SB-Azit 500
Azithromycin Dihydrate USP
Antibacterial (Macrolide)
Composition:
SB-Azit 500 tablet: Each film coated Tablet contains Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg.
Indications
Adult Patients:
- Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
- Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
- Community acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy.
- Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
- Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.
- Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
- Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of SB-Azit in the treatment of chancroid in women has not been established.
Pediatric Patients:
- Acute otitis media (>6 months of age) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
- Community-acquired pneumonia (>6 months of age) due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumonia, or Streptococcus pneumoniae in patients appropriate for oral therapy.
- Pharyngitis/tonsillitis (>2 years of age) caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Dosage & Administration
Adult Patients:
| Indication | Recommended Dose/Duration of Therapy |
| Community-acquired pneumonia
Pharyngitis/tonsillitis (second-line therapy) Skin/skin structure (uncomplicated) |
500 mg as a single-dose on Day 1, followed by
250 mg once daily on Days 2 through 5 |
| Acute bacterial exacerbations of
chronic obstructive pulmonary disease |
500 mg once daily for 3 days
Or 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 |
| Acute bacterial sinusitis | 500 mg once daily for 3 days |
| Genital ulcer disease (chancroid) | One single 1 gram dose |
| Non-gonococcal urethritis and cervicitis | One single 1 gram dose |
| Gonococcal urethritis and cervicitis | One single 2 gram dose |
| SB-Azit tablet can be taken with or without food. | |
Pediatric Patients:
| Indication | Recommended Dose/Duration of Therapy |
| Acute otitis media | 30 mg/kg as a single dose or 10 mg/kg once daily for
3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5. |
| Acute bacterial sinusitis | 10 mg/kg once daily for 3 days. |
| Community-acquired pneumonia | 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg
once daily on Days 2 through 5. |
| Pharyngitis/tonsillitis | 12 mg/kg once daily for 5 days. |
| SB-Azit tablet can be taken with or without food. | |
Side Effects
Azithromycin is well tolerated with a low incidence of side effects. Majority of the side effects were mild to moderate in nature and of gastrointestinal in origin with nausea, abdominal discomfort, vomiting, flatulence and diarrhea. Allergic reactions such as rash have been occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative Macrolides and Penicillins used in clinical trials. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to Azithromycin has not been established.
Contraindications
Contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug & also contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
Use in Pregnancy & Lactation
Pregnancy category B. Recent clinical studies have recommended that Azithromycin should be considered for the initial treatment of chlamydial cervicitis in pregnancy. In other infections, Azithromycin should be used only when clearly needed. It is not known whether Azithromycin is excreted in breast milk. Exercise caution when administering to a nursing woman.
Available Packaging
SB-Azit 500 tablet: Each box contains 12 film coated Tablets in Alu-Alu blister pack.
Price
