Retorin Suspension

Retorin Suspension

erythromycin

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Concise Prescribing Info
Contents
Erythromycin ethylsuccinate
Indications/Uses
Appropriate alternative to penicillin in hypersensitive patients especially in pre- or post-op patients. Acute & chronic bronchitis, Legionnaires' disease, tracheitis, bronchiectasis, pneumonia; acute skin & soft tissue infections; otitis media & externa, mastoiditis, chlamydial conjunctivitis, blepharitis; gingivitis, Vincent's angina; Staphylococcal enterocolitis, cholecystitis, Campylobacter infections; gonorrhoea, syphilis, urethritis, diphtheria, pertussis.
Dosage/Direction for Use
125 mg/5 mL Adult & childn >8 yr Mild to moderate infections 2 g daily in divided doses: 250-500 mg every 6 hr or 0.5-1 g every 12 hr. Severe infections Up to 4 g daily. Acne vulgaris 250 mg tds for 1-4 wk, reduced to bd until improvement. Childn 2-8 yr Mild to moderate infections 1 g daily in divided doses: 250 mg every 6 hr. Severe infections Up to 50 mg/kg daily in divided doses. Infant & baby up to 2 yr Mild to moderate infections 500 mg daily in divided doses: 125 mg every 6 hr. Severe infections Up to 50 mg/kg daily in divided doses. Severe renal impairment Not to exceed 1.5 g daily. May be doubled in severe infections. 200 mg/5 mL Adult Antibacterial 400 mg every 6 hr. Max: 4 g daily. Disseminated gonorrhoea 800 mg every 6 hr for 7 days. Legionnaires' disease 800-1,600 mg every 6 hr. Continuous prophylaxis of Strep infections in patient w/ history of rheumatic heart disease &/or chorea 400 mg every 12 hr. Syphilis 800 mg every 6 hr for 15 days in early syphilis or 30 days in late syphilis. Paed Antibacterial 7.5-12.5 mg/kg every 6 hr or 15-25 mg/kg every 12 hr.
Contraindications
Hypersensitivity. History of congenital or documented acquired QT prolongation, ventricular cardiac arrhythmia, Torsade de pointes. Patients w/ electrolyte disturbances (hypokalaemia, hypomagnesaemia) due to the risk of QT interval prolongation. Concomitant use w/ simvastatin, tolterodine, mizolastine, amisulpride, astemizole, terfenadine, domperidone, cisapride or pimozide; ergotamine, dihydroergotamine.
Special Precautions
Discontinue use if severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous ARs, SJS, TEN, DRESS & acute generalised exanthematous pustulosis occur. Pseudomembranous colitis; Clostridium difficile-associated diarrhoea; QT interval prolongation, cardiac repolarisation effects, risk of developing cardiac arrhythmia & Torsade de pointes; CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia. Infantile hypertrophic pyloric stenosis. May aggravate weakness in patients w/ myasthenia gravis. interference w/ fluorometric urinary catecholamines determination. Rhabdomyolysis w/ or w/o renal impairment in concomitant use w/ statins. Patients on controlled Na diet. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Concomitant use w/ potentially hepatotoxic agents; medicinal products associated w/ QT prolongation. Hepatic impairment. Pregnancy & lactation. May increase jaundice in newborn babies up to 4 wk due to Na benzoate. Elderly.
Adverse Reactions
Eosinophilia; allergic reactions; hallucinations; mitochondrial optic neuropathy; deafness, tinnitus; QTc interval prolongation, Torsade de pointes, palpitations, cardiac rhythm disorders, ventricular tachyarrhythmias; hypotension; upper abdominal discomfort, nausea, vomiting, diarrhoea, pancreatitis, anorexia, infantile hypertrophic pyloric stenosis; cholestatic hepatitis, jaundice, hepatic dysfunction & failure, hepatomegaly, hepatocellular hepatitis; skin eruptions, pruritus, urticaria, exanthema, angioedema, SJS, TEN, erythema multiforme; interstitial nephritis; chest pain, fever, malaise; increased liver enzyme values.
Drug Interactions
Increased serum conc of acenocoumarol, alfentanil, astemizole, bromocriptine, carbamazepine, cilostazol, cyclosporin, digoxin, dihydroergotamine, disopyramide, ergotamine, hexobarbitone, methylprednisolone, midazolam, omeprazole, phenytoin, quinidine, rifabutin, sildenafil, tacrolimus, terfenadine, theophylline, triazolam, valproate, vinblastine, antifungals eg, fluconazole, ketoconazole, itraconazole. Induced metabolism w/ CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort. Increased conc of HMG-CoA reductase inhibitors eg, lovastatin, simvastatin. Decreased effect of contraceptives. Altered metabolism of H1-antagonists eg, terfenadine, astemizole, mizolastine. Antagonism w/ penicillin, cephalosporin, clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines, colistin. Decomposition w/ PIs. Increased anticoagulant effects of warfarin, rivaroxaban. Decreased clearance of triazolam, midazolam & related benzodiazepines. Acute ergot toxicity w/ ergotamine or dihydroergotamine. Elevated cisapride, theophylline levels. Toxicity w/ colchicine. Hypotension, bradyarrhythmias & lactic acidosis w/ verapamil. Inhibited metabolism by cimetidine. Decreased clearance of zopiclone.
MIMS Class
Macrolides
ATC Classification
J01FA01 - erythromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Form
Retorin Suspension powd for oral susp 125 mg/5 mL
Packing/Price
100 mL x 1's
Form
Retorin Suspension powd for oral susp 200 mg/5 mL
Packing/Price
(vanilla flavour) 60 mL x 1's
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