orelox 100mg tablets Uses, Dosage, Side Effects &Warnings

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orelox 100mg tablets Generic drug of the therapeutic class: Infectiology – Parasitology
active ingredients: Cefpodoxime

This medicine is indicated in adults for the treatment of certain bacterial infections with sensitive germs.

What is Orelox 100 mg used for and  indication ?

They arise from the antibacterial activity and pharmacokinetic characteristics of cefpodoxime.

– They are limited in adults to treat infections caused by susceptible organisms, including:

1. . Angina documented to beta-hemolytic streptococcus A.
2. . Acute sinusitis.
3. . Acute bronchial suppuration of subjects at risk (especially alcoholics, smokers, subjects over 65 years old …).
4. . Exacerbations of chronic obstructive pulmonary disease, especially during repeated relapses or at risk.
5. . Bacterial pneumopathies especially in at-risk subjects.
6. – Official recommendations regarding the proper use of antibacterials should be taken into account.

Orelox Dosage

orelox dosage for adults

200 mg or 400 mg daily in 2 doses 12 hours apart, during a meal, either:

– 2 x 200 mg per day, or 2 tablets in the morning and evening:

. Acute sinusitis,

In acute maxillary sinusitis, a 5-day treatment has been shown to be effective.

• . acute bronchial suppurations subjects at risk
• . exacerbations of chronic obstructive pulmonary disease, especially when iterative breakouts or in individuals at risk
• . Bacterial pneumopathies especially in at-risk subjects.

– 2 x 100 mg daily, ie 1 tablet morning and evening in tonsillitis.

The duration of treatment of angina is 5 days.

AT THE SUBJECT AGE:

• When it has normal kidney function, it is not necessary to change the dosage.

IN THE RENAL INSUFFICIENT :

1. When the creatinine clearance values ​​are greater than 40 ml / min, there is no need to change the dosage.
2.  For values ​​below 40 ml / min, the daily dosage will be reduced by half and limited to a single daily dose.

IN THE HEPATIC INSUFFICIENT :

• There is no need to change the dosage.

How it works Orelox :

ANTIBACTERIAL SYSTEMS, ATC Code: J01DA33.

(J: Anti-infectious).

Cefpodoxime proxetil is a semi-synthetic antibiotic of the beta-lactam family of the third generation oral cephalosporin group, a prodrug of cefpodoxime.

After oral administration, cefpodoxime proxetil is absorbed in the intestinal tract and rapidly hydrolysed by non-specific esterases in cefpodoxime, a bactericidal antibiotic.

The mechanism of action of cefpodoxime is based on the inhibition of the synthesis of bacterial walls.

Cefpodoxime is stable against many beta-lactams.

SPECTRUM OF ANTIBACTERIAL ACTIVITY :

The critical concentrations separate the susceptible strains from the intermediate susceptibility strains and the latter, the resistant ones:

S <= 1 mg / L and R> 2 mg / L.

The prevalence of acquired resistance may vary with geography and time for some species.

It is therefore useful to have information on the prevalence of local resistance, especially for the treatment of severe infections.

These data can only provide an orientation on the probabilities of the susceptibility of a bacterial strain to this antibiotic.

When the variability of the prevalence of resistance in France is known (> 10%) (extreme values) for a bacterial species, it is indicated below:

SENSITIVE SPECIES :

–Aerobic Gram-positive :

• . Corynebacterium diphtheriae .
• . Streptococcus .
• . Streptococcus pneumoniae (20-60%).

– Aerobic Gram-negative :

• . Branhamella catarrhalis .
• . Citrobacter koseri .
• . Escherichia coli .
• . Haemophilus influenzae .
• . Klebsiella (0-30%).
• . Neisseria gonorrhoeae .
• . Pasteurella .
• .Proteus mirabilis .
• . Proteus vulgaris (29-38%).
• . Providencia .

– Anaerobic :

• . Fusobacterium (10-20%).
• . Prevotella (30-70%).
• . Propionibacterium acnes .
  

MODERATE SENSITIVE SPECIES ( in vitro of intermediate sensitivity):

Gram-positive aerobes :

• Staphylococcus méti-S.
  

RESISTANT SPECIES :

– Aerobic Gram-positive :

• . Enterococci.
• .Listeria monocytogenes. 
• . Staphylococcus meti-R *.

– Aerobic Gram-negative :

• . Acinetobacter. 
• . Citrobacter freundii. 
• . Enterobacter. 
• . Morganella morganii. 
• . Pseudomonas. 
• . Serratia .

– Anaerobic :

• . Bacteroides fragilis. 
• . Clostridium. 
• . Peptostreptococcus .

* The frequency of resistance to meticillin is approximately 30 to 50% of all staphylococci and occurs mostly in hospital.

What are side effects of  Orelox?

Like all medicines, ORELOX 100 mg film-coated tablets can cause side effects, although not everybody gets them.

Essentially:

• digestive manifestations: diarrhea, nausea, vomiting, stomach pain.

More rarely :

• Gastrointestinal manifestations: As with other broad-spectrum antibiotics, rare cases of enterocolitis (inflammation of the intestine) with bloody diarrhea have been reported as well as rare cases of pseudomembranous colitis (large intestine disease characterized by expulsion of false membranes or mucus, constipation and stomach pain),
• low increase in liver enzymes,
• allergic manifestations: rash, itching, urticaria, Quincke’s edema (abrupt swelling of the face and neck of allergic origin) and allergic shock,
• skin manifestations: various rashes, localized bullous eruption, erythema multiforme (redness of the skin), Stevens-Johnson syndrome and Lyell syndrome (skin detachment can rapidly spread very seriously to the whole body )
• headache,
• feeling of vertigo,
• low increase of urea and creatinine in the blood,
• hematologic manifestations: decrease or elevation of platelets and white blood cells, important but exceptional drop in the number of certain white blood cells (granulocytes) in the blood.

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.

Keep out of the reach and sight of children.

Orelox Interactions

– Food :

A study has shown that whatever the nature of the meal, the bioavailability of cefpodoxime is increased when the product is administered during the meal.

– Changes in gastric pH :

• Increased gastric pH: anti-H2 (ranitidine) and antacids (aluminum hydroxide, sodium bicarbonate) lead to a decrease in bioavailability.
• In contrast, a decrease in gastric pH (pentagastrin) causes an increase in bioavailability.
• The clinical consequences remain to be established.
  

SPECIAL PROBLEMS OF INR IMBALANCE :

• Many cases of increased activity of oral anticoagulants have been reported in patients receiving antibiotics.
• The marked infectious or inflammatory context, the age and the general state of the patient appear as risk factors.
• In these circumstances, it appears difficult to distinguish between the infectious pathology and its treatment in the occurrence of the imbalance of the INR. However, some classes of antibiotics are more involved, including fluoroquinolones, macrolides, cyclins, cotrimoxazole and some cephalosporins.

Orelox Warnings and Precautions

Special warnings

• The occurrence of any allergic manifestation requires stopping treatment.
• Prescription of cephalosporins requires an examination for discovery, allergy to penicillins being crossed with that with cephalosporins in 5 to 10% of cases:

1.  The use of cephalosporins should be extremely cautious in penicillin-sensitive patients: strict medical supervision is required from the first administration.
2. The use of cephalosporins is formally prohibited in subjects with a history of immediate allergy to cephalosporins. In case of doubt, the presence of the doctor at the patient is essential for the first administration, in order to treat the possible anaphylactic accident.

• · The hypersensitivity reactions (anaphylaxis) observed with these two types of beta-lactams can be serious and sometimes fatal.
• · The occurrence of a diarrheal episode may be symptomatic, exceptionally, pseudopembranous colitis whose diagnosis is based on colonoscopy. This accident, rare with cephalosporins, requires the immediate cessation of treatment and the initiation of an appropriate specific antibiotherapy (vancomycin). In this case, the administration of products promoting faecal stasis must absolutely be avoided.
• · Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Precautions for use

• · In patients who are allergic to other beta-lactams, consideration should be given to the possibility of cross-reactivity.
• · In case of severe renal impairment, it may be necessary to adjust the daily dose according to creatinine clearance (see Section “At-Risk” and  .
• · As with other broad-spectrum antibiotics, prolonged use of cefpodoxime proxetil may result in selection of nonsusceptible organisms, which may require discontinuation of treatment.
• · Interactions with laboratory tests Positivity of the Coombs test has been described during treatment with cephalosporins. There may be a false positive reaction when looking for glucose in the urine with reducing substances, but not when using glucose oxidase methods.

Drive and use machines

• Cefpodoxime proxetil can cause feelings of vertigo.
• Patients should be informed of these potential risks and should be aware of their reactions to this medicine before driving or operating machinery.

Orelox and PREGNANCY / BREAST FEEDING / FERTILITY:

Pregnancy :

• Due to the expected benefit, the use of cefpodoxime may be considered during pregnancy if needed, despite insufficient clinical and animal data.

Breastfeeding:

• The passage into breast milk is low and the quantities ingested are much lower than the therapeutic doses. As a result, breastfeeding is possible when taking this antibiotic.
• However, discontinue breastfeeding (or medication) if diarrhea, candidiasis, or rash occurs in infants.

What should I do if I miss a dose?

PREVENT YOUR DOCTOR IMMEDIATELY.

What happens if I overdose from Orelox ?

• – In the absence of any experience to date, the usual symptomatic treatment will be initiated.
• – In case of overdose and especially in patients with renal insufficiency, there is a risk of reversible encephalopathy.

What is  Forms and Composition Orelox ?

FORMS and PRESENTATIONS

• Film-coated tablet:  Box of 10, under pads.

COMPOSITION

	p cp
cefpodoxime	100 mg
(as proxetil: 130.45 mg / cp)

• Excipients: magnesium stearate, carboxymethylcellulose calcium, hydroxypropylcellulose, sodium laurilsulfate, lactose, titanium dioxide, talc, hydroxypropyl methylcellulose.
• Excipient with known effect: lactose.

NOT’s

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general information:

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Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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