CEFOXITINE NORMON 1 g powder and solvent for injectable solution and for infusion
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How to use CEFOXITINE NORMON 1 g powder and solvent for injectable solution and for infusion
Introduction
Package Leaflet: Information for the User
Cefoxitin NORMON 1 g Powder and Solvent for Solution for Injection and Infusion EFG
Cefoxitin (as cefoxitin sodium)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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Contents of the Package Leaflet:
- What is Cefoxitin NORMON and what is it used for
- What you need to know before you use Cefoxitin NORMON
- How to use Cefoxitin NORMON
- Possible side effects
- Storage of Cefoxitin NORMON
- Contents of the pack and further information
1. What is Cefoxitin NORMON and what is it used for
Cefoxitin belongs to a group of antibiotics known as cephalosporins.
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It is indicated for the treatment of infections caused by microorganisms sensitive to cefoxitin, located in the respiratory, urinary, and genital tracts, abdomen, blood (septicemia), bones and joints, skin and soft tissues, burns, or infected wounds, as well as for the prevention of infections in surgery.
2. What you need to know before you use Cefoxitin NORMON
Do not use Cefoxitin NORMON
- If you are allergic (hypersensitive) to cefoxitin or other cephalosporins or any of the other components of this medicine (listed in section 6).
Be cautious with Cefoxitin NORMON
- If you are allergic to beta-lactam antibiotics (such as penicillin), cross-allergy may occur.
- If you experience diarrhea while receiving treatment with cefoxitin, as it may be due to a special type of colitis called pseudomembranous colitis (inflammation of the large intestine), which can be severe. In these cases, your doctor will decide whether to suspend cefoxitin administration and initiate appropriate treatment.
- If you have kidney disease, your doctor may need to adjust the dose of cefoxitin you receive.
- If you are on a low-salt diet, as each gram of Cefoxitin NORMON contains 53.81 mg of sodium.
- If you are undergoing prolonged treatment with cefoxitin, superinfections may occur.
- If you are to undergo any blood tests, inform the healthcare staff that you are being treated with this medicine, as cefoxitin may interfere with the results.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Cefoxitin NORMON.
Using Cefoxitin NORMON with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Some medicines may influence the action of others.
Cefoxitin should not be administered simultaneously with aminoglycosides (other antibiotics).
In case of doubt, consult your doctor or pharmacist.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
In the case of pregnancy, your doctor will decide whether to use this medicine.
Breastfeeding
In the case of breastfeeding, your doctor will decide whether to use this medicine. Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Cefoxitin generally does not affect the ability to drive vehicles or operate machinery.
Cefoxitin NORMON contains sodium
This medicine contains 53.81 mg of sodium (2.34 mmol) (a major component of table salt/cooking salt) per gram. This is equivalent to 2.69% of the maximum recommended daily sodium intake for an adult.
3. How to use Cefoxitin NORMON
Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Cefoxitin will be administered intravenously. Remember to use your medicine.
Your doctor will indicate the appropriate dose and duration of your treatment with cefoxitin. Do not suspend or prolong it, as the expected effect will not be achieved.
If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.
The usual dose is:
Adults:uncomplicated infections: 1 g every 6-8 hours by intravenous injection. For moderately severe or severe infections, 1 g every 4 hours or 2 g every 6-8 hours by intravenous injection is recommended. In cases of life-threatening infections, 2 g every 4 hours or 3 g every 6 hours by intravenous injection may be administered.
A dose reduction may be necessary if you have kidney disease. In such cases, inform your doctor so that the dose can be adjusted accordingly.
Use in children
Children over 3 months:80-160 mg/kg body weight per day, divided into 4-6 equal doses. If you have kidney disease, your doctor may need to reduce the dose.
Cefoxitin is not recommended for use in children under 3 months.
Surgical prophylaxis
Cefoxitin administration should be performed between 30 and 60 minutes before surgery and discontinued within 24 hours thereafter. The following guidelines are recommended:
Adults: 2 g by intravenous injection 30 or 60 minutes before surgery, followed by 2 g every 6 hours.
Children (over 3 months): 30-40 mg/kg 30 or 60 minutes before surgery, followed by 2 g every 6 hours.
Patients undergoing cesarean section: a single dose of 2 g by intravenous injection may be administered at the time of umbilical cord clamping, or 3 doses of 2 g, with the first dose administered at the time of umbilical cord clamping and the next two doses administered 4 and 8 hours after the first dose, respectively.
If you use more Cefoxitin NORMON than you should
Consult your doctor or pharmacist immediately. In case of overdose or accidental administration/ingestion, consult the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount administered/ingested. Bring this leaflet with you.
Information for the doctor:In case of overdose, treatment will be symptomatic and according to medical criteria. Cefoxitin is eliminated by hemodialysis.
If you forget to use Cefoxitin NORMON
Do not use a double dose to make up for forgotten doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
- Allergic reactions:the most common is the appearance of skin lesions of various types. Other possible reactions are itching, swelling of the face, and difficulty breathing.
- Gastrointestinal disorders:nausea, vomiting, and diarrhea.
Uncommon side effects (may affect up to 1 in 100 people):
- Blood disorders:decreases in some blood cells, such as red and white blood cells, have been reported.
Rare side effects (may affect up to 1 in 1,000 people):
- Liver disorders:rarely, transient increases in liver enzymes (transaminases) have been observed.
- Kidney disorders:in some cases, increased creatinine levels in the blood have been observed, indicating poor kidney function.
Side effects of unknown frequency (cannot be estimated from the available data):
- Cardiovascular disorders:hypotension (low blood pressure).
If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Cefoxitin NORMON
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Reconstituted solutions remain stable for 24 hours at room temperature and for 4 days at 8°C.
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 the month shown.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and further information
Composition of Cefoxitin NORMON:
- The active substance is cefoxitin (sodium). Each vial contains 1 g of cefoxitin (sodium). Each ampoule of solvent contains water for injections.
Appearance of the product and pack contents
Cefoxitin NORMON 1 g powder and solvent for solution for injection and infusion EFG is presented in a vial with powder and solvent for solution for injection. Each pack contains a vial of cefoxitin powder and an ampoule with 10 ml of water for injection.
Once reconstituted with its solvent, the solution contains 100 mg of cefoxitin per ml.
Marketing authorization holder and manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
This information is intended for healthcare professionals only:
For intravenous administration, the contents of the vial are dissolved in the 10 ml of solvent from the accompanying ampoule (water for injections). It can be administered by slow intravenous injection over 3 to 5 minutes, after prior dilution in the solvent. For continuous intravenous infusion, the resulting solution can be further diluted in a standard infusion solution (5% glucose, 0.9% sodium chloride, 5% glucose, and 0.9% sodium chloride, or 5% glucose with the addition of 0.02% sodium bicarbonate).
It is not recommended to mix cefoxitin sodium with other medicines.
Date of last revision of this leaflet: July 2022
Detailed and authorized information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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