Cefpodoxime Mylan 100 mg Uses, Dosage, Side Effects, Precautions & Warnings

CEFPODOXIME MYLAN 100 mg film-coated tablets, box of 10
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CEFPODOXIME MYLAN 100 mg film-coated tablets, box of 10 >> Generic drug of Orelox
Therapeutic class: Infectiology – Parasitology
Active ingredients: Cefpodoxime

Medicinal product withdrawn from the market on 07/22/2013

what is Cefpodoxime Mylan tablets 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 MYLAN 100 mg

9 presentations are available for this drug:

  • PVC PVDC aluminum heat-sealed film (s) of 10 tablets
  • PVC PVDC aluminum heat-sealed film (s) of 50 tablet (s)
  • PVC PVDC aluminum heat-sealed film (s) of 100 tablet (s)
  • aluminum heat-sealed film (s) of 10 tablets
  • Aluminum heat-sealed film (s) of 50 tablet (s)
  • aluminum heat-sealed film (s) of 100 tablet (s)
  • aluminum blister pack (s) of 10 tablet (s)
  • aluminum blister pack (s) of 50 tablet (s)
  • aluminum blister (s) of 100 tablet (s)
FEATURE DESCRIPTION
Pharmaceutical class systemic antibacterials
Active substance (s) cefpodoxime proxetil
General medicine no
Pharmaceutical form coated tablet
Route (s) of administration oral
Social security reimbursement rate 65%
Laboratory (s) MYLAN SAS
Conditions of issue available by simple prescription

Cefpodoxime Mylan 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 Mylan Contraindications

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

  • in the event of a known allergy to antibiotics from the cephalosporin group.
  • Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.

How To Take Cefpodoxime Mylan ?

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 MYLAN PHARMA 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 Mylan work?

ANTIBACTERIALS FOR SYSTEMIC USE, ATC code: J01DA33.

(J: Anti-infectives).

  • 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

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

  • 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 (> 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.

MODERATELY SENSITIVE SPECIES (in vitro of intermediate sensitivity)

Gram-positive aerobes:

  • Staphylococcus meti-S.

RESISTANT SPECIES

Aerobic Gram-positive:

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

Aerobic Gram-negative:

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

Anaerobic:

  • . Bacteroïdes 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 Mylan ?

Keep out of the reach and sight of children.

Expiration date

  • Do not use CEFPODOXIME MYLAN 100 mg film-coated tablet after the expiry date stated on the carton.

Storage conditions

  • Store at a temperature not exceeding + 25 ° C.

If necessary, warnings against certain visible signs of deterioration

  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with any unused medicine. These measures will help protect the environment.

Cefpodoxime Mylan Side Effects

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

It is essentially digestive disorders:

  • . diarrhea
  • . nausea, vomiting
  • . abdominal pain.

Also reported a few cases of:

  • . digestive manifestations: as with other broad-spectrum antibiotics, rare cases of enterocolitis with bloody diarrhea have been reported as well as rare cases of pseudomembranous colitis
  • . Hepatobiliary events: transient moderate elevation of transaminases AST and ALT, and alkaline phosphatase
  • . allergic manifestations: skin rashes, pruritus, urticaria, angioedema, anaphylactic shock,
  • . cutaneous manifestations: various rashes, rash localized bullous erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
  • . headache
  • . feelings of dizziness
  • . renal manifestations: slight increase in blood urea and creatinine
  • . haematological manifestations: thrombocytosis, thrombocytopenia, leukopenia and hypereosinophilia, exceptional agranulocytosis.

Cefpodoxime Mylan Interactions

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Effects on ability to Drive and use machines

If you feel dizzy after taking this medicine, you should not drive or operate machinery.

Warnings and Precautions

WARNINGS

  • The occurrence of any allergic manifestation requires discontinuation of treatment.
  • The prescription of cephalosporins requires an examination, allergy to penicillin being cross with the cephalosporin in 5 to 10% of cases
  • The use of cephalosporins should be extremely careful in penicillin-susceptible patients: strict medical supervision is necessary from the first administration.
  • The use of cephalosporins should be strictly prohibited in subjects with a history of immediate type allergy to cephalosporins. In case of doubt, the presence of the doctor near 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 can be symptomatic, exceptionally, of pseudomembranous colitis whose diagnosis is based on colonoscopy.
  • This accident, rare with cephalosporins, requires immediate discontinuation of treatment and the initiation of appropriate specific antibiotic therapy (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 cases of congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.

PRECAUTIONS FOR USE

  • In patients allergic to other beta-lactams, the possibility of cross-allergy must be taken into account.
  • In the event of severe renal insufficiency, it may be necessary to adjust the daily dose according to the creatinine clearance (see paragraph “
  • As with other broad-spectrum antibiotics, prolonged use of cefpodoxime proxetil may result in the selection of non-susceptible bacteria, which may require discontinuation of treatment.

Interactions with laboratory tests :

  • A positive Coombs test has been described during treatment with cephalosporins.
  • A false positive reaction may occur when testing urine for glucose with reducing substances, but not when using glucose oxidase methods.
  • Breast-feeding: there is little passage into breast milk and the quantities 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.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

  • This medicine will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue it.

Feeding with milk

  • Breast-feeding is possible while taking this medicine. However, if digestive problems (diarrhea, candidiasis) or skin rashes appear in your child, stop breastfeeding or taking medication and consult your doctor promptly.
  • In general, during pregnancy and breastfeeding, always seek the advice of your doctor or pharmacist before taking any medication.

What happens if I overdose from Cefpodoxime Mylan ?

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

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 Mylan ?

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

What is  Forms and Composition ?

Appearance and shape

  • White film-coated tablet.
  • 10 tablets in blister packs (Polyamide / Aluminum / PVC).

What is CEFPODOXIME Mylan 100 mg film-coated tablet and contents of the pack?

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

Composition

Active ingredient Coated tablet
Cefpodoxime 100 mg *

* per unit dose

Active ingredients: 

Excipients with known effects ?

  • Lactose monohydrate
Other excipients: Carmellose calciumL-hydroxypropylcellulose, Sodium laurylsulfate, Magnesium stearate, Opadry white 03A28718: Hypromellose, Titanium dioxide, Talc

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.

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