ROXITHROMYCIN 150

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COMPOSITION:
Roxithromycin .................................. 150 mg
Excipients q.s ................................... 1 tablet
(Avicel, sodium starch glycolate, aerosil, magnesium stearate, PVP K30, HPMC, PEG 6000, titanium dioxide, talc).
DOSAGE FORM: Film coated tablets.
PRESENTATION: Box of 3 blisters x 10 tablets.
PHARMACODYNAMICS: Roxithromycin, a macrolide antibiotic with a broad spectrum on Gram-positive and Gram-negative bacteria. Clinically, roxithromycin is usually active against Streptococcus pyogenes, S. viridans, S. pneumoniae, Staphylococcus aureus susceptible to methicilin, Bordetella pertussis, Branhamella catarrhalis, Corynebacterium diphteriae, Mycoplasma pneumoniae, Chlamydia trachomatis, Legionella pneumophilia, Helicobacter pylori and Borrelia burgdorferi.
PHARMACOKINETICS: Roxithromycin is well penentrated into body cells and cavities. Especially, roxithromycin concentration is achieved highly in lung, tonsil, nasal cavity, prostate gland, cervix. Roxithromycin does not cross the blood-brain barrier. Roxithromycin is mainly eliminated by hepatic metabolism, and its metabolites excreted via bile and feces; therefore, it may be prescribed with a normal dose to renal incompetence patients.
INDICATIONS: Treatment of infections caused by Mycoplasma pneumoniae and diseases due to Legionella.
Diphtheria, the beginning phase of whooping-cough and severe infections due to Campylobacter.
Respiratory tract infections due to susceptible microorganisms in patients with allergy to penicillins.
CONTRAINDICATIONS: Hypersensitivity to macrolide antibiotics.
Avoid concomitant use roxithromycin with ergotamine-like vasoconstriction-induced compounds.
Do not use roxithromycin to patients receiving terfenadine, astemizole, cisapride due to the risk of severe arrhythmia.
PRECAUTIONS: Caution should be exercised when roxithromycin is administered to patients with severe hypohepatia.
PREGNANCY AND LACTATION:
Roxithromycin is only prescribed to pregnant women if really necessary. Roxithromycin crosses the breast milk with low concentration.
VEHICLE DRIVERS AND MACHINERY OPERATORS:
The effect of Roxithromycin on the ability to drive vehicles and operate machinery is rarely reported.
INTERACTIONS: The concomitant use of roxithromycin with astemizole, terfenadine, cisapride may cause arrhythmia. Therefore, do not combine these drugs in treatment.
A slight increase has been detected in plasma concentrations of theophylline or ciclosporin, but this does not generally require alteration of the usual dosage.
Roxithromycin may cause an increase in serum levels of disopyramide.
Avoid combination with bromocriptine because roxithromycin enhances the plasma bromocriptine concentration.
ADVERSE EFFECTS: Frequently: nausea, vomitting, epigastralgia, diarrhea.
Less frequently: rash, urticaria, angioedema, purpura, bronchospasm, and anaphylaxis. Dizziness, vertigo, headache, paraesthesia, decreased smell and/or taste. 
Rarely: Increased liver enzyme values. Cholestatic hepatitis, symptom of pancreatitis (very rare).
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE: There is no specific antidote. Gastric lavage, symptomatic and supportive treatment should be advised.
DOSAGE & ADMINISTRATION: Roxithromycin is administered following oral route.
The adult dose should be 1 tablet twice daily, taken before meals. The treatment must not be prolonged beyond 10 days.
Severe renal impairment: reduce 1/2 of the dose.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescriptions only.
Shelf-life: 36 months from the manufacturing date.
Storage conditions: Store in  dry places, not exceeding 30oC, protect from light.
Specifications: Manufacturer's.

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