RULID

Active material: Roksitromitsin
When ATH: J01FA06
CCF: Macrolide antibiotics
When CSF: 06.07.01
Manufacturer: SANOFI-AVENTIS France (France)

Pharmaceutical form, composition and packaging

Pills, coated white, lenticular, cylindrical, с гравировкой “164” на одной стороне.

Excipients: hydroksypropyltsellyuloza, poloxamer, povidone K30, colloidal silicon dioxide, magnesium stearate, talc, corn starch.

The composition of the shell: gipromelloza, dextrose bezvodnaya, Titanium dioxide, propylene glycol.

10 PC. – блистеры (1) – пачки картонные.

Pharmacological action

Semi-synthetic macrolide antibiotic for oral administration.

To the drug-sensitive: Streptococcii groups A and B, including Str. pyogenes, Str. agalactia, Str. Mild, saunguis, viridans. Streptococcus pneuinoniae; Neisseria meningitidis; Branhamella catarrhalis; Bordetella pertussis; Listeria monocytogenes: Corynebacterium diphtheriae; Clostridium; Mycoplasma pneumoniae; Pasteurella multocida; Ureaplasma urealyticum; Chlamydia trachomatis, pneumoniae and psittaci; Legionella pneumophila; Campylobacter; Gardnerella vaginalis. By variably sensitive drug: Haemophilus influenzae; Bacteroides fragilis and Vibrio cholerae. For drug resistant: Enterobacteriaceae, Pseudomonas, Acinetobacter.

Pharmacokinetics

The drug is rapidly absorbed after oral administration. Other macrolides roxithromycin stable in the acidic environment of the stomach. The drug for 15 minutes before meal no effect on the pharmacokinetics of.

It is detected in the serum after 15 minutes after administration. After taking the drug at a dose 0.15 r maximum concentration in blood is, average, 6.6 mg / l and is achieved through the 2.2 no. Taking the drug at intervals 12 h ensures that the effective concentrations in the blood for days. The equilibrium state of the plasma is achieved between 2 and 4 recently. The drug penetrates well into many tissues, especially in light, in the tonsils and prostate. The drug also penetrates well into cells, particularly in neutrophils and monocytes, stimulating their phagocytic activity. Linking blood protein is 96%, It is saturated in nature and decreases in concentrations of more than roxithromycin 4 mg / l.

Roxithromycin is only partially metabolised, more than half of the active substance is excreted unchanged in the feces mostly, and urine. The half-life after a single dose of the drug is, average, 10.5 no.

Testimony

• treatment of susceptible infections of, including upper respiratory tract infections, lower respiratory tract infections, infections of skin and soft tissue, urinary tract infections (including infections, Sexually Transmitted Infections, except for gonorrhea), infection in dentistry.
• Prevention of meningococcal meningitis streets, have been in contact with the patient.

Dosage regimen

Adults appoint 150 mg 2 times / day, in the morning and in the evening, before meals.

Children drug designate depending on body weight, the type of pathogen and the severity of infection. The recommended dose is 5-8 mg / kg / day, Duration of treatment is not more 10 days.

Patients with liver failure drug appointed dose 150 mg 1 time / day.

Side effect

On the part of the digestive tract and liver: nausea, vomiting, stomach ache, diarrhea, transient increase in transaminases and alkaline phosphatase.

Other: allergic reactions.

Contraindications

• Hypersensitivity to macrolides;
• concomitant use of medications such as ergotamine and dihydroergotamine;
• pregnancy;
• lactation.

Pregnancy and lactation

The drug is contraindicated.

Cautions

In appointing the drug to patients with hepatic insufficiency extra care, monitoring of liver function and dose adjustment. In appointing the drug to patients with renal insufficiency, as well as elderly patients need to adjust the dose does not arise.

Overdose

In case of overdose the stomach is washed and symptomatic treatment. There is no specific antidote.

Drug Interactions

The combined use of ergotamine derivatives and ergotaminopodobnymi decongestants not allowed, так как может привести к развитию “эрготизма” и некрозу тканей конечностей. When concomitantly with digoxin may increase its absorption.

Macrolide antibiotics may increase serum concentrations of terfenadine when taken, that can lead to severe ventricular arrhythmias.

Conditions and terms

Shelf life - 2 year.