weeks.

Hospital-acquired pneumonia

Adults: 1-2 g intravenously every 6 hours, in combination with gentamicin 5-7 mg/kg body weight in divided doses for 7 days.
Children: 50 mg/kg body weight (maximum 2 g) intravenously every 6 hours, in combination with gentamicin at a dose of 7.5 mg/kg body weight in 1-3 divided doses for 7 days.
In hospitals with a high prevalence of methicillin-resistant Staphylococcus aureusstrains:
vancomycin is used.

Purulent myositis

Adults: 2 g intravenously or intramuscularly every 6 hours for 5-10 days (if clinical improvement occurs, it is possible to switch to oral administration of 500 mg every 6 hours).
Children: 25-50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 6 hours for 5-10 days.
If improvement occurs: it is possible to switch to oral administration of 12.5-25 mg/kg body weight (maximum 500 mg) every 6 hours.

Septic arthritis - empirical treatment

Adults: 2 g intravenously or intramuscularly every 6 hours, in combination with ceftriaxone, 1-2 g intravenously or intramuscularly every 24 hours.
Children over 2 months: 25-50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 6 hours, in combination with ceftriaxone, administered intravenously or intramuscularly at a dose of 25-50 mg/kg body weight (maximum 2 g) every 24 hours.
Newborns: 25-50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 6 hours, in combination with cefotaxime, administered intravenously at a dose of 50-75 mg/kg body weight (maximum 2 g) every 8 hours.
Septic arthritis caused by Staphylococcus aureus
Adults: 2 g intravenously or intramuscularly every 6 hours for 2-3 weeks (if the duration of parenteral treatment is less than 2-3 weeks, additional oral administration of 1 g every 6 hours is recommended).
Children over 5 years: 25-50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 4-6 hours for 4-6 days (or until clinical improvement occurs), and then 25 mg/kg body weight (maximum 500 mg) orally every 6 hours until the end of the 2-3 week treatment period, or 25 mg/kg body weight (maximum 500 mg) orally every 6 hours until the end of the 2-3 week treatment cycle, after ceftriaxone administration intravenously or intramuscularly at a dose of 50-75 mg/kg body weight (maximum 1 g) every 24 hours for 4-6 days (or until clinical improvement occurs).
Children from 2 months to 5 years: 25-50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 4-6 hours, in combination with ceftriaxone, administered intravenously or intramuscularly at a dose of 50-75 mg/kg body weight (maximum 1 g) every 24 hours for 4-6 days (or until clinical improvement occurs), and then 12.5 mg/kg body weight (maximum 500 mg) orally every 6 hours until the end of the treatment period of 2-3 weeks.
Newborns: 25-50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 4-6 hours, in combination with cefotaxime, administered intravenously at a dose of 50-75 mg/kg body weight (maximum 2 g) every 8 hours for 4-6 days (or until clinical improvement occurs), and then 12.5 mg/kg body weight (maximum 500 mg) orally every 6 hours until the end of the 2-3 week treatment period.

Infective endocarditis - initial empirical treatment

Adults: 2 g intravenously every 4 hours, in combination with benzylpenicillin administered at a dose of 3 million IU every 4 hours and gentamicin 2 mg/kg body weight every 8 hours, intravenously.
Children: 50 mg/kg body weight (maximum 2 g) intravenously every 4 hours, in combination with benzylpenicillin 50,000 IU/kg body weight (maximum 3 million IU) every 4 hours and gentamicin 2.5 mg/kg body weight (maximum 80 mg) every 8 hours, intravenously.
Endocarditis caused by methicillin-sensitive Staphylococcus aureusstrains
Adults: 2 g intravenously every 4 hours for 6 weeks, and gentamicin 1 mg/kg body weight every 8 hours, intravenously, for the first 7 days.
Children: 50 mg/kg body weight (maximum 2 g) intravenously every 4 hours for 6 weeks. Additionally, gentamicin 1 mg/kg body weight every 8 hours, intravenously, for the first 7 days.

Septicaemia - initial empirical treatment

Adults and children over 5 years: 2 g intravenously every 4-6 hours, alternatively in combination with gentamicin administered intravenously at a dose of 5-7 mg/kg body weight every 24 hours or gentamicin 1.5 mg/kg body weight, administered intravenously or intramuscularly every 8 hours.
Children from 2 months to 5 years: 50 mg/kg body weight (maximum 2 g) intravenously every 4-6 hours, in combination with ceftriaxone, 50 mg/kg body weight (maximum 2 g) intravenously or intramuscularly every 24 hours.
Newborns: 50 mg/kg body weight (maximum 2 g) intravenously every 4-6 hours, in combination with cefotaxime, 50-75 mg/kg body weight (maximum 2 g) intravenously every 8 hours.

Use in patients with renal impairment

Prior to Syntarpen administration, patients with renal failure should inform their doctor. In these patients, the doctor will determine the dosage individually, depending on the degree of renal impairment. (see "Warnings and precautions" section 2)

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Treatment duration

The treatment duration depends on the severity and type of infection.
The doctor will determine the appropriate treatment duration, which should be followed.
The method of administration and preparation of solutions is described at the end of the leaflet, in the "Information intended exclusively for healthcare professionals" section.

Using a higher dose of Syntarpen than recommended

Since Syntarpen will be administered by a doctor or nurse, incorrect dosing is unlikely. However, if the patient believes they have received too high a dose, they should immediately inform their doctor.

Missing a dose of Syntarpen

A double dose should not be used to make up for a missed dose.

Stopping Syntarpen treatment

It is essential to use the medicine as directed for the recommended treatment cycle. Treatment should not be discontinued because the patient feels better. If the treatment cycle is discontinued too early, the infection may recur.
If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult their doctor.
In case of further doubts about using this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe side effects

If any of the following severe side effects occur, the doctor should be informed immediately.

The following severe side effectsoccur very rarely(less than 1 in 10,000 people):
Allergic reactions, immediate allergic reactions such as sudden shortness of breath and chest tightness, swelling of the eyelids, face, or lips, severe skin rashes that can occur with blistering of the eyes, mouth, throat, and genitals, loss of consciousness (fainting). Delayed allergic reactions (may occur 48 hours to 2-4 weeks after starting treatment) such as fever, malaise, hives, muscle pain, joint pain, abdominal pain, skin rashes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, symptoms of serum sickness-like reactions such as hives on the skin with a burning sensation, allergic vasculitis.
Severe diarrhea, persistent for a longer period or containing blood, accompanied by abdominal pain or fever. This may be a sign of severe colitis (called pseudomembranous colitis), which can occur after antibiotic use.

Other side effects that may occur during treatment

The following side effects occur frequently(less than 1 in 10 people):

• diarrhea.

The following side effects occur rarely(less than 1 in 1000 people):

• redness of the skin at the injection site or phlebitis.

The following side effects occur very rarely(less than 1 in 10,000 people):

• increased or decreased levels of certain types of white or red blood cells or platelets, and abnormal breakdown of red blood cells, bone marrow suppression;
• nausea, vomiting, oral thrush, black discoloration of the tongue;
• anuria, interstitial nephritis, renal tubular disorders. Symptoms of these disorders are usually rash, fever, increased levels of one type of granulocyte in the blood, hematuria, proteinuria. They usually occur in patients receiving high doses of the medicine and (or) with existing kidney function disorders and subside after the medicine is discontinued;
• transient hyperactivity, excitement, restlessness, drowsiness, disorientation, and (or) dizziness. These symptoms usually occur in patients with renal failure receiving high doses of the medicine;
• fever, pain, and dizziness - subside after the medicine is discontinued;
• elevated liver enzyme activity, in individual cases, hepatitis may occur, and jaundice (signs of cholestatic jaundice caused by bile stasis). These symptoms subside after the medicine is discontinued;
• fever, pain, and dizziness -subside after the medicine is discontinued.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. 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 Syntarpen

Store at a temperature below 25°C. Store the vial in its original packaging to protect it from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your 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 Syntarpen contains

The active substance of the medicine is cloxacillin in the form of cloxacillin sodium.
One vial contains 1 g of cloxacillin in the form of cloxacillin sodium.
The medicine does not contain other ingredients.

What Syntarpen looks like and what the packaging contains

White or almost white, crystalline powder.
Packaging:glass vial containing 1 g of powder, in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: (22) 811-18-14
To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder.

Date of the last update of the leaflet:

Information intended exclusively for healthcare professionals:

Method of administration

Syntarpen can be administered by intramuscular or intravenous injection, intravenous infusion, or injection into the pleural cavity.
Solutions should be prepared immediately before administration.

Method of preparing solutions Intramuscular injection

1 g of powder should be dissolved in 4 ml of water for injection.
Intravenous injection
1 g of powder should be dissolved in 20-40 ml of water for injection. The injection should be administered slowly over 2 minutes.
Intravenous infusion
The vial contents should be dissolved in approximately 500 ml of 0.9% sodium chloride solution or 5% glucose solution and administered over 30-40 minutes.
Cloxacillin solutions should be administered immediately after preparation.

Incompatibilities

Cloxacillin should not be mixed with aminoglycosides, tetracyclines, erythromycin, polymyxin B, or blood products and protein hydrolysates. If it is necessary to administer cloxacillin with another medicine, both products should be administered separately, at different sites, with an interval of about 1 hour.