Doramycin 3000000 IU (10 coated tablets)

The instruction for medical use


of DORAMITsIN medicine

the Trade name
Doramitsin

Mezhdunarodnoye the unlicensed


name Spheromycinum Dosage Form
of the Tablet, coated 3,000,000 ME

Structure
One tablet contains
active agent – ME Spheromycinum 3,000,000,
auxiliary substances: corn starch, sodium of a crosskarmelloz, magnesium stearate, talc, cellulose microcrystalline,
structure of a cover: hydroksipropilmetiltsellyuloza, titan dioxide, talc, polyethyleneglycol 4000, polyethyleneglycol 6000.

The description
of the Tablet, coated, white or almost white color with a milk shade, round, biconvex, with an engraving of DORA on one party. Kernel of a tablet of yellow-white color.

Pharmacotherapeutic group
Antibacterial drugs for system use. Macroleads.
Code of automatic telephone exchange J01FA02

Pharmacological

Pharmacokinetics Absorption properties. Absorption of Spheromycinum happens quickly, but is not full, with big variability (from 10% to 60%). After administration of drug inside in a dose of 6,000,000 ME the maximum concentration of Spheromycinum in plasma makes about 3.3 mkg/ml.
Distribution. Drug well gets into saliva and fabrics (concentration in lungs makes 2060 mkg/g, in tonsils – 20-80 mkg/g, in the infected bosoms – 75-110 mkg/g, in bones – 5-100 mkg/g). In 10 days after the end of treatment the concentration of Spheromycinum in a spleen, a liver, kidneys makes 5-7 mkg/g. Linking with proteins of plasma low (about 10%).
Spheromycinum does not get into cerebrospinal fluid. Gets through a placental barrier (concentration in blood of a fruit makes about 50% of concentration in blood serum of mother). Concentration of Spheromycinum in a placenta is 5 times higher, than the corresponding concentration in blood serum.
Gets and collects in phagocytes (neutrophils, monocytes, peritoneal and alveolar macrophages).
Concentrations of drug in phagocytes are rather high.
Metabolism and removal. Spheromycinum biotransformirutsya in a liver with formation of active metabolites with unspecified chemical structure.
Elimination half-life after administration of drug in a dose of 3,000,000 ME makes about 8 hours.
Elimination half-life is extended at elderly people.
It is removed mainly with bile (concentration is 15-40 times higher, than in serum).
Renal excretion of active Spheromycinum is about 10% of the entered dose.

Doramitsin's pharmacodynamics – an antibiotic from group of macroleads. Works bacteriostatically, breaking intracellular synthesis of protein.
Methicillinum – sensitive strains of Staphylococcus spp., Rhodococcus equi, Branhamella catarrhalis, Bordetella pertussis, Helicobacter pylori, Campylobacter jejuni, Legionella spp., Corynebacterium diphtheriae, Moraxella spp., Mycoplasma pneumoniae, Coxiella spp., Chlamydia spp., Treponema pallidum, Borrelia burgdorferi, Leptospira spp., Propionibacterium acnes., Actinomyces spp., Eubacterium spp., Porphyromonas spp., Mobiluncus spp., Bacteroides spp., Peptostreptococcus spp., Prevotella spp is active concerning Streptococcus spp.
The Minimum Overwhelming Concentration (MOC) ‹=1 mg/l (more than 90% of strains are sensitive).
The antibiotic is moderately active in vitro against Neisseria gonorrhoeae, Ureaplasma urealyticum, Clostridium perfringens.
Positive takes can be noted at concentration of an antibiotic in the inflammation center above, than MPK. Microorganisms, resistant to Spheromycinum (MPK› 4 mg/l, at least, of 50% of strains are steady): Methicillinum – resistant Staphylococcus spp., Enterobacter spp., Pseudomonas spp., Acinetobacter spp., Nocardia asteroides, Fusobacterium spp., Haemophilus spp., Mycoplasma hominis.
Spheromycinum is active in vitro and in vivo concerning Toxoplasma gondii.

Indications
- sharp community-acquired pneumonia (including the atypical, caused Legionella pneumophila, Mycoplasma pneumoniae, Chlamydia spp.)
- exacerbation of chronic bronchitis, an acute bronchitis
- infections of ENT organs (sinusitis, tonsillitis, otitis)
- osteomyelitis, arthritis
- infections of skin and soft tissues (an ugly face, the secondary infected dermatosis, abscesses and phlegmons, including in stomatology)
- infections of a reproductive system (not gonorrheal etiology)
- diseases, sexually transmitted (including genital and extragenital clamidiosis)
- toxoplasmosis (including at pregnant women)
- prevention of meningokkovy meningitis among the persons having contact with patients no more than in 10 days prior to diagnosis
- prevention of acute articulate rheumatism at persons with allergic reaction to penicillin

the Route of administration and doses
For adults inside appoint 2-3 tablets on 3,000,000 ME (i.e. 6 000 000 – 9 000 000 ME) in day for 2 or 3 receptions. The maximum daily dose makes 9,000,000 ME.
Duration of treatment depends on weight and features of a course of infectious process, sensitivity of microflora and is defined by individually attending physician.
Prevention of a spotted fever
Adult appoint 3,000,000 ME each 12 hours within 5 days.
With renal failures in dose adjustment it is not required to patients.

Side effects
- nausea, vomiting, diarrhea
Seldom
- changes of functional trials of a liver, cholestatic hepatitis
- passing paresthesias
- acute hemolysis, thrombocytopenia
- lengthening of QT on the electrocardiogram
- skin rash, a small tortoiseshell, an itching
- an ulcer esophagitis and acute colitis
Very seldom
- a Quincke's disease, an acute anaphylaxis is possible
- pseudomembranous colitis
also the possibility of development of intense injury of a mucous membrane of intestines in patients about AIDS at use of Spheromycinum in high doses concerning a cryptosporidiosis (only 2 cases) Is noted.

Contraindications
- hypersensitivity to Spheromycinum and other components of drug
- the profound abnormal liver functions
- the lactation period

Medicinal interactions
At simultaneous use with the drugs containing a combination of a levodopa and a karbidopa the decrease in level of a levodopa in plasma was observed.
Unlike erythromycin, isoenzymes of R-450 system of a liver do not take part in metabolism of Spheromycinum, it does not interact with cyclosporine or theophylline.

Special instructions
in case of allergic reaction the administration of drug has to be immediately stopped.
With care appoint to patients with abnormal liver functions and obstruction of bilious ways. During use of drug it is necessary to control indicators of function of a liver.
It is necessary to apply with care with ergot alkaloids.
Pregnancy
Doramitsin's use at pregnancy according to indications is possible.
Use in
Tablet Doramitsin pediatrics in a dose of 3,000,000 ME are not applied to children.
Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not cause changes of a psychophysical condition of the patient, does not break ability to run motor transport and to work with potentially dangerous mechanisms.

Overdose
Symptoms: dizziness, nausea, vomiting, diarrhea.
Treatment: if necessary carry out symptomatic therapy. There is no specific antidote.

Form of release and packing
of the Tablet, coated, 3,000,000 ME.
On 5 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 2 blister strip packagings together with the instruction for use in the state and Russian languages put in a pack from cardboard.


To Store storage conditions at a temperature not over 250C.
To store out of children's reach!


3 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription


UNIPHARMA Producer,
El Obour City, Cairo, Egypt.
YuNIFARMA,
El Obur of City, Cairo, Egypt.

It is made for UORLD MEDITSIN, Great Britain
(WORLD MEDICINE, Great Britain)

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of RK, Almaty, Suyunbaya 222 St. of B
Ph. / fax: 8 (7272) 529090
www.worldmedicine.kz