Roxitop

Roxitop

roxithromycin

Manufacturer:

Farmaline

Distributor:

Farmaline
Full Prescribing Info
Contents
Roxithromycin.
Description
Each tablet contains Roxithromycin 150 mg or 300 mg, respectively.
Indications/Uses
Roxitop 150: For the treatment infections caused by susceptible bacteria in respiratory tract, ear, nose, throat, genitourinary track, skin and soft tissue infections.
Roxitop 300: Treatment of infections particularly in ear, nose, throat, bronchopulmonary genital (excluding gonococcal infection) and skin. Prophylaxis of meningococcal meningitis in subjects who have come into contact with patient
Dosage/Direction for Use
Roxitop 150: In adults, take 1 tablet 2 times daily before meal or as prescribed.
Roxitop 300: In adults, the dosage is 300 mg per day administered as 1 tablet of 300 mg once a day immediately before meal.
Overdosage
Action to be taken in case of overdosage gastric lavage with symptomatic treatment. No specific antidote exists.
Warnings
Contraindicated in case of hypersensitivity to this medicine.
This medicine may harm the liver.
Special Precautions
In severe hepatic insufficiency (e.g. hepatic cirrhosis with jaundice and/or ascites), the dose should be reduced by half (E.g. 150 mg once a day in adults).
Use In Pregnancy & Lactation
The safety of roxithromycin for the fetus has not been established in human pregnancy.
Small amounts of roxithromycin are excreted in human breast milk; breast feeding or treatment of the mother should therefore be discontinued as necessary.
Adverse Reactions
Gastrointestinal symptoms nausea, vomiting, epigastric pain. diarrhea, very rarely bloody. In isolated cases, symptoms of pancreatitis have been observed; most patients had received other drugs for which pancreatitis is a known adverse reaction.
Hypersensitivity reactions: as with other macrolide antibiotics, rash, urticaria, angio-oedema; exceptionally purpura, bronchospasm, anaphylactic shock.
Dizziness, headache, paraesthesia.
Moderate increases in ASAT, ALAT and/or alkaline phosphatase, Cholestatic or, more rarely, hepatocellular acute hepatitis. As with other macrolides, disturbances of taste and/or smell have been reported.
Superinfection as with other antibiotics, the use of roxithromycin, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Drug Interactions
Severe vasoconstriction ("ergotism") with possibly necrosis of the extremities has been reported when macrolide antibiotics have been associated with vasoconstrictive ergot alkaloids. Absence of treatment by these alkaloids must always be checked before prescribing roxithromycin. Certain macrolides are capable of a pharmacokinetic interaction with terfenadine leading to increased serum concentrations of the latter. This may result in severe ventricular arrhythmia, typically torsades de pointes. Although such a reaction has not been demonstrated with roxithromycin and studies in a limited number of healthy volunteers have not shown any pharmacokinetic interaction or relevant ECG changes, the association of roxithromycin and terfenadine is not recommended.
Other drugs, such as astemizole, cisapride or pimozide, which are metabolized by hepatic CYP3A isozyme have been associated with QT interval prolongation and/or cardiac arrhythmias (typically torsades de pointes) as a result of increase in their serum level subsequent to interaction with significant inhibitors of this isozyme, including some macrolide antibacterials. Although roxithromycin has no or limited ability to complex CYP3A and therefore to inhibit the metabolism of other drugs processed by this isozyme, a potential for clinical interaction of roxithromycin with the above mentioned drugs can not be either as certained or ruled out in confidence; therefore, association of roxithromycin with such drug is not recommended.
No interaction with warfarin has been found in studies in volunteers: however, increases in prothrombin time or International Normalized Ratio (INR) which may be explained by the infectious episode have been reported in patients treated with roxithromycin and vitamin K antagonists. It is prudent practice to monitor INR during combined treatment with roxithromycin and vitamin K antagonists.
An in-vitro study has shown that roxithromycin can displace protein-bound disopyramide; such an effect in vivo may result in increased serum levels of free disopyramide. Consequently ECG and, if possible, disopyramide serum levels should be monitored.
A study in healthy volunteers has shown that roxithromycin 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, diarrhea, headache or dizziness; cardiac glycoside toxicity may also elicit heart conduction and/or rhythm disorders. Consequently, in patients treated with roxithromycin 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 which may suggest cardiac glycoside overdosage occur.
Roxithromycin, like other macrolide antibiotics, may increase the area under the concentration-time curve and the half-life of midazolam; therefore, the effects of midazolam may be enhanced and prolonged in patients treated with roxithromycin. There is no conclusive evidence for an interaction between roxithromycin and triazolam. A slight increase has been detected in plasma concentrations of theophylline or ciclosporin A, but this does not generally require alteration of the usual dosage.
Storage
Store at the temperature below 30°C and protect from light.
MIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Tab 150 mg x 10 x 10's. 300 mg x 10 x 10's.
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