Zivox, 600 mg 10 pcs

Pharmacotherapeutic group: Oxazolidinone antibiotic.

ATX code: J01XX08

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Linezolid, a synthetic antibacterial drug, belongs to a new class of antimicrobial agents, oxazolidinones, active in vitro against aerobic Gram-positive bacteria, some Gram-negative bacteria and anaerobic microorganisms. Linezolid selectively inhibits protein synthesis in bacteria. Through binding to bacterial ribosomes, it prevents the formation of the functional initiating complex 70S, which is an important component of the translation process during protein synthesis.

Indications

Active ingredient

Composition

How to take, the dosage

The drug can be taken both with and between meals.

Patients who at the beginning of therapy were prescribed the drug intravenously can be subsequently switched to any dosage form of the drug for oral administration, and no dosage adjustment is required, since the bioavailability of linezolid when taken orally is almost 100%. The duration of treatment depends on the causative agent, the localization and severity of the infection and the clinical effect.

Elderly patients: no dose adjustment is required.

Patients with renal insufficiency: no dose adjustment is required. Because 30% of linezolid is eliminated in hemodialysis within 3 hours, linezolid must be taken after dialysis in patients who need it.

Patients with hepatic impairment: no dose adjustment is required.

Interaction

Monoamine oxidase inhibitors

Rifampicin caused decreases in Cmax and AUC of linezolid by an average of 21% and 32%, respectively.

Special Instructions

In established infections (or suspected infections) caused by concomitant Gram-negative microorganisms, additional use of agents acting on Gram-negative flora is indicated.

Contraindications

WARNING

Patients with renal impairment

Because of the unstudied clinical significance of the two primary metabolites of linezolid in patients with severe renal impairment, linezolid should be used with caution in these patients and only if the anticipated benefit exceeds the potential risk.

Patients with hepatic impairment

There is limited clinical evidence recommending the use of linezolid in such patients only if the anticipated benefit exceeds the potential risk.
Linezolid should be used with caution in patients with systemic infections that pose a risk to life, such as infections associated with venous catheters in intensive care units.

Side effects

The frequency of adverse reactions is categorized as follows:

Very frequent: ≥10%

Frequent: ≥1% and < 10%

Infrequent: ≥0.1% and < 1%

Rare: ≥0.01% and < 0.1%

Very rare: < 0.01%

The adverse events associated with taking linezolid are usually mild to moderate in severity. Diarrhea, headache, and nausea are the most common.

Adult patients

Digestive system disorders:

Frequent: diarrhea, nausea, vomiting, constipation, abdominal pain (including spastic), flatulence, oral mucosal candidiasis

Infrequent: change in tongue coloration

Laboratory findings:

Frequent: thrombocytopenia

Infrequent: increased blood triglyceride concentration, increased activity of “liver” enzymes (including alanine aminotransferase (ALT), aspartate aminotransferase (ACT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), lipase, amylase, concentration of total bilirubin and creatinine), increased prolactin concentration

Nervous system disorders:

Frequent: headache, dizziness, seizures

Infrequent: perversion of taste

Central nervous system disorders:

Frequent: insomnia

Urinary system disorders:

Frequent: vaginal candidiasis

Skin disorders:

Frequent: rash

Other:

Frequent: fever

Infrequent: Opportunistic fungal infection

Also noted: increased blood pressure, dyspepsia, itching

Adolescents (12 to 17 years)

Digestive system side:

Frequent: diarrhea, nausea, vomiting, abdominal pain (localized and generalized), liquid stools

Laboratory findings:

Infrequent: eosinophilia, increased blood triglyceride concentration, increased alanine aminotransferase (ALT) activity, lipase, creatinine concentration

Nervous system disorders:

Frequent: headache, vertigo

Skin disorders:

Frequent: rash

Infrequent: itching

Respiratory system disorders:

Frequent: upper respiratory tract infections, pharyngitis, cough

Other:

Frequent: fever, pain of unspecified localization

Spontaneous (postmarketing) findings

Laboratory findings: Reversible myelosuppression (thrombocytopenia, anemia, leukopenia, pancytopenia)

Senses: cases of optic neuropathy, sometimes leading to vision loss (see “Special Indications”).

Allergic reactions: anaphylaxis

Skin disorders: rash, angioedema; bullous skin lesions similar to Stevens-Johnson syndrome

Metabolic disorders: lactoacidosis

Nervous system disorders: peripheral neuropathy, seizures (see “

Digestive system: discoloration of tooth enamel (see “Special Precautions”)

Others: chills, fatigue, serotonin syndrome (see “Interactions with other medicinal products” and “Special Precautions”)

Overdose

Pregnancy use

No safety studies of linezolid use in pregnancy have been conducted, therefore the use of ZIVOX® in pregnancy is possible only if the estimated benefit to the mother outweighs the potential risk to the fetus.