Treda

Soppressione dei batteri intestinali : Le compresse di Treda solfato sono indicate come terapia aggiuntiva come parte di un regime per la soppressione della normale flora batterica dell'intestino, ad esempio preparazione preoperatoria dell'intestino. Viene somministrato in concomitanza con la base con rivestimento enterico di eritromicina (vedere

DOSAGGIO E AMMINISTRAZIONE

Coma epatico (encefalopatia portale-sistemica) : Il treda solfato ha dimostrato di essere un'efficace terapia aggiuntiva nel coma epatico mediante riduzione dei batteri che formano ammoniaca nel tratto intestinale. La successiva riduzione dell'ammoniaca nel sangue ha portato a un miglioramento neurologico.

Soppressione dei batteri intestinali : Le compresse di Treda sono indicate come terapia aggiuntiva come parte di un regime per la soppressione della normale flora batterica dell'intestino, ad esempio preparazione preoperatoria dell'intestino. Viene somministrato in concomitanza con la base con rivestimento enterico di eritromicina (vedere

DOSAGGIO E AMMINISTRAZIONE

Coma epatico (encefalopatia portale-sistemica) : Treda ha dimostrato di essere un'efficace terapia aggiuntiva nel coma epatico mediante riduzione dei batteri che formano ammoniaca nel tratto intestinale. La successiva riduzione dell'ammoniaca nel sangue ha portato a un miglioramento neurologico.

Coma epatico (encefalopatia portale-sistemica) : Il treda solfato ha dimostrato di essere un'efficace terapia aggiuntiva nel coma epatico mediante riduzione dei batteri che formano ammoniaca nel tratto intestinale. La successiva riduzione dell'ammoniaca nel sangue ha portato a un miglioramento neurologico.

Coma epatico (encefalopatia portale-sistemica) : Treda ha dimostrato di essere un'efficace terapia aggiuntiva nel coma epatico mediante riduzione dei batteri che formano ammoniaca nel tratto intestinale. La successiva riduzione dell'ammoniaca nel sangue ha portato a un miglioramento neurologico.

I preparati orali di treda solfato sono controindicati in presenza di ostruzione intestinale e in soggetti con anamnesi di ipersensibilità al farmaco.

I pazienti con anamnesi di ipersensibilità o grave reazione tossica ad altri aminoglicosidi possono avere una sensibilità crociata a Treda.

I preparati orali di Treda solfato sono controindicati nei pazienti con malattia gastrointestinale infiammatoria o ulcerosa a causa del potenziale assorbimento gastrointestinale di Treda.

Le preparazioni orali di Treda sono controindicate in presenza di ostruzione intestinale e in soggetti con una storia di ipersensibilità al farmaco.

I pazienti con anamnesi di ipersensibilità o grave reazione tossica ad altri aminoglicosidi possono avere una sensibilità crociata alla neomicina.

I preparati orali di Treda sono controindicati nei pazienti con malattia gastrointestinale infiammatoria o ulcerosa a causa del potenziale assorbimento gastrointestinale della neomicina.

WARNINGS

(See BOXED WARNINGS).

Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

The risk of hearing loss continues after drug withdrawal.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of Treda have not been conducted. If Treda is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

As with other antibiotics, use of oral Treda may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Treda is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of Treda.

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered Treda are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with the oral use of Treda. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral Treda dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered Treda increases fecal bile acid excretion and reduces intestinal lactase activity.

Laboratory Tests

Patients with renal insufficiency may develop toxic Treda blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the follow ing should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve (eighth cranial nerve) function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Treda sulfate to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy

Category D: (See WARNINGS section.)

Nursing Mothers

It is not known whether Treda is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of oral Treda sulfate in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, Treda should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

WARNINGS

(See BOXED WARNINGS).

Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.

The risk of hearing loss continues after drug withdrawal.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.

Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with the oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Laboratory Tests

Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the follow ing should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve (eighth cranial nerve) function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Treda to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy

Category D: (See WARNINGS section.)

Nursing Mothers

It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efficacy of oral Treda in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

Le reazioni avverse più comuni al treda solfato orale sono nausea, vomito e diarrea. La "Sindrome da malassorbimento" caratterizzata da aumento del grasso fecale, riduzione del carotene sierico e calo dell'assorbimento di xilosio è stata segnalata con una terapia prolungata. Nefrotossicità, ototossicità e blocco neuromuscolare sono stati segnalati (vedi AVVERTENZE SCATOLA e PRECAUZIONI sezioni).

Le reazioni avverse più comuni alla Treda orale sono nausea, vomito e diarrea. La "Sindrome da malassorbimento" caratterizzata da aumento del grasso fecale, riduzione del carotene sierico e calo dell'assorbimento di xilosio è stata segnalata con una terapia prolungata. Nefrotossicità, ototossicità e blocco neuromuscolare sono stati segnalati (vedi AVVERTENZE SCATOLA e PRECAUZIONI sezioni).

A causa del basso assorbimento, è improbabile che si verifichi un sovradosaggio acuto con Treda solfato orale. Tuttavia, la somministrazione prolungata potrebbe comportare livelli di farmaco sistemici sufficienti per produrre neurotossicità, ototossicità e / o nefrotossicità.

L'emodialisi rimuoverà il solfato di Treda dal sangue.

A causa del basso assorbimento, è improbabile che si verifichi un sovradosaggio acuto con Treda orale. Tuttavia, la somministrazione prolungata potrebbe comportare livelli di farmaco sistemici sufficienti per produrre neurotossicità, ototossicità e / o nefrotossicità.

L'emodialisi rimuoverà Treda dal sangue.