LOCABIOTAL ® Fusafungina

On 01/04/2016, the Italian Drug Agency (Aifa) ordered the immediate withdrawal of the packages on the Italian market for the medicine.

The Risk Assessment Committee for EMA (European Medicines Agency) has concluded that the benefits of fusafungine do not outweigh its risks, in particular due to the possible occurrence of severe allergic reactions

LOCABIOTAL ® is a drug based on Fusafungine

THERAPEUTIC GROUP: Preparations for the pharyngeal cavity

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

Indications LOCABIOTAL ® Fusafungina

LOCABIOTAL ® is indicated in the antiseptic, antibacterial and anti-inflammatory treatment of upper respiratory tract diseases such as sinusitis, rhinitis, nasopharyngitis, laryngitis and tracheitis.

Mechanism of action LOCABIOTAL ® Fusafungine

The Fusafungina, active ingredient of LOCABIOTAL ®, is a peptide product extracted from mycetes of the Fusarium lateritium strain, particularly active topically, given the very low degree of systemic absorption.

Its clinical efficacy is due to its antibacterial and anti-inflammatory properties, which though not entirely characterized seem to:

alter the structural surface characteristics of the bacteria, thus exerting a sensitive bacteriostatic and bactericidal activity;
to determine a significant reduction in the secretion of inflammatory cytokines such as TNF alpha, thereby controlling the activity of the cellular elements of phlogosis and its histolytic consequences;
exercise an antioxidant activity, causing a significant reduction of the damage induced by reactive oxygen species.

The absence of detectable systemic absorption significantly improves the safety of antibiotic therapy, reducing the risk of clinically relevant adverse reactions.

Studies carried out and clinical efficacy

THE FUSAFUNGINA IN THE TREATMENT OF ACUTE RINOFARINGITIS

Rhinology. 2004 Dec; 42 (4): 207-12.

Lund VJ, Grouin JM, Eccles R, Bouter C, Chabolle F.

Study conducted on over 500 patients demonstrating the efficacy and safety of Fusafungine in the treatment of acute nasopharyngitis, guaranteeing a clear and rapid improvement in symptoms in a few days of treatment.

EFFICIENCY AND TOLERABILITY OF THE FUSAFUNGINA

Curr Med Res Opin. 2002; 18 (4): 194-200.

Kroslák M.

Interesting work carried out on 166 patients suffering from diseases of the upper respiratory tract that demonstrates how Fusafugina can determine a rapid improvement in nasal and pharyngeal symptoms, while providing excellent patient tolerance and compliance.

ANTI-INFLAMMATORY PROPERTIES OF THE FUSAFUNGINA

Vestn Otorinolaringol. 2010; (2): 51-4.

Lopatin AS, Varvianskaia AV.

Recent study that tries to characterize the anti-inflammatory properties of Fusafungine, thus highlighting the absence of clear molecular mechanisms that justify the conspicuously anti-inflammatory and antioxidant action of this molecule.

Method of use and dosage

LOCABIOTAL ®

Oral and nasal solution 50 mg of Fusafungine per 5 ml of product.

Dosages and timing of intake should be defined by your doctor based on the patient's general health condition and the severity of his / her clinical picture.

Generally 2 sprays are recommended by mouth or by nostril every 4 hours for 4 days in the attack phase to continue the treatment, not more than ten days, with a nebulization by mouth or in the nostril every 4 hours.

Warnings LOCABIOTAL ® Fusafungina

Treatment with LOCABIOTAL ® must necessarily be defined and supervised by your doctor.

In fact, it is recommended to avoid prolonged treatments over time, given both the increased risk of developing adverse reactions to the product or one of its excipients such as propylene glycol and the increase in the potential selection of multi-drug resistant microbial strains.

The patient receiving LOCABIOTAL ® should also consider the presence of alcohol as an excipient.

It is recommended to keep the medicine out of the reach of children.

PREGNANCY AND BREASTFEEDING

Given the lack of studies able to fully characterize the safety profile of Fusafungine for fetal and infant health, it is recommended to limit the use of LOCABIOTAL ® during pregnancy and in the subsequent breastfeeding period, exclusively to cases of inevitable necessity and always under the supervision of your doctor.

Interactions

Drug interactions worthy of clinical note are currently unknown.

Contraindications LOCABIOTAL ® Fusafungine

The use of LOCABIOTAL ® is contraindicated in patients with hypersensitivity to the active substance or to one of its excipients and in children younger than 30 months.

Undesirable effects - Side effects

The use of LOCABIOTAL ® could cause the appearance of sneezing, taste changes, throat irritation, cough, nausea, dry mouth and other signs of local irritation.

The systemic side effects, which require an immediate suspension of the ongoing treatment, are decidedly more rare.