Erythromycin (as erythromycin ethyl succinate) ............................... 250 mg
Excipients q.s.......................................................................................1 sachet
Powder for oral suspension.
Box of 24 sachets x 1.5 g
Box of 50 sachets x 1.5 g
ATC code: J01FA01
EmycinDHG contains erythromycin that is a macrolide antibiotic with a broad spectrum of activity. Erythromycin is usually bacteriostatic, but it may be bactericidal in high concentrations or against highly susceptible organisms. Erythromycin and other macrolides bind reversibly to the 50S ribosomal subunits of susceptible microorganisms and suppress protein synthesis. The actions of erythromycin are increased at mild alkaline pH (about 8.5), particularly in Gram-negative organisms. Erythromycin has a broad antibacterial spectrum of activity, including Gram-positive cocci, Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Bacillus anthracis, Corynebacterium diphteria, Erysipelothris rhusioparthiae, Listeria monocyogenes. Erythromycin is moderately active against anaerobic bacteria, including Clostridium spp., Propionibacterium acnes. Erythromycin also is active against Gram-negative bacteria including Neisseria meningitidis, N. gonorrheae, and Moraxella (Branhamella) catarrhalis, Bordetella spp., some strains of Brucella, Flavobacterium, Legionella spp. and Pasteurella, Haemophilus ducreyi, Helicobacter pyloridis, Campylobacter jejuni. Other organisms sensitive to erythromycin include Actinomyces, Chlamydia, Rickettsia spp., Spirochete such as Treponema pallidum and Borrelia burgdorferi, some Mycoplasmas (notably M. pneumoniae), and some of opportunistic Mycobacteria such as M. scrofulaceum and M. kansasii.
Erythromycin is widely distributed into body fluids and tissues e.g. middle ear exudate, prostatic fluid, semen. Relatively high concentrations are found in the liver, bile and spleen. The concentrations of erythromycin in cerebrospinal fluid are low; however, when meninges are inflamed, the concentration of erythromycin in CSF may be increased. Around 70% to 90% of erythromycin is protein bound. Over 90% of erythromycin is metabolized in the liver, partly under inactive metabolites; it may be agglomerated in patients with severe hepatic impairment. Erythromycin is mainly excreted in bile. About 2% to 5% of an oral dose is excreted unchanged in the urine.
Erythromycin should be used with caution in patients suffering from hepatic disease and hepatic impairment and in those with arrhythmia and other cardiac diseases.
Excipients:
Mannitol contained in the excipients of the drug may cause minor laxatives.
The drug contains aspartame, a source of phenylalanine which may be harmful for people with phenylketonuria.
Sucrose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pregnancy and lactation:
Erythromycin has been reported to cross the placenta in humans; therefore, erythromycin estolate should not be indicated to pregnant women because of risk of hepatotoxicity. There are no reports using other types of erythromycin in pregnant women.
Erythromycin is distributed into breast milk, but no adverse effects in breast-feeding infants have been reported.
Effects on works
The drug does not affect the ability to drive, operate machinery, work at height, and other cases.
Risks of cardiac toxicity, including torsades de pointes, ventricular tachycardia, and death have been reported in some patients receiving astemizole or terfenadine concomitantly with erythromycin.
Concomitant use of erythromycin and carbamazepine, valproic acid has resulted in increased serum concentrations of these drugs and subsequent signs of toxicity. Erythromycin may be antagonistic with chloramphenicol or lincomycin.
Erythromycin decreases the clearance of xanthine derivatives, including aminophylline, theophylline, caffeine; alfentanil, midazolam or triazolam. Therefore, it increases the concentration and action time of these drugs.
Erythromycin therapy in some patients stabilized on warfarin has resulted in prolongation of prothrombin time and bleeding because it reduces the metabolism and clearance of warfarin. Concomitant use of erythromycin and cyclosporine may result in substantial increases in plasma concentrations of cyclosporine and subsequent signs of nephrotoxicity.
Erythromycin inhibits the metabolism of ergotamine and increases the vasospasm effect of ergotamine. Patients receiving concomitant lovastatin and erythromycin should be carefully monitored as cases of rhabdomyolysis.
Common: colic, vomiting, diarrhea, skin rash.
Infrequent: urticaria.
Rare: anaphylactic reaction, arrhythmia, elevated transaminases, increased serum bilirubin, intrahepatic cholestasis, reversible deafness.
Allergic reactions can be treated by epinephrine, corticosteroids and antihistamines. Gastric lavage is used to remove unabsorbed drug from the body. Supportive measures should be applied if required.
Store in dry places, not exceeding 300C, protect from light.
36 months from the manufacturing date.
Read the directions carefully before use.
For more information, please consult a physician.
This drug is for prescription only.
Note: The suspension should be orally taken right after dissolved.
Once opened, the drug sachet should be closed tightly; avoid desiccation to ensure drug quality.
For the treatment of respiratory tract infections, gastrointestinal tract infections, skin and soft tissue infections, neonatal conjunctivitis and Chlamydial conjunctivitis. Prophylaxis of recurrent courses of acute rheumatism.
Patients with hypersensitivity to erythromycin, patients with preexisting hepatic dysfunction and a history of deafness.
The use of erythromycin is considered not to be safe in patients with acute porphyria because of acute courses.
Do not use concomitantly erythromycin and terfenadine, particularly in patients with cardiac disease, arrhythmia, bradycardia, prolongation of Q-T interval, ischemia, electrolyte disorders.
The drug should be taken immediately before meals and the therapy course must be pursued (5-10 days)
Children: Usual dose: 30 - 50 mg/ kg body-weight/ day, in 2 - 4 divided doses.
Children under 2 years of age: ½ sachet x 4 times daily (total dose: 500 mg/ day).
Children from 2 to 8 years of age: 1 sachet x 4 times daily (total dose: 1 g/ day).
The dose may be doubled in severe infections.
Or as directed by the physician.
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