Sintarpen

Leaflet attached to the packaging: patient information

Syntarpen, 2 g, powder for solution for injection/infusion

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 your 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.
• If the patient experiences any side effects, including any side effects 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 methicillin-sensitive staphylococci.

• 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 stages of treatment, oral forms are administered;
• septicemia (a specific reaction of the body to infection);
• bone and marrow inflammation (osteomyelitis).

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.

2. Important information before using Syntarpen

When not to use Syntarpen

If the patient is allergic to cloxacillin or other beta-lactam antibiotics.

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 medications, or other allergic reactions, they should inform their doctor before using the medicine. Allergic 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 (a 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 doctor should be consulted immediately.

If the patient must take Syntarpen for a longer period, the doctor usually orders periodic monitoring of kidney, liver, and peripheral blood morphology.

Prolonged use of antibiotics may cause excessive growth of insensitive bacteria or fungi. If symptoms of new infections occur during treatment with Syntarpen, the medicine should be discontinued and the doctor should be consulted.

If the patient experiences diarrhea during treatment with Syntarpen 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 use appropriate treatment. Medications that inhibit peristalsis or have a constipating effect should not be administered.

Kidney and urinary tract disorders occur most commonly in patients receiving high doses of the medicine and (or) with existing kidney function disorders and subside after discontinuation of the medicine. For this reason, during prolonged use of cloxacillin, the doctor will monitor kidney, liver, and peripheral blood morphology. In the event of renal failure associated with liver function disorders, the doctor will regularly monitor cloxacillin serum levels.

If the patient has cystic fibrosis, the doctor will monitor cloxacillin levels in the blood and consider increasing the dose of the medicine.

In case of doubts, consult your 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 use.

In particular, inform your doctor if you are taking:

probenecid (used to treat gout) - when given with Syntarpen, it may increase the antibiotic level in the blood;

anticoagulants (medicines that prevent blood clots), such as warfarin - when used with Syntarpen, they 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) - when used with Syntarpen, they may enhance its effect;

erythromycin, tetracyclines, chloramphenicol (antibiotics): concurrent use of Syntarpen with any of these medicines may reduce its effectiveness;

aminoglycoside antibiotics (e.g., streptomycin, gentamicin, neomycin) and Syntarpen are physically incompatible, so these medicines should not be administered simultaneously;

proguanil (a medicine used to treat malaria) may decrease cloxacillin levels in the blood and reduce treatment effectiveness.

Patient allergic to cephalosporins may also be allergic to cloxacillin (so-called cross-allergy).

Effect on laboratory test results

In patients receiving Syntarpen, urine glucose test results using certain methods may be falsely positive. Therefore, if such a test is necessary, it is recommended to use enzymatic tests.

Syntarpen may also affect urine steroid test results.

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.

Pregnancy

For safety reasons, Syntarpen should be used during pregnancy only if, in the doctor's opinion, the potential benefits outweigh the possible risks.

Breastfeeding

The medicine passes into breast milk in small amounts. Therefore, breastfeeding may need to be discontinued if the infant experiences gastrointestinal disorders (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 impair concentration (e.g., headache, drowsiness; see section 4 "Possible side effects"), they should not drive or operate machinery.

Syntarpen contains sodium

Each gram of the medicine contains 50.5 mg of sodium (the main component of common salt). This corresponds to 2.5% 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 considered when calculating the total sodium content 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 your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage

The dose depends on the severity of the infection, the sensitivity of the microorganism causing the infection, the patient's condition, age, and weight.

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 and adolescents

Children up to 20 kg of body weight - 25 to 50 mg/kg of body weight per day intravenously or intramuscularly in 4 divided doses, every 6 hours.

Children over 20 kg of body weight - 100 to 200 mg/kg of body weight per day intravenously or intramuscularly in 4 divided doses, every 6 hours. In severe infections, such as infectious endocarditis caused by Staphylococcus spp, the dose can be increased to 300 mg/kg of body weight per day in 4-6 divided doses.

Recommended dosage for specific infections in adults

Pneumonia caused by methicillin-sensitive Staphylococcus aureus

1-2 g intravenously or intramuscularly every 6 hours for 10-14 days.

Purulent myositis caused by methicillin-sensitive Staphylococcus aureus

2 g intravenously or intramuscularly every 6 hours for 5-10 days.

Septic arthritis caused by methicillin-sensitive Staphylococcus aureus

2 g intravenously or intramuscularly every 6 hours for 2-3 weeks.

Osteomyelitis caused by methicillin-sensitive Staphylococcus aureus

2 g intravenously or intramuscularly every 6 hours for 4-6 weeks.

Endocarditis caused by methicillin-sensitive Staphylococcus aureus

native valve - 12 g per day intravenously in 4-6 divided doses for 4-6 weeks,

prosthetic valve - 12 g per day intravenously in 4-6 divided doses for 6 weeks or longer, along with gentamicin at a dose of 3 mg/kg of body weight per day, intravenously or intramuscularly, in 1-2 doses for 2 weeks, and rifampicin at a dose of 900-1200 mg per day in 2-3 divided doses, intravenously or orally, for 6 weeks or longer.

Note:In severe infections, before starting cloxacillin treatment, an antibiogram is recommended.

Using the medicine in patients with kidney function disorders

Patients with renal failure should inform their doctor before taking Syntarpen. In these patients, the doctor will determine the dosage individually, depending on the degree of renal failure (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 section "Information intended exclusively for healthcare professionals".

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 suspects that they have been given 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.

Discontinuing Syntarpen

It is essential to use the medicine as directed for the recommended treatment cycle. The 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 any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 often than in 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 or even 4 weeks after starting treatment) such as fever, malaise, hives, muscle pain, joint pain, abdominal pain, skin rashes, polymorphic erythema, rapidly progressing severe rash with blisters or peeling of the skin and possible blisters in the mouth (Stevens-Johnson syndrome), blistering that, after rupture, forms weeping ulcers, and the epidermis peels off in large flakes (toxic epidermal necrolysis; Lyell's syndrome), symptoms of serum sickness 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 (pseudomembranous colitis), which can occur after antibiotic use.

Other side effects that may occur during treatment

The following side effects occur frequently(no more than 1 in 10 people):

• diarrhea.

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

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

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

• increased or decreased number of certain types of white or red blood cells and platelets, abnormal breakdown of red blood cells, inhibition of bone marrow function;
• nausea, vomiting, oral inflammation, black discoloration of the tongue;
• anuria, interstitial nephritis, disorders of renal tubular function. Symptoms of these disorders are most commonly rash, fever, increased number of one of the types of granulocytes 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 discontinuation of the medicine;
• transient excessive restlessness, excitement, anxiety, drowsiness, disorientation, and (or) dizziness. These symptoms usually occur in patients with renal failure receiving high doses of the medicine;
• elevated liver enzyme activity, in individual cases, hepatitis may occur, jaundice of the skin and whites of the eyes (a sign of cholestatic jaundice caused by bile stasis). These symptoms subside after discontinuation of the medicine;
• fever, pain, and dizziness - subside after discontinuation of the medicine.

Reporting side effects

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

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Syntarpen

Store at a temperature below 30°C.

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiration date (EXP) stated on the packaging. The expiration date refers to the last day of the specified 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 2 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.

The pH value of the prepared solution is 5.0 ÷ 7.0

Packaging:One vial 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, consult the marketing authorization holder.

Date of the last update of the leaflet:

Information intended exclusively for healthcare professionals

Preparation of solutions

Method of administration

Intramuscular injection

The medicine should be injected into large muscle groups. Doses exceeding 1 g are recommended to be injected into two different sites.

Intravenous injection

In intravenous injections (bolus), cloxacillin should be administered over 2 to 10 minutes.

In intravenous infusion, cloxacillin should be administered over 30-40 minutes.

Method of preparation

Intramuscular injection

2 g of powder should be dissolved in 8 ml of water for injections or 0.9% sodium chloride solution.

Intravenous injection

2 g of powder should be dissolved in 20 ml of water for injections or 0.9% sodium chloride solution. Administer slowly over 2 to 10 minutes.

Prepared solutions can be stored for 12 hours at a temperature below 25°C.

Intravenous infusion

The contents of the vial (2 g) should be dissolved in 8 ml of water for injections, and then diluted with 0.9% sodium chloride solution or 5% glucose solution to 50 ml.

Administer over 30 to 40 minutes. Do not exceed a concentration of 40 mg/ml.

The prepared solution can be stored for 12 hours at a temperature below 25°C or for 48 hours at a temperature of 2°C - 8°C (in the refrigerator).

Stability of prepared cloxacillin solutions stored in containers made of PVC

Stability of prepared cloxacillin solutions stored in containers made of polyolefin

The prepared cloxacillin solutions for injection have physical and chemical stability for 12 hours at a temperature below 25°C, while the solutions for infusion can be stored for 12 hours at a temperature below 25°C or for 48 hours at a temperature of 2°C - 8°C (in the refrigerator).

From a microbiological point of view, the medicinal product should be used immediately. If it is not used immediately, the user is responsible for the storage conditions and storage time.

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 medicinal products should be administered separately, at different sites, with an interval of about one hour.