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

Low substituted hydroxypropylcellulose, poloxamer F 68, povidone, magnesium stearate, colloidal silicon dioxide, corn starch, talcum purified, microcrystalline cellulose,

hydroxypropylmethylcellulose, titanium dioxide, propylene glycol, anhydrous dextrose.

Description:White or almost white biconvex tablets, covered with a film membrane.

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, which has a broad spectrum of antibacterial activity. Violates the intracellular synthesis of proteins of microorganisms.

The drug is usually sensitive: Bordetella pertussis, Borrelia burgdorferi, Moraxella (Branhamella) catarrhalis, Campylobacter spp., Chlamydia trachomatis, Chlamydia psittaci, Chlamydia pneumoniae, Clostridium spp., Incl. Clostridium perfringens, Corynebacterium diphtheriae, Enterococcus spp., Gardnerella vaginalis, Methi-S-Staphylococcus spp., Neisseria meningitidis, Helicobacter pylori, Legionella pneumophilia, Lysteria monocytogenes, Mycoplasma pneumoniae, Pasteurella multocida, Peptostreptococcus spp., Porphyromonas spp., Propionibacterium acnes, Rhodococcus egui, Streptococcus spp. The drug is moderately sensitive: Haemophilus influenzae, Ureaplasma urealyticum, Vibrio cholerae, Staphylococcus aureus and Staphylococcus epidermidis. The drug is resistant to: Acinetobacter spp., Bacteroides fragilis, Enterobacteriacea; Methi-R Staphylococcus spp., Pseudomonas spp., Fusobacterium spp., Mycoplasma hominis, Nocardia spp.

Pharmacokinetics:

Roxithromycin is rapidly absorbed after oral administration. Roxithromycin Stable than other macrolides in the acidic environment of the stomach. Meal after 15 minutes. after the drug has no effect on the pharmacokinetics. The active substance is found in the blood serum as early as 15 minutes after ingestion. The maximum concentration in the blood is, on average, 6.6 mg / l and is achieved 2.2 hours after taking the drug at a dose of 150 mg. After a single dose of 300 mg of roxithromycin, the average maximum concentration in the blood is 9.6 mg / l and is achieved 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 and organs (incl.in the lungs, palatine tonsils, the prostate gland), inside cells, especially in neutrophilic leukocytes and monocytes, stimulating their phagocytic activity. Virtually does not penetrate the blood-brain barrier. Connection with plasma proteins - 96%

It is partially metabolized. The half-life (T1 / 2) after a single dose is, on average, 10.5 hours, in children (up to 13 years) - up to 20 hours. In adults with normal kidney and liver function, 65% of roxithromycin is excreted through the intestine. Less than 0.05% of the dose given is excreted in breast milk.

In severe chronic renal failure T1 / 2 - 25 hours.

In elderly patients (60-79 years), T1 / 2 increases.

Indications:

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

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

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

- infections of the skin and soft tissues;

- infections of the genitourinary system (except gonorrhea), including urethritis, cervicovaginitis.

Contraindications:

- increased sensitivity to roxithromycin and other macrolides;

- simultaneous administration of drugs derivatives of ershtamina and dihydroergotamine;

- pregnancy;

- lactation period,

- children under 3 years old or at a body weight of less than 30 kg

Carefully:liver failure, patients older than 65 years.

Dosing and Administration:

Inside. Rulicin® should be taken before meals, with plenty of water.

Adults and children over 12 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 appoint 300 mg once a day.

The duration of taking roksitromitsina depends on the indications for use, the severity of the infectious process and the activity of the pathogen. The average duration of treatment is 5-12 days, with chlamydial and mycoplasmal pneumonia - 14 days, with legionella pneumonia - up to 21 days.

In elderly patients dosage and daily dose of roxithromycin does not change.

Children from 3 to 12 years old (with a body weight of at least 30 kg): the drug is prescribed depending on the weight of the body, the type of pathogen and the severity of the infection process. The recommended dose is 5-8 mg / kg per day in 1-2 divided doses, the duration of treatment is not more than 10 days.

Patients with hepatic insufficiency the drug is prescribed in a dose of 150 mg once a day.

For patients with severe renal insufficiency (creatinine clearance less than 15 ml / min), the recommended dose is 150 mg every 24 hours.

Side effects:

Allergic reactions: rash, hyperemia, urticaria, angioedema, bronchospasm, weakness; rarely anaphylactic shock.

From the gastrointestinal tract: a slight change in taste and a decrease in appetite, nausea, vomiting, abdominal pain, flatulence, diarrhea (very rarely with blood), transient increased activity of "liver" transaminases, cholestatic or hepatocellular acute hepatitis; in some cases, symptoms of pancreatitis, increased activity of alkaline phosphatase, pseudomembranous enterocolitis.

From the nervous system: dizziness, headache, paresthesia.

Other: possible development of superinfection due to the growth of insensitive microorganisms, candidiasis, fever, pigmentation of nails.

Overdose:In case of an overdose, the stomach is washed and symptomatically treated. There is no specific antidote.

Interaction:

The combined use of ergotamine derivatives and ergotaminopodobnymi vasoconstrictors not permitted as this combination can lead to the development of "ergotism" and necrosis of the tissues of the extremities.

With simultaneous admission with digoxin, it is possible to increase its absorption.

Macrolide antibiotics can increase the serum concentrations of terfenadine, astemizole, cisapride, pimozide with simultaneous administration, which may lead to prolongation of the QT interval and / or the development of severe ventricular arrhythmias (ECG monitoring is necessary). Reduces the effectiveness of indirect anticoagulants. Increases T1 / 2 midazolam (increased and prolonged duration of action).

Increases the concentration in the plasma of theophylline, cyclosporin A (does not require correction of the dosing regimen).

Can displace the disopyramide from the connection with plasma proteins, leading to an increase in its concentration in the serum.

Interaction with carbamazepine, ranitidine, antacids, oral contraceptives (estrogen-gestagen containing) is absent.

Special instructions:

With the development of superinfection or pseudomembranous colitis roxithromycin should immediately be abolished and appropriate therapy prescribed.

With hepatic failure perform liver function monitoring.

Form release / dosage:

Tablets, film-coated, 150 mg.

Packaging:

10 tablets per strip from Al / Al. 1 strip is placed in a cardboard box together with instructions for use.

Storage conditions:In dry, the dark place at a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N011805 / 01

Date of registration:31.07.2008

The owner of the registration certificate:Layfors HeltcherLayfors Heltcher India

Manufacturer: & nbsp

Lifesource Healthcare India

Representation: & nbspLayfors HeltcherLayfors HeltcherIndia

Information update date: & nbsp12.06.2016

Illustrated instructions

Instructions

Rulicin® (Rulicin®)