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erythromycin base (Ery-Tab, PCE Dispertab)

 

Classes: Macrolides

Dosing and uses of Ery-Tab, PCE Dispertab (erythromycin base)

 

Adult dosage forms and strengths

tablet

  • 250mg
  • 500mg

tablet, delayed-release particles

  • 250mg
  • 333mg
  • 500mg

PCE DispertaB

  • 333mg
  • 500mg

capsule, delayed release particles

  • 250mg

 

Dose Range

Usual dosage range: 250-500 mg PO q6-12hr or 500 mg q12hr or 333 mg PO q8hr

Severe infections: Up to 4 g/day

Take on empty stomach if possible; PCE Dispertab may be taken with food; base has poorest absorption

 

Legionnaires Disease

1-4 g/day PO in divided doses for 21 days

 

Nongonococcal Urethritis

500 mg PO q6hr for 7 days

 

Bowel Preparation

1 g PO at 1:00, 2:00, and 11:00 PM on day before surgery in combination with PO neomycin and mechanical cleansing of large intestine

 

Lymphogranuloma Venereum

500 mg PO q6hr for 21 days

 

Pertussis

500 mg PO q6hr for 14 days

 

Gastroparesis (Off-label)

250-500 mg PO three times daily before meals

 

Granuloma Inguinale (Off-label)

500 mg PO four times daily for 21 days

 

Chancroid (Off-label)

500 mg PO three times daily for 7 days

 

Pediatric dosage forms and strengths

tablet

  • 250mg
  • 500mg

tablet, delayed-release particles

  • 250mg
  • 333mg
  • 500mg

PCE DispertaB

  • 333mg
  • 500mg

 

Dose Range

Mild to moderate infection: 30-50 mg/kg/day PO divided q6-12hr; not to exceed 2 g/day

Severe infection: 15-50 mg/kg/day PO ; not to exceed 4 g/day

 

Chalmydial Infection

50 mg/kg/day PO divided q6hr for 14 days

 

Pertussis

40-50 mg/kg/day PO divided q6hr for 14 days; not to exceed 2 g/day

 

Streptococcal Pharyngitis, Tonsillitis

20 mg/kg/day PO divided q12hr

 

Bowel Preparation

20 mg/kg PO at 1:00, 2:00, and 11:00 PM on day before surgery in combination with PO neomycin and mechanical cleansing of large intestine

 

Dosing Considerations

Take on empty stomach if possible; PCE Dispertab may be taken with food; base has poorest absorption

 

Ery-Tab, PCE Dispertab (erythromycin base) adverse (side) effects

Frequency not defined

Abdominal pain

Anaphylaxis

Cholestatic hepatitis

Confusion

Diarrhea

Dyspepsia

Fever

Flatulence

Hallucinations

Hearing loss

Headache

Hypertrophic pyloric stenosis

Hypotension

Interstitial nephritis

Mild allergic reactions

Nausea

Nervous system effects, including seizures

Pain

Pruritus

Pseudomembranous colitis

QT prolongation

Rash

Skin eruptions

Tinnitus

Torsades de pointes

Urticaria

Ventricular arrhythmias

Ventricular tachycardia

Vertigo

Vomiting

 

Warnings

Contraindications

Documented hypersensitivity

Coadministration with astemizole, cisapride, lovastatin, simvastatin, or pimozide

Coadministration with ergotamine or dihydroergotamine (postmarketing reports of acute ergot toxicity characterized by vasospasm and ischemia of extremities and other tissues, including central nervous system [CNS])

 

Cautions

Risk of sudden death from cardiac causes when PO erythromycin used concomitantly with drugs that inhibit CYP3A4

Erythromycin is considered moderate inhibitor of CYP3A4; may increase toxicity of CYP3A4 substrates

Colchicine is substrate for both CYP3A4 and efflux transporter P-glycoprotein (P-gp); significant increase in colchicine plasma concentration is anticipated when drug is coadministered with moderate CYP3A4 inhibitors; reduce starting dose of colchicine, and lower maximum colchicine dose

Caution in liver disease; estolate formulation may cause cholestatic jaundice; gastrointestinal (GI) side effects are common; discontinue if nausea, vomiting, malaise, abdominal colic, or fever occurs

Caution in ventricular arrhythmias

Associated with QT prolongation and infrequent cases of arrhythmia

May increase liver function test values in pregnant women

GI effects: Abdominal pain and cramping; diarrhea; nausea and vomiting

Caution in hepatic impairment, history of hepatitis caused by macrolidide, cholestatic hepatitis

Overgrowth of nonsusceptible bacteria or fungi reported with prolonged use

 

Pregnancy and lactation

Pregnancy category: B

Lactation: Drug enters breast milk; use with caution (American Academy of Pediatrics committee states that drug is compatible with nursing)

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Ery-Tab, PCE Dispertab (erythromycin base)

Mechanism of action

Inhibits bacterial growth, possibly by blocking dissociation of peptidyl tRNA from ribosomes, causing RNA-dependent protein synthesis to arrest

 

Absorption

PO absorption is variable but better with salt forms than with base form

Peak plasma time: Base, 4 hr; ethylsuccinate, 0.5-2.5 hr; delayed with food because of differences in absorption

 

Distribution

Distribution: Crosses placenta; enters breast milk, relative diffusion from blood into CSF: minimal even with inflammation

Drug crosses placenta and enters breast milk; relative diffusion from blood into cerebrospinal fluid is minimal even with inflammation

Protein bound: 73-81%

 

Metabolism

Metabolized in liver by CYP3A4

Enzymes inhibited: CYP1A2, CYP3A4

 

Elimination

Half-life: 1.5-2 hr; 5-6hr (end stage renal disease)

Excretion: Feces (primarily), urine (2-15% as unchanged drug)