Active substanceMidekamycinMidekamycin
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  • Macropen®
    granules inwards 
  • Macropen®
    pills inwards 
  • Dosage form: & nbspGranules for the preparation of a suspension for oral administration.
    Composition:

    For 1 g of granules.

    Active substance:

    Midekamycin acetate 200.00 mg1

    Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid, sodium hydrogen phosphate, anhydrous, banana flavor, sunny sunset yellow (E110), hypromellose, silicone antifoam, sodium saccharin, mannitol.

    1(corresponding to 175 mg of midecamycin acetate in a 5 ml suspension)

    Description:

    Fine granules of orange color with a light aroma of banana, without visible impurities.

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

    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).

    Maximum concentrations of midecamycins and midecamycin acetate in serum is 0.5-2.5 mg / l and 1,31-3,3 g / l, respectively, and are achieved within 1-2 hours after ingestion.

    High concentrations of midecamycins and midecamycin acetate created in the internal organs (especially in lung tissue, the parotid and submaxillary 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.
    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.

    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 - 50 mg / kg body weight divided into 3 doses.

    Scheme of appointment for children (daily dose of 50 mg / kg of body weight with a 2-fold intake):

    Children

    Suspension 175 mg / 5 mL

    up to 30 kg (~ 10 years)

    22.5 ml (787.5 mg)

    (4 1/2 dosing spoons) x 2 times a day

    up to 20 kg (~ 6 years)

    15 ml (525 mg)

    (3 dosing spoons) x 2 times a day

    up to 15 kg (~ 4 years)

    10 ml (350 mg)

    (2 dosing spoons) x 2 times a day

    up to 10 kg (~ 1 - 2 years)

    7.5 ml (262.5 mg)

    (1 1/2 dosing spoons) x 2 times a day

    up to 5 kg (~ 2 months)

    3.75 ml (131.25 mg)

    (½ + 1/4 dosing spoon) x 2 times a day

    1 dosing spoon has a measuring division 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.

    In order to prevent diphtheria: midecamycin it is recommended 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 in a dose of 50 mg / kg / day for 7-14 days in the first 14 days from the moment of contact.

    Preparation of the suspension:

    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: 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, carbamazepine and 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.

    Mannitol contained in Macropen (granules for the preparation of a suspension for oral administration) can cause diarrhea.

    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 effect of the drug Macropen® on psychophysiological reactions and the ability to drive and other mechanisms.
    Form release / dosage:Granules for oral suspension, 175 mg / 5 ml.
    Packaging:

    20 g of granules in dark glass bottles (type III), sealed with an aluminum cover with the control of the first opening.

    For 1 bottle complete with a dispensing spoon made of polypropylene, together with instructions for use, put in a pack of cardboard.

    Storage conditions:

    Granules for suspension for oral administration: at a temperature of no higher than 25 ° C, in the original packaging.

    The prepared suspension is suitable for 14 days in a refrigerator or 7 days at a temperature of no higher than 25 ° C.

    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 / 02
    Date of registration:29.01.2009 / 02.02.2018
    Expiration Date:Unlimited
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    KRKA, d.d. Slovenia
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp30.03.2018
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