Type: Tab.
Manufacturer/Distributor: Somatec Pharmaceuticals Ltd.
Generic Name: Azithromycin USP 500mg/tablet
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Indications of Respazit 500 mg Tablet
Respazit 500 mg Tablet is shown for diseases (caused by vulnerable living beings) in lower respiratory tract contaminations counting bronchitis and pneumonia, in upper respiratory tract contaminations counting sinusitis and pharyngitis/tonsillitis, in otitis media, and in the skin and delicate tissue diseases. In sexually transmitted infections in men and ladies, Respazit 500 mg Tablet is demonstrated within the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.
Pharmacology of Respazit 500 mg Tablet
Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:
Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia
Respazit 500 mg Tablet Dosage & Administration
Oral-
Adult:
500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days.
For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.
Children:
10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given. Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:
500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
Interaction of Respazit 500 mg Tablet
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids Azithromycin should be avoided because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P-450 system. As macrolides increase the plasma concentration of digoxin and cyclosporin, caution should be exercised while co-administration. There have been no drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone or Cimetidine.
Contraindications of Respazit 500 mg Tablet
Respazit 500 mg Tablet is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Respazit 500 mg Tablet is contraindicated in patients with hepatic diseases.
Respazit 500 mg Tablet Side Effects
Respazit 500 mg Tablet is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy.
Pregnancy & Lactation
Pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well-controlled studies on pregnant women. Since animal reproduction studies are not always predictive of human response, Respazit 500 mg Tablet should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Respazit 500 mg Tablet is administered to nursing women.
Precautions & Warnings
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. No dose adjustment is needed in patients with renal impairment.
Therapeutic Class of Respazit 500 mg Tablet
Macrolides
Storage Conditions of Respazit 500 mg Tablet
Store below 30° C in a cold, dry, and light-protected location. Keep out of children's reach.
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