Erymax 250mg Gastro-resistant Hard Capsules

Each capsule contains 250mg of erythromycin.

For full list of excipients, see section 6.1.

Gastro-resistant capsule, hard.

Hard gelatin capsule with opaque orange cap and clear orange body, imprinted with “Erymax 250mg”, and containing white and orange enteric coated pellets of erythromycin base.

Erythromycin is an antibiotic effective in the treatment of bacterial disease caused by susceptible organisms.

Examples of its use are in the treatment of upper and lower respiratory tract infections of mild to moderate severity; skin and soft tissue infections including pustular acne.

Erythromycin is usually active against the following organisms in vitro and in clinical infection: Streptococcus pyogenes; Alpha haemolytic streptococci; Staphylococcus aureus; Streptococcus pneumoniae; Haemophilus influenzae; Mycoplasma pneumoniae; Treponema pallidum; Corynebacterium diphtheriae; Corynebacterium minutissimum; Entamoeba histolytica; Listeria monocytogenes; Neisseria gonorrhoeae; Bordetella pertussis; Legionella pneumophila; Chlamydia trachomatis; Propionibacterium acnes.

Oral use.

Adults and elderly

250 mg every six hours - before or with meals. 500 mg every twelve hours may be given if desired; b.i.d. dosage should not be used if dosage exceeds one gram.

Children

The usual dose is 30-50 mg/kg/day erythromycin, in divided doses given twice daily or every six hours. In severe infections, this dose may be doubled; elevated doses should be given every six hours. The drug should be given before or with meals.

Note: Erymax Capsules may be given to children of any age who can swallow the capsules whole.

The capsules should be swallowed whole either before or with food; they should not be chewed.

Streptococcal Infections:

For active infection - a full therapeutic dose is given for at least ten days.

For continuous prophylaxis against recurrences of streptococcal infections in patients with evidence of rheumatic fever or heart disease, the dose is 250 mg b.i.d.

For the prevention of bacterial endocarditis in patients with valvular disease scheduled for dental or surgical procedures of the upper respiratory tract, the adult dose is 1 gram (children 20 mg/kg) 2 hours before surgery. Following surgery, the dose is 500 mg for adults (children 10mg/kg) orally every six hours for 8 doses.

Primary Syphilis: 30-40 grams given in divided doses over a period of 10-15 days.

Intestinal Amoebiasis: 250 mg four times daily for 10 to 14 days for adults: 30 to 50 mg/kg/day in divided doses for 10 to 14 days for children.

Legionnaires' Disease: 1-4 g daily until clinical signs and symptoms indicate a clinical cure. Treatment may be prolonged.

Pertussis: 30-50 mg/kg/day given in divided doses for 5 - 14 days, depending upon eradication of a positive culture.

Acne: initially, 250 mg twice daily, which may be reduced to a maintenance dose of 250 mg once daily after one month according to response.

Use in patients hypersensitive to erythromycin or to any of the excipients, and in patients taking astemizole, terfenadine, cisapride, pimozide, ergotamine, dihydroergotamine, simvastatin, tolterodine, mizolastine, amisulpride or sertindole.

Rhabdomyolysis has been reported with concomitant use of erythromycin and HMG-CoA reductase inhibitors (see sections 4.3 and 4.5).

Patients receiving erythromycin concurrently with drugs which can cause prolongation of the QT interval should be carefully monitored; the concomitant use of erythromycin with some of these drugs is contraindicated (see sections 4.3 and 4.5).

In patients with impaired hepatic function or in those taking concomitant potentially hepatotoxic agents, liver function should be monitored, since a few reports of hepatic dysfunction have been received in patients taking erythromycin as the estolate, base or stearate. Extended administration requires regular evaluation particularly of liver function. Therapy should be discontinued if significant hepatic dysfunction occurs.

Prolonged use of erythromycin has caused overgrowth of nonsusceptible bacteria or fungi; this is a rare occurrence.

It has been reported that erythromycin may aggravate the weakness of patients with myasthenia gravis.

There have been reports suggesting erythromycin does not reach the foetus in adequate concentrations 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.

Erythromycin may interfere with the determination of urinary catecholamines and 17-hydroxycorticosteroids levels.

Owing to the presence of lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.

Cytochrome P450 interactions:

Concomitant use of erythromycin with certain drugs metabolised by the cytochrome P450 system is likely to result in an increased frequency or seriousness of adverse effects associated with these drugs. The concomitant use of erythromycin with mizolastine, amisulpride, astemizole, cisapride, pimozide, sertindole and terfenadine is contraindicated due to the risk of QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de pointes. The concomitant use of erythromycin with ergotamine and dihydroergotamine is contraindicated due to the risk of ergot toxicity. Concomitant use with simvastatin is contraindicated due to the risk of myopathy and rhabdomyolysis whilst concomitant use with tolterodine is contraindicated due to increased risk of overdose.

Other drugs metabolised by the cytochrome P450 system, such as acenocoumarol, atorvastatin, bromocriptine, buspirone, cabergoline, carbamazepine, ciclosporin, cilostazol, clozapine, digoxin, disopyramide, eletriptan, felodipine, hexobarbital, midazolam, phenytoin, quetiapine, quinidine, rifabutin, sildenafil, tacrolimus, tadalafil, theophylline, triazolam, valproate, warfarin and zopiclone, may be associated with elevated serum levels if administered concomitantly with erythromycin. Because of the risk of toxicity, appropriate monitoring should be undertaken, and dosage should be adjusted as necessary.

Other interactions:

Patients receiving concomitant lovastatin and erythromycin should be carefully monitored as cases of rhabdomyolysis have been reported in seriously ill patients. Rhabdomyolysis has also been reported with concomitant simvastatin and erythromycin, and caution is therefore recommended when erythromycin is used concurrently with other HMG-CoA reductase inhibitors. It is recommended that therapy with simvastatin is suspended during the course of treatment.

When oral erythromycin is given concurrently with theophylline, there is also a significant decrease in erythromycin serum concentrations, which could result in subtherapeutic concentrations of erythromycin.

Erythromycin should be used with caution if administered concomitantly with lincomycin, clindamycin or chloramphenicol, as competitive inhibition may occur.

The concomitant use of erythromycin with alfentanil can significantly inhibit the clearance of alfentanil and may increase the risk of prolonged or delayed respiratory depression.

An increased plasma concentration of erythromycin has been reported with concomitant cimetidine treatment, leading to increased risk of toxicity, including reversible deafness.

Like all drugs erythromycin should be used in pregnancy only when clearly indicated. Erythromycin crosses the placental barrier.

Nursing mothers: erythromycin is excreted in human milk and should be used in lactating women only if clearly needed.

None known.

Serious allergic reaction, including anaphylaxis, has been reported.

There have been rare reports of skin rashes, including pruritus, urticaria, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Nausea and abdominal discomfort can occur at elevated doses; diarrhoea and vomiting are less common.

Hepatotoxicity: There have been reports of hepatic dysfunction, with or without jaundice, occurring in patients receiving erythromycin products and due to combined cholestatic and hepatocellular injury although less commonly than with erythromycin estolate. Abnormal liver function tests may occur.

Pancreatitis has been reported rarely.

Superinfections including pseudomembranous colitis have been occasionally reported to occur in association with erythromycin therapy.

Transient hearing disturbances and deafness have been reported with doses of erythromycin usually greater than 4g daily, and usually given intravenously.

There have been isolated reports of transient central nervous system side effects including confusion, hallucinations, seizures, and vertigo; however, a cause and effect relationship has not been established.

Cardiac arrhythmias have been reported rarely in patients receiving erythromycin.

Nausea, vomiting, diarrhoea and hearing loss have been reported.

Treatment

Gastric lavage and general supportive therapy. Erythromycin is not removed by peritoneal dialysis or haemodialysis.

Pharmacotherapeutic group: Antibacterial for systemic use. ATC code: J01FA01.

Erythromycin base and its salts are readily absorbed in the microbiologically active form. Erythromycin is largely bound to plasma proteins and after absorption erythromycin diffuses readily into most body fluids.

Erythromycin acts by inhibition of protein synthesis by binding 50s ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis.

After administration of a single dose of Erymax 250 mg, peak serum levels are attained in approximately 3 hours.

In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in the bile. After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine.

Pre-clinical safety data does not add anything of further significance to the prescriber.

Cellulose acetate phthalate, lactose, potassium phosphate monobasic, povidone, diethyl phthalate, purified water, sunset yellow, titanium dioxide, gelatin, erythrosine, quinoline yellow.

The printing ink contains:

Black iron oxide (E172), shellac, potassium hydroxide and propylene glycol.

None known.

18 months.

Do not store above 25°C. Store in the original package. Protect from moisture and light.

PVdC/ PVC/ Aluminium Blister packs containing 4, 8, 28, 30, 100, 112 capsules.

No special requirements.

Cephalon UK Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

PL 16260/0024

22 March 2010

19 April 2010

POM