STREPTOSIL NEOMYCIN * UNG 20G

STREPTOSIL NEOMYCIN * UNG 20G

Therapeutic indications

Superficial skin infections (folliculitis, furunculosis, small burns and infected wounds).

Dosage and method of use

Skin powderLift the colored cap, press rhythmically and thoroughly the two sides of the bottle holding it horizontally or slightly oblique; lightly sprinkle the affected area with the powder and cover with sterile gauze; renew the application twice a day. It is recommended to apply a light sprinkling, using the minimum necessary of powder to avoid the formation of crusts and to allow a rapid solubilization and diffusion of the components. Do not exceed the recommended dose.OintmentApply a thin layer of ointment 2-3 times a day. Do not exceed the recommended dose.

Contraindications

STREPTOSIL with NEOMYCIN is contraindicated in patients with: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Ear canal infections in case of perforation of the tympanic membrane.

Side effects

Following the use of STREPTOSIL with NEOMYCIN, the following side effects may occur. The frequency of these side effects is unknown.Infections and infestationsBacterial and fungal superinfections.Disorders of the immune systemHypersensitivity reactionsSkin and subcutaneous tissue disordersItching.General disorders and administration site conditionsSwelling, redness.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

STREPTOSIL with NEOMYCIN is not for ophthalmic use; it is indicated for external use only. The application of STREPTOSIL with NEOMYCIN on extensive and deeply injured skin, such as in skin infections secondary to extensive burns and trophic ulcers, could favor the systemic absorption of its active ingredients, exposing patients to serious side effects, such as nephrotoxicity and ototoxicity. The medicine should not be used in ear canal infections in case of eardrum perforation since in these cases the topical use of neomycin can cause deafness (see section 4.3) .As for other aminoglycosides, concomitant and / or sequential systemic or topical administration of other nephrotoxic drugs.Duration of treatmentThe use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena. As with other antibiotics, prolonged use of neomycin can lead to the development of resistant microorganisms, including fungi. If this occurs, treatment must be discontinued and appropriate therapy instituted. After a short period of treatment without appreciable results, or in case of worsening of the patient's condition, it is necessary to evaluate the suspension of treatment.Pediatric populationIn infancy, the product should be administered in cases of real need, under the direct supervision of the doctor. The application of neomycin on large skin areas and for prolonged periods, can cause systemic absorption; this is more likely to occur when occlusive bandages are used, in particular in newborns, since the diaper can act as an occlusive bandage.

Pregnancy and breastfeeding

PregnancyThe safety of topical use of sulfonamides or neomycin during pregnancy has not been established. In pregnant women, the product should be administered in cases of real need, under the direct supervision of the doctor.Feeding timeThere are no adequate studies to evaluate the effects in breastfeeding women and thus to determine the risk in infants. The product should be used in breastfeeding women only if strictly necessary, under direct medical supervision.FertilityNo studies have been conducted to evaluate the effects on human fertility.

Expiration and retention

No special storage precautions.

Interactions with other drugs

Topical neomycin has shown cross-sensitivity with other aminoglycosides; co-administration of another aminoglycoside, especially systemically, is not recommended due to the potential ototoxic and nephrotoxic effects. Topical application of sulfatiazole may give rise to sensitization and preclude subsequent systemic use of sulfonamides.

Overdose

In the event of prolonged applications on large surfaces or lesions, systemic absorption of the drug may occur with passage of sulfatiazole and / or neomycin into the circulation. If overdose is suspected, treatment should be discontinued.

Active principles

10 g of powder contain: sulfatiazole 9.95 g and neomycin sulfate 0.05 g. 20 g of ointment contain: sulfatiazole 0.4 g and neomycin sulfate 0.1 g.

Excipients

skin powder: none. ointment: petroleum jelly, white petroleum jelly, white wax.