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Erythromycin tablets 100 mg

Instruction manual

For medical use of the drug

Erythromycin

(erythromycin)

Structure:

Active substance: erythromycin;

1 tablet contains erythromycin - 100 mg;

excipients: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, anhydrous colloidal silicon dioxide, magnesium stearate.

Dosage form.

Tablets.

Basic physical and chemical properties: tablets of a round form, white or almost white, or white with a yellowish tint, with a biconvex surface. Subtle inclusions are allowed.

Pharmacotherapeutic group.

Antibacterial agents for systemic use. macrolides. erythromycin.

ATX Code J01F A01.

Pharmacological properties.

Pharmacodynamics

Erythromycin is a macrolide antibiotic with a bacteriostatic effect. In high concentrations and in relation to highly sensitive microorganisms, it can have a bactericidal effect. Penetrates through the bacterial cell membrane and reversibly binds to the 50S subunit of bacterial ribosomes; inhibits the translocation of peptides from the acceptor site of the ribosome to the donor, preventing the further synthesis of protein.

Active against gram-positive bacteria: Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus, Corynebacterium diphtheriae, Corynebacterium minutissimum, Listeria monocytogenes; gram-negative bacteria: Bordetella pertussis, Legionella pneumophila, some strains of Haemophilus influenzae, Mycoplasma pneumoniae, as well as relative to Entaemoeba hystolitica, Chlamydia trachomatis, Treponema pallidum.

Gram-negative bacilli are resistant to the action of erythromycin: intestinal, Pseudomonas aeruginosa, as well as shigella, salmonella.

Pharmacokinetics

It is absorbed in the digestive tract, while the rate of absorption depends on the individual characteristics of the body. Bioavailability is 30–65%. The maximum concentration in the blood is reached 2 hours after administration. It is distributed in most tissues and body fluids, penetrates the placental barrier and into breast milk.

Plasma protein binding is 70–90%. It is metabolized in the liver, partially with the formation of inactive metabolites. A significant part of erythromycin is excreted from the body with bile and only 2–5% is unchanged in the urine. The elimination half-life is 1.4–2 hours with normal renal function.

Clinical characteristics.

Indications.

Infections of the respiratory tract, including SARS, ENT infections (tonsillitis, otitis media, sinusitis), purulent-inflammatory diseases of the skin and its appendages, erythrasma, diphtheria, gonorrhea, syphilis, listeriosis, legionnaires disease, infections in dentistry and ophthalmology, infections caused by microorganisms resistant to beta-lactam antibiotics, penicillin, tetracycline, chloramphenicol, streptomycin.

Contraindications

  • Hypersensitivity to erythromycin or to any other component of the drug, to macrolides; severe liver failure; simultaneous use with terfenadine, astemizole, pimozide or cisapride, ergotamine and dihydroergotamine.

Interaction with other drugs and other types of interactions.

The combined use of erythromycin with:

  • astemizole or terfenadine, cisapride, pimozide: the risk of developing cardiotoxicity increases: prolongation of the QT interval, severe heart rhythm disturbances, including arrhythmias of the “torsade de pointes” type, cardiac arrest;
  • ergotamine or dihydroergotamine: acute toxic reactions with vasospasm, dysesthesia are possible (erythromycin inhibits the metabolism of ergotamine and dihydroergotamine, increasing the vascular spasm associated with ergotamine).

The erythromycin biotransformation occurs mainly in the liver with the participation of the cytochrome P450 system. Erythromycin due to the effect on the activity of cytochrome P450 interacts with the following drugs:

  • theophylline, aminophylline, caffeine: increases their concentration in blood serum and toxicity - it is necessary to reduce the doses of these drugs and control their concentration in blood serum;
  • digoxin: increases absorption and its concentration in blood serum;
  • cyclosporine: increases concentration and enhances its nephrotoxicity;
  • carbamezepine: able to reduce its hepatic metabolism, which allows to reduce the dose of carbamezepine to 50% with the simultaneous use of drugs;
  • phenytoin, alfentanil, methylprednisolone, benzodiazepines (such as triazolam, alprazolam), hexobarbital, valproic acid, tacrolimus, rifabutin, zopiclone, bromocriptine, cabergoline: increase the concentration and increase their toxicity - correction is necessary; correction is necessary; correction is necessary;
  • disopyramide, quinidine, procainamide: may lengthen the QT interval or cause ventricular tachycardia;
  • oral contraceptives: increases the risk of hepatotoxicity, reduces their effectiveness;
  • antifungal drugs: it is possible to increase the risk of developing cardiotoxicity (lengthening the QT interval, paroxysmal ventricular tachycardia of the Pirouette type) and, as a result, cardiac arrest. The use of a combination of these drugs is contraindicated;
  • anticoagulants (warfarin, acetocumarol): enhances their effects, which are more

expressed in the elderly. Therefore, prothrombin time should be constantly monitored;

  • HMG-CoA reductase inhibitors (for example, lovastatin, simvastatin): increases their concentration in the blood - increases the risk of rhabdomyolysis, which can usually develop after treatment with erythromycin;
  • sildenafil (Viagra): enhances its systemic effect - it is necessary to reduce the dose of sildenafil;
  • calcium channel blockers, such as felodipine, verapamil: slows down elimination and enhances their effect. There were reports of hypotension, bradyarrhythmias, lactic acidosis while taking them with erythromycin;
  • zafirlukast: reduces its concentration in blood plasma;
  • sulfonamides, tetracycline, streptomycin: increased action of erythromycin;
  • colchicine, vinblastine: toxicity reported with interaction with erythromycin;
  • cimetidine: leads to an increase in the risk of its toxicity, including reverse deafness;
  • levodopa (in combination with carbidopa): inhibition of carbidopa absorption and a decrease in the level of levodopa in blood plasma are possible. With this combination, it is necessary to monitor the clinical picture. Possible dose adjustment of levodopa;
  • lincomycin, clindamycin and chloramphenicol (antagonism), with drugs that increase the acidity of gastric juice, as well as with acidic drinks: can not be used together, since they inactivate erythromycin.

The drug can affect the results of determining the level of catecholamines in the urine, carried out by a fluorometric method.

Features of the application.

Before using erythromycin, a detailed patient history should be collected regarding the hypersensitivity reaction to erythromycin, other macrolides, or other allergens. if an increased sensitivity reaction develops in connection with the use of erythromycin, you should immediately stop using the drug and begin symptomatic treatment.

Before using the drug, it is advisable to determine the causative agent of the disease to reduce the risk of developing resistant forms of bacteria. But treatment with erythromycin can be started before an antibioticogram is taken, after receiving which to continue treatment or carry out an appropriate replacement of the drug.

When using erythromycin preparations, a dysfunction of the liver was reported, including an increase in the level of “liver” enzymes in the blood serum, hepatocellular and / or cholestatic hepatitis with / without jaundice. Erythromycin is excreted mainly by the liver, therefore, it should be used with caution in patients with impaired liver function, with a history of jaundice, or in patients who are treated with potentially hepatotoxic drugs. During prolonged treatment with the drug or when taking large doses, it is necessary to control liver function.

In patients with renal and hepatic insufficiency, in elderly patients, taking into account age-related changes in liver and / or kidney function, the risk of developing an ototoxic effect increases.

Elderly patients have an increased risk of developing torsade de pointes arrhythmias during treatment with erythromycin; the effect of anticoagulation therapy is enhanced when combined with erythromycin.

In the treatment of syphilis in pregnant women, it must be taken into account that the drug does not reach therapeutic concentrations in the fetus, therefore, after the birth of the baby, penicillin should be prescribed to infants whose mothers used erythromycin.

Due to the risk of developing adverse reactions such as lengthening the QT interval on the ECG, the development of ventricular arrhythmias, including ventricular tachycardia and torsade de pointes type of arrhythmia, the drug should be prescribed with caution to patients with a history of arrhythmias.

It is necessary to monitor patients with asthma taking theophylline and erythromycin, including assessing theophylline level in the blood, in order to avoid intoxication.

The drug may increase the symptoms of the disease in patients with myasthenia gravis.

In severe patients taking lovastatin concomitantly with erythromycin, there were cases of rhabdomyolysis with / without renal failure. Therefore, if it is necessary to prescribe combination treatment with lovastatin or other HMG-CoA reductase inhibitors and erythromycin, it is necessary to carefully evaluate the benefit / risk ratio, observe the appearance of symptoms such as muscle pain, weakness and carefully monitor serum creatine kinase and transaminase levels.

Treatment with antibacterial drugs disrupts the normal flora of the colon and can cause excessive growth of resistant strains of Clostridium difficile, the toxins of which are the main cause of pseudomembranous colitis. Pseudomembranous colitis occurs both directly during the administration of the drug, and within 2 months after the end of antibiotic therapy. Cases of pseudomembranous colitis from mild to life-threatening have been reported with almost all antibacterial drugs. Therefore, it is important to consider the possibility of pseudomembranous colitis in patients with diarrhea after taking antibacterial drugs. In mild cases, it is usually sufficient to discontinue the drug, in severe cases, metronidazole or vancomycin should be prescribed. The use of drugs that slow down intestinal motility is contraindicated.

Prolonged or repeated use of erythromycin, like other antibacterial drugs, can lead to excessive growth of insensitive microorganisms, in particular fungi. If superinfection develops during treatment, the administration of erythromycin must be stopped and appropriate measures taken.

The drug may distort the results of determining the level of catecholamines in the urine, carried out by a fluorometric method.

Drugs that increase the acidity of gastric juice, and acidic drinks inactivate erythromycin. Erythromycin should not be washed down with milk and dairy products.

Use during pregnancy or lactation.

The drug crosses the placenta, but the concentration in the blood serum of the fetus is low. there are no adequate and well-controlled studies in pregnant women. therefore, this drug should be used during pregnancy only if absolutely necessary, taking into account the risk / benefit ratio.

Erythromycin passes into breast milk; therefore, breast-feeding should be discontinued during the treatment period.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

Given the presence of adverse reactions (dizziness, hallucinations, convulsions, confusion, reverse hearing loss), during treatment with the drug, it is necessary to refrain from driving vehicles or other mechanisms.

Dosage and administration.

Set individually, depending on the location and severity of the infection, the sensitivity of the pathogen.

Assign inside 1–1.5 hours before or 2-3 hours after eating.

For adults, 200-500 mg 4 times a day, the highest single dose - 500 mg, daily - 2 g.

Children: from 30 to 50 mg / kg body weight per day, divided into 4 doses every 6 hours;

from 3 to 6 years - 500-700 mg per day;

from 6 to 8 years - 700 mg per day;

from 8 to 14 years - up to 1 g per day, dividing the daily dose into 4 doses;

from 14 years old - in a dose for adults.

Elderly patients do not need a dosage change; monitoring of liver function due to its possible impairment in this age group is recommended.

The course of treatment is 5-14 days, after the disappearance of the symptoms of the disease, the drug is used for another 2 days.

Children.

The drug should be used in children from 3 years of age in accordance with the recommendations indicated in the section "method of administration and dose."

Overdose.

Symptoms: nausea, vomiting, diarrhea and a feeling of discomfort in the stomach; impaired liver function, possibly to acute liver failure; hearing loss, tinnitus, dizziness (especially in patients with renal and / or liver failure).

Treatment: gastric lavage, the use of activated carbon, symptomatic treatment. Hemodialysis, peritoneal dialysis, and forced diuresis are not effective.

Adverse Reactions

Digestive system: possible nausea, vomiting, epigastric pain, diarrhea, anorexia, pseudomembranous colitis. cases of pancreatitis have been rarely reported.

Hepatobiliary system: impaired liver function, including increased levels of “liver” enzymes in the blood serum, hepatocellular and / or cholestatic hepatitis with / without jaundice.

Sensory organs: hearing loss and / or tinnitus, which disappears after discontinuation of the drug. There were separate reports of reversible hearing loss, mainly in patients with renal failure and in patients receiving high doses of erythromycin (more than 4 g / day).

Cardiovascular system: prolongation of the QT interval on the ECG, palpitations, ventricular arrhythmias, including ventricular tachycardia and torsade de pointes arrhythmias.

Nervous system: there have been separate reports of transient adverse reactions while taking erythromycin preparations, such as confusion, hallucinations, convulsions, dizziness, nightmares, but a causal relationship has not been reliably established.

Genitourinary system: parenchymal nephritis.

Immune system: allergic reactions, including pruritus, urticaria, anaphylactic shock, skin rash, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. In the event of any of the above allergic reactions, you should immediately stop taking the drug.

Infections and parasitic diseases: during a long or repeated course of treatment with erythromycin, superinfection due to bacteria resistant to the drug may develop.

Blood and lymphatic system: agranulocytosis, eosinophilia.

Other: effects due to chemotherapeutic action: oral candidiasis, vaginal candidiasis; onset of symptoms of myasthenic syndrome / exacerbation of existing myasthenia gravis; fever.

Shelf life.

3 years.

Storage conditions.

In the original packaging at a temperature not exceeding 25 ○ s.

Keep out of the reach of children.

Packaging.

20 tablets in a blister, 1 blister in a pack.

Vacation category.

On prescription.

Manufacturer.

Public Joint Stock Company “Scientific and Production Center“ Borshchag Chemical and Pharmaceutical Plant ”.

The location of the manufacturer and his address of the place of business.

Ukraine, 03134, Kiev, st. peace, 17.

Tags: Erythromycin