Macropen tablets and suspension for children: instructions for use. Macropen - a modern antibiotic for children's health

Trade name:

Macropen®

International non-proprietary name:

midecamycin

Dosage form:

granules for 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 of suspension)

Auxiliarysubstances: 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, dye sunset yellow FCF, E110 1.50 mg, hypromellose 30.00 mg, silicone defoamer 0.17 mg, sodium saccharinate 0.70 mg, mannitol q.s. up to 1000.00 mg.

Description

Fine orange granules with a slight banana flavor 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:

antibiotic - macrolide

ATC code: J01FA03

Pharmacological properties

Pharmacodynamics.

Macropen is a macrolide antibiotic that inhibits the synthesis of proteins in bacterial cells, has a bacteriostatic effect in low doses, and in large doses it is bactericidal. 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.

Pharmacokinetics.

After oral administration, the drug is rapidly and fairly completely absorbed from the gastrointestinal tract (GIT). The maximum concentrations of midecamycin and midecamycin acetate in serum are 0.5-2.5 µg/l and 1.31-3.3 µg/l, respectively, and are reached 1-2 hours after ingestion.

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

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

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

Indications

• respiratory tract infections, including those caused by atypical pathogens (mycoplasmas, legionella, chlamydia and Ureaplasma urealyticum): tonsillopharyngitis, acute otitis media, sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia;
• urinary tract infections caused by pathogens: mycoplasmas, legionella, chlamydia and Ureaplasma urealyticum;
• infections of the skin and subcutaneous tissue;
• for the treatment of enteritis caused by bacteria of the genus Campylobacter,
• treatment and prevention of diphtheria and whooping cough.

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.

Dosage and administration

Inside, should be taken before meals.

Children weighing less than 30 kg: the daily dose of midecamycin is 20-40 mg / kg of body weight, divided into 3 doses, or 50 mg / kg of body weight, divided into 2 doses.

The daily dose of midecamycin for severe infections is 50 mg/kg of body weight, divided into 3 doses.

Scheme of appointment for children (daily dose of 50 mg / kg of body weight with 2 times admission):

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

The duration of treatment is usually 7 to 14 days. Chlamydial infections are treated for 14 days.

For the prevention of diphtheria: midecamycin is recommended at a dose of 50 mg / kg / day, divided into 2 doses for 7 days. A control bacteriological examination is recommended after the end of therapy.

In order to prevent whooping cough, midecamycin is recommended at a dose of 50 mg / kg / day for 7-14 days in the first 14 days from the moment of contact.

Suspension preparation:

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

Shake before use!

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, pruritus, eosinophilia, bronchospasm.

Other: weakness.

Overdose

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

Possible symptoms: nausea, vomiting. Treatment: symptomatic.

Interaction with other drugs

With the simultaneous administration of ergot alkaloids or carbamazepine with Macropen, their metabolism in the liver decreases and serum concentration increases. Therefore, caution should be exercised when taking these drugs at the same time.
Does not affect the pharmacokinetic parameters of theophylline.
With the simultaneous use of Macropen with cyclosporine or anticoagulants (warfarin), the excretion of the latter slows down.

special instructions

With long-term therapy, the activity of liver enzymes should be monitored, especially in patients with impaired liver function.
As with any antimicrobial agent, long-term treatment may lead to overgrowth of resistant bacteria. Prolonged diarrhea may indicate the development of pseudomembranous colitis.
The mannitol contained in Macropen (granules for oral suspension) can cause diarrhea.
In the presence of an allergic reaction to acetylsalicylic acid, azo dye E PO (sunset yellow dye, E110) can cause an allergic reaction, up to bronchospasm.

Influence on the ability to drive a car or other mechanisms

It was not reported about the effect of Macropen on psychophysiological reactions and the ability to drive a car and other mechanisms.

Release form

Granules for oral suspension, 175 mg/5 ml. 20 g of granules in a dark glass bottle (type III) with an aluminum cap with a first opening control.

1 bottle complete with dosing spoon made of polypropylene in a carton pack along with instructions for use.

Storage conditions

Granules for the preparation of a suspension for oral administration: at a temperature not exceeding 25 ° C.

The prepared suspension is suitable for 14 days in the refrigerator or 7 days at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Best before date

Do not use the drug after the expiration date.

Holiday conditions

Released by prescription.

Manufacturer:

JSC Krka, d.d., Novo Mesto, 6 Smarjeska cesta, 8501 Novo mesto, Slovenia

Representative office of JSC Krka, d.d., Novo mesto in the Russian Federation / Organization accepting consumer claims:

125212, Moscow, Golovinskoe shosse, building 5, building 1

Content

In infectious and inflammatory diseases of the respiratory and genitourinary systems, soft tissues, patients are recommended to take oral antibiotics in a full course. Among the effective means of this pharmacological group are Macropen tablets and granules. The drug belongs to macrolides. The antibiotic is characterized by a systemic effect in the body, therefore, before starting a course of treatment, it is necessary to consult a specialist. It is important to minimize the risk of side effects.

Composition and form of release

The medical preparation Macropen has 2 dosage forms - film-coated tablets for oral administration; granules for the preparation of a homogeneous suspension. White round tablets are packed in blisters of 8 pcs. 1 carton contains 2 blisters, instructions for use. Orange granules have a mild banana flavor. They are distributed in 20 g bottles of dark glass. A dosing spoon is included in each package. Features of the chemical composition:

Pharmacological properties

Macropen is a systemic macrolide antibiotic that inhibits protein synthesis in bacterial cells. When using the drug in small doses, a bacteriostatic effect is provided, with an increase in the daily dosage - a pronounced bactericidal effect. According to the instructions for use, the antibiotic is active against such pathogens of infectious diseases:

• hemophilic bacillus;
• diphtheria corynobacteria;
• clostridia;
• listeria;
• mycoplasmas;
• moraxella;
• staphylococci;
• streptococci;
• chlamydia;
• Helicobacter pylori;
• ureaplasma.

The active substance of the drug violates the integrity of the membranes of the pathogenic flora, prevents its further reproduction and viability. When administered orally, midecamycin is rapidly absorbed from the digestive tract and enters the bloodstream. The maximum concentration in the blood serum reaches after 1-2 hours, the therapeutic effect is maintained for 6 hours. The metabolic process takes place in the liver. The antibiotic is excreted in the bile, slightly - by the kidneys with urine.

Indications for Macropen's use

• genitourinary system: chlamydia, cystitis, urethritis, mycoplasmosis, ureaplasmosis;
• respiratory system: otitis media, tonsillitis, pharyngitis, purulent tonsillitis, bronchitis, sinusitis, pneumonia, frontal sinusitis, laryngotracheitis, tonsillopharyngitis, sinusitis;
• soft tissues, subcutaneous tissue: furunculosis, carbuncles, phlegmon, pyoderma, abscesses;
• enteritis, peptic ulcer of the stomach and duodenum, caused by the activity of the pathogenic pathogen Helicobacter Pylori;
• diphtheria, whooping cough (as part of complex therapy);
• low efficiency of treatment with penicillin antibiotics.

Method of application and dosage

Detailed instructions for the use of Macropen determines the daily dose of the drug, depending on the nature of the disease, the form of release of the antibiotic. Tablets and suspension are intended for oral administration in a course of 6-14 days. According to the instructions, a single dose is supposed to be taken before meals or 2 hours after a meal, first diluted with water. This is a general rule for the use of granules and tablets.

Tablets

This form of release is prescribed orally. Take Macropen tablets every 8 hours. The course of drug therapy lasts 5-7 days, individually adjusted by the attending physician. Daily dosages of Macropen depend on the weight and age of the patient:

Suspension

To prepare a therapeutic suspension, Macropen granules must first be diluted in 100 ml of water, mixed until a homogeneous composition is formed without sediment with a pronounced banana taste. This medicine is more often prescribed to children, daily doses depend on the weight of the small patient:

special instructions

Macropen with bronchitis provides positive dynamics already 2-3 days after the start of the course, but the patient needs to undergo treatment to the end. Otherwise, the pathogenic infection in the body progresses again, the disease recurs. The instructions for use also contain other recommendations that are relevant for patients:

1. If after 7 days of treatment there is no positive dynamics of the underlying disease, you need to contact your doctor and replace the indicated medication with an analogue.
2. In acute diarrhea, which worsened at the beginning of the Macropen course, additional diagnostics are required to identify a latent form of pseudomembranous colitis.
3. Macropen does not disrupt the functioning of the nervous system, does not inhibit the psychomotor functions of the body. During treatment, it is allowed to engage in all types of work that require increased concentration of attention, drive vehicles.

Macrofoam for children

In childhood, this is the safest antibiotic, which, according to the instructions for use, is allowed to be used almost from the first days of life. Side effects are extremely rare, the therapeutic effect of Macropen is stable and positive. When treating a child, doctors exclude the development of dysbacteriosis, the main thing is to observe the dosage. When using granules, the doctor reminds that the banana suspension does not cause disgust in the child. The little patient tolerates the prescribed treatment without complications.

drug interaction

Macropen with angina or other infectious and inflammatory disease is recommended as part of complex therapy. Before starting the course, it is required to study the information on drug interactions, which are described in detail in the instructions for use:

1. In combination with other representatives of the macrolide group, the risk of side effects and overdose symptoms increases.
2. With simultaneous use with Cyclosporine, the risk of nephrotoxicity increases, when combined with Warfarin, the likelihood of bleeding is high.
3. In combination with carbamazepine, the transformation of the latter in the liver decreases, and the risk of intoxication increases. The patient is concerned about the following symptoms: urinary retention, ataxia, convulsions.
4. Simultaneous use with Ergometrine and ergotamine contributes to the occurrence of spasm of peripheral vessels (ischemia develops in the patient's body, gangrene of the extremities progresses).

Side effects

When prescribing Macropen to a patient, side effects may occur that only worsen the general state of health. These are described in detail in the instructions for use:

• digestive tract: vomiting, diarrhea, abdominal pain, nausea, lack of appetite, increased activity of hepatic transaminases, increased salivation, jaundice;
• respiratory system: bronchospasm;
• allergic reactions: urticaria, Quincke's edema, angioedema, small rash, hyperemia and swelling of the skin;
• stomatitis;
• eosinophilia (increased number of eosinophils).

Contraindications

The antibacterial drug Macropen is not allowed to be used according to the indications for all patients; the medicine can even harm the health of some. Detailed instructions contain a list of medical contraindications:

• hypersensitivity of the body to midecamycin;
• severe liver failure;
• age up to 3 years (for the use of tablets);
• first trimester of pregnancy;
• breastfeeding period.

Terms of sale and storage

This is a prescription drug that can be purchased at a pharmacy. According to the instructions for use, it is recommended to store Macropen in a dry, dark place at a temperature below 25 degrees. It is desirable to dissolve the granules in water immediately before use. The finished suspension can be stored for 7 days at room temperature, 14 days in the refrigerator. The expiration date is indicated on the package. Expired medication must be disposed of.

Macropen's analogs

Not everyone is suitable for this antibiotic. If side effects occur, it is better to choose a replacement for him. Reliable analogues of Macropen and their characteristics:

1. Clarithromycin. The active substance is clarithromycin. Release form - yellow tablets for oral administration and small granules for suspension. According to the instructions, the antibiotic is prescribed for infections of the upper respiratory tract, skin, soft tissues. Daily doses are 250-500 mg twice a day, the course is 6-14 days.
2. Azithromycin. The active substance is azithromycin dihydrate. Forms of release - capsules and powder for oral administration. According to the instructions, it is recommended to use an antibiotic 1 time per day. Daily doses are described in detail in the instructions, depending on the diagnosis made by the doctor. The course of treatment is 7-10 days.
3. Josamycin. It is a white powder to be dissolved in water before oral administration. The antibiotic is allowed to drink only after a meal. The maximum dose for patients over 14 years of age is 3 g for 3 doses. The course of treatment lasts from 6 to 14 days.

Price

The cost of the drug depends on the form of release of the antibiotic, the number of tablets in the package, the reputation of the pharmacy where the purchase was made. The average price of Macropen is 250-400 rubles.

Video

Children are sick. This is, albeit unpleasant, but a fact. Very often in the case of children, it is bacterial infections of the ENT organs that take place, and the genitourinary system is no exception. And always such pathological processes in the body require medical intervention, which, among other things, includes antibiotic therapy.

Today, the shelves of pharmacies are overflowing with such drugs. We will consider in more detail only one of them, namely, the Macropen suspension: what this remedy helps with. And also get acquainted with the reviews of parents about this antibiotic.

The main active ingredient of Macropen is midecamycin. It is he who determines the entire therapeutic effect of the drug. In order for the drug to be brought to a suspension, the manufacturer cannot do without:

• mannitol;
• propyl 4-hydroxy bezoate;
• methylhydroxybenzoate;
• dye.

Thanks to additional components, the suspension also has a shelf life of two whole weeks in a ready-to-use form.

Operating principle

The antibiotic Macropen, or rather, its active substance, belongs to the group of macrolides. Its spectrum of action includes:

The list of such microorganisms is quite extensive:

• streptococci;
• staphylococci;
• clostridia;
• corynobakeria;
• listeria;
• ureaplasma;
• mycoplasmas;
• legionella;
• chlamydia;
• helicobacteria;
• moraxella;
• bacterodes;
• hemophilic rods;
• campylobacter.

After oral administration, Macropen is almost completely absorbed into the blood from the gastrointestinal tract and within 1-2 hours reaches its maximum concentration in its plasma. In addition, the highest concentration of midecamycin is found precisely in the place where the inflammatory process takes place, as well as in bronchial secretions and skin. The drug is excreted mainly through the filtration of blood in the liver.

This antibiotic inhibits protein synthesis in pathogenic microorganisms. Uninvited guests lose the opportunity to reproduce and their normal life. In small quantities, midecamycin simply does not allow them to multiply and populate neighboring tissues and cells. In large doses, it simply kills the tiny causes of the child's illness.

Indications

The reason for the appointment of Macropen can be any infectious processes in the child's body caused by bacteria sensitive to midecamycin. Among them:

• respiratory tract damage;
• diseases of the genitourinary system;
• lesions of the skin and mucous membranes;

• enteritis;
• diphtheria;
• whooping cough.

In addition, this medicine can be prescribed to a young patient with a severe allergic reaction to penicillin antibiotics.

At what age is it allowed to take

In the official instructions for the use of the drug, there are no clear restrictions on the age of the child. Suspension can be given almost from birth. The only point is that this dosage form of the drug is not prescribed for children weighing more than 30 kg., for them, as for adults, there is a tablet version of the medicine. In all other respects, the dosage is calculated solely by weight, starting from zero.

Contraindications and side effects

Macropen suspension is not prescribed if the child has previously been diagnosed with intolerance to any of the components of the drug, including additional ones. In addition, the drug should not be used in severe liver failure. Due to the fact that it is through this organ that midecamycin is excreted from the body, Macropen is also prescribed with caution for any pathologies associated with the liver.

The list of possible side effects associated with taking the suspension is as follows:

• loss of appetite (up to anorexia in extremely rare cases);
• nausea, up to vomiting;
• allergic manifestations on the skin;
• eosinophilia (it can only be detected by a doctor after a general blood test);
• an increase in the level of liver enzymes in the blood (also determined only by the results of a blood test).

In order to avoid such reactions, it is important to follow the exact dosage indicated by the doctor. You should also follow the recommendations related to the preparation of the suspension and the administration of the drug.

Macropen for children - instructions for use and dosage

The suspension is sold as a powder in a vial. Accordingly, before use, this powder must be brought to the desired condition. Follow a simple algorithm:

• Open the bottle, shake it and open the cap.
• Add 100 milliliters of cold boiled water to the granules.
• Close the vial and shake vigorously to dissolve the granules and distribute the powder evenly throughout the liquid.
• Before each use, do not forget to shake the bottle thoroughly, as during storage the powder will separate from the water and settle to the bottom.

The finished suspension is dosed according to the weight of the child:

• up to 5 kg - 3.75 ml;
• 5-10 kg - 7.5 ml;
• 10-15 kg - 10 ml;
• 15-20 kg - 15 ml;
• 20-25 kg - 22.5 ml.

The amount of the drug is indicated for one dose. Macropen suspension is taken twice a day, according to the recommended dosage. Depending on the severity of the condition of the young patient, the latter can be adjusted by the doctor.

Overdose

There are no specific symptoms of an overdose with a suspension. Most often, a single intake of Macropen in large quantities entails nausea and bouts of vomiting. In this case, specific treatment is not needed. It is enough to take sorbents to quickly release the child's body from the drug. Measures aimed at eliminating the unpleasant symptoms of an overdose are also allowed.

Interaction with other drugs

The manufacturer does not recommend the use of Macropen together with drugs made on the basis of carbamezepine. In this case, the suspension can increase their concentration in the baby's blood. It will also entail changes in the transformation of both drugs in the liver.

In addition, this antibiotic should not be prescribed together with cyclosporine and warfarin drugs. These substances are incompatible. Such an appointment may exacerbate the side effects of drugs.

Analogues

In cases where, for some reason, taking a Macropen suspension is not possible, it makes sense, together with a doctor, to choose a similar drug from the indicative list below:

• Azivok;
• Azibiot;
• Azimed;
• Aziklar;
• Azin;
• Azinort;
• Azitral;
• Azite;
• Azitrox;

• Azithromycin;
• Azicin;
• Wilprafen;
• Dazel;
• Doracimin;
• Erythromycin;

• Ziomycin;
• Zitrox;
• Zomax;
• Ketek;
• Clamed;
• Clarite;
• Claritrohexal;

• Claricite;
• Ormax;
• Renicin;
• Rovalen;
• Roxylide;
• Spiramycin;
• Spiracid;
• Starket;
• Sumamed;

• Fromilid;
• Hemomycin.

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

Azithromycin capsules 500mg №3 - 85 -99 rubles. (Obolenskoye FP Russia), designed for a 3-day course of treatment.

Reviews about Macropen

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

A large number of reviews on the use of suspensions for children. Parents are satisfied with the results of treatment: it quickly and effectively helps with coughs, especially those that are prolonged. Since the treatment lasted up to 10 days, then in parallel the child was given ( , ). Some noted the appearance of adverse reactions in children: nausea, lethargy, vomiting. In such cases, Macropen was canceled. In any case, it is not worth drawing conclusions that the drug is not effective. It depends on the individual characteristics of the organism.

Macrofoam price, where to buy

This drug can be found in any pharmacy. When purchasing Macropen tablets, the price for which in Moscow pharmacies varies and amounts to 268 - 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 rubles

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