ROKSEPTYN

Active material: Roksitromitsin
When ATH: J01FA06
CCF: Macrolide antibiotics
When CSF: 06.07.01
Manufacturer: IPCA LABORATORIES Ltd. (India)

Pharmaceutical form, composition and packaging

Pills dispersible1 tab.
roksitromitsin50 mg

10 PC. – strips (1) – packs cardboard.
10 PC. – strips (2) – packs cardboard.
10 PC. – strips (5) – packs cardboard.

 

Pharmacological action

Semi-synthetic macrolide antibiotic for oral administration. It has a bacteriostatic effect: связываясь с 50S субъединицей рибосом, inhibits translocation reaction and transpeptidation, the formation of peptide bonds between amino acids and peptide chain, inhibits protein synthesis by ribosomes, whereby it inhibits growth and reproduction of bacteria. To the drug-sensitive: Streptococcus group A and B, incl. Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus, Streptococcus saunguis, Streptococcus viridans, Streptococcus pneumoniae; Neisseria meningitidis; Moraxella catarrhalis (Branham); Bordetella pertussis; Listeria monocytogenes; Corynebacterium diphtheriae; Clostridium spp.; Mycoplasma pneumoniae; Pasteurella multocida; Ureaplasma urealyticum; Chlamydia trachomatis, Chlamydia pneumoniae, Chlamydia psittaci; Legionella pneumophila; Campylobacter spp.; Gardnerella vaginalis. Irregular sensitive: Haemophilus influenzae; Bacteroides fragilis and Vibrio cholerae. Resistant: Enterobacteriaceae spp., Pseudomonas spp., Acinetobacter spp. Stable in acidic media.

 

Testimony

Infections of upper and lower respiratory tract (pharyngitis, bronchitis, pneumonia, bacterial infections in patients with COPD, panʙronxiolit, bronchiectasis), ENT (tonsillitis, sinusitis, otitis media), skin and soft tissue (mug, flegmona, boils, folliculitis, impetigo, pyoderma), urinary tract (uretrit, endometritis, cervicitis, vaginitis, incl. infection, Sexually Transmitted Infections, except for gonorrhea), oral (periodontitis), bones (periostitis, chronic osteomyelitis); scarlet fever, Diphtheria, pertussis, trachoma, migratory erythematous rash, Brucellosis. Prevention of meningococcal meningitis in people, were in contact with the patient. Prevention of bacteremia in patients with endocarditis after dental surgery.

 

Contraindications

Hypersensitivity, concomitant use of ergotamine and dihydroergotamine; pregnancy, lactation, infancy (to 2 Months).C care. Hepatic failure.

 

Side effects

Nausea, vomiting, decreased appetite, changes in taste and / or smell, epigastric pain, diarrhea (very rarely with blood), flatulence, activity increase “Hepatic” transaminases and alkaline phosphatase, cholestatic or hepatocellular acute hepatitis, pancreatitis, pseudomembranous enterocolitis; dizziness, headache, paresthesia, allergic reactions (bronchospasm, hives, rash, dermahemia, angioedema, anaphylactic shock), development of superinfection, candidiasis of mouth and vagina, pigmentation nogtey.Peredozirovka. Treatment: gastric lavage, symptomatic treatment, There is no specific antidote.

 

Dosing and Administration

Inside, adult – 150 mg 2 once a day, in the morning and in the evening, before eating or 300 mg dose. A course of treatment – from 5-12 days for respiratory diseases and ENT, to 2-2.5 Months – chronic osteomyelitis. When chlamydia and mycoplasma pneumonia – 14 days, when Legionella pneumonia – to 21 day. When liver failure – 150 mg 1 once a day. Babies (suspension) – 5-8 mg / kg / day (depending on the body weight, the type of pathogen and the severity of infection), no more 10 days. The suspension was prepared immediately before use: scoop filled with water and placed in it 0.5 or 1 tablet for suspension for oral administration; when the tablet disintegrates into small granules, immediately give the child and then drink water.

 

Cautions

When liver failure to monitor liver function.

 

Cooperation

It increases the absorption of digoxin. Increases prothrombin time while receiving warfarin or fenprokoumonom. Увеличивает T1/2 и AUC мидозалама (amplification and prolongation of efficacy). Increases in plasma concentration of theophylline, Cyclosporin A (It does not require correction dosing regimen). Increases plasma concentrations astemizole, cisapride, pimozida, which leads to a lengthening of the QT interval and / or severe arrhythmias (requires monitoring of ECG). May displace disopyramide of connection with plasma proteins, resulting in an increase in its concentration in the serum. Ergotamine and ergotaminopodobnye vasoconstrictor drugs lead to the development “ergotism”, tissue necrosis limbs.

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