Hofmax

Hofmax

azithromycin

Manufacturer:

Pharmahof

Distributor:

Pharmahof
Full Prescribing Info
Contents
Azithromycin.
Description
Each capsule contains Azithromycin dihydrate 262.050 mg equivalent to Azithromycin 250.000 mg.
Action
Pharmacology: Pharmacodynamics: Azithromycin is macrolide antibiotic that exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible organisms, resulting in inhibition of protein synthesis. Nucleic acid synthesis is not affected.
Pharmacokinetics: Absorption: Rapid oral absorption with oral bioavailability is 38%, Cmax is 0.5 mcg/mL (single 500 mg dose) and Tmax 2-3 hours.
Distribution: Azithromycin is widely distributed throughout the body with tissue concentrations exceeding serum concentrations by 10- to 100-fold. Volume of distribution is 31.1 L/kg (oral). It distributes well into skin, lungs, sputum, tonsils and cervix: penetration into CSF is poor.
Metabolism: Some hepatic metabolism to inactive metabolites.
Elimination: Primarily excreted unchanged in bile; about 6% of dose is excreted unchanged in urine.
Indications/Uses
Azithromycin is indicated for: Acute bacterial exacerbations of chronic obstructive pulmonary disease caused by: H. influenzae, M. catarrhalis, S. pneumoniae.
Acute bacterial sinusitis caused by: H. influenzae, M. catarrhalis, S. pneumoniae.
Acute otitis media caused by: H. influenzae, M. catarrhalis, S. pneumoniae.
Community-acquired pneumonia (CAP) caused by: H. influenzae, M. pneumoniae, S. pneumoniae, Chlamydophila pneumoniae.
Genital ulcer disease (chancroid) in men caused by: Haemophilus ducreyi.
Pharyngitis/tonsillitis caused by: S. pyogenes.
Uncomplicated skin and skin structure infections caused by: S. aureus, S. pyogenes, Streptococcus agalactiae.
Urethritis and cervicitis caused by: Chlamydia trachomatis.
Urethritis and cervicitis caused by: Neisseria gonorrhoeae.
Dosage/Direction for Use
Recommended dose: Adults: Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate severity): Usual dosage: 500 mg/day for 3 days.
Alternative dosage: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5.
Acute bacterial sinusitis: 500 mg/day for 3 days.
Community-acquired pneumonia (mild severity): 500 mg as a single dose on the first day followed by 250 mg once daily on day 2 through 5.
Genital ulcer disease (chancroid): 1 g as a single dose.
Gonococcal urethritis/cervicitis: 2 g as a single dose.
Nongonococcal urethritis/cervicitis: 1 g as a single dose.
Pharyngitis/tonsillitis (as second-line therapy): 500 mg as a single dose on the first day followed by 250 mg once daily on day 2 through 5.
Uncomplicated skin/skin structure infections: 500 mg as a single dose on the first day followed by 250 mg once daily on day 2 through 5.
Children: 2 years of age and older: Pharyngitis/tonsillitis: Usual dosage: 12 mg/kg once daily for 5 days.
Maximum dose: 500 mg/day.
6 months of age and older: Acute bacterial sinusitis: 10 mg/kg once daily for 3 days.
Acute otitis media: Usual dosage: 30 mg/kg given as a single dose.
Alternative dosage: 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day, followed by 5 mg/kg on days 2 through 5.
Community-acquired pneumonia: 10 mg/kg as a single dose on the first day, followed by 5 mg/kg on days 2 through 5.
Dosage adjustment in renal impairment: Use with caution in patients with GFR <10 mL/minute.
Dosage adjustment in hepatic impairment: Use with caution due to potential for hepatotoxicity (rare). Specific guidelines for dosing in hepatic impairment have not been established.
Mode of administration: Azithromycin can be taken with or without food.
Overdosage
Symptoms: The toxic symptoms following an overdose of a macrolide antibiotic may include abdominal pain, diarrhea, nausea and vomiting.
Treatment: Treatment include usual supportive measures. Hemodialysis and peritoneal dialysis are not particularly effective.
Contraindications
Hypersensitivity to azithromycin, other macrolide antibiotics, or any component of the formulation.
Warnings
Contraindicated in patients with hypersensitivity to this drug.
Azithromycin may cause liver damage.
Special Precautions
Use with caution in patients with pre-existing liver disease; hepatic impairment with or without jaundice.
Discontinue if symptoms of malaise, nausea, vomiting, abdominal colic, and fever.
Allergic reactions have been reported (rare); reappearance of allergic reaction may occur without further azithromycin exposure.
Azithromycin may mask or delay symptoms of incubating gonorrhea or syphilis, so appropriate culture and susceptibility tests should be performed prior to initiating azithromycin.
Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis.
Use caution with renal dysfunction.
Prolongation of the QTc interval has been reported with macrolide antibiotics; use caution in patients at risk of prolonged cardiac repolarization.
Use with caution in patients with myasthenia gravis.
Use In Pregnancy & Lactation
Pregnancy Risk: Category B. There is no adequate and well-controlled studies of macrolides in pregnant women. Use azithromycin only when clearly needed.
Lactation: Azithromycin accumulates in breast milk, but is considered to be probably compatible with breast-feeding. Use with caution.
Adverse Reactions
Gastrointestinal: Diarrhea, nausea, abdominal pain, anorexia, cramping, vomiting, oral candidiasis, tongue discoloration (rare).
Dermatologic: Pruritus, rash.
Genitourinary: Vaginitis, acute renal failure.
Cardiovascular: Arrhythmias, hypotension.
Central nervous system: Aggressive reaction, anxiety, hyperactivity, paresthesia, syncope.
Hematologic: Thrombocytopenia.
Hepatic: Cholestatic jaundice, rare case of hepatic necrosis and hepatic failure.
Special senses: Hearing disturbances, including deafness and/or tinnitus, taste loss and smell perversion.
Miscellaneous: Arthralgia, edema.
Drug Interactions
Azithromycin is a metabolism substrate of CYP3A4 (minor) and CYP3A4 inhibitor (weak). Avoid concomitant use of azithromycin with artemether, BCG, dronedarone, lumefantrine, nilotinib, pimozide, quinine, tetrabenazine, thioridazine and ziprasidone.
Azithromycin may increase the effects of cardiac glycosides, cyclosporine, dronedarone, pimozide, QTc-prolonging agents, quinine, tacrolimus, tetrabenazine, thioridazine, vitamin K antagonist and ziprasidone.
The effect of azithromycin may be increased by alfuzosin, artemether, chloroquine, ciprofloxacin, conivaptan, gadobutrol, lumefantrine, nilotinib and quinine.
Azithromycin may decrease the effects of BCG and Typhoid vaccine.
Storage
Storage below 30°C.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Cap 250 mg (white opaque, no. 0 containing white or almost white powder) x 1 x 6's.
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