Macropen - instructions for use, doses, side effects, contraindications

Active substanceMidekamycinMidekamycin

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Macropen®

granules inwards

KRKA, dd, Novo mesto, AO

Macropen®

pills inwards

KRKA, dd, Novo mesto, AO

Dosage form: & nbspfilm-coated tablets

Composition:

For 1 tablet

Core:

Active substance:

Midekamycin 421,00¹ mg

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

Film Sheath: butyl methacrylate copolymer, macrogol, titanium dioxide (E171), talc

¹421,00 mg (with activity of midekamycin 950 μg / mg) = 400,00 mg (with activity of midecamycin 1000 μg / mg).

Description:

Round, slightly biconvex tablets, covered with a film shell of white color, with a risk on one side, with a bevel.

View of the fracture: a rough mass of white color.

Pharmacotherapeutic group:Antibiotic - macrolide

ATX: & nbsp

J.01.F.A.03 Midekamycin

Pharmacodynamics:Macropen - macrolide antibiotic, inhibiting the synthesis of proteins of bacterial cells, has a bacteriostatic effect in low doses, in large bactericidal. Reversibly binds to the 50S subunit of the ribosomal membrane of bacteria. 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 ingestion, the preparation is quickly and completely absorbed from the gastrointestinal tract (GIT).

The maximum concentrations of midecamycin and midecamycin acetate in the serum are 0.5-2.5 μg / L and 1.31-3.3 μg / L, respectively, and are achieved 1-2 hours after ingestion.

High concentrations of meadecamycin and midecamycin acetate are created in the internal organs (especially in lung tissue, parotid and submandibular glands) and skin. The minimum suppressive concentration (MPC) is maintained for 6 hours. The half-life period is approximately 1 hour. The connection with proteins is 47% of meadecamycin and 3-29% of metabolites.

The drug is metabolized in the liver with the formation of 2 active metabolites, which have antimicrobial activity. It is excreted with bile and to a lesser degree (about 5%) by the kidneys.

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

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- respiratory tract infections, including those caused by atypical pathogens (mycoplasma, legionella, chlamydia and Ureaplasma urealyticum): tonsillopharyngitis, acute otitis media, sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia;

- Urinary tract infections caused by pathogens: mycoplasma, legionella, chlamydia and Ureaplasma urealyticum;

- infections of the skin and subcutaneous tissue;

- for treatment of enteritis caused by bacteria of the genus Campylobacter,

- treatment and prevention of diphtheria and pertussis.

Contraindications:

Hypersensitivity to midecamycin / midecamycin acetate and any other components of the drug.
Severe hepatic insufficiency.
Children up to 3 years (for tablets).

Carefully:Pregnancy and lactation period, the presence of an allergic reaction to acetylsalicylic acid.

Pregnancy and lactation:

Use of the drug during pregnancy is indicated only in cases where the potential benefit to the mother exceeds the risk to the fetus.

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

Dosing and Administration:

Inside, should be taken before meals.

Adults and children weighing more than 30 kg 1 tablet 400 mg 3 times a day.

The maximum daily dose of midecamycin for adults is 1600 mg.

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

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

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

In order to prevent diphtheria midecamycin it is recommended to take in a dose of 50 mg / kg / day, divided into 2 doses for 7 days. Recommended control bacteriological study after the termination of therapy. With a view to preventing pertussis midecamycin it is recommended to take in a dose of 50 mg / kg / day for 7-14 days in the first 14 days from the moment of contact.

Side effects:

From the gastrointestinal tract: a decrease in appetite, stomatitis, nausea, vomiting and diarrhea, a feeling of heaviness in the epigastrium, an increase in the activity of "liver" transaminases and hyperbilirubinemia, jaundice.

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

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

Other: weakness.

Overdose:

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

Symptoms are: nausea, vomiting.

Treatment: symptomatic.

Interaction:

With the simultaneous administration of ergot alkaloids or carbamazepine with Macropen, their metabolism in the liver decreases and serum concentration increases. Therefore, with the simultaneous administration of these drugs should be careful.

Has no effect on the pharmacokinetic parameters of theophylline.

With the simultaneous use of Macrofen with cyclosporine shi anticoagulants (warfarin) excretion of the latter slows down.

Special instructions:

With prolonged therapy, hepatic enzyme activity should be monitored, especially in patients with impaired liver function.

As with any other antimicrobial drugs, prolonged treatment can lead to an excessive growth of resistant bacteria. Prolonged diarrhea can indicate the development of pseudomembranous colitis.

In the presence of an allergic reaction to acetylsalicylic acid, the azo dye E 110 (dye sunset yellow, E110) can cause an allergic reaction, up to the bronchospasm.

Effect on the ability to drive transp. cf. and fur:It was not reported on the influence of Macropen on psychophysiological reactions and the ability to drive and other mechanisms.

Form release / dosage:

Tablets, film-coated, 400 mg.

Packaging:

For 8 tablets in a blister of the combined material PVC / PVDCH and aluminum foil.

2 blisters together with instructions for use are placed in a cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015069 / 01

Date of registration:29.01.2009 / 13.03.2017

Expiration Date:Unlimited

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

MERCK KGaA & Co. Werk Spittal Austria

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp30.03.2018

Illustrated instructions

Instructions

Macropen® (Macropen®)