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Operoxolid Uses |
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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.
Operoxolid is used to treat ear, nose and throat infections, pneumonia (lung infection), skin infections and infections of the genitalia.
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.
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 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.
Diarrhea, nausea, vomiting, dizziness, headache, blurred vision, or redness/discomfort/pain/swelling at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular heartbeat, confusion, easy bruising/bleeding, ringing in the ears. Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, chest pain, yellowing eyes or skin, dark urine, severe stomach/abdominal pain, persistent nausea or vomiting, unusual fatigue, persistent signs of infection (e.g., fever, sore throat). This medication may rarely cause a severe intestinal condition (pseudomembranous colitis) due to a resistant bacteria. This condition may occur while receiving therapy or even weeks after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool. Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection), or a new type of bacterial infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
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.
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.) | $ 0.11 |
Operoxolid 50 (Vietnam) | |
Operoxolid 50 50 mg x 10 Packs x 2 g | |
Optino (India) | |
Optino 150 mg Tablet (Shinto Biotec Ltd) | $ 0.11 |
OPTINO tab 150 mg x 10's (Shinto Biotec Ltd) | $ 1.19 |
Orbis | |
Orbis 150 mg Tablet (Cataliq Laboratories Pvt. Ltd.) | $ 0.11 |
Orbis Kid | |
Orbis Kid 50 mg Tablet (Cataliq Laboratories Pvt. Ltd.) | $ 0.05 |
Othrox | |
Othrox 30 ml Syrup (Biomax Laboratories) | $ 0.10 |
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) | $ 10.32 |
Oxirog 150mg TAB / 10x10 (Auriga) | $ 10.32 |
OXIROG tab 150 mg x 10's (Auriga) | $ 1.03 |
Oxirog 150mg TAB / 10x10 (Auriga) | $ 10.32 |
OXIROX | |
OXIROX Capsule/ Tablet / 300mg / 10 units (Guruchem Laboratories) | $ 2.86 |
OXIROX Capsule/ Tablet / 150mg / 10 units (Guruchem Laboratories) | $ 1.00 |
Oysirox | |
Oysirox 50 mg Tablet (Oyster Labs Limited) | $ 0.03 |
Oysirox 30 ml Syrup (Oyster Labs Limited) | $ 0.10 |
Oysirox 150 mg Tablet (Oyster Labs Limited) | $ 0.09 |
PD ROX | |
PD ROX Capsule/ Tablet / 150mg / 10 units (Parenteral Drugs) | $ 1.03 |
PD ROX 150MG TABLET 1 strip / 10 tablets each (Parenteral Drugs India Ltd) | $ 1.02 |
PD Rox 150mg Tablet (Parenteral Drugs India Ltd) | $ 0.10 |
PD-ROX (India) | |
150 mg x 10's (Parenteral Drugs) | $ 1.03 |
Pd-Rox 150mg TAB / 10 (Parenteral Drugs) | $ 1.03 |
PD-ROX tab 150 mg x 10's (Parenteral Drugs) | $ 1.03 |
Pd-Rox 150mg TAB / 10 (Parenteral Drugs) | $ 1.03 |
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) | $ 0.59 |
150 mg x 10's (Moraceae) | $ 1.19 |
50 mg x 10's (Moraceae) | $ 0.79 |
Punchorox 50mg SUSP / 30ml (Moraceae) | $ 0.59 |
Punchorox 150mg TAB / 10 (Moraceae) | $ 1.19 |
See 1988 substitutes for Operoxolid |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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