Levomycetinum
Producer: JSC Himfarm Republic of Kazakhstan
Code of automatic telephone exchange: J01BA01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent – chloramphenicol of 500,0 mg.
Excipients: cellulose microcrystallic, sodium of starch glikolit, a gidroksipropilmetiltsellyuloza, calcium stearate.
Pharmacological properties:
Pharmacokinetics. After intake levomycetinum is quickly and completely soaked up from digestive tract. Bioavailability makes 80%. The maximum concentration in blood is reached in 2-3 hours, therapeutic concentration in blood remains within 4-5 hours after reception. Gets into bodies, fabrics and liquids of an organism, passes through a blood-brain barrier, well gets into cerebrospinal fluid (to 50% of content in blood). Drug passes through a placenta, it is found in maternal milk. Therapeutic concentration of drug at its use inside come to light in a vitreous, a cornea, an iris of the eye, watery moisture of an eye (drug does not get into a crystalline lens). Linkng with proteins of plasma makes 50-60%. It is metabolized in a liver. The elimination half-life makes 1,5-3,5 hours. It is removed generally with urine (mainly in the form of inactive metabolites), partially – with bile and a stake. In intestines under the influence of colibacilli it is hydrolyzed with formation of inactive metabolites.
Pharmacodynamics. Levomycetinum – an antibiotic of a broad spectrum of activity. It is effective in relation to many gram-positive and gram-negative bacteria (to causative agents of purulent infections, a typhoid, dysentery, meningococcal infections, hemophilic bacteria, brucellas, etc.), to rickettsiae, chlamydias, spirochetes. Affects strains of the bacteria steady against penicillin, streptomycin, streptocides. Drug слабоактивен rather acid resisting bacteria, pyocyanic stick, clostridiums and protozoa. Breaks protein synthesis in cells of microorganisms. In therapeutic concentration has bacteriostatic action. Drug resistance of microorganisms develops rather slowly, and, as a rule, at the same time there is no cross resistance to other chemotherapeutic means.
Indications to use:
- the infectious and inflammatory diseases caused by microorganisms, sensitive to levomycetinum, including: typhoid, paratyphoid, dysentery, generalized form of a salmonellosis, brucellosis, tularemia, whooping cough, sapropyra and other rickettsioses
- brain abscess
- sepsis
- infections of bodies of a small pelvis
- clamidiosis.
At the infectious processes of other etiology caused by the activators sensitive to action of levomycetinum, drug is shown in case of inefficiency of other chemotherapeutic means.
Route of administration and doses:
Inside, in 30 minutes prior to food (in case of nausea or vomiting – in an hour after food).
Single dose for adult 250-500 mg (1/2-1tab.), daily - 2 g (4 таб.). In especially hard cases (a typhoid, peritonitis and others) it is possible to appoint drug in a dose to 4 g (8 таб.) in days.
The maximum daily dose for adults - 4 g (under strict observation of the doctor and control of a condition of blood and function of kidneys).
Frequency rate of use 3-4 times a day.
Single dose for children of 6-8 years - 125 mg (1/4 таб.); 8 years - 250 mg are more senior (1/2 таб.).
To children usually appoint 3-4 times a day.
The course of treatment makes 7-10 days.
Features of use:
Treatment by Levomycetinum should be carried out only to destination and under control of the doctor. Before therapy it is necessary to exclude existence at the patient of hypersensitivity to chloramphenicol and other amfenikola.
With caution it is necessary to take Levomycetinum at cardiovascular diseases and tendency to allergic reactions.
In the course of treatment systematic control of function of kidneys, a liver and composition of peripheral blood is necessary. At emergence of signs of disturbance of a hemopoiesis drug should be cancelled. However symptoms of aplastic anemia (a pharyngalgia, pallor of skin, the increased temperature, bleedings), as a rule, appear only in several weeks after the termination of a course of treatment. Therefore at emergence of such symptoms it is necessary to see a doctor urgently.
With care apply to the patients receiving earlier treatment by cytostatic drugs or radiation therapy.
Unacceptably uncontrolled purpose of Levomycetinum and its use at easy forms of infectious processes, especially in children's practice.
At a concomitant use of ethanol development of disulfiramopodobny reaction is possible (a hyperemia of integuments, tachycardia, nausea, vomiting, reflex cough, spasms).
At an abnormal liver function and/or kidneys correction of the mode of dosing is necessary: it is necessary to reduce a dose of drug or to increase an interval between receptions.
It is necessary to take with caution drug to the persons managing motor transport or working with other mechanisms in connection with risk of development of possible undesirable reactions from a nervous system.
Side effects:
- a leukopenia, thrombocytopenia, a reticulocytopenia, reduction of level of hemoglobin in blood, cytoplasmatic vacuolation of early erythrocyte forms, an agranulocytosis, aplastic anemia
- nausea, vomiting, diarrhea, meteorism, irritation of mucous membranes, intestinal microflora oppression, dysbacteriosis, consecutive fungal infection
- glossitis, stomatitis.
Seldom:
- peripheral neuritis, optic neuritis, decrease in visual acuity and hearing
- headache, depression, confusion of consciousness, delirium, visual and auditory hallucinations, paralysis of eyeglobes, taste disturbance
- skin rash, small tortoiseshell, fever, Quincke's disease
- development of consecutive infection, reaction of a bacteriolysis ( Yarisha-Gerksgeymer's reaction) is possible
In some cases:
- damage of a liver, superinfetion
- Quincke's edema, anaphylaxis.
Interaction with other medicines:
It is impossible to appoint levomycetinum together with drugs which oppress a hemopoiesis (the streptocides derivative of pyrazyl ketone, cytostatics), and also with radiation therapy.
Chloramphenicol suppresses fermental system of P450 cytochrome therefore at simultaneous use with Phenytoinum, indirect anticoagulants (for example, warfarin) note weakening of metabolism of these drugs, delay of removal and increase in their concentration in a blood plasma.
At simultaneous use of Levomycetinum with peroral hypoglycemic drugs (Tolbutamidum, Chlorproramidum) strengthening of hypoglycemic action due to suppression of metabolism of these drugs in a liver and increases in their concentration in a blood plasma is noted.
Barbiturates (phenobarbital), rifampicin, рифабутин reduce concentration of Levomycetinum in blood serum and reduce its efficiency.
Levomycetinum can reduce efficiency of estrogenosoderzhashchy oral contraceptives, weaken effects of iron preparations, folic acid, cyanocobalamine.
Levomycetinum reduces antibacterial effect of penicillin and cephalosporins. Levomycetinum can reduce effect of macroleads (erythromycin) and linkozamid (clindamycin, lincomycin).
At a concomitant use of ethanol development of disulfiramopodobny reaction is possible (a hyperemia of integuments, tachycardia, nausea, vomiting, reflex cough, spasms).
Contraindications:
- hypersensitivity to chloramphenicol, other amfenikola and/or to other components of drug
- oppression of a hemopoiesis, blood disease
- the expressed abnormal liver functions and/or kidneys
- deficit of enzyme glyukozo-6-fosfatdegidrogenazy
- skin diseases (psoriasis, eczema, fungus diseases)
- children's age up to 6 years
- pregnancy, lactation period.
Overdose:
Symptoms: pallor of skin, a pharyngalgia, the increased temperature, bleeding, weakness.
At overdose at children development of side reactions, characteristic of Levomitsetin, is possible.
Treatment: drug withdrawal, gastric lavage, use of sorbents, symptomatic therapy.
Storage conditions:
To store in the dry, protected from light place, at a temperature not above 30 °C.
To store in the place, unavailable to children!
Issue conditions:
According to the recipe
Packaging:
On 10 tablets in a blister strip packaging from a film of polyvinyl chloride and aluminum foil.
Blister strip packagings place in boxes from a cardboard bandbox or corrugated. On number of packagings put instructions on a medical use in group packaging in the state and Russian languages.
