PORTEX ® Azithromycin

PORTEX ® is a drug based on Azithromycin

THERAPEUTIC GROUP: Antibacterials - Antibiotics for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications PORTEX ® Azithromycin

PORTEX ® is used clinically in the treatment of infections of various organs and systems supported by microorganisms sensitive to macrolides therapy and in particular with Azithromycin.

Great efficacy has been demonstrated especially in the treatment of upper and lower respiratory tract infections.

Mechanism of action PORTEX ® Azithromycin

PORTEX ® is a drug based on Azithromycin, a semi-synthetic active ingredient derived from Erythromycin and therefore belonging to the family of macrolides with 15 carbon atoms.

Taken orally, Azithromycin is rapidly absorbed at the intestinal level, thanks also to the greater stability in an acid environment compared to its predecessors, reaching the plasma peak in just 2-3 hours.

Mostly linked to plasma proteins, it is widely distributed among the various tissues, persisting in the center from 2 to 4 hours, to be subsequently eliminated mainly through the bile through the intestine.

As macrolide, its therapeutic action, particularly effective against Gram-negative aerobic microorganisms responsible for infections affecting the respiratory system, is performed through the inhibition of the 50S ribosomal subunit involved in the interaction with the peptidyltransferase, then in the subsequent lengthening of the nascent peptide chain.

In some cases the indiscriminate use of these antibiotics could facilitate the appearance of resistance mechanisms, responsible for the overlap of opportunistic infections such as those sustained by Clostridium difficile.

For this reason it is important that the therapy with PORTEX ® is defined and constantly supervised by your doctor.

Studies carried out and clinical efficacy

1 INTERACTION BETWEEN METADONE AND AZITHROMYCIN

Am J Med Sci. 2012 Oct 25.

Case report reporting the appearance of a fatal arrhythmia associated with a lengthening of the QT interval due to the simultaneous administration of Azithromycin in a patient on chronic methadone treatment.

2. EFFECTIVENESS OF AZITROMYCIN IN THE IMPROVEMENT OF THE QUALITY OF LIFE OF SMALL PATIENTS WITH RESPIRATORY DISORDERS

BMC Pediatr. 2012 Aug 14; 12: 122.

Extensive clinical trial demonstrating how the use of Azithromycin in small patients with bronchiectasis can significantly reduce respiratory complications, improving both spirometric parameters and quality of life.

3. ALTERNATIVE METHODS OF ADMINISTRATION OF AZITROMYCIN

J Cardiovasc Dis Res. 2012 Oct; 3 (4): 319-22. doi: 10.4103 / 0975-3583.102720.

Interesting study that demonstrates how oral administration of azithromycin could be replaced in rectal patients especially in pediatric patients, guaranteeing the same therapeutic efficacy thanks to the maintenance of excellent pharmacokinetic profiles.

Method of use and dosage

PORTEX ®

500 mg film-coated tablets of Azithromycin;

The dosing schedule generally involves the daily use of 500 mg of Azithromycin in a single administration.

In cases of severe infections, especially those affecting the lower respiratory tract or the otorhinolaryngology apparatus, the dosage could be doubled, while still respecting the daily single dose, while in the course of liver disease adapted according to the needs.

Warnings PORTEX ® Azithromycin

In order for PORTEX ® therapy to guarantee maximum therapeutic efficacy and minimize possible side effects, it is necessary for this to be anticipated by a careful medical examination to evaluate the prescriptive appropriateness and the possible presence of conditions incompatible with the Azithromycin intake.

Particular caution should be reserved especially for patients suffering from hepatic or cardiac pathologies, for which often the use of this drug could determine an exacerbation of the symptomatology with lengthening of the QT interval, arrhythmias, increase of hepatic transaminases and medium-severe type hepatopathies .

For the same reason it would be advisable to limit the time taken to take those recommended by the doctor, given that the abuse of this antibiotic, profoundly altering the intestinal microflora, could determine the appearance of serious intestinal infections such as pseudo-membranous colitis supported by Clostridium difficile .

PORTEX ® contains lactose and glucose; it is therefore contraindicated in patients with lactase enzyme deficiency, lactose intolerance and glucose-galactose malabsorption syndrome.

PREGNANCY AND BREASTFEEDING

Given the absence of clinical trials capable of fully characterizing the safety profile of azithromycin on the unborn child and infant, it would be appropriate to limit the use of this antibiotic exclusively to cases of inevitable necessity

Interactions

Therapy with PORTEX ® could result in alteration of the safety profile and clinical efficacy of therapies based on oral anticoagulants, cyclosporine, digoxin and cardioactive active ingredients.

Therefore it is recommended to always consult your doctor before taking this drug.

Contraindications PORTEX ® Azithromycin

PORTEX ® is contraindicated in patients with inadequately controlled hepatic and cardiac diseases and in subjects hypersensitive to the active substance or to one of its excipients.

Undesirable effects - Side effects

Although the use of azithromycin is safe and well tolerated, it should be remembered that the use, especially prolonged, of this antibiotic may cause the appearance of nausea, diarrhea, abdominal cramps, headache, irritability, sensory changes, hypotension, alterations of the liver function and osteo-articular pain.