Eryc Information
Eryc (Erythromycin)
Eryc (Erythromycin) Description
Eryc (Erythromycin) capsules contain enteric-coated pellets of erythromycin base for oral administration. Each Eryc (Erythromycin) capsule contains 250 mg of erythromycin base. Also contains: lactose NF, povidone USP, FD&C Yellow #6 and other ingredients. The capsule shell contains gelatin NF, titanium dioxide USP, FD&C Yellow #6.
Erythromycin is produced by a strain of (formerly ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids but it is the base which is microbiologically active. Erythromycin base is (3 *, 4 *, 5 *, 6 *, 7 *, 9 *, 11 *, 12 *, 13 *, 14 *)-4-[(2,6-Dideoxy-3--methyl-3--methyl-α-L--hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D--hexopyranosyl]oxy]-oxacyclotetradecane-2,10-dione.
Eryc (Erythromycin) 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 patients do not achieve acceptable serum levels. Erythromycin is largely bound to plasma proteins, and the freely dissociating bound fraction after administration of erythromycin base represents 90% of the total erythromycin absorbed. After absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid, but the passage of the drug across the blood-brain barrier increases in meningitis. The drug is excreted in human milk. The drug crosses the placental barrier, but fetal plasma levels are low. Erythromycin is not removed by peritoneal dialysis or hemodialysis.
In the presence of normal hepatic function erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine.
The enteric coating of pellets in Eryc (Erythromycin) capsules protects the erythromycin base from inactivation by gastric acidity. Because of their small size and enteric coating, the pellets readily pass intact from the stomach to the small intestine and dissolve efficiently to allow absorption of erythromycin in a uniform manner. After administration of a single dose of a 250 mg Eryc (Erythromycin) capsule, peak serum levels in the range of 1.13 to 1.68 mcg/mL are attained in approximately 3 hours and decline to 0.30 to 0.42 mcg/mL in 6 hours. Optimal conditions for stability in the presence of gastric secretion and for complete absorption are attained when Erythromycin is taken on an empty stomach.
Eryc (Erythromycin) Indications And Usage
Erythromycin is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:
Upper respiratory tract infections of mild to moderate degree caused , or (when used concomitantly with adequate doses of sulfonamides, since many strains of are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information).
Lower respiratory tract infections of mild to moderate severity caused by or .
Listeriosis caused by .
Pertussis (whooping cough) caused by . Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.
Respiratory tract infections due to .
Skin and skin structure infections of mild to moderate severity caused by or (resistant staphylococci may emerge during treatment).
Diphtheria: Infections due to , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.
Erythrasma: In the treatment of infections due to .
Syphilis caused by : Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.
Intestinal amebiasis caused by (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.
Acute pelvic inflammatory disease caused by : Erythromycin lactobionate for injection, USP followed by erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.
Erythromycins are indicated for the treatment of the following infections caused by : conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to .
When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by .
Legionnaires’ Disease caused by . Although no controlled clinical efficacy studies have been conducted, and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease.
Eryc (Erythromycin) Contraindications
Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.
Erythromycin is contraindicated in patients taking terfenadine or astemizole. (See ).
Eryc (Erythromycin) Warnings
There have been reports of prolonged QT syndrome in geriatric patients receiving oral erythromycin products.
There have been reports of hepatic dysfunction, with or without jaundice, occurring in patients receiving oral erythromycin products.
There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen.
Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Eryc (Erythromycin) Precautions
Prescribing Eryc (Erythromycin) 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 of drug-resistant bacteria. Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function. (See and )
There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.
Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.
When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.
Patients should be counseled that antibacterial drugs including Eryc (Erythromycin) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Eryc (Erythromycin) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Eryc (Erythromycin) or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QTc interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed. (See ). In addition, deaths have been reported rarely with concomitant administration of terfenadine and erythromycin.
There have been postmarketing reports of drug interactions when erythromycin is coadministered with cisapride, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to the inhibition of hepatic metabolism of cisapride by erythromycin.
There has been an isolated report of drug interaction occurring with the concomitant administration of erythromycin and quinidine in their usual oral forms, resulting in QT prolongation, torsades de pointes and cardiac arrest. Caution and close monitoring is recommended when the drugs are administered concomitantly.
Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase of serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.
Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels.
There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to this drug may be more pronounced in the elderly.
Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysethesia.
Erythromycin has been reported to decrease the clearance of triazolam and midazolam and, thus, may increase the pharmacologic effect of these benzodiazepines.
The use of erythromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of erythromycin with carbamazepine, cyclosporine, hexobarbital, phenytoin, alfentanil, disopyramide, lovastatin, bromocriptine, valproate, terfenadine and astemizole. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving erythromycin.
Clinical studies with Eryc (Erythromycin) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of the decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
See with regard to prolongation of QT syndrome in geriatric patients with erythromycin products.
Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin. (See, .)
Eryc (Erythromycin) 250 mg capsules do not contain sodium.
Eryc (Erythromycin)
Eryc (Erythromycin)
Eryc (Erythromycin)
Eryc (Erythromycin)
Eryc (Erythromycin)
Eryc (Erythromycin)
