Active ingredients: Cefpodoxime
Orelox 100 mg film-coated tablets
Orelox 200 mg film-coated tablets
Why is Orelox used? What is it for?
Orelox is an antibiotic used to kill the bacteria that cause infection in your body. It belongs to a class of antibiotics called "cephalosporins".
Your doctor has prescribed Orelox for you because you have one (or more) of the following types of infections:
- tonsillitis
- sinusitis
- acute chest infection in patients with chronic bronchitis
- pneumonia
Contraindications When Orelox should not be used
DO NOT take Orelox
- if you are allergic (hypersensitive) to cefpodoxime or other cephalosporins, or to any of the other ingredients of Orelox
- if you have had a severe allergic reaction to particular antibiotics (penicillins, monobactams and carbapenems) as you may also be allergic to cefpodoxime.
If you think any of these apply to you, talk to your doctor before taking Orelox. You must not take Orelox.
Take special care with Orelox
- If you have been told that your kidneys are not working very well. Also, if you are undergoing any type of treatment (such as dialysis) for kidney failure. You may take Orelox but may need a lower dose.
- If you have ever had an "inflammation of the gut called colitis, or other serious diseases that affect the gut."
- This medicine can alter the results of some blood tests (such as cross-matching and Coombs' test). It is important to tell your doctor that you are taking this medicine if you have to undergo these tests.
- This medicine can also alter the results of urinalysis to determine sugar levels (such as Benedict's or Fehling's tests). Tell your doctor if you have diabetes and need to check your urine frequently. This is because other tests may be used to monitor your diabetes while you are taking this medicine.
Tell your doctor or pharmacist if any of these apply to you.
Interactions Which drugs or foods may change the effect of Orelox
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This medicine can be affected by other medicines that are eliminated by the kidney. This is especially the case if these other medicines can affect the way your kidneys work. There are a number of medicines that can cause this, so check with your doctor or pharmacist before taking this drug. In particular, tell your doctor or pharmacist if you are taking:
- Antacids (used to treat indigestion)
- Anti-ulcer agents (used to treat ulcers) such as ranitidine and cimetidine
- Diuretics (used to increase urine flow)
- Aminoglycoside antibiotics used in the treatment of infections
- Probenecid (used in the treatment of gout)
- Anticoagulants such as warfarin.
Antacids and anti-ulcers (such as ranitidine and cimetidine) should be taken 2-3 hours after taking Orelox. Your doctor knows about these medicines and will change your treatment if he considers it necessary.
If you are having tests (blood, urine or diagnostic tests) while you are taking this medicine, make sure your doctor knows that you are taking Orelox.
Warnings It is important to know that:
Tell your doctor before taking Orelox:
- If you are pregnant, if you are trying to get pregnant or if you think you might get pregnant
- If you are breastfeeding
Your doctor will weigh the benefit of treatment with Orelox against the risk to your baby.
Driving and using machines
If you get dizzy after taking this medicine, you should not drive or use machines.
Important information about some of the ingredients of Orelox
Orelox contains lactose. If you have been told by your doctor that you are intolerant to some sugars, please inform your doctor before taking this medicine.
Dose, Method and Time of Administration How to use Orelox: Posology
Always take Orelox exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
The usual dose is given below:
Adults and the elderly without kidney problems:
Sinus infections: 200 mg twice daily.
Tonsillitis: 100 mg twice a day.
Chest infections and pneumonia: 200 mg twice daily.
Adults with kidney problems:
Depending on the severity of your kidney problems, the usual dose of cefpodoxime for the type of infection you have may be given once a day instead of twice a day or even every other day. Your doctor will decide the dose you need.
If you are being treated with hemodialysis then you may need to take a dose after each dialysis session. Your doctor will tell you how much to take each time.
How to take Orelox:
It is important to take the medicine at the same times each day. You should always take the tablets with meals as food helps to absorb the tablets.
If you forget to take Orelox
If you forget to take a dose of your medicine at the right time, you should take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. Just take the next dose at the right time. Continue as before.
If you stop taking Orelox
Keep taking the medicine until your doctor tells you to stop. Do not stop treatment just because you are starting to feel better. If you stop taking the medicine, your condition may come back or get worse.
If you have any further questions on the use of Orelox, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Orelox
If you have accidentally taken too much medicine, contact your doctor or pharmacist, who will tell you what to do.
Side Effects What are the side effects of Orelox
Like all medicines, Orelox can cause side effects, although not everybody gets them. Side effects are listed by frequency.
Conditions that require special attention
The following serious side effects have occurred in a small number of people, but their exact frequency is not known:
- Severe allergic reaction. The signs include prominent rash and itching, swelling, sometimes of the face or mouth causing difficulty in breathing.
- Rash, blistered and looks like small marks (central dark spot surrounded by a paler area, with a dark ring around the edge).
- Widespread rash with blisters and peeling of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.)
All of these adverse reactions need urgent medical attention. If you think you are having any of these types of reactions, stop taking this medicine and contact your doctor or the nearest emergency department.
Common side effects (affects less than 1 in 10 people) include:
- Stomach problems: Bloating, nausea, vomiting, stomach pain, flatulence (wind) and diarrhea
If you suffer from severe diarrhea or see blood in your diarrheal stools you should stop taking the medicine and inform your doctor immediately.
- Problems with food: loss of appetite
Uncommon side effects (affects less than 1 in 100 people) include:
- Hypersensitivity reactions (these are skin rashes which are less severe allergic reactions than those listed above, lumpy skin rash (hives), itching)
- Headache
- Tingling
- Dizziness
- Ringing in the ears
- Weakness and general ill feeling.
Rare side effects (affects less than 1 in 1000 people) include:
- Changes in blood tests that check how the liver is working
- Anemia
- Lowering of the number of blood cells (symptoms can include tiredness, new infections and easy bruising or bleeding)
- Increase in some types of white blood cells
- Increase in the number of small cells that are needed for blood clotting.
Very rare side effects (affects less than 1 in 10,000 people) include:
- Anaphylactic reactions (e.g. bronchospasm, purpura and edema of the face and extremities)
- Worsening of kidney function
- Liver damage
- A course of cefpodoxime can temporarily increase the risk of getting infections caused by other types of germs. For example, thrush may occur.
- A type of anemia that can be severe and is caused by the breakdown of red blood cells.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Keep out of the reach and sight of children.
Do not use Orelox after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.
Do not use Orelox if you notice any visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other Information
What Orelox contains
Orelox 100 mg film-coated tablets:
The active substance is cefpodoxime proxetil 130.45 mg (equivalent to cefpodoxime 100 mg)
Orelox 200 mg film-coated tablets
The active ingredient is cefpodoxime proxetil 260.90 mg (equivalent to cefpodoxime 200 mg):
The other ingredients are: magnesium stearate, calcium carmellose, hydroxypropylcellulose, sodium lauryl sulfate, lactose, titanium dioxide, talc, hypromellose.
What Orelox looks like and contents of the pack
Film-coated tablets.
ORELOX 100 mg film-coated tablets, 12 tablets
ORELOX 200 mg film-coated tablets, 6 tablets.
Medical advice / trainingAntibiotics are used to treat bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics for you, you need them specifically for your current illness. Despite the administration of antibiotics, some bacteria can survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective. Misuse of antibiotics increases resistance. You can also help bacteria become more resistant and thus slow down treatment or decrease the effectiveness of antibiotics if you do not comply with the appropriate:
- dosage
- timetables
- duration of treatment.
Consequently, to maintain the effectiveness of this drug:
- Use antibiotics only under prescription.
- Strictly follow the prescription.
- Do not reuse an antibiotic without a prescription, even if you want to treat a similar disease.
- Never give your antibiotic to another person; it may not be suitable for their disease.
- After your treatment is complete, return any unused medications to your pharmacy to make sure they will be disposed of properly.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ORELOX - TABLETS COATED WITH FILM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
ORELOX 100 mg film-coated tablets
One tablet contains:
Active principle: cefpodoxime proxetil 130.45 mg (equivalent to cefpodoxime 100 mg)
Excipients: lactose 21.55 mg
ORELOX 200 mg film-coated tablets
One tablet contains:
Active principle: cefpodoxime proxetil 260.90 mg (equivalent to cefpodoxime 200 mg)
Excipients: lactose 43.1 mg
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Film-coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cefpodoxime is indicated for the treatment of the following infections caused by susceptible microorganisms in adults (see sections 4.4 and 5.1):
Upper respiratory infections:
• Acute bacterial sinusitis
• Tonsillitis (only for 100 mg tablets)
Lower respiratory tract infections:
• Acute exacerbation of chronic bronchitis
• Bacterial pneumonia - cefpodoxime may not be the suitable option depending on the organism involved, see section 4.4
Official guidelines on the appropriate use of antibacterial agents should be considered.
04.2 Posology and method of administration
Route of administration: oral.
The tablets should be taken with food to ensure optimal absorption.
Adults and adolescents with normal renal function
Upper respiratory infections:
• Acute bacterial sinusitis: 200 mg twice daily.
• Tonsillitis: 100 mg twice daily (for 100 mg tablets only).
Lower respiratory tract infections
• Acute exacerbation of chronic bronchitis: 200 mg twice daily
• Bacterial pneumonia: 200 mg twice a day
Senior citizens:
There is no need to adjust the dose in elderly patients with nominal renal function.
Children
A pediatric formulation of cefpodoxime is available for infants and children.
Hepatic impairment
No dosage adjustments are required in case of hepatic impairment.
Renal impairment
No modification of cefpodoxime dosage is required if creatinine clearance exceeds i
40 ml / min. Below this value, pharmacokinetic studies indicate an increase in plasma half-life and maximum plasma concentrations, and therefore the dosage should be adjusted appropriately.
NOTE1: The single dose is 100 mg or 200 mg, depending on the type of infection.
04.3 Contraindications
• Hypersensitivity to cefpodoxime, to any other cephalosporin or to any of the excipients.
• Previous history of immediate and / or severe hypersensitivity reactions (anaphylaxis) to penicillin or other beta-lactam antibiotics.
04.4 Special warnings and appropriate precautions for use
Cefpodoxime is not the preferred antibiotic for the treatment of staph pneumonia and should not be used in the treatment of atypical pneumonia caused by organisms such as Legionella, Mycoplasma And Chlamydia. Cefpodoxime is not recommended for the treatment of pneumonia caused by S. pneumoniae (see section 5.1).
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In the event of severe hypersensitivity reactions, treatment with cefpodoxime should be stopped immediately and appropriate emergency measures taken.
Before starting treatment, it should be checked whether the patient has a history of severe hypersensitivity reactions to cefpodoxime, other cephalosporins or any other type of beta-lactam agent. Care should be taken when cefpodoxime is administered to patients with a "History of non-severe hypersensitivity to beta-lactam agents.
In severe renal insufficiency it may be necessary to reduce the dosage regimen depending on the creatinine clearance (see section 4.2).
Colitis and pseudomembranous colitis associated with antibacterial agents have been reported with almost all antibacterial agents, including cefpodoxime, and can range in severity from moderate to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea during or shortly after administration of cefpodoxime (see section 4.8). Interruption of cefpodoxime therapy and the administration of a specific treatment should be considered Clostridium difficile. Medicinal products that inhibit peristalsis should not be given.
Cefpodoxime should always be prescribed with caution in patients with a history of gastrointestinal disease, particularly colitis.
As with all beta-lactam antibiotics, neutropenia and, more rarely, agranulocytosis may develop, particularly during prolonged treatment. For treatments longer than 10 days, blood counts should be monitored, and treatment discontinued if neutropenia is observed.
Cephalosporins can be absorbed from the surface of red blood cell membranes and react with antibodies directed against the drug. This can result in a positive Coombs test and, very rarely, in haemolytic anemia. Cross-reactivity with penicillin can occur due to this reaction.
Changes in renal function have been observed with cephalosporin antibiotics, particularly when administered concomitantly with potentially nephrotoxic drugs such as aminoglycosides and / or potential diuretics. In these cases, renal function must be monitored.
As with other antibiotics, prolonged use of cefpodoxime can cause the proliferation of non ~ sensitive organisms (Candida And Clostridium difficile), which may require the interruption of treatment.
Interactions with laboratory tests
A false positive for glucose in the urine can occur with Benedict's or Fehling's solutions, or with the copper sulfate test, but not with tests based on enzymatic reactions of glucose oxidase.
The medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactosis malabsorption or should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
No clinically significant interactions with other drugs were reported during the course of the clinical trials.
H2 blockers and antacids reduce the bioavailability of cefpodoxime. Probenecid reduces the excretion of cephalosporins. Cephalosporins potentially increase the anticoagulant effect of coumarins and reduce the contraceptive effect of estrogen.
Oral anticoagulants
Co-administration of cefpodoxime and warfarin may enhance the anticoagulant effect. There have been numerous reports of increased oral anticoagulant activity in patients taking antibacterial agents, including cephalosporins. The risk may vary depending on the underlying infection, age and general status of the patient therefore it is difficult to establish what the contribution of cephalosporins to the increase in INR (International Normalized Ratio) is. It is recommended to monitor the INR frequently during and immediately after concomitant administration of cefpodoxime with an oral anticoagulant agent.
Studies have shown that bioavailability decreases by approximately 30% when cefpodoxime is administered with drugs that neutralize gastric pH or inhibit acid secretion. Therefore, these drugs such as mineral-type antacids and H2 blockers such as ranitidine, which can cause gastric pH increase, should be taken 2-3 hours after cefpodoxime administration.
04.6 Pregnancy and breastfeeding
Pregnancy
No or limited clinical data are available on the use of cefpodoxime in pregnant women.
Animal studies do not indicate any indirect or direct harmful effects on reproductive toxicity (see section 5.3).
Because of the benefit of antibiotic treatment, the use of cefpodoxime may be considered during pregnancy if necessary.
The medicine should be prescribed with caution to pregnant women.
Feeding time
Cefpodoxime is excreted in breast milk in small quantities. Cefpodoxime can be used during breastfeeding.
The question of whether to continue breastfeeding in the event of diarrhea or fungal mucosal infections in the nursing infant must be considered. The possibility of sensitization must be borne in mind.
04.7 Effects on ability to drive and use machines
Dizziness has been reported during treatment with cefpodoxime and this may impair the ability to drive or use machines.
04.8 Undesirable effects
Undesirable effects are listed below by system organ class and frequency. Frequencies are defined as follows:
• very common (≥ 1/10)
• common (≥ 1/100,
• uncommon (≥ 1/1000,
• rare (≥ 1 / 10,000,
• very rare (
• not known (frequency cannot be estimated from the available data)
Disorders of the blood and lymphatic system
Rare: haematological disorders such as decreased hemoglobin, thrombocytosis, thrombocytopenia, leukocytopenia and / or eosinophilia.
Very rare: haemolytic anemia.
Nervous system disorders
Uncommon: headache, paraesthesia, dizziness.
Ear and labyrinth disorders
Uncommon: tinnitus.
Gastrointestinal disorders
Common: stomach pressure, nausea, vomiting, abdominal pain, flatulence, diarrhea. Bloody diarrhea can occur as a symptom of enterocolitis. The possibility of pseudomembranous enterocolitis should be considered if severe or prolonged diarrhea occurs during or shortly after treatment (see section 4.4).
Metabolism and nutrition disorders
Common: loss of appetite.
Disorders of the immune system
Hypersensitivity reactions of all severity have been observed (see section 4.4).
Very rare: anaphylactic reactions, bronchospasm, purpura and angioedema.
Renal and urinary disorders
Very rare: slightly increased levels of creatinine and urea in the blood.
Hepatobiliary disorders
Rare: temporary increases in ASAT, ALAT and alkaline phosphatase and / or bilirubin. These laboratory abnormalities, which can be explained by the presence of the infection, can rarely exceed twice the upper limit of the stated range and produce liver injury, usually cholestatic and very often asymptomatic.
Very rare: liver damage.
Skin and subcutaneous tissue disorders
Uncommon: mucus skin hypersensitivity reactions, rash, hives, itching.
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme.
Infections and infestations
Multiplication of non-sensitive microorganisms may occur (see section 4.4).
General disorders and administration site conditions
Uncommon: asthenia or malaise.
04.9 Overdose
In the event of overdose with cefpodoxime, symptomatic and supportive therapy is indicated.
In case of overdose, particularly in patients with renal insufficiency, encephalopathy may occur. Encephalopathy is usually reversible once plasma cefpodoxime levels have fallen.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: beta-lactam antibacterials, third generation cephalosporins. ATC code: J01DD13.
Mechanism of action
Cefpodoxime inhibits bacterial cell wall synthesis following binding to penicillin-binding proteins (PBPs). This involves disruption of cell wall biosynthesis (peptidoglycan), which leads to bacterial cell lysis and cell death.
Pharmacokinetic / pharmacodynamic relationship
For cephalosporins it has been shown that the pharmacokinetic-pharmacodynamic index is the most important
related to efficacy in vivo is the percentage of the dosing range for which the concentration of the unbound drug remains above the minimum inhibitory concentration (MIC) of cefpodoxime for individual target species (ie% T> MIC).
Resistance mechanism (s)
Resistance to cephalosporins is due to a number of mechanisms:
1) alteration of the permeability of the outer membrane in Gram-negative organisms;
2) alteration of penicillin-binding proteins (PBPs);
3) production of beta-lactamase;
4) efflux pumps in bacteria.
Breakpoints
1 clinical breakpoints for the MIC tests of the European Commission on Antibiotic Sensitivity Tests
(EUCAST) are shown below.
Clinical MIC breakpoints of EUCAST for cefpodoxime (05-01-2011, v 1.3):
1 Susceptibility of staphylococci to cephalosporins is inferred from susceptibility to cefoxitin
2 The sensitivity of beta-lactams of groups A, B, C and G of beta-haemolytic streptococcus can be inferred from the sensitivity to penicillin.
3 Species with MIC values above the breakpoint sensitivity are very rare and not yet reported. Antibiotic susceptibility testing and determination on any isolated organism should be repeated and if the result is confirmed the isolated organism should be sent to the reference laboratory.
* Insufficient data
Sensitivity
The prevalence of acquired resistance can vary geographically and with time for species selected and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
§ intermediate natural sensitivity
+ resistance speed> 50% in at least 1 region
% ESBL producing species are always resistant
05.2 Pharmacokinetic properties
Cefpodoxime proxetil is recovered in the intestine and is hydrolyzed to the active metabolite cefpodoxime. When cefpodoxime proxethyl is administered orally to the fasting subject as a 100 mg tablet of cefpodoxime, 51.5% is absorbed and absorption is increased when given with food. The volume of distribution is 32.3. Her peak levels of cefpodoxime are reached within 2-3 hours after administration. The maximum plasma concentration is 1.2 mg / l and 2.5 mg / l after administration of a dose of 100 mg and 200 mg, respectively. After administration of 100 and 200 mg twice daily for 14.5 days, the pharmacokinetic parameters of cefpodoxime remain unchanged.
The serum protein binding of cefpodoxime is 40% mainly with albumin. The bond is of the non-saturable type.
Concentrations of cefpodoxime above the minimum inhibitory concentration (MIC) of common pathogenic microorganisms can occur in lung parenchyma, bronchial mucosa, pleural fluid, tonsils, interstitial fluid and prostate tissue.
Since a large part of the dose of cefpodoxime is excreted in the urine, the concentration is high (the concentration observed in intervals of 0-4, 4-8, 8-12 hours after administration of a single dose exceeds the MIC90 of common pathogenic organisms of urinary tract). Good distribution of cefpodoxime has also been observed in renal tissue, with concentrations above MIC90 of common pathogenic urinary tract organisms, 3-12 hours after administration of a single dose of 200 mg (1.6-3.1 mcg / g). Concentrations of cefpodoxime in bone marrow and cortical tissue are similar.
Studies in healthy volunteers show median concentrations of cefpodoxime in total ejaculate 6-12 hours after administration of a single dose of 200 mg above the MIC90 of N. gonorrhoeae.
The major route of elimination is renal, 80% is eliminated unchanged in the urine, with a half-life of approximately 2.4 hours.
05.3 Preclinical safety data
Preclinical data based on conventional studies of acute toxicity, repeated dose toxicity, reproductive toxicity and genotoxicity have shown no particular hazards for humans that have not already been considered in other sections of the Summary of Product Characteristics.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Magnesium stearate, calcium carmellose, hydroxypropylcellulose, sodium lauryl sulfate, lactose, titanium dioxide, talc, hypromellose.
06.2 Incompatibility
No incompatibilities were observed in the clinical studies.
06.3 Period of validity
Orelox 100 mg film-coated tablets: 3 years.
Orelox 200 mg film-coated tablets: 2 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
The tablets are packaged in aluminum / PVC thermoformed blisters.
Orelox 100 mg film-coated tablets, 12 tablets.
Orelox 200 mg film-coated tablets, 6 tablets.
06.6 Instructions for use and handling
Any unused medicine or waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
sanofi-aventis S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
Orelox 100 mg film-coated tablets, 12 tablets - A.I.C. 027970019
Orelox 200 mg film-coated tablets, 6 tablets - A.I.C. 027970045
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Orelox 100 mg film-coated tablets, 12 tablets: 31.10.1994 / 15.11.2009
Orelox 200 mg film-coated tablets, 6 tablets: 31.05.1999 / 15.11.2009
10.0 DATE OF REVISION OF THE TEXT
August 2012
