Azithro 250mg အဇီသရို မိုင်စင် ပဋိဇီဝ ပိုးသတ်ဆေး
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Product Details
အဇီသရို မိုင်စင် ပဋိဇီဝ ပိုးသတ်ဆေး ဆရာဝန် ညွှန်ကြားချက်ဖြင့်သာသောက်ရန်
Generic Medicine Info
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Indications and Dosage
Intravenous
Community-acquired pneumonia
Adult: 500 mg as a single daily dose for at least 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 500 mg daily to complete 7-10 days.
Intravenous Pelvic inflammatory disease
Adult: 500 mg daily as a single dose for 1 or 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 250 mg daily to complete 7 days.
Ophthalmic Bacterial conjunctivitis
Adult: As 1% solution: Instill 1 drop into affected eye(s) bid (8-12 hours apart) for 2 days then 1 drop once daily for the next 5 days. As 1.5% (as dihydrate) solution: Instill 1 drop into the conjunctival fornix bid (morning and evening) for 3 days.
Child: As 1% solution: ≥1 year Same as adult dose. As 1.5% solution: Same as adult dose. Oral Chancroid, Uncomplicated genital infections due to Chlamydia trachomatis
Adult: 1 g as a single dose.
Oral Prophylaxis of disseminated Mycobacterium avium complex (MAC) infections
Adult: 1.2 g once weekly.
Oral Acute otitis media
Child: ≥6 months As immediate release suspension: 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose in day 1, followed by 5 mg/kg/day on days 2-5.
Oral Acute bacterial sinusitis
Adult: As tab, cap or immediate release suspension: 500 mg once daily for 3 days. As extended release suspension: 2 g as a single dose.
Child: As immediate release suspension: 10 mg/kg once daily for 3 days. Oral Respiratory tract infections, Skin and soft tissue infections
Adult: As tab, cap, or immediate release suspension: 500 mg daily for 3 days. Alternatively, 500 mg as single dose on day 1 followed by 250 mg daily on days 2-5.
Child: ≥6 months As immediate release suspension: 10 mg/kg daily for 3 days or 10 mg/kg on day 1, followed by 5 mg/kg/day on days 2-5. >45 kg: Same as adult dose. Oral Uncomplicated gonorrhoea
Adult: 1 g or 2 g as a single dose, in combination with ceftriaxone.
Oral Pharyngitis, Tonsillitis
Child: >2 years As immediate release preparation: 12 mg/kg/day for 5 days.
Oral Community-acquired pneumonia
Adult: As tab, cap, or immediate release suspension: 500 mg on day 1, followed by 250 mg once daily on days 2-5. As extended release suspension: 2 g as a single dose.
Child: ≥6 months As immediate release suspension: 10 mg/kg as single dose on day 1 followed by 5 mg/kg/day on days 2-5. As extended release suspension: 60 mg/kg as a single dose. Max: 2 g. |
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Administration
Tab & Susp: May be taken with or without food. May be taken w/ meals to reduce GI discomfort.
Cap &Amp; Extended Release Microspheres: Should be taken on an empty stomach. Take 1 hr before or 2 hr after meals. |
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Reconstitution
Intravenous:
Powder for inj: Add 4.8 mL of sterile water for inj to the 500 mg vial. Further diluted to a concentration of 1 mg/mL (500 mL) to 2 mg/mL (250 mL) in normal saline, 5% dextrose in water or lactated ringer solution. |
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Contraindications
Hypersensitivity to macrolide antibiotics. History of hepatic dysfunction/cholestatic jaundice following previous antibiotic use.
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Special Precautions
Patients with myasthenia gravis, electrolyte disturbance particularly hypokalaemia and hypomagnesaemia; bradycardia, cardiac arrhythmia, severe cardiac insufficiency, congenital or documented QT prolongation, history of torsades de pointes. Severe renal (GFR <10 mL/min) and hepatic impairment. Children. Pregnancy and lactation. Azithromycin should not be given long-term to prevent bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a hematopoietic stem cell transplant.
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Adverse Reactions
Significant: Myasthenia gravis.
Ear and labyrinth disorders: Deafness. Eye disorders: Pruritus, burning, stinging of the eye or ocular discomfort, sticky eye sensation, foreign body sensation (ophthalmic). Gastrointestinal disorders: Diarrhoea, vomiting, abdominal pain, nausea, flatulence, dyspepsia, dysgeusia. General disorders and admin site conditions: Injection site pain, fatigue. Investigations: Decreased lymphocyte count and blood bicarbonate; increased eosinophil count, basophils, monocytes and neutrophils. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Headache, dizziness, paraesthesia. Skin and subcutaneous tissue disorders: Pruritus, rash. Potentially Fatal: Rarely, serious hypersensitivity reactions (e.g. anaphylaxis, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis drug reaction with eosinophilia and systemic symptoms), fulminant hepatitis leading to liver failure, prolonged cardiac repolarisation and QT interval, cardiac arrhythmia, torsades de pointes, Clostridium difficile associated diarrhea (CDAD). |
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IV/Ophth/Parenteral/PO: B
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Patient Counseling Information
Ophthalmic: Avoid using contact lenses during treatment. This drug may cause blurred vision, if affected, do not drive or operate machinery.
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Monitoring Parameters
Monitor liver function values and blood count with differential. Perform culture and susceptibility testing before initiating therapy.
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Overdosage
Symptoms: Diarrhoea, reversible hearing loss, severe nausea and vomiting. Management: Initiate symptomatic and supportive measures as necessary.
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Drug Interactions
Increased risk of prolonged QT interval with class IA (e.g. quinidine, procainamide) and class III (e.g. dofetilide, amiodarone, sotalol) antiarrhythmics; pimozide cisapride and terfenadine. Increased serum concentrations of digoxin, colchicine, and ciclosporin. May potentiate the effects of oral anticoagulants (e.g. warfarin).
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Action
Description: Azithromycin is a macrolide antibiotic under the azalide group. It inhibits RNA-dependent protein synthesis by binding to the 50s ribosomal subunit, preventing the translocation of peptide chains.
Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: Approx 37%. Time to peak plasma concentration: Approx 2-3 hours (oral, immediate release). Distribution: Extensively distributed in the tissues (skin, lungs, tonsils, cervix) and sputum. Present in breastmilk. Volume of distribution: 31-33 L/kg. Plasma protein-binding: 7-51%. Metabolism: Metabolised in the liver to inactive metabolites. Excretion: Via bile (50%, as unchanged drug); urine (6-14%, as unchanged drug). Terminal elimination half-life: 68-72 hours (conventional preparations); 59 hours (extended release). |
Azithro 250mg အဇီသရို မိုင်စင် ပဋိဇီဝ ပိုးသတ်ဆေး
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