Operoxolid indications
Operoxolid 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.
Uses of Operoxolid in details
Operoxolid is used to treat ear, nose and throat infections, pneumonia (lung infection), skin infections and infections of the genitalia.
Operoxolid description
Operoxolid is a semi-synthetic macrolide antibiotic. It is very similar in composition, chemical structure and mechanism of action to erythromycin, azithromycin, or clarithromycin. Operoxolid prevents bacteria from growing, by interfering with their protein synthesis. Operoxolid binds to the subunit 50S of the bacterial ribosome, and thus inhibits the translocation of peptides. Operoxolid 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.
Operoxolid dosage
Oral
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.
Operoxolid interactions
Operoxolid 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. Operoxolid does not appear to interact with oral contraceptives, prednisolone, carbamazepine, ranitidine or antacids. Theophylline. A study in normal subjects concurrently administered Operoxolid 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 Operoxolid cannot be excluded, administration of Operoxolid to patients taking ergot alkaloids is contraindicated. Disopyramide. An in vitro study has shown that Operoxolid 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 Operoxolid, which has a much lower affinity for cytochrome P450 than erythromycin. However, in the absence of a systematic interaction study, concomitant administration of Operoxolid 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 Operoxolid 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 Operoxolid with the above mentioned drugs cannot be either ascertained or ruled out in confidence. Thus, concomitant administration of Operoxolid and such drugs is not recommended. Warfarin. While no interaction was observed in volunteer studies, Operoxolid appears to interact with warfarin. Increases in prothrombin time (international normalised ratio (INR)) have been reported in patients treated concomitantly with Operoxolid 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 Operoxolid 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 Operoxolid 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. Operoxolid, 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 Operoxolid. There is no conclusive evidence for an interaction between Operoxolid and triazolam. Cyclosporin. A slight increase in plasma concentrations of cyclosporin A has been observed. This does not generally necessitate altering the usual dosage.
Operoxolid side effects
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.
Operoxolid contraindications
Known allergy to macrolides.
Concomitant administration of Operoxolid with vasoconstrictive ergot (alkaloid) derivatives is contra-indicated since symptoms of ergotism have been described with other macrolides.
Active ingredient matches for Operoxolid:
Roxithromycin in Vietnam.
| Unit description / dosage (Manufacturer) | Price, USD |
| OpeRoxolid 150 mg x 1 Blister 10 Tablet | |
| OpeRoxolid 150 mg x 1 Blister x 10 Tablet | |
List of Operoxolid substitutes (brand and generic names): | |
| Onirox | |
| Onirox 150 mg Tablet (Osho Laboratories (P) Ltd.) | $ 0.08 |
| Operoxolid 50 (Vietnam) | |
| Operoxolid 50 50 mg x 10 Packs x 2 g | |
| Optino (India) | |
| Optino 150 mg Tablet (Shinto Biotec Ltd) | $ 0.08 |
| OPTINO tab 150 mg x 10's (Shinto Biotec Ltd) | $ 0.90 |
| Orbis | |
| Orbis 150 mg Tablet (Cataliq Laboratories Pvt. Ltd.) | $ 0.08 |
| Orbis Kid | |
| Orbis Kid 50 mg Tablet (Cataliq Laboratories Pvt. Ltd.) | $ 0.04 |
| Othrox | |
| Othrox 30 ml Syrup (Biomax Laboratories) | $ 0.07 |
| Overal (Italy) | |
| Overal Bambini (Italy) | |
| Oxicin 150 (Vietnam) | |
| Oxicin 150 150 mg x 1 Blister x 10 Tablet | |
| OXIROG (India) | |
| 150 mg x 10x10 (Auriga) | $ 7.83 |
| Oxirog 150mg TAB / 10x10 (Auriga) | $ 7.83 |
| OXIROG tab 150 mg x 10's (Auriga) | $ 0.78 |
| Oxirog 150mg TAB / 10x10 (Auriga) | $ 7.83 |
| OXIROX | |
| OXIROX Capsule/ Tablet / 300mg / 10 units (Guruchem Laboratories) | $ 2.17 |
| OXIROX Capsule/ Tablet / 150mg / 10 units (Guruchem Laboratories) | $ 0.76 |
| Oysirox | |
| Oysirox 50 mg Tablet (Oyster Labs Limited) | $ 0.03 |
| Oysirox 30 ml Syrup (Oyster Labs Limited) | $ 0.07 |
| Oysirox 150 mg Tablet (Oyster Labs Limited) | $ 0.07 |
| PD ROX | |
| PD ROX Capsule/ Tablet / 150mg / 10 units (Parenteral Drugs) | $ 0.78 |
| PD ROX 150MG TABLET 1 strip / 10 tablets each (Parenteral Drugs India Ltd) | $ 0.78 |
| PD Rox 150mg Tablet (Parenteral Drugs India Ltd) | $ 0.08 |
| PD-ROX (India) | |
| 150 mg x 10's (Parenteral Drugs) | $ 0.78 |
| Pd-Rox 150mg TAB / 10 (Parenteral Drugs) | $ 0.78 |
| PD-ROX tab 150 mg x 10's (Parenteral Drugs) | $ 0.78 |
| Pd-Rox 150mg TAB / 10 (Parenteral Drugs) | $ 0.78 |
| Pediatric Roxitil (South Korea) | |
| Pedilid (Bangladesh) | |
| Pedrox (Bangladesh) | |
| Pharex Roxithromycin (Philippines) | |
| Pharex Roxithromycin 150 mg x 100's | $ 77.78 |
| Pharex Roxithromycin 300 mg x 50's | $ 72.22 |
| Pinsheng (China) | |
| Plethirox (Philippines) | |
| Plethirox 150 mg x 100's (Sel-J) | |
| pms-Roxithromycin (Vietnam) | |
| pms-Roxithromycin 150 mg x 2 Blister x 10 Tablet | |
| Polipharm-Roxithromycin (Vietnam) | |
| Polipharm-Roxithromycin 150 mg x 10 Blister x 10 Tablet | |
| Poliroxin (Thailand) | |
| Poliroxin / alufoil 150 mg x 50 x 10's (Polipharm) | |
| Pu Hong (China) | |
| PUNCHOROX (India) | |
| 50 mg x 30ml (Moraceae) | $ 0.45 |
| 150 mg x 10's (Moraceae) | $ 0.90 |
| 50 mg x 10's (Moraceae) | $ 0.60 |
| Punchorox 50mg SUSP / 30ml (Moraceae) | $ 0.45 |
| Punchorox 150mg TAB / 10 (Moraceae) | $ 0.90 |
See 1988 substitutes for Operoxolid | |
References
- PubChem. "roxithromycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "roxithromycin". http://www.drugbank.ca/drugs/DB00778 (accessed September 17, 2018).
- DTP/NCI. "roxithromycin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Operoxolid are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Operoxolid. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
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Information checked by Dr. Sachin Kumar, MD Pharmacology
