Zivox (linezolid) coated tablets 600 mg. №10

Description

Zivox (linezolid) coated tablets 600 mg. №10

Composition

active substance: linezolid;

1 tablet contains 600 mg of linezolid;

Excipients: corn starch, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, magnesium stearate, purified water, Opadry White YS-1-18202-A, carnauba wax.

Dosage form

Film-coated tablets.

Main physical and chemical properties: white to off-white, film-coated tablets, embossed with “ZYV” on one side and “600” on the other.

Pharmacotherapeutic group

Antibacterial agents for systemic use. ATX code J01X X08.

Pharmacological properties

Linezolid is a synthetic antibacterial drug that belongs to a new class of antimicrobials – oxazolidinones. It is active in vitro against aerobic gram-positive bacteria and anaerobic microorganisms. Linezolid selectively inhibits bacterial protein synthesis due to its unique mechanism of action. It binds directly to bacterial ribosomes (23S with 50S subunits) and prevents the formation of the 70S functional initiation complex (an important component of the translation process).

The prevalence of acquired resistance may vary geographically and over time for individual species, so it is advisable to rely on local information on the resistance of microorganisms, especially in the treatment of severe infections. If necessary, when the level of prevalence of resistance of microorganisms at the local level is such that the benefits of using the drug, at least for some types of infections, is in doubt, you should consult an expert.

Sensitive microorganisms:

• gram-positive aerobic microorganisms: Enterococcus faecalis, Enterococcus faecium *, Staphylococcus aureus *, coagulase-negative staphylococci, Streptococcus agalactiae *, Streptococcus pneumoniae *, Streptococcus pyogenes *, Group C strecicoco;
• gram-positive anaerobic microorganisms: Clostridium perfringens, Peptostreptococcus anaerobius, Peptostreptococcus species;
• resistant microorganisms: Haemophilus influenza, Moraxella catarrhalis, Neisseria species, Enterobacteriaceae, Pseudomonas species;
• although linezolid shows some in vitro activity against Legionella, Chlamydia pneumoniae and Mycoplasma pneumoniae, there are insufficient data to confirm clinical efficacy in these cases.

Indications

Zivox is used in the treatment of infectious diseases that are caused by microflora sensitive to linezolid. In the treatment of diseases caused by gram-negative bacteria, the drug is recommended to be used in conjunction with other antibacterial agents.

Zivox is prescribed for:

• community-acquired and nosocomial pneumonia;
• complicated infections of the skin and its appendages;
• skin lesions caused by Streptococcus pyogenes and methicillin-sensitive Staphylococcus aureus;
• infectious diseases caused by enterococci, as well as their strains resistant to vancomycin.

Contraindications

Zivox is not prescribed in case of hypersensitivity to its components, patients under 12 years of age, as well as patients who suffer from uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, carcinoid syndrome.

Zivox should be used with caution in patients who have previously been diagnosed with severe renal insufficiency, pregnancy and lactation, and life-threatening systemic infections.

Method of application and dose

The dose of Zivox is selected individually. When using the drug in solution for infusion, it is administered intravenously. The daily dose is divided into two. Infusion duration from 30 to 120 minutes.

In the treatment of nosocomial and community-acquired pneumonia, as well as infections of the skin and soft tissues, the patient receives 600 mg of the drug every 12 hours. Duration of treatment from 1 to 2 weeks.

When using a suspension prepared from granules or tablets, the drug is taken orally regardless of food.

Granules for the preparation of a suspension for oral administration, coated tablets, a suspension prepared from granules and tablets are taken orally with or without food. In the treatment of hospital and community-acquired forms of pneumonia, the patient receives 600 mg of the drug every 12 hours. In the treatment of skin and soft tissue infections, the patient receives from 400 to 600 mg every 12 hours.

Overdose

To date, no cases of overdose with Zivox have been reported.

At emergence of signs of poisoning to the patient appoint gastric lavage and reception of activated charcoal

Side effects

Nausea, diarrhea, abdominal pain, flatulence, constipation, taste changes, cramps, headaches, allergic reactions, vaginal candidiasis, insomnia, fever, headaches and upper respiratory tract infections may occur during treatment with Zivox.