Roxithromycin Copyfarm Uses

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Roxithromycin Copyfarm indications


Roxithromycin Copyfarm 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


• 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 Roxithromycin Copyfarm in details

Roxithromycin Copyfarm is used to treat ear, nose and throat infections, pneumonia (lung infection), skin infections and infections of the genitalia.

Roxithromycin Copyfarm description

Roxithromycin Copyfarm is a semi-synthetic macrolide antibiotic. It is very similar in composition, chemical structure and mechanism of action to erythromycin, azithromycin, or clarithromycin. Roxithromycin Copyfarm prevents bacteria from growing, by interfering with their protein synthesis. Roxithromycin Copyfarm binds to the subunit 50S of the bacterial ribosome, and thus inhibits the translocation of peptides. Roxithromycin Copyfarm 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.

Roxithromycin Copyfarm dosage



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.

Roxithromycin Copyfarm interactions

Roxithromycin Copyfarm 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. Roxithromycin Copyfarm does not appear to interact with oral contraceptives, prednisolone, carbamazepine, ranitidine or antacids. Theophylline. A study in normal subjects concurrently administered Roxithromycin Copyfarm 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 Roxithromycin Copyfarm cannot be excluded, administration of Roxithromycin Copyfarm to patients taking ergot alkaloids is contraindicated. Disopyramide. An in vitro study has shown that Roxithromycin Copyfarm 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 Roxithromycin Copyfarm, which has a much lower affinity for cytochrome P450 than erythromycin. However, in the absence of a systematic interaction study, concomitant administration of Roxithromycin Copyfarm 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 Roxithromycin Copyfarm 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 Roxithromycin Copyfarm with the above mentioned drugs cannot be either ascertained or ruled out in confidence. Thus, concomitant administration of Roxithromycin Copyfarm and such drugs is not recommended. Warfarin. While no interaction was observed in volunteer studies, Roxithromycin Copyfarm appears to interact with warfarin. Increases in prothrombin time (international normalised ratio (INR)) have been reported in patients treated concomitantly with Roxithromycin Copyfarm 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 Roxithromycin Copyfarm 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 Roxithromycin Copyfarm 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. Roxithromycin Copyfarm, 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 Roxithromycin Copyfarm. There is no conclusive evidence for an interaction between Roxithromycin Copyfarm and triazolam. Cyclosporin. A slight increase in plasma concentrations of cyclosporin A has been observed. This does not generally necessitate altering the usual dosage.

Roxithromycin Copyfarm 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.





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.

Roxithromycin Copyfarm contraindications


Known allergy to macrolides.

Concomitant administration of Roxithromycin Copyfarm with vasoconstrictive ergot (alkaloid) derivatives is contra-indicated since symptoms of ergotism have been described with other macrolides.

Active ingredient matches for Roxithromycin Copyfarm:

Roxithromycin in Finland.

List of Roxithromycin Copyfarm substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet, Film-Coated; Oral; Roxithromycin 300 mg
Roxithroxyl 150 mg x 10 Blister x 10 Tablet (Bangkok Lab & Cosmetic)
Roxithroxyl 150 mg x 100's (Bangkok Lab & Cosmetic)
Roxithroxyl 150 mg x 10 x 10's (Bangkok Lab & Cosmetic)
Roxithroxyl 300 mg x 10 x 10's (Bangkok Lab & Cosmetic)
Roxithroxyl film-coated tab 150 mg 10 x 10's (Bangkok Lab & Cosmetic)
Roxithroxyl film-coated tab 150 mg 100's (Bangkok Lab & Cosmetic)
Roxithroxyl film-coated tab 300 mg 10 x 10's (Bangkok Lab & Cosmetic)
ROXITID 150MG TABLET 1 strip / 10 tablets each (Ranbaxy Laboratories Ltd)$ 0.52
Roxitin 150 mg x 50 x 10's (T P Drug)
Roxitin 150 mg x 500's (T P Drug)
ROXITIS Capsule/ Tablet / 150mg / 10 units (Medley)$ 0.66
ROXITIS Dispersible Tablet / 50mg / 10 units (Medley)$ 0.30
Roxitis 50mg TAB / 10 (Medley)$ 0.30
Roxitis 150mg TAB / 10 (Medley)$ 0.66
Roxitis 50mg/5mL SUSP / 30ml (Medley)$ 0.36
50 mg x 10's (Medley)$ 0.30
150 mg x 10's (Medley)$ 0.66
50 mg x 5 mL x 30ml (Medley)$ 0.36
Roxitis 150 mg x 10 Blister x 10 Tablet (Medley)
ROXITIS tab 50 mg x 10's (Medley)$ 0.30
ROXITIS tab 150 mg x 10's (Medley)$ 0.66


  1. PubChem. "roxithromycin". (accessed September 17, 2018).
  2. DrugBank. "roxithromycin". (accessed September 17, 2018).
  3. 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.". (accessed September 17, 2018).


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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