Retorin Suspension

Retorin Suspension

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Full Prescribing Info
Contents
Erythromycin ethylsuccinate.
Description
Each 5 ml suspension contains Erythromycin Ethyl Succinate equivalent to 200 mg Erythromycin.
Excipients/Inactive Ingredients: Contains Ponceau 4R as colouring agent, and Vanilla as flavouring agent.
Action
Pharmacology: Phamacodynamics: Mode or Mechanisms of Action: Erythromycin is a bacteriostatic macrolide antibiotic. However, it may be bactericidal in high concentrations or when used against highly susceptible organisms. It is thought to penetrate the bacterial cell membrane and to reversibly bind to the 50 S subunit of bacterial ribosomes or near the P or donor site so that binding of tRNA (transfer RNA) to the donor site is blocked. Translocation of peptides from the A or acceptor site to the P is prevented and subsequent protein synthesis is inhibited. Erythromycin is effective only against actively dividing organisms.
Pharmacokinetics: Distribution: To most body fluids except cerebrospinal fluid.
Protein binding: High.
Metabolism: hepatic (free drug); partially, to inactive metabolites; may accumulate in patients with severe hepatic disease.
Erythromycin Ethyl Succinate is hydrolysed to free drug in the gastro-intestinal tract and in the blood.
Half-life: Normal renal function: 1.4 to 2 hours.
Impaired renal function: 4.8 to 6 hours.
Time to peak serum concentration: 1 to 4 hours.
Excretion: Hepatic, primarily by hepatic concentration and excretion in the bile.
Renal, by glomerular filtration; 2 to 5% excreted unchanged following oral administration; faeces, small amounts.
Breast milk may exceed maternal serum concentrations.
In dialysis: Dialysis does not remove significant amount of erythromycin from the blood.
Toxicology: Cross-sensitivity: Patients intolerant of one erythromycin or other macrolides may be intolerant of other erythromycins also.
Pregnancy/Reproduction: Erythromycins cross the placenta; however, fetal plasma concentrations are low. Although problems in humans have not been documented, risk-benefit must be considered.
Breast-feeding: Erythromycins are excreted in breast milk in concentration that may exceed maternal serum concentrations. Although problems in humans have not been documented, risk-benefit must be considered.
Indications/Uses
Genitourinary tract infections, Pneumonia, Diphtheria, Erythrasma, Gonorrhoea, Legionnaires disease, Listeria infections, Pertussis, Pharyngitis, Respiratory tract infections: upper and lower, Rheumatic fever (prophylaxis) skin and soft tissue infections, and Syphilis.
Dosage/Direction for Use
Usual adult dose: Antibacterial; the equivalent of erythromycin 400mg every six hours.
Note: Gonorrhoea (disseminated): the equivalent of erythromycin: 800 mg every six hours for seven days.
Legionnaires disease: The equivalent of erythromycin 800 mg to 1.6 grams every six hours.
Streptococcal prophylaxis continuous prophylaxis of streptococcal infections in patients with a history of rheumatic heart disease and / or chorea: Oral, the equivalent of erythromycin 400 mg every twelve hours.
Syphilis: the equivalent of erythromycin 800 mg every six hours for fifteen days (early syphilis) or thirty days (late syphilis).
Usual adult prescribing limits: Antibacterial, the equivalent of erythromycin: Up to 4 grams daily.
Note: Doses up to the equivalent of 8 grams of erythromycin daily are apparently well tolerated.
Usual paediatric dose: Antibacterial, the equivalent of erythromycin: 7.5 to 12.5 mg per kg of body weight every six hours; or 15 to 25 mg per kg of body weight every twelve hours.
Overdosage
Symptoms and treatment for overdosage, and antidote(s): In case of over-dosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures. Erythromycin is not removed by peritoneal dialysis or haemodialysis. Allergic reactions may be treated by administering epinephrine, adrenocorticoids and antihistamines.
Contraindications
Should not be used in patients with a known history of allergy to this drug.
Special Precautions
Erythromycin is principally excreted by the liver. Caution should be exercised in administering the antibiotic to patients with impaired hepatic function. There have been reports of hepatic dysfunction, with or without jaundice occurring in patients receiving oral erythromycin products. During prolonged or repeated therapy, there is a possibility of overgrowth or non-susceptible bacteria or fungi. If such infections occur, the drug should be discontinued and appropriated therapy instituted. Areas of localized infection may require surgical drainage in addition to antibiotic therapy.
Dental: Systemic erythromycin may cause oral candidiasis (sore mouth and tongue) in patients undergoing long-term therapy. Consider risk-benefit in patients with a history of cardiac arrhythmias or QT prolongation and in patients with loss of hearing.
Warning: Rare cases of serious cardiovascular adverse events including deaths, cardiac arrests, torsade de pointes and other ventricular arrhythmias have been observed, when used in patients taking concomitant terfenadine.
Use in pregnancy & lactation: The safety of erythromycin for use during pregnancy has not been established. Erythromycin crosses the placental barrier. Erythromycin also appears in breast milk.
Use In Pregnancy & Lactation
The safety of erythromycin for use during pregnancy has not been established. Erythromycin crosses the placental barrier. Erythromycin also appears in breast milk.
Adverse Reactions
Gastro-intestinal tract disturbances especially in large doses, but serious side effects are rare. Nausea, vomiting and diarrhoea occur infrequently with usual oral dose. Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred.
Pseudomembranous colitis has been rarely reported in association with erythromycin therapy. 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. Occasional case reports of cardiac arrhythmias such as ventricular tachycardia have been documented in patients receiving erythromycin therapy. There have been isolated reports of other cardiovascular symptoms such as chest pain, dizziness and palpitations; however, a cause and effect relationship has not been established.
Drug Interactions
Recent data from studies of erythromycin reveal that its use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and with potential theophyllline toxicity. In such case of theophylline toxicity and / or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.
Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels. There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia. Erythromycin has been reported to decrease the clearance of triazolam and midazolam and thus may increase the pharmacologic effect of these benzodiazepines. Patients receiving concomitant lovastatin and erythromycin should be carefully monitored; cases of rhabdomyolysis have been reported in seriously ill patients. The use of erythromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum erythromycin e.g., carbamazepine, alfentanil, disopyramide, lovastatin, bromocryptine, cyclosporine, hexobarbital and phenytoin. Serum concentrations of drugs metabolized by the cytochrome P450 systems should be monitored closely in patients concurrently receiving erythromycin. The effects of chloramphenicol and lincomycins may be antagonized by erythromycin. Erythromycin should be given with caution if other hepatotoxic or ototoxic drugs are given concomitantly. At bacteriostatic concentrations, erythromycin may interfere with the bactericidal effect of penicillins in the treatment of meningitis or in other situations where a rapid bactericidal effect is necessary; it is best to avoid concurrent therapy.
Caution For Usage
User instructions: Continue the treatment as prescribed by the physician.
Storage
Store in a cool dry place below 30°C, in a well-closed container.
Protect from heat and light.
The oral suspension should be refrigerated and used within the period stated.
Shelf-Life: 3 years.
MIMS Class
ATC Classification
J01FA01 - erythromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Powd for oral susp 200 mg/5 mL (almost pink to pink colour dry powder, forming pink colour on reconstitution with water; vanilla flavour) x 60 mL.
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