INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ROXXIBID (Tablets)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ROXXIBID (Tablets)

COMPOSITION:
Each ROXXIBID tablet contains
roxithromycin 150 mg.

PHARMACOLOGICAL CLASSIFICATION:
A. 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Roxithromycin is a semi-synthetic macrolide antibiotic with a wide spectrum of activity. By achieving high intracellular concentrations in macrophages and polymorphonuclear leucocytes, roxithromycin enhances adhesive and chemotactic functions resulting in phagocytosis and bacterial lysis. Roxithromycin also has intracellular bactericidal activity.
Roxithromycin has the following spectrum of antibacterial activity in vitro :
(In vitro sensitivity does not necessarily imply in vivo efficacy)
Streptococcus pneumoniae (Pneumococcus), Streptococcus agalactiae , Listeria monocytogenes, Neisseria meningitidis (Meningococcus), Mycoplasma pneumoniae, Legionella pneumophila, Chlamydia trachomatis, Helicobacter (Campylobacter), Ureaplasma urealyticum, Gardnerella vaginalis, Moraxella catarrhalis (Branhamella catarrhalis), Bordetella pertussis, Haemophilus ducreyi.
Variable in vitro sensitivity has been shown against: Staphylococcus aureus, Haemophilus influenzae, Group A beta-haemolytic Streptococcus (Streptococcus pyogenes), Staphylococcus epidermidis.
Pharmacokinetics:
Roxithromycin is rapidly absorbed after oral administration, with peak serum levels being reached after 2.2 hours. Food has no effect on oral bioavailability when roxithromycin is administered before a meal. Roxithromycin is essentially (96%) bound to alpha-1acid glycoproteins. Roxithromycin is partly metabolised in the liver, with more than 50% of the dose being excreted in the faeces as unchanged parent drug. The remainder is excreted in the urine. The average elimination half-life is 10.5 hours, but may be prolonged in children, in patients with hepatic impairment (25 hours), in the elderly (27 hours) and in the renally impaired (18 hours).
Transmission to the cerebrospinal fluid is slow.

INDICATIONS:
ROXXIBID
is indicated in the treatment of mild to moderate infections caused by susceptible organisms including:
Sinusitis, tonsillitis, otitis media and pharyngitis caused by Group A beta-haemolytic Streptococci and Streptococcus pneumoniae.
Acute bronchitis and pneumonia caused by Streptococcus pneumoniae.
Atypical pneumonia caused by Mycoplasma pneumoniae .
Erysipelas and pyoderma caused by Staphylococcus aureus and Group A beta-haemolytic Streptococci.
Non-gonococcal urethritis in males, due to Chlamydia trachomatis and Ureaplasma urealyticum.
CONTRA-INDICATIONS:
Hypersensitivity to roxithromycin or other macrolides. Concomitant administration with vasoconstrictive ergot (alkaloid) derivatives (see “INTERACTIONS”).

WARNINGS:
Dosage adjustments are necessary as accumulation of ROXXIBID may occur in renal and hepatic insufficiency (see “DOSAGE AND DIRECTIONS FOR USE”).
ROXXIBID should not be used with the following:
Vasoconstrictive ergot alkaloids.
Astemizole and terfenadine.
Pimozide and cisapride.
Warfarin.
Midazolam.
Digoxin.
Theophylline.
Disopyramide.
Cyclosporin.
Lovastatin.
(See “INTERACTIONS”)

INTERACTIONS:
Vasoconstrictive ergot alkaloids
- Symptoms of ergotism have been described following concomitant use of macrolides and ergot alkaloids. Concomitant administration is contra-indicated (see “CONTRAINDICATIONS”).
Astemizole and terfenadine - Severe ventricular arrhythmias, namely torsades de pointes, have occurred with concomitant use of ROXXIBID.
Concomitant use with ROXXIBID is not recommended.
Pimozide and cisapride (metabolised by hepatic CYP3A4 isoenzymes) - Prolongation of QT intervals, cardiac arrhythmias and cardiac arrest have been associated with certain macrolides due to isoenzyme inhibition, resulting in an increase in serum concentrations. Concurrent use with ROXXIBID is not recommended.
Warfarin - Increases in prothrombin time or INR have been reported in patients using ROXXIBID. Careful monitoring of INR is advised.
Midazolam - The effects of midazolam may be prolonged and increased.
Digoxin - Cardiac glycoside toxicity due to decreased digoxin metabolism in patients using ROXXIBID and digoxin concomitantly may occur. The ECG and serum levels of digoxin should be monitored and patients should be observed for signs and symptoms of digoxin toxicity (vomiting, nausea, arrhythmias).
Theophylline - Concurrent use with ROXXIBID may result in increased serum theophylline concentrations which may lead to theophylline toxicity.
DisopyramideIn vitro studies have shown ROXXIBID to displace disopyramide from protein-binding sites. As this could result in raised free serum levels of disopyramide, ECG monitoring is advised during concurrent use.
CyclosporinROXXIBID increases cyclosporin serum concentrations which may increase the risk of nephrotoxicity.
LovastatinROXXIBID inhibits lovastatin metabolism which leads to increased concentrations of lovastatin and may increase the risk of rhabdomyolysis.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Adults : 150 mg every 12 hours before food.
In the treatment of infections caused by beta-haemolytic streptococci, ROXXIBID should be administered for at least 10 days.
Severe hepatic impairment : 150 mg once daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
:
Blood disorders:
•        Eosinophilia, agranulocytosis.
Immune system disorders:
•        Hypersensitivity reactions (pruritus, rash, urticaria, angioedema, purpura, bronchospasm, anaphylactic shock).
Nervous system disorders:
•        Dizziness, headache, paraesthesia.
Cardiac disorders:
•        Arrhythmias.
Gastrointestinal disorders:
•        Gastric pain, nausea, vomiting, diarrhoea, acute pancreatitis.
Hepatobiliary disorders:
•        Increased liver enzymes, cholestatic or acute hepatocellular hepatitis.
General disorders:
•        Taste and/or smell disturbances, superinfection.
Special precautions:
Use of ROXXIBID may cause an overgrowth of nonsusceptible organisms. Appropriate measures should be taken to prevent or treat such superinfection.
ROXXIBID should be used with care in patients with a history of arrhythmias or a prolonged QT interval (see “INTERACTIONS”).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
White, circular, biconvex, film-coated tablets plain on both sides.

PRESENTATION:
Blister packs of 10, 20 and 100 tablets.

STORAGE INSTRUCTIONS:
Store in a cool, dry place, below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
37/20.1.1/0367

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Rosen Heights, Pasita Street,
Rosen Park, Bellville, 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 2005

© CIPLA MEDPRO (PTY) LTD
951 VA

New addition to this site: December 2016
Source: Company website
http://www.cipla.co.za/wp-content/uploads/2013/10/sep_roxxibid.pdf

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