NAZEN [Mometasone furoate] 0.05 mg Nasal spray
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MOLEROY
instructions for the medical use of the medicinal product
Tradename
Moleroy, Молерой
International non-proprietary name or generic name
Moxifloxacin, Моксифлоксацин
Composition
Each film coated tablet contains:
Active substance: moxifloxacin (as moxifloxacin hydrochloride) 400 mg
Excipients: lactose monohydrate, microcrystalline cellulose, primogel, starch, PVP K-30, talc, magnesium stearate.
Each 250 ml of solution contains:
Active substance: moxifloxacin (as moxifloxacin hydrochloride) 400 mg
Excipients: sodium chloride, water for injection.
Tablets.
Solution for infusion.
Antimicrobial agent is fluoroquinolone.
Pharmacodynamics
Antimicrobial agent from the group of fluoroquinolones, has a bactericidal effect. Shows activity against a wide range of gram-positive and gram-negative microorganisms, anaerobic, acid-fast and atypical bacteria: Mycoplasma spp., Chlamydia spp., Legionella spp. Effective against bacterial strains resistant to beta-lactams and macrolides. It is active against most strains of microorganisms: gram-positive - Staphylococcus aureus (including strains insensitive to methicillin), Streptococcus pneumoniae (including strains resistant to penicillin and macrolides), Streptococcus pyogenes (group A); gram negative - Haemophilus influenzae (including both β-lactamase-producing and non-β-lactamase-producing strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including both β-lactamase-producing and non-β-lactamase-producing coli strains), Enterobacia; atypical - Chlamydia pneumoniae, Mycoplasma pneumoniae. According to in vitro studies, although the microorganisms listed below are sensitive to moxifloxacin, nevertheless, its safety and efficacy in the treatment of infections has not been established. Gram-positive microorganisms: Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohnii, Staphylococcus epidermidis (including strains susceptible to methicillin), Staphylococcus hemolyticus. Gram-negative microorganisms: Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter intermedius, Enterobacter sakazaki, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii. Anaerobic microorganisms: Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaornicron, Bacteroides uniformis, Fusobacterium spp., Porphyromonas spp., Porphyromonas. Anaerobius ramosum. Atypical microorganisms: Legionella pneumophila, Caxiella burnettii.
Blocks topoisomerases II and IV, enzymes that control the topological properties of DNA, and are involved in DNA replication, repair and transcription. The action of moxifloxacin depends on its concentration in the blood and tissues. The minimum bactericidal concentrations are almost indistinguishable from the minimum inhibitory concentrations.
After oral administration, moxifloxacin is absorbed quickly and almost completely. After a single dose of moxifloxacin at a dose of 400 mg, Cmax in the blood is reached within 0.5-4 hours and is 3.1 mg / l.
After a single infusion at a dose of 400 mg for 1 hour, Cmax is reached at the end of the infusion and is 4.1 mg / l, which corresponds to an increase of approximately 26% compared to the value of this indicator when taken orally. With repeated intravenous infusions at a dose of 400 mg for 1 hour, Cmax varies in the range from 4.1 mg / l to 5.9 mg / l. Average Css of 4.4 mg / L are reached at the end of the infusion.
The absolute bioavailability is about 91%.
The binding to blood proteins (mainly albumin) is about 45%.
Moxifloxacin is rapidly distributed in organs and tissues. Vd is approximately 2 l / kg. High concentrations of moxifloxacin, exceeding those in plasma, are created in the lung tissue (including in alveolar macrophages), in the mucous membrane of the bronchi, in the nasal sinuses, in soft tissues, skin and subcutaneous structures, foci of inflammation. In the interstitial fluid and in saliva, the drug is determined in a free form, not bound to proteins, in a concentration higher than in plasma. In addition, high concentrations of the active substance are determined in the organs of the abdominal cavity and peritoneal fluid, as well as in the tissues of the female genital organs.
Biotransformed to inactive sulfo compounds and glucuronides. Moxifloxacin is not biotransformed by microsomal liver enzymes of the cytochrome P450 system.
It is excreted in the urine, as well as in the feces, both unchanged and in the form of inactive metabolites. With a single dose of 400 mg, about 19% is excreted unchanged in the urine, about 25% in the feces. T1 / 2 is approximately 12 hours. The average total clearance after administration at a dose of 400 mg ranges from 179 ml / min to 246 ml / min.
Infectious and inflammatory diseases caused by sensitive microorganisms: acute sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia; uncomplicated infections of the skin and soft tissues, complicated infections of the skin and subcutaneous structures; complicated intra-abdominal infections, including polymicrobial infections, incl. intraperitoneal abscesses; uncomplicated inflammatory diseases of the pelvic organs, incl. salpingitis and endometritis.
Hypersensitivity to moxifloxacin, other quinolones and any other component of the drug; pregnancy and the period of breastfeeding; a history of tendon pathology that developed as a result of treatment with quinolone antibiotics, epileptic syndrome (epilepsy), liver failure, QT prolongation syndrome; children and adolescents up to 18 years old.
Method of administration and dosage
Tablets
Inside, at a dose of 400 mg 1 time per day.
The duration of treatment is determined by the severity of the infection and the clinical effect and can range from 5 to 21 days.
The course of treatment for exacerbation of chronic bronchitis - 5 days, community-acquired pneumonia - 10 days, acute sinusitis, skin and soft tissue infections - 7 days.
Solution for infusion
Intravenous (injected slowly, over at least 60 minutes) at a dose of 400 mg 1 time per day.
The solution can be injected directly or through a T-shaped catheter with compatible infusion solutions: water for injection; sodium chloride solution 9 mg / ml; dextrose solutions 50 mg / ml, 100 mg / ml and 400 mg / ml; Ringer's solution, Ringer's lactate solution.
A mixture of Moleroy solution with the above infusion solutions remains stable for 24 hours at room temperature. If Moleroy solution is prescribed together with other drugs, each drug should be used separately.
The duration of treatment is determined by the location and severity of the infection, as well as the clinical effect. At the initial stages of treatment, Moleroy can be used in the form of a solution for infusion, and then, if indicated, it can be prescribed for oral administration in the form of film-coated tablets.
• Community-acquired pneumonia: the total duration of stepwise therapy (intravenous followed by oral administration) is 7-14 days;
• Complicated infections of the skin and subcutaneous structures: the total duration of stepwise therapy (intravenous administration followed by oral administration) is 7-21 days;
• Complicated intra-abdominal infections: the total duration of sequential therapy (intravenous administration followed by oral administration) is 5-14 days.
Do not exceed the recommended dose.
The recommended duration of treatment should not be exceeded.
Elderly patients do not need to change the dosage regimen.
Special instructions and precautions
Before starting treatment, appropriate tests should be performed to identify the microorganisms that caused the disease and to assess susceptibility to moxifloxacin.
The use of broad-spectrum antibacterial drugs, including moxifloxacin, is associated with the risk of developing pseudomembranous colitis. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea.
During therapy with quinolones, incl. moxifloxacin, tendinitis and tendon rupture may develop, especially in the elderly and patients receiving GCS. At the first symptoms of pain or inflammation at the site of injury, the use of Moleroy should be discontinued and the affected limb should be relieved.
Use with caution in diseases of the central nervous system (including diseases suspicious of involvement of the central nervous system), predisposing to the occurrence of seizures and lowering the threshold of convulsive readiness; in patients with a history of psychosis and / or psychiatric illness; in patients with potentially proarrhythmic conditions such as acute myocardial ischemia and cardiac arrest, especially in women and elderly patients; with myasthenia gravis; with cirrhosis of the liver; when taken simultaneously with drugs that reduce the content of potassium; in patients with a genetic predisposition or an actual deficiency of glucose-6-phosphate dehydrogenase.
Influence on the ability to drive vehicles and mechanisms
Application during pregnancy and during breastfeeding
Use during pregnancy and during breastfeeding is contraindicated.
Interaction with other medicinal products
With the simultaneous use of antacids, minerals, multivitamins worsen absorption (due to the formation of chelate complexes with polyvalent cations) and reduce the concentration of moxifloxacin in plasma (simultaneous administration is possible with an interval of 4 hours before or 2 hours after taking moxifloxacin).
When taking moxifloxacin against the background of the use of other fluoroquinolones, the development of phototoxic reactions is possible.
Ranitidine reduces the absorption of moxifloxacin.
From the digestive system: abdominal pain, nausea, diarrhea, vomiting, dyspepsia, flatulence, constipation, increased activity of hepatic transaminases, taste perversion.
From the side of the central nervous system and peripheral nervous system: dizziness, insomnia, nervousness, anxiety, asthenia, headache, tremor, paresthesia, leg pain, convulsions, confusion, depression.
From the side of the cardiovascular system: tachycardia, peripheral edema, increased blood pressure, palpitations, chest pain.
On the part of laboratory parameters: a decrease in the level of prothrombin, an increase in amylase activity.
From the hematopoietic system: leukopenia, eosinophilia, thrombocytosis, thrombocytopenia, anemia.
From the musculoskeletal system: back pain, arthralgia, myalgia.
From the reproductive system: vaginal candidiasis, vaginitis.
Allergic reactions: rash, itching, urticaria.
During therapy with fluoroquinolones, inflammation and rupture of the tendon can develop, especially in elderly patients and in patients receiving concomitant corticosteroids. At the first sign of pain or inflammation of the tendons, patients should stop treatment and release the affected limb from the load.
Symptoms: increased side reactions.
Treatment: symptomatic and supportive therapy.
Tablets
Store in a cool and dry place at temperatures below 30°C.
Solution for infusion
Store in a dry place at a temperature not exceeding 25°C. Protect from light.
Keep out of the reach of children!
2 years. Do not use after the expiration date printed on the package.
Dispensed by prescription.
Release form
Tablets
5 tablets in aluminum foil blister. 1 blister with instructions for use in a cardboard box.
Solution for infusion
1 bottle of 250 ml with solution. Bottle with instructions for use in a cardboard box.