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Roxitromycine Uses |
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Roxitromycine is indicated for the treatment of the following types of mild to
moderately severe infections caused by or likely to be caused by susceptible
micro-organisms: • upper respiratory tract infection - acute pharyngitis, tonsillitis and
sinusitis
• dental infections
• lower respiratory tract infection - acute bronchitis; acute exacerbations
of chronic bronchitis and community acquired pneumonia
• skin and skin structure infections
• non-gonococcal urethritis.
Roxitromycine is used to treat ear, nose and throat infections, pneumonia (lung infection), skin infections and infections of the genitalia.
Roxitromycine is a semi-synthetic macrolide antibiotic. It is very similar in composition, chemical structure and mechanism of action to erythromycin, azithromycin, or clarithromycin. Roxitromycine prevents bacteria from growing, by interfering with their protein synthesis. Roxitromycine binds to the subunit 50S of the bacterial ribosome, and thus inhibits the translocation of peptides. Roxitromycine has similar antimicrobial spectrum as erythromycin, but is more effective against certain gram-negative bacteria, particularly Legionella pneumophila. It can treat respiratory tract, urinary and soft tissue infections. It is in the United States, but is available in Australia.
Susceptible infections
Adult: 150 mg bid or 300 mg once daily for 5-10 days in susceptible infections.
Child: 6-40 kg: 5-8 mg/kg daily.
Renal impairment: Dosage adjustment may be required.
Hepatic impairment: Usual daily doses should be halved in hepatic impairment.
Roxitromycine has a much lower affinity for cytochrome P450 than erythromycin, and consequently has fewer interactions. Interactions may be observed, however, with drugs that bind to alpha-1-acid glycoprotein, e.g. disopyramide. Roxitromycine does not appear to interact with oral contraceptives, prednisolone, carbamazepine, ranitidine or antacids. Theophylline. A study in normal subjects concurrently administered Roxitromycine and theophylline has shown some increase in the plasma concentration of the latter. While a change in dosage is usually not required, patients with high levels of theophylline at commencement of treatment should have levels monitored. Ergot alkaloids. Reactions of ergotism with possible peripheral necrosis have been reported after concomitant therapy of macrolides with vasoconstrictive ergot alkaloids, particularly ergotamine and dihydroergotamine. Because a clinical interaction with Roxitromycine cannot be excluded, administration of Roxitromycine to patients taking ergot alkaloids is contraindicated. Disopyramide. An in vitro study has shown that Roxitromycine can displace protein bound disopyramide; such an effect in vivo could result in increased serum levels of disopyramide. Consequently, ECG and, if possible, disopyramide serum levels should be monitored. Terfenadine. Some macrolide antibiotics (e.g. erythromycin) may increase serum levels of terfenadine. This can result in severe cardiovascular adverse events, including QT prolongation, torsades de pointes and other ventricular arrhythmias. Such a reaction has not been documented with Roxitromycine, which has a much lower affinity for cytochrome P450 than erythromycin. However, in the absence of a systematic interaction study, concomitant administration of Roxitromycine and terfenadine is not recommended. Astemizole, cisapride, pimozide. Other drugs, such as astemizole, cisapride or pimozide, which are metabolised by the hepatic isozyme CYP3A4, have been associated with QT interval prolongation and/or cardiac arrhythmias (typically torsades de pointes) as a result of an increase in their serum level subsequent to interaction with significant inhibitors of this isozyme, including some macrolide antibacterials. Although Roxitromycine has no or limited ability to complex CYP3A4 and hence to inhibit the metabolism of other drugs processed by this isozyme, a potential for clinical interaction of Roxitromycine with the above mentioned drugs cannot be either ascertained or ruled out in confidence. Thus, concomitant administration of Roxitromycine and such drugs is not recommended. Warfarin. While no interaction was observed in volunteer studies, Roxitromycine appears to interact with warfarin. Increases in prothrombin time (international normalised ratio (INR)) have been reported in patients treated concomitantly with Roxitromycine and warfarin or the related vitamin K antagonist phenprocoumon, and severe bleeding episodes have occurred as a consequence. Digoxin and other cardiac glycosides. A study in healthy volunteers has shown that Roxitromycine may increase the absorption of digoxin. This effect, common to other macrolides, may very rarely result in cardiac glycoside toxicity. This may be manifested by symptoms such as nausea, vomiting, diarrhoea, headache or dizziness. Cardiac glycoside toxicity may also elicit heart conduction and/or rhythm disorders. Consequently, in patients treated with Roxitromycine and digoxin or another cardiac glycoside, ECG and, if possible, the serum level of the cardiac glycoside should be monitored. This is mandatory if symptoms suggesting cardiac glycoside overdosage have occurred. Midazolam. Roxitromycine, like other macrolides, may increase the area under the midazolam concentration-time curve and the midazolam half-life. Thus, the effects of midazolam may be enhanced and prolonged in patients treated with Roxitromycine. There is no conclusive evidence for an interaction between Roxitromycine and triazolam. Cyclosporin. A slight increase in plasma concentrations of cyclosporin A has been observed. This does not generally necessitate altering the usual dosage.
The incidence of common adverse reactions is based upon two U.S. and five non-U.S. controlled clinical trials in 1,526 patients [110 females and 239 males less than 18 years of age, and 635 females and 542 males 18 years of age and older] treated with Budesonide Nasal Spray at doses up to 400 mcg once daily for 3-6 weeks. The table below describes adverse events occurring at an incidence of 2% or greater and more common among Budesonide Nasal Spray-treated patients than in placebo-treated patients in controlled clinical trials. The overall incidence of adverse events was similar between Budesonide and placebo.
Epistaxis.
Pharyngitis.
Bronchospasm.
Coughing.
Nasal Irritation.
A similar adverse event profile was observed in the subgroup of pediatric patients 6 to 12 years of age.
Two to three percent (2-3%) of patients in clinical trials discontinued because of adverse events. Systemic corticosteroid side effects were not reported during controlled clinical studies with Budesonide Nasal Spray.
If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism, ie, Cushing’s Syndrome, and adrenal suppression could occur.
Adverse events reported from post-marketing experience include: immediate and delayed hypersensitivity reactions (including anaphylactic reaction, urticaria, rash, dermatitis, angioedema and pruritus), glaucoma, increased intraocular pressure, cataracts, nasal septum perforation, pharynx disorders (throat irritation, throat pain, swollen throat, burning throat, and itchy throat), anosmia, and palpitations.
Cases of growth suppression have been reported for intranasal corticosteroids including Budesonide.
Known allergy to macrolides.
Concomitant administration of Roxitromycine with vasoconstrictive ergot (alkaloid) derivatives is contra-indicated since symptoms of ergotism have been described with other macrolides.
Roxithromycin in Netherlands.
Unit description / dosage (Manufacturer) | Price, USD |
Tablet; Oral; Roxithromycin 150 mg | |
Tablet; Oral; Roxithromycin 300 mg | |
List of Roxitromycine substitutes (brand and generic names): | |
Roxitromin (Brazil) | |
Roxitromycine CF (Netherlands) | |
Roxitromycine Sandoz (Netherlands) | |
Roxitron (Poland, Thailand) | |
Roxitron 150 mg x 10 x 10's (ICN) | |
ROXITROY | |
ROXITROY TABLET 1 strip / 10 tablets each (Troikaa Pharmaceuticals Ltd) | $ 0.79 |
ROXIVA | |
ROXIVA Capsule/ Tablet / 50mg / 10 units (Viva Laboratories) | $ 0.39 |
ROXIVA Capsule/ Tablet / 150mg / 10 units (Viva Laboratories) | $ 0.96 |
Roxivar (India) | |
Roxivar 50mg TAB / 10 (Zota) | $ 0.36 |
Roxivar 150mg TAB / 10 (Zota) | $ 0.72 |
50 mg x 10's (Zota) | $ 0.36 |
150 mg x 10's (Zota) | $ 0.72 |
ROXIVAR tab 50 mg x 10's (Zota) | $ 0.36 |
ROXIVAR tab 150 mg x 10's (Zota) | $ 0.72 |
ROXIVIK | |
ROXIVIK 150MG TABLET 1 strip / 10 tablets each (Suvik Hitek Pvt Ltd) | $ 0.85 |
Roxivinol (Greece) | |
Roxivista (India) | |
ROXIVISTA Liquid / 50mg per 5ml / 30ml units (Cadila (Genvista)) | $ 0.46 |
ROXIVISTA Capsule/ Tablet / 50mg / 10 units (Cadila (Genvista)) | $ 0.58 |
ROXIVISTA Capsule/ Tablet / 150mg / 10 units (Cadila (Genvista)) | $ 0.78 |
150 mg x 10's (Cadila (Genvista)) | $ 0.78 |
Roxivista 150mg TAB / 10 (Cadila (Genvista)) | $ 0.78 |
ROXIVISTA 150MG TABLET 1 strip / 10 tablets each (Cadila (Genvista)) | $ 0.23 |
ROXIVISTA 50MG SUSPENSION 1 bottle / 30 ML suspension each (Cadila (Genvista)) | $ 0.17 |
ROXIVISTA tab 150 mg x 10's (Cadila (Genvista)) | $ 0.78 |
Roxivista 150mg Tablet (Cadila (Genvista)) | $ 0.02 |
Roxivista 50mg Suspension (Cadila (Genvista)) | $ 0.17 |
ROXIWIN (India) | |
ROXIWIN tab 150 mg x 10's (Impact) | |
ROXIZ (India) | |
50 mg x 10's (Ritz Pharma) | $ 0.72 |
Roxiz 50mg TAB / 10 (Ritz Pharma) | $ 0.72 |
ROXIZ tab 50 mg x 10's (Ritz Pharma) | $ 0.72 |
Roxiz 50mg TAB / 10 (Ritz Pharma) | $ 0.72 |
ROXIZED (India) | |
50 mg x 10's (Zota) | $ 0.36 |
150 mg x 10's (Zota) | $ 0.78 |
Roxized 50mg TAB / 10 (Zota) | $ 0.36 |
Roxized 150mg TAB / 10 (Zota) | $ 0.78 |
ROXIZED 150MG SYRUP 1 bottle / 30 ML syrup each (Zota) | $ 0.44 |
ROXIZED tab 50 mg x 10's (Zota) | $ 0.36 |
ROXIZED tab 150 mg x 10's (Zota) | $ 0.78 |
Roxized 50mg TAB / 10 (Zota) | $ 0.36 |
Roxized 150mg TAB / 10 (Zota) | $ 0.78 |
Roxized 50mg Syrup (Zota) | $ 0.44 |
Roxl (Vietnam) | |
Roxl-150 (Philippines) | |
Roxl-150 150 mg x 10's | |
See 1988 substitutes for Roxitromycine |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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