Roxithromycin pills 150mg 10 pcs.

Composition

Active ingredient:

roxithromycin-150.00 mg.

Excipients (core):

microcrystalline cellulose – 127.50 mg;

sodium carboxymethyl starch-9.00 mg;

povidone (polyvinylpyrrolidone) – 9.00 mg;

magnesium stearate-3.00 mg;

colloidal silicon dioxide-1.50 mg.

Excipients (shell):

Opadray II White – 10.00 mg, including polyvinyl alcohol-4.69 mg; macrogol-3350-2.36 mg; talc-1.74 mg; titanium dioxide-1.21 mg

. Pharmacological action

Semisynthetic antibiotic of the macrolide group. The mechanism of action is caused by a violation of the intracellular protein synthesis of microorganisms. At low concentrations, it has a bacteriostatic effect, and at high concentrations, it has a bactericidal effect.

Active against gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, methicillin-sensitive strains of Staphylococcus aureus; against Gram-negative bacteria: Moraxella catarrhalis.

Roxithromycin is also active against Mycoplasma pneumoniae, Ureaplasma urealyticum, and Chlamydia spp. Roxithromycin’s activity against Haemophilus influenzae is less pronounced than that of erythromycin.

It is inactive against Mycoplasma hominis. Pseudomonas spp., Enterobacter spp., and Acinetobacter spp. are resistant to roxithromycin.

Indications

Mild to moderate infections caused by roxithromycin-sensitive pathogens:For adults

• Upper respiratory tract infections: pharyngitis, tonsillitis, acute sinusitis.
• Lower respiratory tract infections: pneumonia (including pneumonia caused by “atypical” pathogens, including Chlamydia psittaci, Chlamydia pneumoniae, Moraxella catarrhalis, Legionella pneumophila), bronchitis.
• Skin and soft tissue infections.
• Urinary tract infections caused by Chlamydia trachomatis and Ureaplasma urealyticum.
• Infections in odontology, infections of the oral cavity and teeth.

For children

• Upper respiratory tract infections: tonsillitis, pharyngitis, acute sinusitis.
• Lower respiratory tract infections: pneumonia (including pneumonia caused by “atypical” pathogens, including Chlamydia psittaci, Chlamydia pneumoniae, Moraxella catarrhalis, Legionella pneumophila), bronchitis.
• Skin and soft tissue infections.

Contraindications

* Hypersensitivity to roxithromycin, other macrolides or other components of the drug; * pregnancy; * lactation period; * porphyria; • concomitant administration of ergot vasoconstrictor alkaloids (ergotamine and dihydroergotamine) • * concomitant administration of cisapride, pimozide, astemizole and terfenadine; * children under 12 years of age or with a body weight of less than 40 kg (for this dosage form).

Side effects

From the liver: increased activity of “hepatic” transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (ACT) and/or alkaline phosphatase), acute cholestatic or hepatocellular hepatitis (sometimes with the development of jaundice).

From the gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea (sometimes with blood), pancreatitis, pseudomembranous colitis.

Nervous system disorders: dizziness, headache, paresthesia, changes in taste (including ageusia), olfactory disturbances (including

anosmia), hallucinations, temporary hearing loss, hypoacusia (incomplete hearing loss), vertigo.

Skin reactions: rash, redness, purpura.

Allergic reactions: urticaria, angioedema, bronchospasm, eosinophilia; anaphylactic shock, erythema multiforme.

Other: possible development of superinfection, candidiasis.

Interaction

When used concomitantly with indirect anticoagulants, the anticoagulant effect may be enhanced.

When used concomitantly with ergot preparations, ergotamine-like vasoconstrictors, ergotism may develop up to necrosis of the limb tissues.

When used concomitantly with digoxin, digoxin absorption increases.

With simultaneous use, a slight increase in the concentrations of midazolam and triazolam in blood plasma is possible.

When used concomitantly with theophylline, it is possible to increase the concentration of theophylline in blood plasma.

It is impossible to exclude the possibility of increasing plasma concentrations of cisapride, astemizole, terfenadine when they are used simultaneously with roxithromycin.

When used concomitantly with cyclosporine, it is possible to slightly increase the concentration in the blood and the toxic effect of cyclosporine.

When used concomitantly with ethambutol, there is a synergistic effect on Mycobacterium avium.

How to take, course of administration and dosage

Inside. The drug should be taken before meals, washed down with a sufficient amount of liquid. Adults and children over 12 years of age (with a body weight of more than 40 kg): the standard dose is 150 mg 2 times a day, with an interval of 12 hours or 300 mg once (for adults only). In elderly patients, the single and daily dose of roxithromycin does not change.

In patients with renal insufficiency With renal insufficiency, roxithromycin is prescribed at a dose of 150 mg 2 times a day.

In patients with severe hepatic insufficiency

In patients with severe hepatic insufficiency (for example, cirrhosis of the liver with jaundice or ascites), the dose should be reduced by 2 times, that is,150 mg of roxithromycin once a day.

Overdose

Symptoms: increased dose-dependent side effects may occur.

Treatment: gastric lavage, symptomatic therapy.

There is no specific antidote.

Special instructions

Use with caution in patients with impaired liver and kidney function.

If superinfection or pseudomembranous colitis develops, roxithromycin should be discontinued immediately and appropriate therapy should be prescribed.

Use with caution concomitantly with terfenadine and astemizole.

In experimental studies no carcinogenic effects were detected.

Form of production

Film-coated tablets

Active ingredient

Roxithromycin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Indications

Pneumonia, Skin Infections, Urinary Tract Infections, Bronchitis, Pharyngitis, Sinusitis, Vaginal Infections

Weight

Weight: 10 g.