EMYCINDHG 250

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INFORMATION FOR MEDICAL STAFF

EmycinDHG 250

 

COMPOSITION:

Erythromycin (as erythromycin ethyl succinate) ............................... 250 mg

Excipients q.s.......................................................................................1 sachet

(Aspartame, mannitol, orange-flavored powder, sodium lauryl sulfate, sucrose).

PHARMACEUTICAL FORM: Powder for oral suspension.

PHARMACODYNAMIC PROPERTIES:

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.

PHARMACOKINETIC PROPERTIES:

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.

PRESENTATIONS:

Box of 24 sachets x 1.5 g    

Box of 50 sachets x 1.5 g

THERAPEUTIC INDICATIONS:

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.

DOSAGE & ADMINISTRATION:

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.

CONTRAINDICATIONS:

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.

PRECAUTIONS:

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 laxative.

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.

INTERACTIONS:

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.

UNDESIRABLE EFFECTS:

Common: colic, vomiting, diarrhea, skin rash.

Infrequent: urticaria.

Rare: anaphylactic reaction, arrhythmia, elevated transaminases, increased serum bilirubin, intrahepatic cholestasis, reversible deafness.

OVERDOSE:

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.

SIGNS AND RECOMMENDATIONS SHOULD BE NOTED:

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.

STORAGE CONDITIONS: Store in dry places, not exceeding 300C, protect from light.

SHELF-LIFE: 36 months from the manufacturing date.

DATE OF REVISION OF THE TEXT:  June 8, 2018  

 

 

 

INFORMATION FOR THE USER

EmycinDHG 250

Read all of this leaflet carefully before you start taking this medicine.

Keep out of reach of children

Immediately tell your doctor or pharmacist of undesired effects encountered during the treatment.

The 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.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Erythromycin ............................... 250 mg

Excipients q.s.....................................1 sachet

(Aspartame, mannitol, orange-flavored powder, sodium lauryl sulfate, sucrose).

PRODUCT DESCRIPTION: White to ivory-white, dry, fragrant powder.

PRESENTATION:

Box of 24 sachets x 1.5 g    

Box of 50 sachets x 1.5 g

WHAT THE DRUG IS USED FOR:

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.

HOW TO TAKE THIS MEDICINE:

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.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

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.

UNDESIRABLE EFFECTS:

Common: colic, vomiting, diarrhea, skin rash.

Infrequent: urticaria.

Rare: anaphylactic reaction, arrhythmia, elevated transaminases, increased serum bilirubin, intrahepatic cholestasis, reversible deafness.

Inform your physician about any adverse effects occur during the treatment.

WHAT OTHER MEDICINE OR FOOD SHOULD BE AVOIDED WHILE TAKING THIS MEDICINE:

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.

WHAT SHOULD YOU DO IF YOU MISS A DOSE:

The next dose should be taken as directed. Do not take extra medicine to make up the missed dose to avoid overdose.

HOW TO STORE THIS MEDICINE: Store dry places, not exceeding 300C, protect from light.

SIGNS AND SYMPTOMS OF DRUG OVERDOSE:

Symptoms: Nausea, vomiting, diarrhea, loss of hearing (temporary).

WHAT TO DO WHEN YOU HAVE TAKEN MORE THAN THE RECOMMENDED DOSAGE:

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.

WHAT ARE THE PRECAUTIONS WHEN TAKING THIS MEDICINE:

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 laxative.

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.

WHEN SHOULD YOU CONSULT YOUR DOCTOR, PHARMACIST:

If you need further information, please consult your doctor or pharmacist.

SHELF-LIFE: 36 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: June 8, 2018  

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