Bostolox 200

Bostolox 200

201912-0132 • 6802 Views • Box of 01 blister x 10 film-coated tablets with a package insert.
COMPOSITION

Each BOSTOLOX 200 film-coated tablet contains:

Active ingredients:

Cefpodoxime (cefpodoxime proxetil) 200 mg

BOSTOLOX SUSPENSION is indicated for the treatment of the following infections when caused by susceptible pathogens  in adults, specifically in:

Documented group A beta-hemolytic streptococcal throat infection.

 Acute sinusitis.

 Acute bronchial suppuration in at-risk patients (particularly alcoholics, smokers, patients over 65 years of age, etc.).

 Exacerbation of chronic obstructive pulmonary disease, particularly in repeat episodes or in atrisk patients.

Bacterial lung diseases, particularly in at-risk patient.

Consideration should be given to the official guidance on the appropriate use of antibacterial agents

POSOLOGY, METHOD OF ADMINITRATION

Posology 

Dosage varies according to indications for treatment.

For reference, the usual dose is 200 mg or 400 mg per day.

Use a dose of 100 mg × 2 times / day, in cases of bacterial infections in the throat; the duration of treatment is 5 days.

Dose of 200 mg × 2 times / day in the following cases:

- Acute sinusitis; in acute maxillary sinusitis, a 5-day course of treatment has been shown to be effective.

- Acute bronchitis.

- Exacerbation of chronic obstructive pulmonary disease

- Bacterial lung diseases.

Elderly

No dose adjustment is required if the elderly subject has normal renal function

Patients with impaired renal function

No dose adjustment is required when creatinine clearance is above 40 ml/min. If creatinine clearance is below 40 ml/min, the daily dose should be halved and limited to one single daily dose.

Patients with liver failure

No dose adjustment required.

In all cases, the doctor's prescription must be followed.

Treatment Time

For treatment to be effective, this antibiotic must be taken regularly at the dose and for the time prescribed by your doctor.

The disappearance of fever or any other symptoms does not mean that you are completely cured. Feeling tired is not caused by antibiotic treatment but by the infection itself. Reducing the dose or stopping treatment will have no effect on these sensations and will only prolong recovery.

Special cases: the duration of treatment for some cases of sinusitis and tonsillitis is 5 days.

How to use

Oral route. Drink twice daily, with meals.

CONTRAINDICATIONS

Patients with hypersensitivity to cefpodoxime or any of the excipients.

Patients with hypersensitivity to cephalosporin antibiotics.

People with porphyria

WARNING AND PRECAUTIONS FOR USE

Cefpodoxime is not a preferred antibiotic for the treatment of staphylococcal 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 due to S. pneumoniae.

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefpodoxime must be discontinued immediately and adequate emergency measures to the patient.

Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefpodoxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if
cefpodoxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

In cases of severe renal insufficiency it may be necessary to reduce the dosage regimen dependent on the creatinine clearance.

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all anti-bacterial agents, including cefpodoxime, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of cefpodoxime. Discontinuation of therapy with cefpodoxime and the administration of specific treatment for Clostridium difficile should be considered. 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 extended treatment. For cases of treatment lasting longer than 10 days, the blood count should be monitored and treatment discontinued if neutropenia is found.

Cephalosporins may be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug, activation of the system can cause red blood cell destruction. This can produce a positive Coomb's test and very rarely, haemolytic anaemia. Cross-reactivity may occur with penicillin for this reaction.

Changes in renal function have been observed with cephalosporin antibiotics, particularly when given concurrently with potentially nephrotoxic drugs such as aminoglycosides and/or potential diuretics. In such cases, renal function should be monitored.

A false positive reaction may occur when testing for glucose in the urine with “benedict” solution, “fehling” solution or copper sulphate tablets, but not when using glucose oxidase methods

Be careful with excipients

BOSTOLOX 100 and BOSTOLOX 200: patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

In addition, the product contains less than 1 mmol of sodium and 1 mmol of potassium: can be considered "potassium- and sodium-free".

Bostolox 100 products contain red number 40 (allura red ac) which may cause allergic reactions.

Shelf-life

36 months from the manufacturing date. Do not use after the expiry date.

Al/Al blister. Box of 01 blister x 10 film-coated tablets with a package insert.

Al/Al blister. Box of 02 blisters x 10 film-coated tablets with a package insert.

Al/Al blister. Box of 5 blisters x 10 film-coated tablets with a package insert.

Al/Al blister. Box of 10 blisters x 10 film-coated tablets with a package insert.

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