Azilide/Azilide DT

Azilide/Azilide DT

azithromycin

Manufacturer:

Micro Labs

Distributor:

Brown & Burk Phils
Full Prescribing Info
Contents
Azithromycin dihydrate.
Description
Azilide: Each film coated tablet contains: Azithromycin (as dihydrate) 250 mg and 500 mg, respectively.
Azilide DT: Each film coated tablet contains Azithromycin (as dihydrate) 100 mg.
Action
Pharmacology: Azilide DT: Azithromycin binds to be 50S-ribosomal sub-unit and avoid the translocation of peptide chains from one side of the ribosome to the other. As a consequence of this, RNA-dependent protein synthesis in sensitive organism is prevented. Nucleic acid synthesis is not affected. Azithromycin is effective against Aerobic and facultative gram positive microorganism: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus aureus, Streptococcus agalaciae, Streptococcus pneumonia and Streptococcus pyogenes aerobic and facultative gram-negative microorgamsms, Haemophilus ducreyi, Haemophilus influenza, Moraxella catarrhalis, Neisseria gonorrhea and other microorganisms: Chlamydia pneumonia, Chlamydia trachemasis, Mycoplasma pneumoniae.
Pharmacokinetics:
Azilide: Peak plasma concentrations are extensively distributed to the tissues, and tissue concentration are achieved 2 to 3 hours after a dose, but azithromycin is extensively distributed to the tissues, and tissues concentrations subsequently remain much higher than those in the blood; in contrast to most other antibacterials, plasma concentrations are therefore of little value as a guide to efficacy. High concentrations are taken up into white blood cells. There is little diffusions into the CSF when the meninges are not inflamed. Small amount of Azithromycin (Azitide) are demethylated in the liver, and it is excreted in bile as unchanged drug and metabolites. About 6% of an oral dose (representing about 20% of the amount in the systemic circulation) is excreted in the urine. The terminal elimination half life is probably in excess of 40 hours.
Azilide DT: After oral administration the bioavailability of azithromycin is approximately 37%. Peak plasma levels are reached after 2 to 3 hours (Cmax after a single dose of 500 mg orally was approximately 0.4 mg/L) the serum protein binding of azithromycin is available in the concentration range approximately human exposure decreasing from 51% at 0.02 mcg/mL to 7% at 2 mcg/mL. Following oral administration, azithromycin is widely distributed throughout the body with an apparent volume of distribution of 31.1 L/kg. Plasma concentrations of azithromycin following single 500 mg oral and i.v. Doses declined a polyphasic pattern with mean apparent plasma clearance of 630 mL/min and terminal elimination half life of 68 hours. Binary excretion of azithromycin predominantly as unchanged drug is a major route of elimination.
Indications/Uses
Azilide: For the treatment of respiratory-tract infections, in skin and soft tissue infections, and in uncomplicated genital infections. It may also be used for the prophylaxis, and as a component of regimens in the treatment of Mycobacterium avium complex (MAC) infections.
Azilide DT: Used for infections from respiratory pathogens (e.g. S. pyogenes, S. pneumoniae, M. Catarrhalis, C. Trachomatis, Legionella sp, Mycoplasma pneumoniae, S. aureus and H. influenzae) C. pneumoniae and M. avium infection. Uncomplicated chlamydial urethritis, cervicitis or pharyngitis. It is an alternative drug for multi drug resistant Salmonella typhi infection outside the CNS.
Dosage/Direction for Use
Azilide: The usual adult dose of Azithromycin is 500 mg as a single dose daily for 3 days. Alternatively, an initial dose of 500 mg may be followed by 250 mg daily for a further of 4 days. For uncomplicated genital infections due to Chlamydia trachomatis, the equivalent of l g of azithromycin is given as a single dose. A single dose of 2 g may be given for uncomplicated gonorrhea. For prophylaxis of disseminated MAC infections, Azithromycin 1.2 g may be given once weekly. In children over 6 months of age the dose is 10 mg per kg body weight once daily for 3 days. Children over 6 months of age for pneumonia or otitis media is 10 mg per kg on the first day, then 5 mg per kg daily for a further 4 days, and the dose for pharyngitis or tonsillitis in children aged over 2 years is 12 mg per kg once daily for 5 days. Or as prescribed by the physician.
Azilide DT: Children under 16 years: Respiratory tract, skin and soft tissue infection: 500 mg on day followed by 250 mg once daily on the day 2-5.
Children under 2 years old: Pharyngitis, tonsillitis: 12 mg/kg body weight once daily for 5 days, maximum dose of 500 mg per day.
Chancroid: 20 mg/kg single dose orally: maximum dose of 1 gram.
Uncomplicated chlamydial urethritis or cervicitis: 10 mg/kg single dose maximum dose of 1 gram.
Infant and Children under 6 months: Respiratory tract infection: 10 mg/kg body weight on day 1, max dose 500 mg followed by 5 mg/kg on day 2 to 5 once daily, max. dose of 250 mg per day.
Otitis media: Single dose a single dose per day.
3-day regimen: 10 mg/kg once daily for 3 days.
5-day regimen: 10 mg/kg on day l orally; max. Dose: 500 mg per day followed by 5 mg/kg on day 2-5 once daily; max. Dose of 250 mg per day. Or as prescribed by the physician.
Special Precautions
Azilide: Should not be given to patients with hepatic impairment.
Adverse Reactions
Azilide: Gastrointestinal disturbances are most frequent adverse effects but are usually mild and less frequent than with erythromycin. Transient elevations of liver enzyme values have been reported and, rarely, cholestatic jaundice. Rashes, headache and dizziness may occur. Severe hypersensitivity reactions occur rarely but may be prolonged. Transient alterations in neutrophil counts have been seen in patients receiving azithromycin. Pain and inflammation may occur at the site of intravenous infusions.
Azilide DT: Most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug, Anorexia. Constipation, dyspepsia, flatulence, vomiting, diarrhea rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis, asthenia, paresthesia, fatigue, malaise, thrombocytopenia, convulsions, dizziness/vertigo, headache, somnolence have been reported.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
Presentation/Packing
Azilide: FC tab 250 mg x 6's. 500 mg x 3's.
Azilide DT: Dispersible tab 100 mg x 15's.
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