Active ingredients: Cefpodoxime
Orelox children 40 mg / 5 ml granules for oral suspension
Why is Orelx Children 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 Orelx Children 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.
Precautions for use What you need to know before you take Orelx Children
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 Orelx Children
Using Orelox with other medicines
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:
Pregnancy and breastfeeding
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 Orelx Children: 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 Orelx Children
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 Orelx Children
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
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 CHILDREN 40 MG / 5 ML GRANULES FOR ORAL SUSPENSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 grams of granules contain:
Active principle: cefpodoxime proxetil 6,261 g (equivalent to cefpodoxime 4,800 g) corresponding to cefpodoxime 40 mg / 5 ml of reconstituted suspension.
Excipients:
Sucrose 601.33 mg / 5 ml dose
Lactose quantum satis at 0.835 g / 5 ml dose
Aspartame 20mg / 5ml serving
Banana flavor powder (contains sorbitol) 40mg / 5ml serving
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Granules for oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Cefpodoxime is indicated for the treatment of the following infections caused by organisms susceptible to cefpodoxime (see sections 4.4 and 5.1), in children up to 11 years of age:
Upper respiratory infections:
• Acute bacterial sinusitis
• Tonsillitis
• Otitis media, acute
Lower respiratory tract infections:
• Bacterial pneumonia
In case of bacterial pneumonia cefpodoxime may not be the suitable option depending on the pathogen 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.
Adults and the elderly
Not applicable for this medicine.
Infants (> 28 days), children (up to 11 years)
The average recommended dose for children is 8 mg / kg per day given in two divided doses at 12-hour intervals.
The dose to be taken is indicated on the measuring cup. The graduations correspond to the weight of the child in kg from 5 kg (2.5 ml) to 25 kg (12.5 ml) with intermediate graduations of 1 kg each (0.5 ml).
The dose to be taken is read directly on the measuring cup
The following table provides the dosage regimen for children according to the body weight graduations indicated on the measuring cup:
Children weighing at least 25 kg can take 12.5 ml suspension twice daily or alternatively 1 100 mg film-coated tablet twice daily.
Hepatic impairment
No dose adjustments are required in case of hepatic impairment.
Renal impairment
No dose modification of cefpodoxime is required if creatinine clearance exceeds 40ml / min-1 / 1.73m2.
Below this value, pharmacokinetic studies indicate an increase in the plasma elimination half-life and maximum plasma concentrations and, therefore, the dosage should be adjusted appropriately.
The suspension can be taken with or without food.
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.
The product should not be administered to children with phenylketonuria due to the presence of aspartame among the excipients (20 mg / 5 ml).
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, M.icoplasma 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.
Caution should be exercised 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).
Antibiotic agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibiotic agents, including cefpodoxime, and can range in severity from mild to life-threatening. Therefore it is important to consider this diagnosis in patients who present with diarrhea during or shortly after treatment with cefpodoxime (see section 4.8). The interruption of therapy with cefpodoxime and the administration of a specific treatment for Clostridium difficile must be taken into consideration. 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 should 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.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
This medicine contains aspartame, a source of phenylalanine. It can be harmful if you have phenylketonuria.
The banana flavor powder of this medicine contains sorbitol. Patients with rare hereditary problems of fructose intolerance 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 lead to a decrease in 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, medicinal products 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
Not applicable.
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, ≤1 / 1000)
• 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
Municipality: ploss of appetite.
Disorders of the immune system
Hypersensitivity reactions of all degrees of 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 moderate increases in ASAT, ALAT and alkaline phosphatase and / or bilirubin. These laboratory abnormalities, which can also 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 cutaneous hypersensitivity reactions. rash, hives, itching
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme.
Infections and infestations
Growth of non-sensitive organisms may occur (see section 4.4).
General disorders and conditions related to the administration site
Uncommon: asthenia or malaise.
04.9 Overdose
In the event of overdose with cefpodoxime, symptomatic and supportive therapy should be instituted.
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: other 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 most important pharmacokinetic-pharmacodynamic index 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)
Bacterial resistance to cephalosporins is due to a number of mechanisms:
l) 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
The clinical breakpoints for the European Commission's MIC tests on Antibiotic Sensitivity Testing (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 may vary geographically and with time for selected species 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 proxetil 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. Peak levels of cefpodoxime are reached within 2-3 hours after dosing.The maximum plasma concentration is 1.2 mg / L and 2.5 mg / L after administration of a 100 mg and 200 mg dose, respectively. After oral intake of 100 and 200 mg twice daily for 14.5 days, the pharmacokinetic parameters of cefpodoxime remain unchanged.
The serum protein bond is about 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 most of the dose of cefpodoxime is excreted in the urine, the concentration is high. (Concentration observed in intervals of 0-4, 4-8, 8-12 hours after administration of a single dose exceeds the MIC90 of common pathogenic urinary tract microorganisms). 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.
The major route of elimination is renal, 80% is eliminated unchanged in the urine, with a half-life of approximately 2.4 hours.
CHILDREN
In children, studies have shown that maximum plasma concentration occurs approximately 2-4 hours after administration. A single dose of 5 mg / kg in children aged 4-12 produced a similar maximum concentration to that in adults treated with a dose of 200 mg.
In patients less than 2 years of age who received repeated doses of 5 mg / kg every 12 hours, mean plasma concentrations, 2 hours post dose, are between 2.7 mg / l (1-6 months) and 2, 0 mg / l (7 months-2 years).
In patients aged 1 month to 12 years treated with repeated doses of 5 mg / kg every 12 hours, the residual plasma concentrations at steady-state are between 0.2 - 0.3 mg / l (1 month-2 years) and 0.1 mg / l (2-12 years).
05.3 Preclinical safety data
There are no findings from chronic toxicity investigations to suggest that undesirable effects not known to date can occur in humans.
Furthermore, in vivo and in vitro studies did not give any indication of a potential cause of reproductive toxicity or mutagenicity. Carcinogenicity studies have not been conducted.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Calcium Carmellose. Sodium chloride. Sodium glutamate. Aspartame. Iron oxide. Carmellose sodium. Sucrose. Citric acid monohydrate. Hydroxypropylcellulose. Sorbitan trioleate. Talc. Anhydrous colloidal silica. Aroma of banana powder (isoamyl acetate, isoamyl isovalerianate, ethyl butyrate, geranyl formate, acetic aldehyde, citral, nonyl aldehyde, orange oil, vegetable gum, sorbitol, malt dextran). Potassium sorbate. Lactose monohydrate.
06.2 Incompatibility
///
06.3 Period of validity
2 years.
The reconstituted suspension can be stored for no more than 10 days in the refrigerator (+ 2 ° C to + 8 ° C).
06.4 Special precautions for storage
The granulate must be stored at a temperature not exceeding + 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
ORELOX children granules for oral suspension - 1 bottle of 50 ml in amber glass with a notch to 50 ml + measuring cup with graduated notches from 5 kg to 25 kg in weight.
ORELOX children granules for oral suspension - 1 bottle of 100 ml in amber glass with a notch to 100 ml + measuring cup with graduated notches from 5 kg to 25 kg in weight.
06.6 Instructions for use and handling
Preparation of the suspension:
• remove the capsule that protects the granulate from humidity by pulling the two small wings and discard the capsule.
• the preparation of the extemporaneous suspension is carried out by adding water up to the level indicated by the groove engraved in the glass of the bottle (The final volume of the suspension is 50 or 100 ml).
• shake the bottle in order to make the suspension homogeneous.
07.0 MARKETING AUTHORIZATION HOLDER
sanofi-aventis S.p.A. - Viale L. Bodio, 37 / B - Milan
08.0 MARKETING AUTHORIZATION NUMBER
ORELOX children granules for oral suspension, 50 ml bottle - AIC 027970021
ORELOX children granules for oral suspension, 100 ml bottle - AIC 027970033
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
04.03.1996 / 15.11.2009
10.0 DATE OF REVISION OF THE TEXT
August 2012
