Macropen, 175mg/5ml suspension, 115ml vials

Composition

Active ingredient:  

Midecamycin acetate 200 mg;

Auxiliary substances:

methyl parahydroxybenzoate;

propyl parahydroxybenzoate;

citric acid;

sodium hydrophosphate anhydrous;

banana flavor;

dye “Sunny Sunset” yellow FCF (E 110);

hypromellose;

silicone defoamer;

sodium saccharinate;

mannitol.

Pharmacological action

Macropen® — a macrolide antibiotic that inhibits the synthesis of bacterial cell proteins, has a bacteriostatic effect in small doses, in large doses — 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:  Streptococcus spp., Staphylococcus spp., Corynebacterium diphtheriae, Listeria monocytogenes, Clostridium spp. ; some gram-negative bacteria:  Neisseria spp., Moraxella catarrhalis, Bordetella pertussis, Helicobacter spp., Campylobacter spp., Bacteroides spp.

Pharmacokinetics

After oral use, the drug is rapidly and fairly fully absorbed from the gastrointestinal tract.

Cmax of Midecamycin and Midecamycin acetate in serum — 0.5–2.5 mcg/l and 1.31–3.3 mcg/l, respectively, are reached 1-2 hours after oral use.

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.

BMD persists for 6 h. T1 / 2 — approximately 1 h. Protein binding — 47% of Midecamycin and 3-29% of 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 cirrhosis of the liver, plasma concentrations, AUC, and T1/2 significantly increase.

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 atypical pathogens-mycoplasmas, legionella, chlamydia and Ureaplasma urealyticum;
• skin and subcutaneous tissue infections;
• enteritis caused by bacteria of the genus Campylobacter;
• diphtheria and whooping cough (treatment and prevention).

Contraindications

• hypersensitivity to Midecamycin / Midecamycin acetate and any other components of the drug;
• severe liver failure;
• children under 3 years of age (for tablets).

With caution:  pregnancy; lactation period; presence of an allergic reaction to acetylsalicylic acid.

Side effects

From the gastrointestinal tract:  decreased appetite, stomatitis, nausea, vomiting, diarrhea, heaviness in the epigastrium, increased activity of hepatic transaminases, 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 services:  weakness.

Interaction

When ergot alkaloids or carbamazepine are co-administered with Macropen®, their metabolism in the liver decreases and their serum concentration increases. Therefore, caution should be exercised when taking these medications at the same time.

It does not affect the pharmacokinetic parameters of theophylline.

Concomitant use of Macropen® with cyclosporine or anticoagulants (warfarin) slows down the elimination of the latter.

How to take, course of use and dosage

Macropen is taken before meals.

Adults are prescribed an average daily dose of 1.2 g (400 mg 3 times a day).

The maximum daily dose is 1.6 g.

Children are prescribed Macropen depending on body weight, preferably in suspension.

The daily dose is 30-50 mg per kg of body weight,2 times a day.

The duration of the course is 7-10 days, with chlamydia 14 days.

Overdose

Symptoms (possible): nausea, vomiting.

Treatment:  symptomatic.

Special instructions

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

As with any other antimicrobial medication, long-term treatment can lead to an overgrowth of resistant bacteria. Prolonged diarrhea may indicate the development of pseudomembranous colitis.

The mannitol contained in Macropen® (oral suspension granules) may cause diarrhea.

Form of production

Pellets for preparation of oral suspension

Storage conditions

At a temperature not exceeding 25 °C.

Active ingredient

Midecamycin

Conditions of release from pharmacies

By prescription

Dosage form

suspension for oral use

Description

For adults, For children, For children from birth

Indications

Urinary Tract Infections, Tonsillitis, Bronchitis, Otitis Media, Enteritis, Infectious Diseases, Sore Throat, Sinusitis, Pneumonia, Whooping Cough, Skin infections