Erythromycin

ERYTHROMYCIN

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

[Up to 1000mg] [250ml] [2 hours]

Stability / Miscellaneous

Adults:
Usual oral dose: 500mg to 1g po q12h or 250mg to 1g po q6h.
Usual IV dose: 250mg to 1g q6h. Max 4 g/day.
Renal dosing: >10/ No change || <10/ 50-75% of usual dose. Max 2g/day. || Hemo: no supplement.

DOSAGE AND ADMINISTRATION
For the treatment of severe infections in adults and children, the recommended intravenous dose of erythromycin lactobionate is 15 to 20 mg/kg/day. Higher doses, up to 4 g/day, may be given for severe infections. Erythrocin Lactobionate-I.V. (sterile erythromycin lactobionate) in the ADD-Vantage system should be administered by intermittent intravenous infusion. Due to the irritative properties of erythromycin, I.V. push is an unacceptable route of administration.

Continuous infusion of erythromycin lactobionate has been preferred due to the slower infusion rate and lower concentration of erythromycin; however, intermittent infusion at six hour intervals is effective. Intravenous erythromycin should be replaced by oral erythromycin as soon as possible.

The drug should be administered as a single dose from the ADD-Vantage flexible diluent container. Discard any unused portion.

For intermittent infusion: administer one-fourth the total daily dose of erythromycin lactobionate by intravenous infusion in 20 to 60 minutes at intervals not greater than every six hours. The final diluted solution of erythromycin lactobionate is prepared to give a concentration of 1 to 5 mg/mL. No less than 100 mL of I.V. diluent should be used. Infusion should be sufficiently slow to minimize pain along the vein.

For treatment of acute pelvic inflammatory disease caused by N. Gonorrhoeae. In female patients hypersensitive to penicillins, administer 500 mg erythromycin lactobionate every six hours for three days, followed by oral administration of 250 mg erythromycin stearate or base every six hours for seven days.

For treatment of Legionnaires' Disease: Although optimal doses have not been established, doses utilized in reported clinical data were 1 to 4 grams daily in divided doses.

In the treatment of Group A beta-hemolytic streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for ten days. The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.3

In prophylaxis against bacterial endocarditis the oral regimen for penicillin allergic patients is erythromycin 1 gram, 1 hour before the procedure followed by 500 mg six hours later.

Preparation of Solution:
ADD-Vantage:
The Erythrocin Lactobionate-I.V. ADD-Vantage vial may be used with either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP in the ADD-Vantage flexible diluent container. The 500 mg and 1 g ADD-Vantage vials must be used as single doses with the 100 mL and 250 mL ADD-Vantage flexible diluent containers, respectively. The resulting solutions will contain erythromycin activity equal to approximately 5 mg/mL and 4 mg/mL, respectively.

Standard vials:
Preparation of Solution:

1. PREPARE THE INITIAL SOLUTION OF ERYTHROCIN® LACTOBIONATE-I.V. BY ADDING 10 ML OF STERILE WATER FOR INJECTION, USP, TO THE 500 MG VIAL OR 20 ML OF STERILE WATER FOR INJECTION, USP, TO THE 1 G VIAL. Use only Sterile Water for Injection, USP, as other diluents may cause precipitation during reconstitution. Do not use diluents containing preservatives or inorganic salts. After reconstitution, each mL contains 50 mg of erythromycin activity. The initial solution is stable at refrigerator temperature for two weeks, or for 24 hours at room temperature.

2. ADD THE INITIAL DILUTION TO ONE OF THE FOLLOWING DILUENTS BEFORE ADMINISTRATION to give a concentration of 1 g of erythromycin activity per liter (1 mg/mL) for continuous infusion or 1 to 5 mg/mL for intermittent infusion: 0.9% SODIUM CHLORIDE INJECTION, USP; LACTATED RINGER’S INJECTION, USP; NORMOSOL®-R.

3.THE FOLLOWING SOLUTIONS MAY ALSO BE USED PROVIDING THEY ARE FIRST BUFFERED WITH NEUT ® (4% SODIUM BICARBONATE, HOSPIRA) by adding 1 mL of Neut® per 100 mL of solution:

5% DEXTROSE INJECTION, USP
5% DEXTROSE AND LACTATED RINGER’S INJECTION
5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJECTION, USP

Neut® (4% sodium bicarbonate, Hospira) must be added to these solutions so that their pH is in the optimum range for erythromycin lactobionate stability. Acidic solutions of erythromycin lactobionate are unstable and lose their potency rapidly. A pH of at least 5.5 is desirable for the final diluted solution of erythromycin lactobionate.

No drug or chemical agent should be added to an erythromycin lactobionate-I.V. fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined.

Do not administer unless solution is clear and container is undamaged. Discard any unused portion.

Stability (package insert):
In 0.9% Sodium Chloride Injection, USP
The final diluted solution of erythromycin lactobionate should be completely administered within 8 hours in order to assure proper potency. [Note: Some studies support stability at room temperature or under refrigeration for up to 24 hours]

In 5% Dextrose Injection, USP
The final diluted solution of erythromycin lactobionate should be completely administered within 2 hours in order to assure proper potency.

No drug or chemical agent should be added to an Erythrocin Lactobionate-I.V. fluid admixture unless its effect on the chemical and physical stability of the solution has first been determined.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

WARNING: Do not use flexible container in series connections.

HOW SUPPLIED
Erythrocin Lactobionate-I.V. (sterile erythromycin lactobionate) is supplied as a sterile, lyophilized powder as follows:

Single-dose ADD-Vantage Vial - 500 mg - Package of 10
Single-dose ADD-Vantage Vial - 1 g - Package of 10

Erythrocin Lactobionate-I.V. (Sterile Erythromycin Lactobionate, USP) is supplied as a sterile, lyophilized powder in packages of ten vials (NDC 0409-6482-01), each vial containing the equivalent of 500 mg of erythromycin.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

©Hospira 2004
EN-0528
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Source: [package insert]