Xitrocin - instructions for use, dose, side effects, contraindications

The active substance is roxithromycin	50 mg	100 mg,	150 mg
Excipients:
microcrystalline cellulose	33.49 mg	66.98 mg	100.47 mg
lactose monohydrate	19.25 mg	38.50 mg	57.75 mg
carmellose sodium	2.75 mg	5.50 mg	8.25 mg
povidone-90	1.10 mg	2.20 mg	3.30 mg
poloxamer-188	0.11 mg	0.22 mg,	0.33 mg
talc	2.20 mg	4.40 mg	6.60 mg
sodium stearyl fumarate	1.10 mg	2.20 mg	3.30 mg
Shell composition:
hypromellose	3.30 mg	6.60 mg	9.90 mg
macrogol-8000	1.00 mg	2.00 mg	3.00 mg
giprolase	0.17 mg	0.34 mg	0.51 mg
titanium dioxide	0.53 mg	1.06 mg	1.59 mg

Description:Round biconvex tablets covered with a film coat of white or almost white color.

Pharmacotherapeutic group:Antibiotic-macrolide.

ATX: & nbsp

J.01.F.A Macrolides

J.01.F.A.06 Roxithromycin

Pharmacodynamics:

Roxithromycin is a semisynthetic antibiotic of the macrolide group for oral administration. Bacteriostatic action: binding to the 50S ribosomal subunit, inhibits the translocation and transpeptidation reaction, the formation of peptide bonds between the amino acids and the peptide chain inhibits protein synthesis by ribosomes, resulting in inhibiting the growth and reproduction of bacteria.

In vitro, the drug is susceptible to Streptococcus agalactiae, Streptococcus pneumoniae (Pneumococcus), Neisseria meningitidis (Meningococcus), Listeria monocytogenes, Mycoplasma pneumoniae, Chlamydia trachomatis, Ureaplasma urealyticum, Legionella pneumophila, Helicobacter pylori, Gardnerella vaginalis, Bordetella pertussis, Moraxella catarrhalis (Branhamella catarrhalis ), Haemophilus ducreyi, Enterococcus spp., Clostridium spp., Incl. Clostridium perfringens.

The following microorganisms demonstrated variable in vitro sensitivity: Group A beta-hemolytic streptococcus, Staphylococcus aureus, Haemophilus influenzae, Staphylococcus epidermidis.

Pharmacokinetics:

Roxithromycin is rapidly absorbed after oral administration. Roxithromycin Stable than other macrolides in the acidic environment of the stomach. Eating 15 minutes after taking the drug does not affect the pharmacokinetics of the drug.

The active substance is detected in the blood plasma after only -15 minutes after administration. After taking the drug at a dose of 150 mg, the maximum concentration (Cmax) in the blood is, on average, 6.6 mg / l and is achieved after 2.2 hours.After a single administration of 300 mg of roxithromycin, the maximum concentration in the blood is 9.6 mg / l and is reached after 1.5 hours.

Taking the drug with an interval of 12 hours ensures the preservation of effective concentrations in the blood during the day.

Roxithromycin penetrates well into many tissues, especially the lungs, palatine tonsils and the prostate gland, as well as into neutrophils and monocytes, stimulating their phagocytic activity. Allocates; with breast milk. It is partially metabolized. Binding with proteins depends on the concentration level and is about 96% and decreases with an increase in the concentration of roxithromycin above 4 mg / l. In plasma only unchanged drug is determined.

In adults with normal renal and liver function, 65% of roxithromycin is excreted through the intestine, with kidneys no more than 10%.

Half-life (T_1/2) after a single dose is, on average, 10.5 h.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to roxithromycin, including:

- infections of the upper respiratory tract and ENT - organs (acute pharyngitis, tonsillitis, sinusitis, otitis media);

- Infections of the lower respiratory tract (pneumonia, including / caused by atypical pathogens, bronchitis, bacterial infections in chronic obstructive pulmonary diseases);

- infections of the skin, subcutaneous tissue and soft tissues;

- Urinary tract infections of non-gonococcal etiology: urethritis.

Contraindications:

- Increased sensitivity to roxithromycin and other macrolides, to other components of the drug;

- simultaneous administration of the drug with cisapride, pimozide, astemizole, terfenadine;

- children's age up to 4 years (for this dosage form);

- malabsorption of glucose-galactose, lactose intolerance, lactase insufficiency (the preparation contains lactose),

- simultaneous reception of ergotamine, dihydroergotamine (risk of developing symptoms of ergotism).

Carefully:Hepatic insufficiency (cirrhosis of the liver with jaundice and / or ascites), renal insufficiency, advanced age, simultaneous reception with colchicine, dopamine stimulants - ergot alkaloids (including bromocriptine, cabergoline, lisuride, pergolide), cyclosporine, theophylline, in patients with congenital lengthening of the QT interval, electrolyte imbalance (eg, hypokalemia,hypomagnesemia), simultaneous medicaments interval prolonging Q-T (including antiarrhythmic IA and Class III), warfarin, disopyramide, digoxin, bradycardia, myasthenia gravis.

Pregnancy and lactation:Pregnancy and lactation are contraindications to the prescription of the drug.

Dosing and Administration:

Inside, before eating, without chewing, squeezed with enough water.

Tablets can not be divided.

Adults and children over 15 years of age (with a body weight of more than 40 kg): 150 mg of the drug 2 times a day, with an interval of 12 hours. It is possible to administer 300 mg once a day. The course of treatment is determined individually, depending on the indications, the severity of the infection process and the activity of the pathogen; for infections caused by beta-hemolytic streptococcus, the course of treatment should be at least 10 days.

Children from 4 to 15 years: the recommended dose is 5-8 mg / kg per day (not more than 300 mg / day) in 2 divided doses, the course of treatment is not more than 10 days.

Children with a body weight of 12 to 23 kg are prescribed 50 mg twice a day. Children with a body weight of 24 to 40 kg are prescribed 100 mg of the drug 2 times / day.

In elderly patients- dosage regimen and daily dose of roxithromycin does not change. Patients with hepatic insufficiency the drug is prescribed in a dose of 150 mg once a day.

A course of treatment:

Adults and children over 15 years of age - not less than 10 days.

Children from 4 to 15 years-no more than 10 days.

Side effects:

Disorders from the gastrointestinal tract

Nausea, vomiting, pain in the epigastric region, diarrhea, pancreatitis.

Disturbances from the nervous system

Dizziness, headache, change in taste and / or smell, paresthesia.

Immune system disorders

Allergic reactions (bronchospasm, urticaria, rash, purpura, angioedema, anaphylactic shock).

Disturbances from the skin and subcutaneous tissues

Epidermal toxic necrolysis, Stevens-Johnson syndrome.

Violations of the blood and lymphatic system

Agranulocytosis, neutropenia and eosinophilia.

Mental disorders:

Hallucinations.

Disturbances from the liver and bile ducts

Increased activity of "liver" transaminases and alkaline phosphatase (alkaline phosphatase), cholestatic or hepatocellular acute hepatitis.

Disorders from the metabolism and nutrition

Decreased appetite.

Infectious and parasitic diseases

Development of superinfection.

If any of these side effects are aggravated, or if you notice any other side effects not listed in the instructions, report it the doctor.

Overdose:In case of an overdose, the stomach is washed and symptomatically treated. There is no specific antidote. Hemodialysis is not effective.

Interaction:

Increases the absorption of digoxin, increasing the risk of its toxic effects (requires ECG monitoring and digoxin concentration in blood plasma).

Clinically significant interaction with warfarin was not revealed. An increase in prothrombin time or the International Normalized Relationship (MHO) has been reported with simultaneous intake with vitamin K antagonists, so during the treatment period it is necessary to monitor MHO.

Increases T_1/2 and AUC (area under the curve) of midazolam (strengthening and increasing the duration of action).

Increases the concentration in the plasma of theophylline, cyclosporine.

Increases the serum concentration of astemizole, cisapride, pimozide, which leads to an extension of the Q-T interval and / or severe arrhythmias (ECG monitoring is necessary).

Can displace the disopyramide from the connection with plasma proteins, leading to an increase in its concentration in the blood serum (requires monitoring of the ECG and the concentration of disopyramide in the blood plasma).

Ergotamine and ergotamine-like vasoconstrictive LS lead to the development of "ergotism", necrosis of the tissues of the extremities.

Special instructions:

With liver failure during the period of treatment, it is necessary to monitor the function of the liver.

Xitrocin can prolong the QT interval in patients with hypokalemia, atrioventricular conduction disorders, with arrhythmia, or with an increase in the QT interval, and therefore ECG should be monitored regularly.

Roxithromycin, as well as other macrolides, should be given with caution to patients taking antiarrhythmic drugs of class IA and III (see point C with caution).

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 50 mg, 100 mg, 150 mg

Packaging:

For 10 tablets in a glass tube with a stopper. Each tube, together with the instructions for use, is placed in a cardboard box.

For 10 tablets in PVC / AL (polyvinyl chloride film / aluminum foil).Each blister along with the instruction for use is placed in a cardboard box.

Storage conditions:Store in a place protected from moisture, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001217

Date of registration:16.11.2011 / 11.09.2012

Expiration Date:16.11.2016

The owner of the registration certificate:Pabianicki Pharmaceutical Plant Polfa, JSCPabianicki Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

PABIANICE PHARMACEUTICAL WORKS POLFA Poland

Representation: & nbspPABYNITSKY PHARMACEUTICAL FACTORY POLFA JSC PABYNITSKY PHARMACEUTICAL FACTORY POLFA JSC Poland

Information update date: & nbsp06.02.2018

Illustrated instructions

Instructions

Xitrocin (Xitrocin)