Cefpodoxime Biogaran 100 MG Uses, Dosage, Side Effects, Precautions & Warnings

Generic drug of Orelox
Therapeutic class: Infectiology – Parasitology
Active ingredients: Cefpodoxime

what is Cefpodoxime Biogaran 100 MG used for and indication?

This medication is indicated in adults for the treatment of certain bacterial infections caused by susceptible bacteria.

PRESENTATION (S) AVAILABLE FOR CEFPODOXIME BIOGARAN 100 MG

polyamide PVC-Aluminum blister pack (s) of 10 tablet (s)

FEATURE	DESCRIPTION
Pharmaceutical class	systemic antibacterials
Active substance (s)	cefpodoxime proxetil
General medicine	Yes
Pharmaceutical form	coated tablet
Route (s) of administration	oral
Social security reimbursement rate	65%
Laboratory (s)	BIOGARAN
Conditions of issue	available by simple prescription

Cefpodoxime Biogaran Dosage

• The dosage varies according to the therapeutic indication.
• As an indication, the usual dosage is 200 to 400 mg per day.
• The dosage should be adjusted in the event of renal impairment.

Cefpodoxime Biogaran Contraindications

Do not take CEFPODOXIME BIOGARAN 100 mg film-coated tablets in the following cases:

• in case of known allergy to antibiotics from the cephalosporin group.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

How To Take Cefpodoxime Biogaran ?

Frequency of administration

• Two taken per day, during meals.

Duration of the treatment

• To be effective, this antibiotic should be used regularly at the prescribed doses, and for as long as your doctor advises you.
• Just because the fever, or any other symptom is gone, does not mean that you are completely cured.
• The possible feeling of fatigue is not due to the antibiotic treatment but to the infection itself. Reducing or stopping your treatment will have no effect on this feeling and will delay your recovery.
• Special case: the duration of treatment for certain sinusitis and certain tonsillitis is 5 days.
• IN ALL CASES, STRICTLY COMPLY WITH THE PRESCRIPTION OF YOUR DOCTOR.
• If you have the impression that the effect of CEFPODOXIME BIOGARAN 100 mg film-coated tablet is too strong or too weak, talk to your doctor or pharmacist.

Administration mode

• Oral route.
• Swallow the tablets with a glass of water.

how does Cefpodoxime Biogaran work?

Pharmacotherapeutic group: ANTIBACTERIALS FOR SYSTEMIC USE, ATC code: J01DA33.

(3rd generation cephalosporins)

• 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 environment and rapidly hydrolyzed by non-specific esterases to cefpodoxime, a bactericidal antibiotic.
• The mechanism of action of cefpodoxime is based on inhibition of the synthesis of bacterial walls.
• Cefpodoxime is stable against many beta-lactamases.

SPECTRUM OF ANTIBACTERIAL ACTIVITY

Critical concentrations separate susceptible strains from intermediate susceptibility strains and the latter from resistant:

S ≤ 1 mg / l and R> 2 mg / l

• The prevalence of acquired resistance may vary depending on 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 guidance on the probabilities of the sensitivity of a bacterial strain to this antibiotic.

When the variability of the prevalence of resistance in France is known for a bacterial species, it is indicated in the table below:

	Categories	Frequency of resistance acquired in France (> 10%) (extreme values)
	SENSITIVE SPECIES
	Gram-positive aerobes
	Corynebacterium diphtheriae
	Streptococcus
	Streptococcus pneumoniae	20 – 60%
	Gram-negative aerobes
	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
	MODERATELY SENSITIVE SPECIES
	(in vitro of intermediate sensitivity)
	Gram-positive aerobes
	Staphylococcus meti-S
RESISTANT SPECIES
Gram-positive aerobes
Enterococci
Listeria monocytogenes
Staphylococcus meti-R *
Gram-negative aerobes
Acinetobacter
Citrobacter freundii
Enterobacter
Morganella morganii
Pseudomonas
Serratia
Anaerobic
Bacteroides fragilis
Clostridium
Peptostreptococcus
* The frequency of resistance to methicillin is approximately 30 to 50% of all staphylococci and is mainly found in hospitals.

How To Store Cefpodoxime Biogaran ?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiration date refers to the last day of that month.
• Store at a temperature not exceeding 25 ° C.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Cefpodoxime Biogaran Side Effects

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

Basically:

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

More rarely :

• digestive 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 (disease of the large intestine characterized by expulsion of false membranes or mucus, constipation and stomach pain),
• low increase in liver enzymes,
• allergic manifestations: skin rashes, itching, urticaria, angioedema (sudden swelling of the face and neck of allergic origin) and allergic shock,
• skin manifestations: various rashes, localized bullous rash, erythema multiforme (skin disease in the form of redness), Stevens-Johnson syndrome and Lyell syndrome (peeling of the skin which can quickly spread very seriously throughout the body ),
• headache,
• dizziness,
• small increase in urea and creatinine in the blood,
• haematological manifestations: decrease or increase in the level of platelets and white blood cells, significant but exceptional drop in the number of certain white blood cells (granulocytes) in the blood.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Cefpodoxime Biogaran 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.

Change in gastric pH

• Increase in gastric pH: anti-H2 (ranitidine) and anti-acids (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.

Particular 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 general condition of the patient appear to be risk factors. Under these circumstances, it appears difficult to distinguish between the infectious pathology and its treatment in the occurrence of the INR imbalance. 
• However, certain classes of antibiotics are more involved: these include fluoroquinolones, macrolides, cyclins, cotrimoxazole and certain cephalosporins.

Effects on ability to Drive and use machines

This medicine can have a major influence on the ability to drive or use machines, in particular because of the possible occurrence of dizziness or encephalopathy (which may result in convulsions, confusion, disturbances of consciousness, or abnormal movements) (see sections 3 and 4).

Warnings and Precautions

Special warnings

• Any allergic manifestation (rash, itching, etc.) during treatment should be reported to your doctor immediately.
• There is a possibility of allergy (5 to 10% of cases) in subjects allergic to penicillins.
• Inform your doctor of any allergy or allergic manifestations which have occurred during treatment with antibiotics of the penicillin group.
• The occurrence of diarrhea during antibiotic treatment should not be treated without medical advice.

Due to the presence of lactose, this medication should not be used in cases of galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).

Precautions for use

• Because of the need to adapt the treatment, it is important to tell the doctor about any kidney disease.
• This medicine can cause a false positive reaction to certain laboratory tests (test for glucose in the urine, Coombs test).

KEEP OUT OF REACH OF CHILDREN.

IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

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

Feeding with milk

Passage into breast milk is low and the amounts ingested are much lower than the therapeutic doses. As a result, breast-feeding is possible while taking this antibiotic.

However, stop breast-feeding (or the medication) if diarrhea, candidiasis or rash occurs in the infant.

What happens if I overdose from Cefpodoxime Biogaran ?

What should I do if I miss a dose?

• Not applicable.
• Not applicable.
• Not applicable.
• Not applicable.
• Not applicable.

What happens if you stop taking Cefpodoxime Biogaran ?

• Not applicable.
• Not applicable.
• Not applicable.
• Not applicable.
• Not applicable.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse for more information.

What is  Forms and Composition ?

Composition

WHAT CEFPODOXIME BIOGARAN 100 MG CONTAINS?

The active substance is:

• Cefpodoxime ……… 100 mg

As Cefpodoxime proxetil.

For a film-coated tablet.

The other ingredients are:

Carmellose calcium, lactose monohydrate, L-hydroxypropylcellulose, sodium laurilsulfate, magnesium stearate.

Film- coating : white OPADRY 03A28718: hypromellose, titanium dioxide (E171), talc.

FORMS and PRESENTATIONS

WHAT CEFPODOXIME BIOGARAN 100 MG FILM-COATED TABLET LOOKS LIKE AND CONTENTS OF THE OUTER CARTON  ?

• This drug is in the form of film-coated tablet.
• Box of 10 tablets.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

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.