Macropen prig.suspenzii granules for oral 20g 175mg / 5ml vial

Description

Composition
Active substance:
1 g of granulate contains: mg midecamycin acetate (corresponding to 175 mg of midecamycin acetate in 5 ml supenzii).
Excipients:
Methyl parahydroxybenzoate 1.00 mg propyl parahydroxybenzoate 0.20 mg, 0.25 mg citric acid, sodium hydrogen phosphate, anhydrous 16.75 mg banana flavoring powder 14.00 mg, colorant sunset yellow FCF, E110 1.50 mg hypromellose 30,00 mg, 0.17 mg silicone defoamer, sodium saccharinate 0.70 mg mannitol qs to 1000.00 mg.
Description:
Granules for oral suspension: fine granules orange color with a slight banana flavor without visible impurities.
The aqueous suspension prepared in 100 ml of water, orange with a slight banana flavor.
Product form:
Granules for suspension 20 g.
Contraindications
Hypersensitivity to midecamycin / midecamycin acetate and any other components of the preparation.
Severe hepatic insufficiency.
Children up to age 3 years (for tablets).
Carefully:
pregnancy and lactation, allergy to aspirin.
Dosage
175 mg / 5 ml
Indications
Infectious-inflammatory diseases caused by susceptible to malaria infections:
respiratory infections, including those caused by atypical pathogens (Mycoplasma, Legionella, Chlamydia and Ureaplasma urealyticum): tonzillofaringit, 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 the treatment of enteritis caused by bacteria of the genus Campylobacter,
treatment and prevention of diphtheria and pertussis.
Interaction with other drugs
When simultaneous administration of ergot alkaloids shi carbamazepine with reduced Makropenom their metabolism in the liver and increased serum concentration. Therefore, while taking these drugs with caution.
No impact on the pharmacokinetic parameters of theophylline.
When you use both macrofoams with cyclosporine shi anticoagulants (warfarin) is slowing down the latter.
Overdose
There are no reported cases of severe overdose caused Makropenom.
Possible symptoms: nausea, vomiting.
Treatment: symptomatic.
pharmachologic effect
Pharmacological group:
Macrolide antibiotic.
Pharmacodynamics:
Macropen – macrolide antibiotic that inhibits protein synthesis of the bacterial cells, has a bacteriostatic effect at low doses, bolshih- bactericidal. Reversibly binds to the 50S ribosomal subunit of the bacterial membrane. It is effective against intracellular bacteria: 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 quickly and adequately 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 inhibitory concentration (MIC) is maintained for 6 hours. The half-life of about 1 hr. Communication with protein – 47% and 3-29% midecamycin metabolites.
The drug is metabolized in the liver to form two active metabolites, with antimicrobial activity. Excreted in the bile and to a lesser extent (about 5%) by the kidneys.
When hepatic cirrhosis: a significantly increased plasma concentration, area under the curve “concentration-time” and half-life.
Pregnancy and breast-feeding
Use of the drug during pregnancy is shown only in those cases where the potential benefit to the mother outweighs the risk to the fetus.
Nursing mothers should stop breast-feeding during treatment Makropenom, since the drug is excreted into breast milk.
Conditions of supply of pharmacies
On prescription.
side effects
On the part of the gastrointestinal tract: loss of appetite, stomatitis, nausea, vomiting and diarrhea, feeling of heaviness in the epigastrium, increased activity of “liver” transaminases, hyperbilirubinemia and jaundice.
In rare cases, there may be severe and prolonged diarrhea, which may indicate the development of pseudomembranous colitis.
Allergic reactions. skin rash, urticaria, pruritus, eosinophilia, bronchospasm.
Miscellaneous: weakness.
special instructions
When long-term therapy should be monitored the activity of liver enzymes, especially in patients with impaired liver function.
As with any other antimicrobial agents, long-term treatment can lead to excessive growth of resistant bacteria. Prolonged diarrhea may indicate the development of pseudomembranous colitis.
Mannitol contained in Makropene (granules for oral suspension) may cause diarrhea.
In the presence of an allergic reaction to acetylsalicylic acid, azo dye E 110 (dye is sunset yellow, E110) can cause allergic reactions, up to bronchospasm.
Effects on ability to drive a car or other mechanisms:
Reported macrofoams influence on physiological reactions and the ability to drive a car and other mechanisms.
Storage conditions
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 higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside should be taken before meals.
Midecamycin daily dose is 20-40 mg / kg body weight, divided into 3 doses, or 50 mg / kg body weight, divided into 2 doses.
The daily dose midecamycin in severe infections – 50 mg / kg body weight, divided into 3 doses.
The duration of treatment typically is from 7 to 14 days. Chlamydial infection 14 days.
In order to prevent diphtheria midecamycin recommended to take a dose of 50 mg / kg / day, divided into 2 doses for 7 days. Recommended monitoring bacteriological examination after the end of therapy. In order to prevent pertussis midecamycin recommended to take a dose of 50 mg / kg / day for 7-14 days during the first 14 days from the time of contact.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist