Macropen tablets: instructions for use, price, reviews for children, analogues

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

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 . Its effectiveness has been noted against gram-positive (clostridium, streptococcus, listeria, staphylococcus, corynobacteria), gram-negative (campylobacter, moraxella, Haemophilus influenzae, Helicobacter, bacteroides) bacteria , as well as intracellular microorganisms (mycoplasma, chlamydia, ureaplasma).

Pharmacokinetics

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).

Buy Macropen film-coated tablets 400 mg No. 16 in pharmacies

Instructions for use Macropen tablet p.o 400 mg No. 16

Dosage forms tablets 400 mg Synonyms There are no synonyms. Group Antibiotics - macrolides and azalides International nonproprietary name Midecamycin Composition Active substance: Midecamycin. Manufacturers Krka d.d. (Slovenia), Krka dd., Novo mesto (Slovenia) Pharmacological action Antibacterial. In small doses it has a bacteriostatic effect, in large doses it has a bactericidal effect. After oral administration, it is quickly and completely absorbed, creating Cmax after 1-2 hours. It easily penetrates tissues (lungs, parotid and submandibular glands, skin) and accumulates in them in higher concentrations than in the blood. MIC persists for 6 hours. In the liver it forms two pharmacologically active metabolites. It is excreted mainly in bile, a small part is excreted in urine (less than 5%). Acts on gram-positive bacteria (Streptococcus spp., Staphylococcus spp., Corynebacterium diphtheriae, Listeria monocytogenes, Erysipelothrix spp.), gram-negative bacteria (Neisseria spp., Moraxella catarrhalis, Bordetella pertussis, Helicobacter spp., Campylobacter spp., Haemophilus influenzae), anaerobic bacteria (Clostridium spp., Bacteroides spp.), intracellular pathogens (Mycoplasma hominis, Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum, Legionella pneumophila). Side effects Anorexia, nausea, vomiting, diarrhea, transient increase in the activity of hepatic transaminases in the blood plasma, eosinophilia, allergic skin reactions, stomatitis; very rarely - persistent diarrhea, which may indicate pseudomembranous colitis. Indications for use Infections of the respiratory tract and genitourinary system caused by intracellular microorganisms. Infections of the respiratory tract, skin, subcutaneous tissue, etc., caused by bacteria sensitive to penicillin, for the treatment of patients with hypersensitivity to penicillin. Enteritis caused by bacteria of the genus Campylobacter. Diphtheria and whooping cough (treatment and prevention). Contraindications Hypersensitivity to midecamycin or other macrolides, severe liver failure. Directions for use and dosage : Orally, before meals. Adults and children weighing more than 30 kg - 400 mg 3 times a day (maximum daily dose for adults - 1600 mg). For children weighing less than 30 kg - in a daily dose of 20-40 mg/kg, divided into 3 doses or 50 mg/kg in 2 doses, for severe infections - 50 mg/kg in 3 doses. The duration of treatment is usually 7-14 days, for chlamydial infections - 14 days. Overdose No information available. Interaction When taken simultaneously with macropen, the excretion of cyclosporine and warfarin, the biotransformation of carbamazepine and ergot alkaloids are reduced. Special instructions Use during pregnancy and breastfeeding: possible if the expected effect of therapy exceeds the potential risk to the fetus. Breastfeeding should be stopped during treatment. During long-term treatment, it is necessary to monitor liver function in cases of liver impairment in history. Storage conditions List B. Store in a dry place at a temperature not exceeding 25 degrees. WITH.

Indications for use

Infections caused by microorganisms sensitive to the drug:

respiratory tract infections ( tonsillitis, pharyngitis, otitis media, sinusitis, bronchitis, pneumonia );
urinary tract infections 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.

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 400 mg No. 16 Tablets

Trade name: Macropen® International nonproprietary name: Midecamycin Dosage form: Film-coated tablets, 400 mg Composition: One tablet contains the active substance - midecamycin 421.0 mg (in terms of midecamycin content 950 μg/mg), excipients: potassium polakrilin, talc, microcrystalline cellulose, magnesium stearate, film shell: copolymer of basic butylated methacrylate, polyethylene glycol, titanium dioxide E 171, talc. Description: Round, slightly biconvex, white film-coated tablets, with a chamfer and a score on one side. Pharmacotherapeutic group: Antimicrobial drugs for systemic use. Macrolides.

Pharmacological properties:

Pharmacokinetics Absorption. Medicamycin and mediamycin acetate are rapidly and relatively well absorbed and reach maximum serum concentrations of 0.5 mcg/ml to 2.5 mcg/ml and 1.31 mcg/ml to 3.3 mcg/ml, respectively, within 1 to 2 hours. Eating slightly reduces maximum concentrations, especially in children (4 to 16 years). Therefore, it is recommended to take midecamycin before meals. Distribution.Midecamycin penetrates well into tissues, where it reaches more than 100% concentration than in the blood. High concentrations were found in bronchial secretions and in the skin. The volume of distribution of midecamycin acetate is large: 228 - 329 liters in healthy volunteers. 47% of midecamycin and 3 - 29% of metabolites are protein bound. Midecamycin acetate is excreted into breast milk. After a dose of 1200 mg/day, 0.4 mcg/ml - 1.7 mcg/ml midecamycin acetate is detected in breast milk. Metabolism and removal. Midecamycin is primarily metabolized into active metabolites in the liver. It is excreted primarily in bile, and only about 5% in urine. Significant increases in maximum serum concentrations, area under the curve, and half-life may be observed in patients with cirrhosis. Pharmacodynamics Antibacterial action Midecamycin is a broad-spectrum macrolide antibiotic whose activity is similar to that of erythromycin. It is active against gram-positive bacteria (staphylococci, streptococci, pneumococci, Bacillus anthracis, Corynebacterium diphtheriae, and Listeria monocytogenes), against some gram-negative bacteria (Bordetella pertussis, Campylobacter, Moraxella catarrhalis and Neisseria spp.), anaerobes (Clostridium spp. and Bacteroides spp.) and other bacteria such as mycoplasma, ureaplasma, chlamydia and legionella. In vitro bacterial susceptibility to midecamycin acetate (MDM-acetate) and midecamycin (MDM) Average MIC90 (µg/ml) Bacteria MDM-acetate MDM Streptococcus pneumoniae 0.5 0.10 Streptococcus pyogenes 0.67 0.20 Streptococcus viridans 0.28 0.39 Staphylococcus a ureus 1.5 1.5 Listeria monocytogenes 2 1.5 Bordetella pertussis 0.25 0.20 Legionella pneumophila 0.1 0.12 – 1 Moraxella catarrhalis 2 — Helicobacter pylori 0.5 — Propionibacterium acnes 0.12 — Bacteroides fragilis 5.5 3.13 Mycoplasma pneumoniae 0.024 0.0078 Ureaplasma urealyticum 0.34 1. 56 Mycoplasma hominis 2.3 — Gardnerella vaginalis 0.08 — Chlamydia trachomatis 0.06 — Chlamydia pneumoniae 0.5 — Criteria for midecamycin, regarding interpretation, the MICs are the same as for other macrolides, according to NCCLS (National Committee on Clinical Laboratory Standards) standards. Bacteria are defined as sensitive if their MIC90 is ? 2 µg/ml, how resistant if their MIC90? 8 µg/ml. Antimicrobial effectiveness of metabolites Metabolites of midecamycin have a similar antibacterial spectrum as midecamycin, but their effect is somewhat weaker. Results from some animal trials have demonstrated that the efficacy of midecamycin and midecamycin acetate is better in vivo than in vitro. This is partly due to high concentrations of active metabolites in tissues. Mechanism of action. Midecamycin inhibits RNA-dependent protein synthesis at the stage of protein chain elongation. Midecamycin reversibly binds to the 50S subgroup and blocks the transpeptidation and/or translocation reaction. Due to the different structure of ribosomes, communication with the ribosomes of a eukaryotic cell does not occur. This is why the toxicity of macrolides to human cells is low. Like other macrolide antibiotics, midecamycin has a primarily bacteriostatic effect. However, it may also have a bactericidal effect, which depends on the type of bacterium, the drug concentration at the site of action, the size of the inoculum and the reproductive stage of the microorganism. In vitro activity is reduced in acidic conditions. If the pH value in the culture medium of Staphylococcus aureus or Streptococcus pyogenes increases from 7.2 to 8.0, the MIC for midecamycin is two times lower. If the pH drops, the situation is reversed. High intracellular concentrations of macrolides are achieved as a result of their good lipid solubility. This is especially important when treating infections caused by microorganisms with an intracellular development cycle, such as chlamydia, legionella and listeria. Midecamycin has been shown to accumulate in human alveolar macrophages. Macrolides also accumulate in neutrophils. While the ratio between extracellular and intracellular concentrations ranges from 1 to 10 for erythromycin, it is over 10 for newer macrolides, including midecamycin. The accumulation of neutrophils at the site of infection may further increase the concentration of macrolides in infected tissues. In vitro studies have shown that midecamycin also affects immune functions. Thus, increased chemotaxis has been established in comparison with erythromycin. Medicamycin appears to stimulate natural killer cell activity in vivo. All of these studies indicate that midecamycin affects the immune system, which may be important for the in vivo antibiotic action of midecamycin. Sustainability. Resistance to macrolides develops due to the following reasons: reduced permeability of the outer cell membrane (Enterobacter), drug inactivation (S. aureus, E. coli) and, most importantly, an altered site of action. From a geographic perspective, the prevalence of bacterial resistance to macrolides is highly variable. Resistance of methicillin-susceptible S. aureus ranges from 1% to 50%, while most methicillin-resistant S. aureus strains are also macrolide resistant. Resistance of pneumococci is mostly below 5%, but in some parts of the world it is over 50% (Japan). Resistance of Streptococcus pyogenes to macrolides ranges from 1% to 40% in Europe. Resistance develops very rarely in Mycoplasmas, Legionella and C. diphteriae. Indications for use: - infections of the respiratory tract and genitourinary tract caused by mycoplasmas, legionella, chlamydia and Ureaplasma urealyticum; - infections of the respiratory tract, skin and subcutaneous tissue and all other infections caused by bacteria sensitive to midecamycin and penicillin in patients with hypersensitivity to penicillin; — enteritis caused by bacteria of the genus Campylobacter; - treatment and prevention of diphtheria and whooping cough. Directions for use and dosage: Macropen should be taken before meals. Adults and children weighing more than 30 kg: one 400 mg tablet 3 times a day. The maximum daily dose of midecamycin for adults is 1600 mg. The duration of treatment is usually from 7 to 14 days. Chlamydial infections are treated for 14 days. Side effects: During treatment with Macropen, mild gastrointestinal disturbances (decreased appetite, stomatitis, nausea, vomiting and diarrhea) may occur. In rare cases, severe and prolonged diarrhea may occur, which may indicate the development of pseudomembranous colitis. Allergic reactions (skin rash, urticaria, itching, eosinophilia), increased transaminase activity and jaundice are also possible. Contraindications: - hypersensitivity to the active substance or auxiliary components of the drug - severe liver failure - children under 6 years of age. Drug interactions: Macrolides are known to interact with other medications. Macrolide antibiotics affect liver metabolism by inactivating cytochrome P450. Unlike erythromycin, midecamycin and midecamycin acetate do not bind to microsomal oxidases of liver cells and do not produce stable complexes with cytochrome P450. As a result, they do not affect the pharmacokinetics of theophylline. Midecamycin may increase serum levels of cyclosporine (two-fold) and prolong the elimination half-life and AUC (area under the curve) of carbamazepine. Caution is advised in patients taking carbamazepine or cyclosporine concomitantly and serum levels should be monitored whenever possible. Concomitant use of midecamycin and ergot alkaloids may cause decreased hepatic metabolism and increased serum concentrations of ergot alkaloids. Caution should be used when using warfarin concomitantly because midecamycin may slow its elimination, increasing the risk of hemorrhage. 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. 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. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms. The effect of Macropen on psychophysiological reactions and the ability to drive a car and other mechanisms has not been reported. Overdose: Symptoms: When taking excess doses, nausea and vomiting may occur. Treatment: Symptomatic. Release form: Film-coated tablets, 400 mg.

Packaging: 8 tablets in a blister pack made of polyvinyl chloride and polyvinyl dichloride film and printed aluminum foil. 2 contour packages in a cardboard box along with instructions for use. Storage conditions: Store in a place protected from moisture, at a temperature not exceeding 25 0C. Keep out of the reach of children! Shelf life: 3 years. Do not use after expiration date. Conditions for dispensing from pharmacies: By prescription

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 often occurs when other antibiotics are prescribed. 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.

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 .

When using Macropen with warfarin , the risk of bleeding increases, with cyclosporine - the risk of nephrotoxicity, with ergometrine and ergotamine - peripheral vascular spasm ( ischemia and possible gangrene of the extremities).

Macropen's analogs

Level 4 ATC code matches:
Ecositrin

Azicine

Rovamycin

AzitRus

Safocid

Clarithromycin

Sumamed Forte

Klarbakt

Azithromycin

Azitro Sandoz

Sumamed

ZI-Factor

Azitral

Azimed

Azicide

Spiramycin-vero

Zitrolide

Ecomed

Klacid SR

Klacid

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 - 85 -99 rub. (Obolenskoye FP Russia), designed for a 3-day course of treatment.

Reviews about Macropen

Reviews about Macropen are in most cases 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.

Special instructions for the use of the drug Macropen

During long-term treatment, liver enzyme activity should be monitored, especially in patients with impaired liver function. Long-term use of the drug can lead to the development of superinfection. Persistent diarrhea may be a manifestation of pseudomembranous colitis. No negative effects on the fetus have been identified, however, the use of the drug during pregnancy is indicated only if the expected therapeutic effect for the expectant mother exceeds the potential risk to the fetus. Since the drug is excreted in breast milk, breastfeeding should be discontinued during treatment.

Macropen price, where to buy

This drug can be found in any pharmacy. By purchasing Macropen tablets, the price of which in Moscow pharmacies varies and ranges from 268 to 376 rubles. 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 RussiaRussia
Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

ZdravCity

Macropen granules for Prig Susp.
for internal approx. 175 mg/5 ml 115 ml JSC KRKA, d.d., Novo mesto 542 rub. order
Macropen tablets p.p.o. 400 mg 16 pcs. Merck KGaA and Co. Werk Spittal / KRKA SA, d.d.
468 RUR order

Pharmacy Dialogue

Macropen (tab. 400 mg No. 16)KPKA
RUB 453 order
Macropen (susp. 175 mg/5 ml 115 ml)KPKA
530 rub. order
Macropen (tab. 400 mg No. 16)KPKA
RUB 445 order

Pharmacy24

Macropen 175 mg/5 ml 115 ml granules
96 UAH. order
Macropen 400 mg No. 16 tablets KRKA, d.d., Novo Mesto, Slovenia/Merck KGaA i Co., Werk Spital, Austria
106 UAH order

PaniPharmacy

Macropen tablets Macropen tablets. p/o 400 mg No. 16 Slovenia, KRKA dd Novo Mesto
116 UAH order
Macropen liquid Macropen granules for suspension 175 mg/5 ml 115 ml Slovenia, KRKA dd Novo Mesto
120 UAH order

Macropen 175 mg/5 ml 115 ml por.d/susp. for oral administration

Instructions for medical use of the drug MACROPEN® Trade name Macropen® International nonproprietary name Midecamycin Dosage form Granules for the preparation of an oral suspension 175 mg/5 ml Composition One gram of granulate contains the active substance - midecamycin acetate 200.00 mg, excipients: methyl parahydroxybenzoate, propyl para- hydroxybenzoate, citric acid, anhydrous sodium hydrogen phosphate, banana flavor (powder), yellow iron oxide (E 172), hypromellose, silicone defoamer, sodium saccharin, mannitol. Description Small yellow granules with a slight banana smell without visible impurities. After adding 100 ml of water and vigorous shaking, a yellow suspension with a slight banana smell should form. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Macrolides. ATC code J01FA03 Pharmacological properties Pharmacokinetics Absorption Midecamycin is rapidly and relatively well absorbed, reaching maximum serum concentrations from 0.5 mcg/ml to 2.5 mcg/ml within 1 to 2 hours. Eating slightly reduces maximum concentrations, especially in children (4 to 16 years). Therefore, it is recommended to take midecamycin before meals. Distribution Midecamycin penetrates well into tissues, where it reaches more than 100% concentration than in the blood. High concentrations were found in bronchial secretions and in the skin. The volume of distribution of midecamycin acetate is large: 228 - 329 liters. 47% of midecamycin and 3 - 29% of metabolites are protein bound. Midecamycin acetate is excreted into breast milk. After a dose of 1200 mg/day, 0.4 mcg/ml - 1.7 mcg/ml midecamycin acetate is detected in breast milk. Metabolism and elimination Midecamycin is primarily metabolized to active metabolites in the liver. It is excreted primarily in bile, and only about 5% in urine. Significant increases in maximum serum concentrations, area under the curve, and half-life may be observed in patients with cirrhosis. Pharmacodynamics Macropen® is a broad-spectrum macrolide antibiotic whose activity is similar to that of erythromycin. Macropen® is active against gram-positive bacteria (staphylococci, streptococci, pneumococci, Bacillus anthracis, Corynebacterium diphtheriae, and Listeria monocytogenes), against some gram-negative bacteria (Bordetella pertussis, Campylobacter, Moraxella catarrhalis and Neisseria spp.), anaerobes (Clostridium spp. . and Bacteroides spp.) and other bacteria such as mycoplasma, ureaplasma, chlamydia and legionella. The criteria for Macropen® regarding the interpretation of MIC (minimum inhibitory concentration) are the same as for other macrolides according to NCCLS (National Committee on Clinical Laboratory Standards) standards. Bacteria are defined as sensitive if their MIC90 ≤ 2 μg/ml, and as resistant if their MIC90 ≥ 8 μg/ml. Metabolites have a similar antibacterial spectrum, but their effect is somewhat weaker. Mechanism of action Macropen® inhibits RNA-dependent protein synthesis at the stage of protein chain elongation. Midecamycin reversibly binds to the 50S subgroup and blocks the transpeptidation and/or translocation reaction. Due to the different structure of ribosomes, communication with the ribosomes of a eukaryotic cell does not occur. This is why the toxicity of macrolides to human cells is low. Like other macrolide antibiotics, Macropen® has a mainly bacteriostatic effect. However, it may also have a bactericidal effect, which depends on the type of bacterium, the drug concentration at the site of action, the size of the inoculum and the reproductive stage of the microorganism. In vitro activity is reduced in acidic conditions. If the pH value in the culture medium of Staphylococcus aureus or Streptococcus pyogenes increases from 7.2 to 8.0, the MIC for midecamycin is two times lower. If the pH drops, the situation is reversed. High intracellular concentrations of macrolides are achieved as a result of their good lipid solubility. This is especially important when treating infections caused by microorganisms with an intracellular development cycle, such as chlamydia, legionella and listeria. Midecamycin has been shown to accumulate in human alveolar macrophages. Midecamycin also accumulates in neutrophils. The intracellular concentration of midecamycin exceeds its extracellular concentration by more than 10 times. The accumulation of neutrophils at the site of infection may further increase the concentration of midecamycin in infected tissues. Macropen® also affects immune functions. Indications for use - infections of the respiratory tract and genitourinary tract caused by mycoplasmas, legionella, chlamydia and Ureaplasma urealyticum - infections of the respiratory tract, skin and subcutaneous tissue and all other infections caused by bacteria sensitive to midecamycin and penicillin, in patients with hypersensitivity to penicillin - enteritis caused by bacteria of the genus Campylobacter - treatment and prevention of diphtheria and whooping cough Method of administration and dosage To prepare the suspension, you need to open the lid of the bottle and add 100 ml of distilled water (the use of freshly boiled and cooled water is allowed), close the lid of the bottle and shake well until a homogeneous suspension is formed ( about 2-3 minutes). The prepared suspension must be shaken before use. Measure out the required amount using the included measuring spoon. 1 scoop contains 175 mg of midecamycin. The suspension must be taken before meals. Below is the prescription schedule (daily dose 50 mg/kg body weight): Children Suspension 175 mg/5 ml up to 30 kg (~ 10 years) 2 x 22.5 ml (787.5 mg or 4.5 scoops) up to 20 kg ( ~ 6 years) 2 x 15 ml (525 mg or 3 scoops) up to 15 kg (~ 4 years) 2 x 10 ml (350 mg or 2 scoops) up to 10 kg (~ 1 - 2 years) 2 x 7, 5 ml (262.5 mg or 1.5 measuring spoons) up to 5 kg (~ 2 months) 2 x 3.75 ml (131.25 mg, measure to 3.75 ml mark on measuring spoon) ) The daily dose of Macropen® is 20 – 40 mg/kg body weight, divided into three doses or 50 mg/kg body weight in two doses, in case of severe infections, 50 mg/kg body weight in three doses. The duration of treatment is usually from 7 to 14 days. Chlamydial infections are treated for 14 days. Side effects Uncommon (≥1/1,000 to <1/100): - nausea, loss of appetite, vomiting, diarrhea and stomatitis Very rare (<1/10,000): - eosinophilia - pseudomembranous colitis - rash, urticaria, itching - increased transaminase activity and jaundice If serious side effects occur, you must stop taking the drug. Contraindications - hypersensitivity to the active substance or auxiliary components of the drug; - severe liver failure Drug interactions Macrolides are known to interact with other drugs. Macrolide antibiotics affect liver metabolism by inactivating cytochrome P450. Unlike erythromycin, Macropen® does not bind to microsomal oxidases of liver cells and does not produce stable complexes with cytochrome P450. As a result, it does not affect the pharmacokinetics of theophylline. Macropen® may increase serum levels of cyclosporine (two-fold) and prolong the half-life and AUC (area under the curve) of carbamazepine. Caution is recommended in children taking carbamazepine or cyclosporine concomitantly, and serum levels should be monitored whenever possible. Concomitant use of Macropen® and ergot alkaloids may cause decreased hepatic metabolism and increased serum concentrations of ergot alkaloids. Caution should be exercised when using warfarin concomitantly because Macropen® may slow its elimination, which increases the risk of hemorrhage. Special instructions This dosage form is intended only for children weighing less than 30 kg. Adults and children weighing more than 30 kg should take the drug in tablet form. During long-term therapy, the activity of liver enzymes should be monitored, especially in children 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. Overdose Symptoms: nausea and vomiting. Treatment is symptomatic. Release form and packaging 20 g in dark glass bottles with a capacity of 150 ml with a screw-on aluminum cap and an internal polyethylene lining. 1 bottle, complete with a polypropylene dosing spoon, along with instructions for use in the state and Russian languages, is placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 25 0C. Store in original packaging. Keep out of the reach of children! Shelf life: 3 years The finished suspension is 14 days when stored in a refrigerator or 7 days at a temperature not exceeding 25 0C. Do not use after the expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer KRKA, d.d. Novo Mesto, Slovenia Registration certificate holder KRKA, d.d., Novo Mesto, Slovenia Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan Representative office of “KRKA, tovarna zdravil, dd, Novo mesto” in the Republic of Kazakhstan , 050059, Almaty, Al-Farabi Ave., 5/1, building 1 b, 2nd floor. tel. fax www.krka.si