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Trade Names:
Akne-mycin
- Ointment 2%

Trade Names:
E.E.S. 200
- Suspension 200 mg per 5 mL as ethylsuccinate

Trade Names:
E.E.S. 400
- Tablets 400 mg as ethylsuccinate
- Suspension 400 mg per 5 mL as ethylsuccinate

Trade Names:
E.E.S. Granules
- Powder for oral suspension 200 mg per 5 mL when reconstituted as ethylsuccinate

Trade Names:
Emgel
- Gel 2%

Trade Names:
Ery-Tab
- Tablets, enteric-coated 250 mg
- Tablets, enteric-coated 333 mg
- Tablets, enteric-coated 500 mg

Trade Names:
Eryc
- Capsules, delayed release 250 mg

Trade Names:
Erycette
- Pads 2%

Trade Names:
Eryderm
- Solution 2%

Trade Names:
Erygel
- Gel 2%

Trade Names:
Ery-Ped 200
- Suspension 200 mg per 5 mL as ethylsuccinate

Trade Names:
Ery-Ped 400
- Suspension 400 mg per 5 mL as ethylsuccinate

Trade Names:
Ery-Ped Drops
- Suspension 100 mg per 2.5 mL as ethylsuccinate

Trade Names:
Erythromycin Estolate
- Suspension, oral 125 mg per 5 mL
- Suspension, oral 250 mg per 5 mL

Trade Names:
Erythrocin Lactobionate
- Powder for injection, lyophilized 1 g

Trade Names:
Erythrocin Stearate
- Tablets, film-coated 250 mg
- Tablets, film-coated 500 mg as stearate

Trade Names:
PCE Dispertab
- Tablets with polymer-coated particles 333 mg
- Tablets with polymer-coated particles 500 mg

Trade Names:
Romycin
- Ointment, Ophthalmic 5 mg/g

Mechanism of Action

Pharmacology

Interferes with microbial protein synthesis.

Pharmacokinetics

Absorption

Orally administered erythromycin base and its salts are readily absorbed. Because of interindividual variation in absorption, some patients do not achieve optimal serum concentrations.

Distribution

Erythromycin diffuses into most body fluids. In the absence of meningeal inflammation, low concentrations are achieved in the spinal fluid; however, passage across the blood-brain barrier increases in meningitis. Although erythromycin crosses the placenta, fetal plasma levels are low. Erythromycin is extensively bound to plasma protein.

Elimination

Erythromycin is not removed by peritoneal dialysis. Erythromycin is concentrated in the liver and excreted in the bile. Less than 5% is recovered in the active form in the urine.

Indications and Usage

Treatment of infections of respiratory tract, skin and skin structure, and STDs caused by susceptible organisms; treatment of pertussis, diphtheria, erythrasma, intestinal amebiasis, conjunctivitis of newborn, Legionnaire disease, listeriosis, nongonococcal urethritis, pneumonia of infancy, urogenital infections during pregnancy; treatment of acute pelvic inflammatory disease, syphilis, uncomplicated urethral, endocervical, or rectal infections in adults; prevention of attacks of rheumatic fever; prevention of bacterial endocarditis.

Treatment of superficial ocular infections caused by strains of susceptible organism; prophylaxis of neonatal conjunctivitis.

Treatment of acne vulgaris.

Unlabeled Uses

Treatment of bacillary angiomatosis; campylobacter enteritis; chancroid; granuloma inguinale; ecthyma impetigo; inclusion conjunctivitis in adults; extremity wound infection; leptospirosis; early Lyme disease; lymphogranuloma venereum; tick-borne and louse-bourn relapsing fever; tetanus; cellulitis.

Contraindications

Hypersensitivity to erythromycin or any macrolide antibiotic; coadministration of cisapride or pimozide; preexisting liver disease (with estolate salt); epithelial herpes simplex keratitis; fungal disease of eye; vaccinia or varicella (ophthalmic use).

Dosage and Administration

Duration of treatment will vary depending on site of systemic infection (eg, treat pneumonia of infancy for at least 3 wk). For adult dosage calculation of erythromycin ethylsuccinate, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate salt to 250 mg of erythromycin activity as the base, stearate, or estolate. Depending on the severity of the infection, the dosage may be increased up to 4 g/day; however, twice daily dosing is not recommended for doses larger than 1 g daily. For treatment of severe infections in adults and children, the recommended IV dose of erythromycin lactobionate is 15 to 20 mg/kg/day (max, 4 g/day).

PO 250 to 500 mg every 6 h, 500 mg every 12 h, or 333 mg every 8 h. IV 15 to 20 mg/kg/day; up to 4 g/day in very severe infections.

PO 30 to 50 mg/kg/day in divided doses (max, 4 g/day).

PO 250 mg every 6 h, 333 mg every 8 h, or 500 mg every 12 h for at least 10 days.

PO 30 to 50 mg/kg/day in equally divided doses for at least 10 days (max, 4 g/day).

Topical Apply daily to 4 times daily to affected area.

PO 30 to 64 g in divided doses over a period of 10 to 15 days.

PO 40 to 50 mg/kg/day in divided doses for 5 to 14 days.

PO 500 mg every 12 h, 400 mg every 6 h, 333 mg every 8 h, or 250 mg every 6 h for 10 to 14 days.

PO 30 to 50 mg/kg/day in equally divided doses for 10 to 14 days (max, 4 g/day).

PO 50 mg/kg/day in 4 divided doses for at least 14 days.

PO Optimal dose not established; 1 to 4 g in divided doses.

PO 500 mg 4 times daily or 666 mg (two 333 mg tablets) every 8 h for at least 7 days.

PO 50 mg/kg/day in 4 divided doses for at least 21 days.

PO 500 mg 4 times daily or 666 mg (two 333 mg tablets) every 8 h for at least 7 days.

400 mg every 6 h for 10 days.

250 mg twice daily given continuously.

IV 500 mg every 6 h for 3 days, followed PO by 250 mg every 6 h, 333 mg every 8 h, or 500 mg every 12 h for 7 days.

PO 500 mg 4 times daily or two 333 mg tablets every 8 h for at least 7 days.

PO 1 g 1 h before procedure followed by 500 mg 6 h later.

PO 20 mg/kg 1 h before procedure followed by 10 mg/kg 6 h later.

Ophthalmic 0.5-inch ribbon of ointment placed in eye every 3 to 4 h.

Ophthalmic 0.5-inch ribbon of ointment placed in eye 2 to 3 times daily.

Ophthalmic 0.2- to 0.4-inch ribbon of ointment placed in each conjunctival sac at time of delivery.

Topical Apply twice daily, morning and evening.

800 mg every 8 h for 7 days.

General Advice

• Oral
• Administer erythromycin base or stearate on an empty stomach.
• Administer erythromycin ethylsuccinate, estolate, or enteric-coated erythromycin without regard to meals. Administer with food if GI upset occurs.
• Advise patient receiving tablets or capsules of erythromycin base to swallow whole and not to crush, chew, open, or break.
• Administer tablets and capsules with a full glass of water.
• Shake suspension well before measuring dose. Measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or medicine cup.
• Shake oral drops well before measuring dose. Measure and administer prescribed dose of oral drops using dosing syringe or dosing spoon.

• Injection
• For administration by continuous or intermittent IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
• Reconstitute powder for injection with 10 mL sterile water for injection for 500 mg vial or 20 mL sterile water for injection for 1 g vial. Shake vial until powder has dissolved. Reconstituted solution contains 50 mg erythromycin activity/mL.
• Do not reconstitute with any other diluent than sterile water for injection as other diluents may cause precipitation. Do not reconstitute with any diluent containing preservatives or inorganic salts.
• Further dilute reconstituted solution with sodium chloride 0.9% injection, lactated Ringer's injection, or Normosol-R to give a final concentration of 1 mg erythromycin activity/mL for continuous IV infusion, or 1 to 5 mg erythromycin activity/mL for intermittent infusion.
• Reconstituted solution also may be further diluted with dextrose 5% injection, dextrose 5% and lactated Ringer's solution, or dextrose 5% and sodium chloride 0.9% if they are first buffered with sodium bicarbonate 4% or Neut (1 mL sodium bicarbonate 4% or Neut per 100 mL of solution).
• For intermittent infusion, infuse prescribed dose over a period of 20 to 60 min at intervals of less than or equal to 6 h.
• Inspect solution visually before administration. Do not administer if solution is cloudy, discolored, or contains particulate matter.

• Topical
• For topical use only. Keep away from mouth, nose, eyes, and other mucus membranes.
• Apply sparingly to affected areas morning and evening using gloved finger or applicator. Wash hands before and after applying medication.
• Before applying, thoroughly wash affected areas with warm water and soap, rinse, and pat dry.
• Do not use any other topical acne medication unless ordered by health care provider.

• Ophthalmic ointment
• For topical instillation in the eye only. Not for use in the ear or on the skin.
• Wash hands before and after instilling ointment. Have patient tilt head backward or lie down and gaze upward. Gently pull down lower lid to form a pouch. Place prescribed amount of ointment with a sweeping motion inside the lower eyelid. Have patient close eye(s) for 1 to 2 min and roll the eyeball in all directions. Remove excessive ointment from around eye with tissue.
• If using more than 1 ophthalmic ointment, wait at least 10 min before instilling second drug.

Storage/Stability

Store erythromycin base and stearate at controlled room temperature (59° to 86°F). Store erythromycin estolate oral suspension in refrigerator (36° to 46°F) to maintain optimal taste. Store erythromycin ethylsuccinate tablets and powder for oral suspension below 86°F. Store reconstituted erythromycin ethylsuccinate oral suspension in refrigerator to preserve taste and use within 10 days. Store reconstituted erythromycin ethylsuccinate oral drops at or below 77°F and use within 35 days. Store premixed erythromycin ethylsuccinate oral suspension in refrigerator to preserve taste until dispensed. Refrigeration is not required if used within 14 days of initial use.

Store powder for injection at controlled room temperature (59° to 86°F). Reconstituted solution is stable for 2 wk if refrigerated (36° to 46°F) or for 24 h at room temperature. Final diluted solution must be completely administered within 8 h of dilution in order to ensure proper potency.

Store Erygel and Emgel between 59° and 77°F. Store Akne-Mycin ointment below 80°F. Store Ery Pads between 59° and 86°F. Store Eryderm solution below 86°F.

Drug Interactions

May increase anticoagulant effects.

May increase serum bromocriptine levels.

Plasma levels may be elevated, increasing the risk of life-threatening cardiac arrhythmia and torsades de pointes; coadministration with erythromycin is contraindicated.

Plasma levels may be elevated by erythromycin, increasing the pharmacologic effects and risk of toxicity (eg, rhabdomyolysis with lovastatin or simvastatin).

Antagonism may occur with topical erythromycin; coadministration is not recommended.

May cause increased digoxin levels.

Ergot toxicity may occur.

May inhibit erythromycin metabolism, increasing plasma levels and adverse effects.

May decrease Cl of methylprednisolone.

Risk of life-threatening cardiac arrhythmias, including torsades de pointes, may be increased.

Rifabutin plasma levels may be increased while erythromycin levels and antibiotic activity may be decreased.

Laboratory Test Interactions

Erythromycin interferes with fluorometric urinary catecholamine determinations.

Adverse Reactions

Cardiovascular

QT prolongation and ventricular arrhythmia (including torsades de pointes).

CNS

Convulsions.

Dermatologic

Mild eruptions; erythema multiforme; Stevens-Johnson syndrome; toxic epidermal necrolysis; erythema and peeling (topical use).

EENT

Reversible hearing loss primarily in patients with renal insufficiency.

GI

Abdominal pain; anorexia; diarrhea; nausea; pancreatitis; pseudomembranous colitis; vomiting.

Hepatic

Hepatitis; hepatic dysfunction.

Lab Tests

Abnormal LFTs.

Miscellaneous

Allergic reactions ranging from urticaria to anaphylaxis.

Precautions

Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Hypersensitivity

Serious reactions, including anaphylaxis, have occurred.

Hepatic Function

Use drug cautiously. Hepatic function impairment, with or without jaundice, has occurred. Cholestatic hepatitis has occurred. Monitor patient for signs and symptoms of liver dysfunction (eg, flu-like symptoms, persistent nausea, fatigue, right upper quadrant abdominal pain, yellowing of skin or eyes, dark urine). Discontinue therapy immediately if noted or suspected and inform health care provider.

Superinfection

Prolonged use of antibiotics may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Acne therapy

Cumulative irritant effect may occur.

Infantile hypertrophic pyloric stenosis

Has been reported.

Myasthenia gravis

Aggravation of myasthenia gravis has been reported.

Ophthalmic ointments

May slow corneal epithelial healing.

Ototoxicity

May occur, especially in patients with renal or hepatic insufficiency, elderly patients, and those administered large doses.

Pseudomembranous colitis

Consider possibility in patients in whom diarrhea develops. Immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.

Rhabdomyolysis

Ensure patient receiving concomitant lovastatin and erythromycin is carefully monitored for development of rhabdomyolysis. Notify health care provider immediately if noted or suspected.

Overdosage

Symptoms

Severe nausea, vomiting, diarrhea, epigastric distress, hearing loss, vertigo.

Patient Information

• Review dosing schedule and prescribed length of therapy with patient. Advise patient that dose, dosing frequency, and duration of therapy are dependent on site and cause of infection and response to treatment.
• Advise patient or caregiver that injection is used when infection is severe and needs immediate treatment with large doses of antibiotic, or if oral therapy is not feasible. Advise patient or caregiver that injection will be prepared by a health care professional, administered in a health care setting, and oral therapy will be started as soon as possible.
• Instruct patient using tablets and capsules to take prescribed dose with a full glass of water and to swallow whole and not to crush, chew, break, or open.
• Instruct patient or caregiver using oral suspension to shake suspension well and then measure and administer prescribed dose using dosing spoon, dosing syringe, or medicine cup.
• Instruct patient or caregiver using oral drops to shake drops well and then measure and administer prescribed dose using dosing spoon or dosing syringe.
• Advise patient using erythromycin base or stearate to take each dose on an empty stomach.
• Advise patient using erythromycin ethylsuccinate, estolate, or enteric-coated erythromycin to take each dose without regard to meals but to take with food if stomach upset occurs.
• Reinforce the need to take exactly as prescribed and complete the entire course of therapy, even if symptoms of infection have disappeared. Caution patient or caregiver that skipping doses or not completing the full course of therapy may allow the infection to worsen and increase the possibility that the bacteria will become resistant to the antibiotic and may cause infections that will not be treatable in the future.
• Advise patient to discontinue therapy and contact health care provider immediately if any of the following occur: skin rash; hives; itching; shortness of breath; persistent or worsening flu-like symptoms; persistent nausea; fatigue; right upper belly pain; yellowing of skin or eyes; dark urine.
• Advise patient to report signs of superinfection to health care provider: black furry tongue, white patches in mouth, foul-smelling stools, vaginal itching or discharge.
• Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not treat at home even if diarrhea occurs after stopping the antibiotic.

• Topical
• Caution patient that medication is for topical use only and to keep medication away from the mouth, nose, eyes, and other mucus membranes.
• Advise patient to apply sparingly to affected areas morning and evening using fingers or applicator. Remind patient to wash hands before and after applying medication.
• Instruct patient to thoroughly wash affected areas with warm water and soap, then rinse and pat dry before applying medication.
• Caution patient not to use any other topical acne medication unless ordered by health care provider.
• Advise patient to notify health care provider if acne does not improve, worsens, or if application-site reactions occur.

• Ophthalmic Ointment
• Remind patient that ointment is only for instillation in the eye and is not to be used in the ear or on the skin.
• Instruct patient in proper use of ointment: wash hands before and after instilling ointment; tilt head backward or lie down and gaze upward; gently pull down lower lid to form a pouch and place prescribed amount of ointment with a sweeping motion inside the lower eyelid; close eye(s) for 1 to 2 min and roll the eyeball in all directions; remove excessive ointment around eye with tissue.
• Caution patient to avoid contaminating ointment by not touching the tip of tube to any surface and to replace cap after using.
• Advise patient that ointment may cause temporary blurring of vision and to avoid activities requiring visual acuity until blurring clears.
• Advise patient using more than 1 ophthalmic ointment product to wait at least 10 min before instilling second drug.
• Advise patient to notify health care provider if eye infection does not improve, worsens, or if eye or eyelid irritation occurs.