Macropen release form

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Macropen

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Macropen is an antibacterial agent of the macrolide group, inhibiting the synthesis of proteins in bacterial cells, having a bactericidal effect in large doses, and a bacteriostatic effect in small doses.

Table of contents:

Release form and composition

Dosage forms of Macropen:

  • Film-coated tablets: round, white, with beveled edges and a notch on one side, slightly biconvex, at the break - a white mass with a rough surface (8 tablets in a blister, 2 blisters in a cardboard box);
  • Granules for the preparation of a suspension for oral administration: orange, small, without visible impurities, with banana aroma (20 g each in dark glass bottles with an aluminum cap with tamper evident, complete with a dosage spoon; 1 set in a cardboard box). Prepared aqueous suspension: orange in color, with a slight banana odor.

Composition of 1 tablet:

  • Active substance: midecamycin – 400 mg;
  • Additional substances: magnesium stearate, potassium polacriline, microcrystalline cellulose, talc;
  • Film shell: titanium dioxide, methacrylic acid copolymer, talc, macrogol.

5 ml of the finished suspension contains:

  • Active substance: midecamycin acetate – 175 mg;
  • Additional substances: citric acid, propyl parahydroxybenzoate, methyl parahydroxybenzoate, banana flavor, anhydrous sodium hydrogen phosphate, sunset yellow dye FCF (E110), silicone defoamer, hypromellose, mannitol, sodium saccharinate.

Indications for use

Macropen is recommended for use for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

  • Respiratory tract infections: acute otitis media, tonsillopharyngitis, sinusitis, community-acquired pneumonia, exacerbation of chronic bronchitis (including those initiated by atypical pathogens Chlamydia spp., Legionella spp., Mycoplasma spp., Ureaplasma urealyticum);
  • Infections of the skin and subcutaneous tissue;
  • Infections of the genitourinary system caused by Chlamydia spp., Legionella spp., Mycoplasma spp., Ureaplasma urealyticum;
  • Enteritis caused by Campylobacter spp.

The drug is also prescribed for the treatment and prevention of whooping cough and diphtheria.

Contraindications

  • Severe liver failure;
  • Age up to 3 years (for tablets);
  • Hypersensitivity to the components of the product.

You should take the drug with extreme caution if you have a history of an allergic reaction to acetylsalicylic acid, since the sunset yellow dye can provoke an allergic reaction, including bronchospasm.

During pregnancy, use is possible only if the expected benefit from the drug outweighs the potential threat from side effects. Due to the fact that Macropen is excreted in breast milk, breastfeeding should be interrupted while taking the drug.

Directions for use and dosage

Both dosage forms of the drug are taken orally before meals.

Tablets for adults and children weighing more than 30 kg are recommended to be taken 3 times a day, 1 piece. (400 mg), the maximum dose for adults per day is 4 pcs. (1600 mg).

Children weighing less than 30 kg take 50 mg/kg body weight per day in 2 divided doses, or mg/kg in 3 divided doses; for severe infections, the daily dose is 50 mg/kg, divided into 3 doses.

Recommended single doses of suspension for children (daily dose is 50 mg/kg in 2 divided doses) depending on body weight and age with a frequency of use 2 times a day:

  • Less than 5 kg (about 2 months) – 131.25 mg (3.75 ml);
  • Less than 10 kg (about 1-2 years) – 262.5 mg (7.5 ml);
  • Less than 15 kg (about 4 years) – 350 mg (10 ml);
  • Less than 20 kg (about 6 years) – 525 mg (15 ml);
  • Less than 30 kg (about 10 years) – 787.5 mg (22.5 ml).

The duration of the course varies from 7 to 14 days, and for the treatment of chlamydial infections it is 14 days.

To prevent diphtheria, Macropen is taken per day at a dose of 50 mg/kg, divided into 2 times, for 7 days; after completion of the course, a control bacteriological study is recommended.

To prevent whooping cough, the drug is used for 7-14 days, no later than the first 14 days from the moment of contact with a carrier of the disease, at a dose of 50 mg/kg per day.

To prepare the suspension, add 100 ml of distilled or boiled water to the granules contained in the bottle and shake vigorously. It is recommended to shake the prepared suspension before each use.

Side effects

  • Allergic reactions: skin itching, urticaria, skin rash, bronchospasm, eosinophilia;
  • Digestive system: nausea, loss of appetite, diarrhea, vomiting, feeling of heaviness in the epigastrium, stomatitis, hyperbilirubinemia, jaundice, increased activity of liver transaminases; in some cases - prolonged and severe diarrhea;
  • Other: weakness.

There are no reports of severe overdose caused by taking the drug. Possible symptoms of this condition may be vomiting and nausea; therapy is symptomatic.

special instructions

Mannitol, which is part of granules intended for the preparation of a suspension, can cause diarrhea.

When carrying out long-term therapy, monitoring the activity of liver enzymes is required, especially in patients with impaired liver function.

Macropen, like other antimicrobial drugs, can lead to overgrowth of resistant bacteria when taken over a long period of time. Prolonged diarrhea may be a sign of the development of pseudomembranous colitis.

Drug interactions

It should be taken into account that with simultaneous use of midecamycin:

  • Reduces metabolism in the liver and increases serum concentrations of carbamazepine and ergot alkaloids, as a result, caution must be exercised when combining them;
  • Slows down the elimination of cyclosporine or anticoagulants (warfarin);
  • Does not affect the pharmacokinetic parameters of theophylline.

Terms and conditions of storage

Store at a temperature not exceeding 25 °C in a place protected from moisture and out of reach of children.

Shelf life – 3 years. The prepared suspension, if stored in the refrigerator, can be used for 14 days, and at a temperature not exceeding 25 °C - 7 days.

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Macropen tab. p.p.o. 400mg n16

Macropen tablets 400 mg 16 pcs.

Macropen 400 mg n16 tablet

Macropen gran. d/susp. internal 175mg/5ml 115ml n1

Macropen 175mg/5ml granules for injection. suspension for oral administration 20g No. 1 bottle

Macropen granules for suspension 175 mg/5 ml

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MACROPENE

White film-coated tablets on the fracture there is a white mass with a rough surface.

Excipients: potassium polacrilin, magnesium stearate, talc, microcrystalline cellulose.

Shell composition: methacrylic acid copolymer, macrogol, titanium dioxide, talc.

8 pcs. - blisters (2) - cardboard packs.

The granules for preparing a suspension for oral administration are small, orange in color, with a slight banana odor, without visible impurities; the prepared aqueous suspension is orange in color, with a slight banana odor.

Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid, sodium hydrogen phosphate anhydrous, banana flavor, powder, sunset yellow dye FCF (E110), hypromellose, silicone defoamer, sodium saccharinate, mannitol.

20 g - dark glass bottles (1) complete with a dosage spoon - cardboard packs.

Antibiotic of the macrolide group. Inhibits protein synthesis in bacterial cells. Reversibly binds to the 50S subunit of the bacterial ribosomal membrane. In low doses the drug has a bacteriostatic effect, in high doses it has a bactericidal effect.

Active against intracellular microorganisms: Mycoplasma spp., Chlamydia spp., Legionella spp., Ureaplasma urealyticum; gram-positive bacteria: Streptococcus spp., Staphylococcus spp., Corynebacterium diphtheriae, Listeria monocytogenes, Clostridium spp.; gram-negative bacteria: Neisseria spp., Moraxella catarrhalis, Bordetella pertussis, Helicobacter spp., Campylobacter spp., Bacteroides spp.

After oral administration, midecamycin is quickly and fairly completely absorbed from the gastrointestinal tract.

C max in the serum of midecamycin and midecamycin acetate are 0.5-2.5 µg/l and 1.31-3.3 µg/l, respectively, and are achieved 1-2 hours after oral administration.

High concentrations of midecamycin and midecamycin acetate are created in internal organs (especially in lung tissue, parotid and submandibular glands) and skin. MIC is maintained for 6 hours.

Midecamycin binds to proteins by 47%, its metabolites - by 3-29%.

Midecamycin is metabolized in the liver to form 2 metabolites with antimicrobial activity.

T1 /2 is approximately 1 hour. Midecamycin is excreted in bile and to a lesser extent (about 5%) in urine.

Pharmacokinetics in special clinical situations

In liver cirrhosis, plasma concentrations, AUC and Tmax significantly increase1/2.

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

— respiratory tract infections: tonsillopharyngitis, acute otitis media, sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia (including those caused by atypical pathogens Mycoplasma spp., Chlamydia spp., Legionella spp. and Ureaplasma urealyticum);

— infections of the genitourinary system caused by Mycoplasma spp., Chlamydia spp., Legionella spp. and Ureaplasma urealyticum;

- infections of the skin and subcutaneous tissue;

— treatment of enteritis caused by Campylobacter spp.;

- treatment and prevention of diphtheria and whooping cough.

- children under 3 years of age (for tablets);

- hypersensitivity to midecamycin/midecamycin acetate and other components of the drug.

with caution during pregnancy, lactation, and also if there is a history of an allergic reaction to taking acetylsalicylic acid.

The drug should be taken before meals.

For adults and children weighing more than 30 kg, Macropen is prescribed 400 mg (1 tablet) 3 times a day. The maximum daily dose for adults is 1.6 g.

For children weighing less than 30 kg, the daily dose is mg/kg body weight in 3 divided doses or 50 mg/kg body weight in 2 divided doses, for severe infections - 50 mg/kg body weight in 3 divided doses.

The prescription regimen for Macropen in the form of a suspension for children (daily dose of 50 mg/kg body weight in 2 doses) is presented in the table.

The duration of treatment is from 7 to 14 days, for the treatment of chlamydial infections - 14 days.

To prevent diphtheria, the drug is prescribed at a dose of 50 mg/kg/day, divided into 2 doses, for 7 days. A control bacteriological study after completion of therapy is recommended.

To prevent whooping cough , the drug is prescribed at a dose of 50 mg/kg/day for 7-14 days in the first 14 days from the moment of contact.

To prepare the suspension, add 100 ml of boiled or distilled water to the contents of the bottle and shake well. It is recommended to shake the prepared suspension before use.

From the digestive system: loss of appetite, stomatitis, nausea, vomiting, diarrhea, feeling of heaviness in the epigastrium, increased activity of liver transaminases and jaundice; in some cases, severe and prolonged diarrhea, which may indicate the development of pseudomembranous colitis.

Allergic reactions: skin rash, urticaria, itching, eosinophilia, bronchospasm.

There are no reports of cases of serious intoxication caused by taking the drug Macropen.

Symptoms: possible nausea, vomiting.

Treatment: symptomatic therapy.

With the simultaneous use of Macropen with ergot alkaloids and carbamazepine, their metabolism in the liver decreases and their concentration in the serum increases. Therefore, caution should be exercised when prescribing these drugs simultaneously.

When Macropen is used simultaneously with cyclosporine and anticoagulants (warfarin), the elimination of the latter is slowed down.

Macropen does not affect the pharmacokinetic parameters of theophylline.

As with the use of any other antimicrobial drugs, overgrowth of resistant bacteria is possible with long-term therapy with Macropen. Prolonged diarrhea may indicate the development of pseudomembranous colitis.

During long-term therapy, liver enzyme activity should be monitored, especially in patients with impaired liver function.

Mannitol contained in suspension granules may cause diarrhea.

If you have a history of an allergic reaction to acetylsalicylic acid, azo dye E110 (sunset yellow dye) can cause an allergic reaction, including bronchospasm.

Impact on the ability to drive vehicles and operate machinery

The effect of Macropen on the speed of psychomotor reactions and the ability to drive a car and other mechanisms has not been reported.

The use of Macropen during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Midecamycin is excreted in breast milk. When using Macropen during lactation, breastfeeding should be stopped.

The drug is used according to indications, in the recommended dosage form and in doses taking into account the age of the patients.

Contraindication: children under 3 years of age (for tablets).

The drug is contraindicated for use in severe liver failure.

During long-term therapy, liver enzyme activity should be monitored, especially in patients with impaired liver function.

The drug is available with a prescription.

Tablets should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C. Granules for preparing the suspension should be stored at a temperature not exceeding 25°C. Shelf life: 3 years.

The prepared suspension can be used for 14 days if stored in the refrigerator and for 7 days if stored at a temperature not exceeding 25°C.

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Source: http://health.mail.ru/drug/macropen_1/

Macropen

Description current as of 12/27/2014

  • Latin name: Macropen
  • ATX code: J01FA03
  • Active ingredient: Midecamycin (Midecamycin)
  • Manufacturer: KRKA (Slovenia)

Compound

Tablets: midecamycin 400 mg, magnesium stearate, potassium polacriline, talc and MCC as excipients.

Granules: midecamycin acetate 175 mg and excipients.

Release form

Granules in a bottle for the preparation of a suspension of 175 mg/5 ml.

pharmachologic effect

Pharmacodynamics and pharmacokinetics

The antibiotic Macropen belongs to the group of macrolides. By inhibiting the synthesis of proteins in microbial cells, it has a bacteriostatic effect in small doses, and a bactericidal effect in large doses. Its effectiveness has been noted against gram-positive (clostridium, streptococcus, listeria, staphylococcus, corynobacteria), gram-negative (campylobacter, moraxella, hemophilus influenzae, helicobacter, bacteroides) bacteria, as well as intracellular microorganisms (mycoplasma, chlamydia, ureaplasma).

After administration, it is quickly and completely absorbed from the gastrointestinal tract. The maximum concentration of the drug in the serum is after 1–2 hours. At this level, the concentration remains for up to 6 hours. Eating slightly reduces the concentration of the drug in the blood, so it is recommended to take it before meals. The highest concentrations are created in the lungs, parotid gland and skin.

The drug is metabolized in the liver and excreted in the bile and kidneys (to a lesser extent).

Indications for use

Infections caused by microorganisms sensitive to the drug:

  • respiratory tract infections (tonsillitis, pharyngitis, otitis media, sinusitis, bronchitis, pneumonia);
  • infections of the urinary system, caused, among other things, by mycoplasma, ureaplasma, chlamydia;
  • infections of mucous membranes and skin;
  • enteritis caused by Campylobacter;
  • diphtheria and whooping cough;
  • treatment of patients who cannot tolerate penicillin antibiotics.

Contraindications

  • sensitivity to midecamycin;
  • severe liver failure;
  • age up to 3 years (for taking tablets).

Side effects

  • epigastric pain, nausea, vomiting, loss of appetite, diarrhea, jaundice;
  • pseudomembranous colitis;
  • skin rash, urticaria, skin itching;
  • eosinophilia;
  • bronchospasm;
  • weakness.

Instructions for use Macropen (Method and dosage)

Macropen has two forms of release - tablets and suspension, which is prepared from granules by adding water.

Macropen tablets, instructions for use

Macropen is prescribed every 8 hours.

Adults and children (body weight 30 kg or more) - 400 mg 3 times. For adults, the daily dose (maximum) is 1600 mg.

Children weighing less than 30 kg - 20–40 mg/kg, dividing the daily dose into 3 times. The daily dose for severe infections can be 50 mg/kg, also divided by 3 times.

Macropen suspension, instructions for use

This form of release is used in childhood. Depending on the child’s body weight, the dosage is calculated and taken 2 times a day:

  • from 0 to 5 kg -3.75 ml of suspension 2 r/s;
  • from 5 to 10 kg -7.5 ml of suspension 2 r/s;
  • from 10 to 15 kg - 10 ml of suspension 2 r/s;
  • from 15 to 20 kg - 15 ml of suspension 2 r/s;
  • from 20 to 25 kg—22.5 ml of suspension 2 r/s.

To prepare the suspension, add 100 ml of water to the granules in the bottle. The course of treatment with Macropen is 7-10 days, and in the case of chlamydial infection, 14 days.

The answer to the question of what Macropen tablets are for is that this antibiotic is prescribed for any infections, but most often for respiratory tract infections. It is effective in 90% of patients with tonsillopharyngitis, acute otitis media and sinusitis, chronic bronchitis and pneumonia. Due to its low toxicity and high efficiency, Macropen is used in newborns in the treatment of chlamydial respiratory tract infection.

There is a high effectiveness of using this drug for angina. Since the antibiotic is broad-spectrum, the infection of the nasopharynx is quickly suppressed, and the symptoms of the disease are stopped. Macropen for angina is prescribed 400 mg 3 times a day.

Macropen is also widely used for sinusitis. And depending on the severity of this disease, the dose in adults can be 1200 mg - 1600 mg per day. With timely administration of Macropen for sinusitis, the likelihood of complications is reduced and in many cases, therapeutic puncture of the maxillary sinus can be avoided.

Macropen for children

In pediatric practice, this drug is considered the most effective and safest antibiotic. Pediatricians encounter virtually no side effects.

Macropen does not cause dysbiosis, which is often encountered when prescribing other antibiotics. Antifungal agents are not prescribed when using this drug (only in weakened infants). Macropen for children is available in a form convenient for administration - the prepared suspension has a pleasant taste, so there are no problems during treatment. This is also evidenced by reviews from parents who note the effect of treatment in cases where penicillin antibiotics are no longer effective.

Overdose

There are no reports of cases of overdose. Possible symptoms are nausea, vomiting.

Interaction

When using the drug with carbamazepine, its transformation in the liver decreases and, accordingly, the concentration in the serum increases, which increases the risk of the toxic effects of the latter: urinary retention, ataxia, convulsions.

Terms of sale

Dispensed by prescription.

Storage conditions

Tablets and granules in a bottle are stored in a dry place, the temperature should not exceed 25°C. The finished suspension is stored for 7 days at room temperature and 14 days in the refrigerator.

Best before date

Shelf life: 3 years.

Macropen's analogs

There are no analogues for the active substance. Analogues of Macropen belonging to the same pharmacological group (second generation macrolides): Clarithromycin, Azithromycin, Josamycin.

The price of analogues Clarithromycin 500 mg No. 14 is 311 – 456 rubles. (manufactured by Pliva), designed for a 7-day course of treatment.

Azithromycin capsules 500 mg No. 3 — rub. (Obolenskoye FP Russia), designed for a 3-day course of treatment.

Reviews about Macropen

Reviews about Macropen are mostly positive. Most of them are about the use of the drug for sinusitis. High efficiency is noted - in many cases, with timely administration of the drug, the patient's condition quickly improves, and puncture can be dispensed with. Duration of treatment is from 7 to 14 days. It is important to complete the course of treatment, otherwise the “hidden” infection may become chronic.

A large number of reviews about the use of the suspension for children. Parents are satisfied with the results of the treatment: it quickly and effectively helps with coughs, especially prolonged ones. Since the treatment lasted up to 10 days, the child was given probiotics (Linex, Bactisubtil) in parallel. Some noted the appearance of adverse reactions in children: nausea, lethargy, vomiting. In such cases, Macropen was canceled. In any case, there is no point in drawing conclusions that the drug is not effective. It depends on the individual characteristics of the organism.

Macropen price, where to buy

This drug can be found in any pharmacy. When purchasing Macropen tablets, the price of which in Moscow pharmacies varies and amounts to rub. for 16 capsules, you can make a request on the Internet and choose a more acceptable option. The price of Macropen suspension is from 270 rubles. up to 306 rub.

  • Online pharmacies in Russia Russia
  • Online pharmacies in Ukraine Ukraine
  • Online pharmacies in Kazakhstan Kazakhstan

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BIOSPHERE

Education: Graduated from the Sverdlovsk Medical School (1968 - 1971) with a degree in Paramedic. He graduated from the Donetsk Medical Institute (1975 - 1981) with a degree in epidemiologist and hygienist. He completed his postgraduate studies at the Central Research Institute of Epidemiology in Moscow (1986 - 1989). Academic degree - Candidate of Medical Sciences (degree awarded in 1989, defense - Central Research Institute of Epidemiology, Moscow). Completed numerous advanced training courses in epidemiology and infectious diseases.

Work experience: Work as head of the disinfection and sterilization department 1981 - 1992. Work as head of the department of especially dangerous infections 1992 - 2010. Teaching activity at the Medical Institute 2010 - 2013

It treats tracheitis in children well. Dysbacteriosis and allergies are possible. It is inconvenient to give to a child at night.

good antibiotic! I give it 5+

A good drug, it has saved me many times! I use it to treat a severe cough. And before that I tried another drug - zero effect. And then after a couple of days there was improvement.

A friend told me about him and also praised him!

My husband was treated for pneumonia and was prescribed Macropen. He was cured in 2 weeks. We were afraid that there would be consequences from taking antibiotics, but everything worked out! I think it's an excellent medicine!

Sivaya: I started taking ginkum before the session because I was very worried that I wouldn’t have time to do everything.

Igor: it helps, try it, I wanted de-nol, but it’s easier

Konstantin: What I liked about the drug Prostanorm: reasonable price, pronounced effect of taking it.

Valentina: I, too, am all about diet and exercise. I hoped for loads, I thought that my healthy lifestyle.

All materials presented on the site are for reference and informational purposes only and cannot be considered a treatment method prescribed by a doctor or sufficient advice.

The site administration and the authors of the articles are not responsible for any losses and consequences that may arise when using the site materials.

Source: http://medside.ru/makropen

Macropen - instructions for use, analogs, reviews and release forms (granules for preparing a suspension, 400 mg tablets) of a drug for the treatment of sore throat, sinusitis and other infections in adults, children and pregnancy. Compound

In this article you can read the instructions for use of the drug Macropen. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Macropen in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Macropen in the presence of existing structural analogues. Use for the treatment of sore throat, sinusitis and other infectious diseases in adults, children, as well as during pregnancy and lactation. Composition of the drug.

Macropen is an antibiotic of the macrolide group. Inhibits protein synthesis in bacterial cells. Reversibly binds to the 50S subunit of the bacterial ribosomal membrane. In low doses the drug has a bacteriostatic effect, in high doses it has a bactericidal effect.

Active against intracellular microorganisms: Mycoplasma spp., Chlamydia spp., Legionella spp., Ureaplasma urealyticum; gram-positive and gram-negative bacteria.

Midecamycin + excipients.

After oral administration, Macropen is quickly and fairly completely absorbed from the gastrointestinal tract. High concentrations of midecamycin and midecamycin acetate are created in internal organs (especially in lung tissue, parotid and submandibular glands) and skin. Midecamycin is excreted in bile and to a lesser extent (about 5%) in urine.

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

  • respiratory tract infections: tonsillopharyngitis, acute otitis media, sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia (including those caused by atypical pathogens Mycoplasma spp., Chlamydia spp., Legionella spp. and Ureaplasma urealyticum);
  • infections of the genitourinary system caused by Mycoplasma spp., Chlamydia spp., Legionella spp. and Ureaplasma urealyticum;
  • infections of the skin and subcutaneous tissue;
  • treatment of enteritis caused by Campylobacter spp.;
  • treatment and prevention of diphtheria and whooping cough.

Film-coated tablets 400 mg.

Granules for the preparation of suspension for oral administration (ideal children's form).

Instructions for use and dosage

The drug should be taken before meals.

For adults and children weighing more than 30 kg, Macropen is prescribed 400 mg (1 tablet) 3 times a day. The maximum daily dose for adults is 1.6 g.

For children weighing less than 30 kg, the daily dose is mg/kg body weight in 3 divided doses or 50 mg/kg body weight in 2 divided doses, for severe infections - 50 mg/kg body weight in 3 divided doses.

The prescription regimen for Macropen in the form of a suspension for children (daily dose of 50 mg/kg body weight in 2 doses) is presented below:

  • up to 5 kg (approx. 2 months) - 3.75 ml (131.25 mg) 2 times a day;
  • up to 10 kg (approx. 1-2 years) - 7.5 ml (262.5 mg) 2 times a day;
  • up to 15 kg (approx. 4 years) - 10 ml (350 mg) 2 times a day;
  • up to 20 kg (approx. 6 years) - 15 ml (525 mg) 2 times a day;
  • up to 30 kg (approx. 10 years) - 22.5 ml (787.5 mg) 2 times a day.

The duration of treatment is from 7 to 14 days, for the treatment of chlamydial infections - 14 days.

To prevent diphtheria, the drug is prescribed at a dose of 50 mg/kg per day, divided into 2 doses, for 7 days. A control bacteriological study after completion of therapy is recommended.

To prevent whooping cough, the drug is prescribed at a dose of 50 mg/kg per day for 7-14 days in the first 14 days from the moment of contact.

To prepare the suspension, add 100 ml of boiled or distilled water to the contents of the bottle and shake well. It is recommended to shake the prepared suspension before use.

  • decreased appetite;
  • stomatitis;
  • nausea, vomiting;
  • diarrhea;
  • feeling of heaviness in the epigastrium;
  • increased activity of liver transaminases and jaundice;
  • severe and prolonged diarrhea, which may indicate the development of pseudomembranous colitis;
  • skin rash;
  • hives;
  • skin itching;
  • eosinophilia;
  • bronchospasm;
  • weakness.
  • severe liver failure;
  • children under 3 years of age (for tablets);
  • hypersensitivity to midecamycin/midecamycin acetate and other components of the drug.

Use during pregnancy and breastfeeding

The use of Macropen during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Midecamycin is excreted in breast milk. When using Macropen during lactation, breastfeeding should be stopped.

Use in children under 12 years of age

The drug is used according to indications, in the recommended dosage form and in doses taking into account the age of the patients.

As with the use of any other antimicrobial drugs, overgrowth of resistant bacteria is possible with long-term therapy with Macropen. Prolonged diarrhea may indicate the development of pseudomembranous colitis.

During long-term therapy, liver enzyme activity should be monitored, especially in patients with impaired liver function.

Mannitol contained in suspension granules may cause diarrhea.

If you have a history of an allergic reaction to acetylsalicylic acid, azo dye E110 (sunset yellow dye) can cause an allergic reaction, including bronchospasm.

Impact on the ability to drive vehicles and operate machinery

The effect of Macropen on the speed of psychomotor reactions and the ability to drive a car and other mechanisms has not been reported.

With the simultaneous use of Macropen with ergot alkaloids and carbamazepine, their metabolism in the liver decreases and their concentration in the serum increases. Therefore, caution should be exercised when prescribing these drugs simultaneously.

When Macropen is used simultaneously with cyclosporine and anticoagulants (warfarin), the elimination of the latter is slowed down.

Macropen does not affect the pharmacokinetic parameters of theophylline.

Analogues of the drug Macropen

The drug Macropen has no structural analogues for the active substance.

Analogs by pharmacological group (Macrolides and azalides):

Source: http://instrukciya-otzyvy.ru/259-makropen-po-primeneniyu-analogi-granuly-dlya-prigotovleniya-suspenzii-tabletki-angina-gaymorit.html

Macropen ® (Macropen ® )

Active substance:

Content

Pharmacological group

Nosological classification (ICD-10)

3D images

Compound

pharmachologic effect

Directions for use and doses

Adults and children weighing >30 kg: 1 tablet. (400 mg) 3 times a day. The maximum daily dose for adults is 1600 mg.

Children weighing <30 kg: daily dose - 20-40 mg/kg, divided into 3 doses or 50 mg/kg in 2 doses.

For severe infections: daily dose - 50 mg/kg, divided into 3 doses.

The prescription regimen for Macropen ® in the form of a suspension for children (daily dose - 50 mg/kg with 2 doses) is presented in the table.

The duration of treatment is from 7 to 14 days, for the treatment of chlamydial infections - 14 days.

To prevent diphtheria, a dose of 50 mg/kg/day is recommended, divided into 2 doses, for 7 days. A control bacteriological study after completion of therapy is recommended.

To prevent whooping cough, a dose of 50 mg/kg/day is recommended for 7–14 days in the first 14 days from the moment of contact.

Add 100 ml of water (boiled or distilled) to the contents of the bottle and shake well.

Shake before use!

Release form

Film-coated tablets, 400 mg. 8 tablets each in a blister; 2 blisters are packed in a cardboard box.

Granules for the preparation of suspension for oral administration, 175 mg/5 ml. 20 g in a dark glass bottle with an aluminum cap with tamper evident, complete with a polypropylene dosing spoon; 1 set is packed in a cardboard box.

Manufacturer

Representative office of JSC "KRKA, d.d., Novo Mesto" in the Russian Federation / organization accepting consumer complaints: Moscow, Golovinskoye Shosse, 5, bldg. 1, fl. 22.

Tel.: ; Fax .

Conditions for dispensing from pharmacies

Storage conditions for the drug Macropen ®

Keep out of the reach of children.

Shelf life of the drug Macropen ®

Do not use after the expiration date stated on the package.

Synonyms of nosological groups

Prices in Moscow pharmacies

The information is intended solely for comparing prices in stationary pharmacies operating in accordance with Article 55 of the Federal Law “On the Circulation of Medicines” dated April 12, 2010 N 61-FZ.

film-coated tablets 400 mg, 16 pcs.

granules for the preparation of suspension for oral administration 175 mg/5 ml, 1 pc.

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Opinion of “Doctors of the Russian Federation” about the drug Macropen ®

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Macropen - official instructions for use

Registration number:

Trade name:

International nonproprietary name:

Dosage form:

granules for the preparation of suspension for oral administration

Compound

1 g of granules contains:

Active substance: midecamycin acetate 200.00 mg (corresponding to 175 mg of midecamycin acetate in 5 ml suspension)

Excipients: methyl parahydroxybenzoate 1.00 mg, propyl parahydroxybenzoate 0.20 mg, citric acid 0.25 mg, sodium hydrogen phosphate, anhydrous 16.75 mg, banana flavor, powder 14.00 mg, sunset yellow dye FCF, E110 1.50 mg, hypromellose 30.00 mg, silicone defoamer 0.17 mg, sodium saccharinate 0.70 mg, mannitol qs up to 1000.00 mg.

Description

Small orange granules with a slight banana aroma without visible impurities.

Description of the suspension: an aqueous suspension prepared in 100 ml of water, orange in color with a slight banana aroma.

Pharmacotherapeutic group:

Pharmacological properties

Macropen is a macrolide antibiotic that inhibits the synthesis of proteins in bacterial cells; it has a bacteriostatic effect in low doses and a bactericidal effect in large doses. Reversibly binds to the 50S subunit of the bacterial ribosomal membrane. It is effective against intracellular microorganisms: Mycoplasma spp., Chlamydia spp., Legionella spp., Ureaplasma urealyticum; gram-positive bacteria: Stretococcus spp., Staphylococcus spp., Corynebacterium diphtheriae, Listeria monocytogenes, Clostridium spp. and some gram-negative bacteria: Neisseria spp., Moraxella catarrhalis, Bordetella pertussis, Helicobacter spp., Campylobacter spp., Bacteroides spp.

After oral administration, the drug is quickly and fairly completely absorbed from the gastrointestinal tract (GIT). Maximum serum concentrations of midecamycin and midecamycin acetate are 0.5-2.5 mcg/L and 1.31-3.3 mcg/L, respectively, and are achieved 1-2 hours after oral administration.

High concentrations of midecamycin and midecamycin acetate are created in internal organs (especially in lung tissue, parotid and submandibular glands) and skin. The minimum inhibitory concentration (MIC) persists for 6 hours. The half-life is approximately 1 hour. Protein binding - 47% midecamycin and 3-29% metabolites.

The drug is metabolized in the liver to form 2 active metabolites with antimicrobial activity. It is excreted in the bile and to a lesser extent (about 5%) by the kidneys.

In liver cirrhosis: plasma concentrations, area under the concentration-time curve and half-life increase significantly.

Indications

Contraindications

  • Hypersensitivity to midecamycin/midecamycin acetate and any other components of the drug;
  • severe liver failure.

Pregnancy and lactation

The use of the drug during pregnancy is indicated only in cases where the potential benefit to the mother outweighs the risk to the fetus.

Nursing mothers should stop breastfeeding during treatment with Macropen, as the drug is excreted into breast milk.

Directions for use and doses

Orally, should be taken before meals.

Children weighing less than 30 kg: the daily dose of midecamycin is mg/kg body weight, divided into 3 doses, or 50 mg/kg body weight, divided into 2 doses.

1 dosing spoon has measuring divisions of 1.25 ml, 2.5 ml and 5 ml.

Side effects

From the gastrointestinal tract: loss of appetite, stomatitis, nausea, vomiting and diarrhea, feeling of heaviness in the epigastrium, increased activity of “liver” transaminases and hyperbilirubinemia, jaundice.

In rare cases, severe and prolonged diarrhea may occur, which may indicate the development of pseudomembranous colitis.

Allergic reactions: skin rash, urticaria, itching, eosinophilia, bronchospasm.

Overdose

There are no reports of cases of serious overdose caused by Macropen.

Possible symptoms: nausea, vomiting. Treatment: symptomatic.

Interaction with other drugs

When ergot alkaloids or carbamazepine are taken simultaneously with Macropen, their metabolism in the liver decreases and serum concentration increases. Therefore, caution should be used when taking these drugs together.

Does not affect the pharmacokinetic parameters of theophylline.

When Macropen is used simultaneously with cyclosporine or anticoagulants (warfarin), the elimination of the latter slows down.

special instructions

During long-term therapy, the activity of liver enzymes should be monitored, especially in patients with impaired liver function.

As with any antimicrobial drug, long-term treatment may result in overgrowth of resistant bacteria. Prolonged diarrhea may indicate the development of pseudomembranous colitis.

Mannitol contained in Macropen (granules for oral suspension) may cause diarrhea.

If there is an allergic reaction to acetylsalicylic acid, azo dye E PO (sunset yellow dye, E110) can cause an allergic reaction, including bronchospasm.

Effect on the ability to drive a car or use other machinery

The effect of Macropen on psychophysiological reactions and the ability to drive a car and other mechanisms has not been reported.

Release form

Storage conditions

Best before date

Do not use the drug after the expiration date.

Vacation conditions

Dispensed by prescription.

Manufacturer:

JSC Krka d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Representative office of JSC "KRKA, d.d., Novo Mesto" in the Russian Federation / Organization accepting consumer complaints:

125212, Moscow, Golovinskoe highway, building 5, building 1

Source: http://medi.ru/instrukciya/makropen_3264/

Macropen: instructions for use

The drug Macropen belongs to the macrolide group of antibiotics.

Composition and release form of the medicinal product

The drug Macropen is available in the form of tablets for oral use. The tablets are coated with a protective film coating and packaged in blisters of 8 pieces, 2 blisters in a cardboard box. The drug comes with detailed instructions for the drug.

Each tablet of the drug contains 0.4 g of the active ingredient - Midecamycin, as well as a number of excipients.

Pharmacological properties of the drug

Macropen is an antibiotic from the macrolide group. The drug inhibits protein synthesis in the cells of infectious agents. In low doses, the drug has a bacteriostatic effect (stops the growth and reproduction of pathological microorganisms), in higher doses it has a bactericidal effect (completely destroys the pathogen).

The drug Macropen exhibits high therapeutic activity against the following infectious agents:

Indications for use

Macropen tablets are prescribed to patients for diseases caused by microflora sensitive to the active ingredient. These include:

  • Infectious and inflammatory processes of the upper and lower respiratory tract: tonsillitis, pharyngitis, otitis media, sinusitis, sinusitis, frontal sinusitis, bronchitis (acute and chronic), pneumonia, laryngotracheitis;
  • Inflammatory and infectious diseases of the genitourinary system - cystitis, urethritis, chlamydia, ureaplasmosis, mycoplasmosis;
  • Infections of soft tissues and subcutaneous fat - carbuncles, boils, pyoderma, abscesses, phlegmon;
  • As part of complex therapy for gastric ulcers caused by the bacterium Helicobacter pylori;
  • As part of complex therapy for childhood infections - diphtheria and whooping cough.

Contraindications

This drug can be used in therapy only as prescribed by a doctor after conducting a preliminary full examination of the patient and establishing the sensitivity of the pathogen to Macropen. Before starting to use the tablets, the patient is advised to carefully study the accompanying instructions for the drug, since the medicine has a number of the following contraindications for use:

  • Individual intolerance to the components of the drug;
  • Severe renal and liver dysfunction, severe hepatic or renal failure;
  • Age in children under 3 years for this dosage form;
  • 1st trimester of pregnancy.

The drug is used with caution in the second half of pregnancy, during breastfeeding and in the presence of a history of severe allergic reactions to acetylsalicylic acid preparations.

Method of administration and dosage regimen of the drug

According to the instructions, adult patients are prescribed 1 tablet of Macropen 3-4 times a day, depending on the severity of the disease, the characteristics of the body and the presence of complications. The drug is taken orally before meals or 1 hour after meals; if necessary, the tablet is crushed or chewed with a sufficient amount of liquid. The duration of drug therapy should not exceed 7 days. If there is no expected therapeutic effect, the patient is recommended to consult a doctor again to clarify the sensitivity of the infectious agent to the drug.

For children over 3 years of age, the daily dose of the drug is calculated individually depending on body weight and tolerability of the drug.

Use during pregnancy and lactation

In the first trimester of pregnancy, the use of Macropen tablets, like any other antibiotic from the macrolide group, is contraindicated, as this can negatively affect the development of the internal organs and systems of the unborn baby.

In the second and third trimesters of pregnancy, the use of Macropen tablets is possible only if there are vital indications, in the case when the expected benefit to the mother significantly exceeds the possible risk to the fetus. Treatment is carried out under the strict supervision of specialists.

Since the active ingredient of the drug can be excreted in breast milk, the use of Macropen during lactation is not recommended. If treatment is necessary, a nursing mother should consider switching her baby to an adapted milk formula.

Side effects

During treatment with Macropen tablets, patients experienced the development of the following side effects:

  • From the digestive tract - pain in the stomach, nausea, increased salivation, vomiting, diarrhea, lack of appetite, enlarged liver and liver transminase activity; in rare cases, with an increase in the recommended dose, organ function may be suppressed;
  • Stomatitis;
  • Vaginal dysbiosis in women with long-term use in large doses;
  • From the respiratory system – bronchospasm;
  • Allergic skin rashes;
  • Urticaria, development of angioedema in rare cases.

Overdose

With an increase in the recommended dose and long-term use of the drug, patients may develop signs of overdose, which are expressed in an increase in the above side effects and inhibition of liver and kidney function.

If you accidentally ingest a large number of tablets, the patient should rinse the stomach as soon as possible and give enterosorbents to drink. If necessary, symptomatic treatment is carried out.

As a rule, if the recommended dose is observed, cases of drug overdose are very rare.

Interaction of the drug with other drugs

The drug Macropen should not be prescribed simultaneously with other antibiotics from the macrolide group, as this increases the likelihood of side effects and overdose.

The simultaneous use of the drug with Cyclosporine and Warfarin slows down the process of removing the latter from the body, as a result of which patients may develop negative reactions. This should be taken into account and the dose adjusted if necessary for this drug interaction.

special instructions

Use of the drug Macropen for more than 7 days can lead to the development of sensitivity of the pathogen to the active component of the drug. If there is no desired therapeutic effect, the patient should consult a doctor to select another drug.

If persistent diarrhea develops during treatment with Macropen, the patient should consult a doctor to exclude the development of pseudomembranous colitis.

It is strictly forbidden to independently cancel treatment with the drug or reduce the dose prescribed by the doctor if the condition improves. This may lead to the development of pathogen resistance to Macropen and the resumption of the clinical picture of the disease, which will require the selection of a stronger drug in high doses.

The drug does not affect the functioning of the nervous system and does not inhibit the speed of psychomotor reactions.

Macropen analogues

The drug Macropen has a number of drugs similar in their effect:

The listed drugs have different dosages and age restrictions, so before replacing Macropen with one of the listed analogues, you should definitely consult your doctor.

Conditions of release and storage

The drug Macropen is dispensed from pharmacies with a doctor's prescription. The tablets should be stored at a temperature of no more than 25 degrees out of the reach of children. The expiration date is indicated on the packaging; after its expiration, the drug must be disposed of.

Macropen price

The average cost of Macropen in tablet form in Moscow pharmacies is 320 rubles.

Source: http://bezboleznej.ru/makropen