Roxifirst 50/Roxifirst 150

Roxifirst 50/Roxifirst 150

roxithromycin

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Roxithromycin.
Description
Roxifirst 50: Each 1 sachet contains: Roxithromycin 50 mg.
Roxifirst 150: Each tablet contains: Roxithromycin 150 mg.
Excipients/Inactive Ingredients: Roxifirst 50: sq. for 1 sachet.
Action
Roxifirst 50: Pharmacology: Pharmacodynamics: New generation macrolide antibiotics, a major role in Gram-positive bacteria, anaerobes, such as chlamydia and mycoplasma. In vitro antibacterial activity of erythromycin and similar antibacterial effect than in the erythromycin 1-4 times.
Pharmacokinetics: 0.3 g oral, better absorption peak concentrations higher peak time of 1.59 ± 0.42 hours, peak concentrations µ 7.15 ± 1.40 g/L, and its wider distribution, lung, tonsil tissue, the higher the concentration, eliminate slower, the elimination half-life of 13.81 ± 3.19 hours. The goods mainly from the phony drugs from faeces.
Indications/Uses
Roxifirst 50: Adapt to the sensitive strains caused by the following infections: upper respiratory infection; lower respiratory tract infections; ENT infection; genital infection (Neisseria gonorrhoeae infection); skin and soft tissue infection; can also be used for Mycoplasma pneumoniae, Chlamydia trachomatis infection and disease such as Legionella.
Roxifirst 150: It is used to treat infections caused by roxithromycin-sensitive bacteria.
There are, in particular: Ear nose and throat infections such as tonsillitis, pharyngitis, sinusitis and otitis media, due to Group A beta-haemolytic Streptococci and Streptococcus pneumoniae.
Bronchopulmonary infections such as bronchitis, pneumonia (including mycoplasma or legionella) and pertussis, due to Streptococcus pneumoniae.
Genito-urinary infections such as urethritis, cervicitis, crevico-vaginitis (caused by chlamydia, mycoplasma, and ureaplasma urealyticum but excluding gonococcal infections).
Skin infections such as furunkulosis, pyoderma, impetigo and erysipelas, due to Staphylococcus aureus and Group A beta-haemolytic Streptococci.
Dosage/Direction for Use
Roxifirst 50: Oral.
6-11 kg children, as early as late equal packet; 12-23 kg children early, the night a packet; 24-40 kg children, early, late of the two packets.
Roxifirst 150: 150 mg (one tablet) orally twice daily, or up to 300 mg (two tablets) once daily, before meals.
To treat beta-haemolytic streptococcal infections, the therapeutic dose must be given for a minimum of 10 days.
The dose should be halved to 150 mg daily in patients with severe impaired hepatic function.
Overdosage
Roxifirst 150: Treatment is symptomatic and supportive.
Contraindications
Roxifirst 50: Liver, renal dysfunction, pregnant women, breastfeeding women.
Roxifirst 150: Hypersensitivity to roxithromycin or other macrolide antibiotics.
The concomitant administration of ROXIFIRST 150 with vasoconstrictive ergot alkaloid derivatives.
Safety in pregnancy and lactation has not been established. (See Use in Pregnancy & Lactation.)
Warnings
Roxifirst 150: Caution should be observed when using ROXIFIRST 150 in patients with severe impaired hepatic function.
Special Precautions
Roxifirst 150: Accumulation of ROXIFIRST 150 may occur in renal insufficiency. The half-life is prolonged in elderly patients (>65 years).
Use In Pregnancy & Lactation
Safety in pregnancy and lactation has not been established.
Side Effects
Roxifirst 150: More frequently: Gastro-intestinal disorders: Nausea, vomiting, diarrhea and gastric pain.
Less frequently: Hepato-biliary disorders: Increases in AST and ALT and hepatitis have been reported.
Skin and hypersensitivity reactions: Rashes and other hypersensitivity reactions.
Nervous system disorders: Headache and dizziness.
Blood disorders: Changes in blood cell count.
Musculoskeletal disorders: Weakness.
Drug Interactions
Roxifirst 150: Concomitant administration with astemizole, terfenadine and cisapride may result in serious adverse effects, including ventricular arrhythmias.
ROXIFIRST 150 may also cause suppression of the gastrointestinal flora responsible for the metabolism of digoxin and possibly oral contraceptives.
Concomitant administration with theophylline may cause theophylline toxicity.
Storage
Store in a dry place, not exceeding 30°C. Protect from light.
Roxifirst 50: Shelf-Life: 24 months from the manufacturing date.
MIMS Class
ATC Classification
J01FA06 - roxithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Roxifirst 50: Powd for oral susp (sachet) 50 mg x 1.5 g x 20's.
Roxifirst 150: Tab 150 mg x 10 x 10's.
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