ERY-TAB Delayed-release tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

PD-Rx Pharmaceuticals, Inc.

Λέξεις κλειδιά

55289-217

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1. Description

ERY-TAB (erythromycin delayed-release tablets) is an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects ...

2. Clinical Pharmacology

Orally administered erythromycin base and its salts are readily absorbed in the microbiologically active form. Interindividual variations in the absorption of erythromycin are, however, observed, and some ...

3. Indications and Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB should be used only to treat or prevent infections that are proven ...

4. Contraindications

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide, ergotamine, ...

5. Warnings

Hepatotoxicity There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving ...

6.1. General

Prescribing ERY-TAB in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development ...

6.2. Information for Patients

Patients should be counseled that antibacterial drugs including ERY-TAB should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ERY-TAB is prescribed ...

6.4. Drug Interactions

Theophylline Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline ...

6.5. Drug/Laboratory Test Interactions

Erythromycin interferes with the fluorometric determination of urinary catecholamines.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term oral dietary studies conducted with erythromycin stearate in rats up to 400 mg/kg/day and in mice up to about 500 mg/kg/day (approximately 1-2 fold of the maximum human dose on a body surface ...

6.7. Pregnancy

Teratogenic Effects There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base by oral gavage at 350 mg/kg/day (approximately twice the maximum ...

6.8. Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

6.9. Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is administered to a nursing woman.

6.10. Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

6.11. Geriatric Use

Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION). ...

7. Adverse Reactions

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, ...

9. Overdosage

In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin ...

10. Dosage and Administration

In most patients, ERY-TAB (erythromycin delayed-release tablets) are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when ERY-TAB 250 mg, ERY-TAB ...

11. How Supplied

ERY-TAB (erythromycin delayed-release tablets, USP) are supplied as white oval enteric-coated tablets debossed on one side with the Arbor logo, A, and on the other side with a two letter Code designation, ...

12. Storage and Handling

Store below 86°F (30°C).

14. References

1. Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, ...