Mefoxin

Package leaflet: Information for the patient

Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use, 1 g / 10 ml Powder and solvent for injectable solution for intravenous use, 2 g / 20 ml Powder and solvent for injectable solution for intravenous use

cefoxitin
Please read this leaflet carefully before using this medicine 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Mefoxin is and what it is used for
2. What you need to know before using Mefoxin
3. How to use Mefoxin
4. Possible side effects
5. How to store Mefoxin
6. Contents of the pack and other information

1. What Mefoxin is and what it is used for

The active substance of Mefoxin is cefoxitin, which belongs to a group of medicines called beta-lactam antibiotics. Cefoxitin acts against serious infections caused by a particular type of bacteria known as Gram-negative, considered difficult to treat, or by mixed-type bacteria including Gram-negative bacteria resistant to common antibiotics.
Mefoxin is particularly used in debilitated (cachectic) and/or immunocompromised patients (with reduced natural defence capacity).

2. What you need to know before using Mefoxin

Do not use Mefoxin

• if you are allergic to cefoxitin or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to cephalosporins;
• if you are allergic to lidocaine and are using the solution for intramuscular use (which contains lidocaine).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Mefoxin.
Before starting treatment with Mefoxin, your doctor should carry out a careful assessment to determine whether you have previously experienced allergic reactions (hypersensitivity) to beta-lactam antibiotics. A severe, rapidly occurring allergic reaction (anaphylactic shock) cannot be ruled out.
If you are undergoing long-term treatment with Mefoxin, your doctor will regularly monitor your liver and kidney function, particularly kidney function if you are also taking medicines that may cause kidney damage (nephrotoxic medicines).
As with other antibiotics, prolonged use may promote the development of microorganisms resistant to this medicine (including fungi). In such cases, consult your doctor to adopt appropriate therapeutic measures.
Take special care with Mefoxin:
If you have kidney problems. Your daily dose of Mefoxin must be reduced if you have reduced kidney function, with decreased urine output (either transient or persistent) (see "How to use Mefoxin"). At normal doses, an excess of the medicine in your body may occur if your kidney function is impaired.
If you are allergic to penicillin, since there is a possibility of developing partial cross-allergy between different antibiotics such as penicillins and cephalosporins (taking a beta-lactam antibiotic like Mefoxin may lead to allergy to another type of antibiotic, and vice versa).
If you have previously experienced any type of allergy, especially to medicines, even if different from Mefoxin. If you experience an allergic reaction after using Mefoxin, stop taking the medicine immediately and contact your doctor.
If you have a history of gastrointestinal disease, particularly inflammation of the colon. Pseudomembranous colitis (inflammation of the colon associated with antibiotic use) has been observed with nearly all antibiotics and may range from mild to life-threatening. If you develop diarrhoea during treatment with Mefoxin, contact your doctor immediately, as diarrhoea may be a symptom of pseudomembranous colitis.

Bacterial resistance
Third-generation cephalosporins, like other beta-lactams, may induce phenomena whereby microorganisms become resistant to certain antibiotics (microbial resistance). This is more likely in Enterobacteriaceae and Pseudomonas species, particularly in patients with weakened immune defenses (immunocompromised), and possibly when multiple antibiotics of the same class (beta-lactams) are used concomitantly.

Meningitis
Mefoxin is not recommended for the treatment of meningitis. If meningitis is suspected, consult your doctor for appropriate antibiotic therapy.

Other medicines and Mefoxin
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pay particular attention if you are taking the following medicines:

• other antibiotics, such as penicillins, cephalosporins, or aminoglycoside antibiotics; Mefoxin may interact with these medicines, increasing their toxic effects on the kidneys;
• probenecid (used to treat gout);
• aspirin (acetylsalicylic acid), phenylbutazone (used against inflammation), or other anti-inflammatory drugs at high doses, as they may increase blood levels of Mefoxin.

Interactions with laboratory tests
Mefoxin may interfere with certain laboratory tests, causing false positive results in urine glucose tests (glycosuria) when using Benedict, Fehling, or Clinitest methods.
If you need to undergo such a test, inform laboratory personnel that you are being treated with Mefoxin, as enzymatic methods should be used instead.
High concentrations of cefoxitin in urine may interfere with the measurement of 17-hydroxy-corticosteroids (components of certain human hormones) using the Porter-Silber reaction (a chemical reaction used in hormonal function assessment), leading to slight false increases in reported levels.
Mefoxin may cause positive (sometimes false) Coombs test results (a laboratory test used to detect the presence of certain antibodies).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
During pregnancy and breastfeeding, use Mefoxin only when clearly needed and under direct medical supervision.
Avoid breastfeeding during treatment with Mefoxin, as cefoxitin passes into breast milk.

Driving and using machines
Mefoxin does not affect the ability to drive vehicles or operate machinery.

Information on excipients
Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially "sodium-free".

3. How to use Mefoxin

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment may be started before the results of sensitivity tests are available.
Mefoxin can be administered into a vein (intravenous administration) or into a muscle
(intramuscular administration) (see reconstitution instructions for each route of administration).
The dose and route of administration should be determined by the physician according to the severity
of the infection, the susceptibility of the causative organism, and the patient's clinical condition.
Recommended dose for adults is 1 g or 2 g of Mefoxin every 8 hours.
Usual adult dose

Use in patients with impaired kidney function (renal insufficiency)
If you suffer from renal insufficiency, an initial loading dose of 1-2 g may be administered. Afterwards,
follow the recommendations for the maintenance dose (see table below).
Maintenance dose in adults
with impaired kidney function

If you are undergoing blood dialysis (haemodialysis), a loading dose of 1-2 g should be administered after each dialysis session (blood filtration using machines), and maintenance doses should be given according to the instructions in the previous table.

Use in children
The recommended dose in children from 3 months of age is 20–40 mg/kg every 6–8 hours.
In severe infections, the total daily dose may be increased up to 200 mg/kg, but must not exceed 12 g per day.
In children with reduced kidney function (renal insufficiency), the dosing frequency should be reduced as indicated for adults.

Method of administration
Intravenous administration (into the vein):
Intravenous administration must be performed only by healthcare professionals.
Reconstitute the powder with water for injection: 1 g is soluble in 2 ml. Although Mefoxin is highly soluble, for intravenous use it is preferable to add 10 ml of water for injection to the 1 g vial and 20 ml of water for injection to the 2 g vial.
Shake to dissolve and withdraw the entire contents of the vial into a syringe. Mefoxin may be injected slowly intravenously over 3–5 minutes. This medicine may also be administered by infusion.
When Mefoxin is administered together with another antibiotic, it is important that they are not mixed in the same syringe or in the same infusion container, as is the case with most beta-lactam antibiotics.

Intramuscular administration (into the muscle):
Reconstitute 1 g of Mefoxin with 2 ml of sterile water for injection or with 0.5% lidocaine hydrochloride solution. Lidocaine hydrochloride should be used as a diluent only for intramuscular administration and must never be used for intravenous administration.

If you use more Mefoxin than you should
Toxic effects due to overdose have not been reported.
In case of accidental ingestion/over-administration of an excessive dose of Mefoxin, inform your doctor or nurse immediately, or go to the nearest hospital.

If you forget to use Mefoxin
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Mefoxin is generally well tolerated. Side effects have rarely required discontinuation of treatment and have mostly been transient and mild in severity.
The most common side effects are local reactions at the injection site.
The following side effects may occur with the use of Mefoxin:

• thrombophlebitis (inflammation of superficial veins, possibly with local redness and swelling) (following intravenous administration);
• pain, hardening, and tenderness at the injection site (following intramuscular administration);
• allergic reactions such as skin rash, exfoliative dermatitis (skin irritation with peeling), urticaria, itching, fever, and other allergic reactions, including anaphylaxis (a severe, rapidly occurring allergic reaction);
• low blood pressure (hypotension);
• symptoms of pseudomembranous colitis (such as diarrhea), which may occur during or after antibiotic therapy (see "Warnings and precautions");
• nausea and vomiting;
• blood abnormalities: increased number of white blood cells (eosinophilia), reduced number of white blood cells (leukopenia, including granulocytopenia and neutropenia), reduced number of red blood cells (anemia, including hemolytic anemia), reduced platelet count (thrombocytopenia), and disturbances in blood cell production (bone marrow suppression);
• positive direct Coombs test (a laboratory test used to detect certain antibodies), particularly in patients with elevated levels of nitrogenous substances in the blood (hyperazotemic patients);
• transient increases in liver enzyme levels (SGOT, SGPT, serum LDH, serum alkaline phosphatase) and yellowish discoloration of the skin, mucous membranes, and whites of the eyes due to liver disorders (jaundice);
• increased levels of serum creatinine and/or blood urea nitrogen (indicating possible kidney dysfunction).

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

5. How to store Mefoxin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store the medicine at a temperature not exceeding 30°C.
After reconstitution, Mefoxin is stable for 24 hours at room temperature and for 48 hours under refrigeration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Mefoxin contains
Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use

• The active substance is cefoxitin sodium salt. Each sterile powder vial contains 1.05 g of cefoxitin sodium salt (equivalent to 1.0 g of free cefoxitin acid).
• The components in the vial are: lidocaine hydrochloride, sodium chloride, water for injectable preparations.

Mefoxin 1 g / 10 ml Powder and solvent for injectable solution for intravenous use

• The active substance is cefoxitin sodium salt. Each sterile powder vial contains 1.05 g of cefoxitin sodium salt (equivalent to 1.0 g of free cefoxitin acid).
• The vial contains water for injectable preparations.

Mefoxin 2 g / 20 ml Powder and solvent for injectable solution for intravenous use

• The active substance is cefoxitin sodium salt. Each sterile powder vial contains 2.10 g of cefoxitin sodium salt (equivalent to 2.0 g of free cefoxitin acid).
• The vial contains water for injectable preparations.

Description of the appearance of Mefoxin and package contents
Mefoxin 1 g / 2 ml Powder and solvent for injectable solution for intramuscular use
Packaged as one sterile powder vial + one 2 ml solvent ampoule
Mefoxin 1 g / 10 ml Powder and solvent for injectable solution for intravenous use
Packaged as one sterile powder vial + one 10 ml solvent ampoule
Mefoxin 2 g / 20 ml Powder and solvent for injectable solution for intravenous use
Packaged as one sterile powder vial + one 20 ml solvent ampoule

Marketing Authorization Holder
I.B.N. SAVIO S.r.l. – Via del Mare, 36 – Pomezia (RM)

Manufacturer
Vial
Vianex S.A., Plant D,
Ag. Stephanos 25018 – Patras – Greece
Biopharma S.r.l.
Via delle Gerbere, 22/30
00134 Rome

Solvent ampoules
Vianex S.A., Plant A,
12 Km Athens-Lamia National Road
14451 Metamorphosis Attiki, Athens - Greece
Injectalia S.r.l.
Via Castagnetta, 7
00040 Pomezia (RM)
LABORATORIO FARMACEUTICO CT S.R.L.
Via Dante Alighieri 71
18038 – Sanremo
Italy
“For 1 g/10 ml pack only”
Packaging and release
Vianex S.A., Plant D,
Ag. Stephanos 25018 – Patras - Greece
Biopharma S.r.l.
Via delle Gerbere, 22/30
00134 Rome