Azithromycin 250 Tablets ,azithromycin 500 tablets,azithromycin suspension

COMPOSITION

AZISEN-500 Tablets
Each tablet contains:
Azithromycin Dihydrate equivalent to
Azithromycin (anhydrous) USP ……………………….. 500 mg

AZISEN -250 Tablets
Each tablet contains:
Azithromycin Dihydrate equivalent to
Azithromycin (anhydrous) USP …………...............….. 250 mg

AZISEN-200 Rediuse Oral Suspension
Each 5 ml contains:
Azithromycin USP (as dihydrate) equivalent to
Azithromycin (anhydrous) ……………………….. … 200 mg
Flavoured syrup base q.s.

INDICATIONS

Adults

Oral Tablets
Azithromycin tablets are indicated in the treatment of the following infections:

Acute bacterial exacerbations of chronic obstructive pulmonary diseasedue to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae .
Acute bacterial sinusitis due to Haemophilus influenzae , Moraxella catarrhalis orStreptococcus pneumoniae .
Community-acquired pneumonia due to Chlamydia 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 . Abscesses usually require surgical drainage.
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 azithromycin in the treatment of chancroid in women has not been established.

AZISEN , at the recommended dose, should not be relied upon to treat syphilis.

Paediatric Use

Rediuse suspension and DT

Upper respiratory tract infections (URTIs)

Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis orStreptococcus pneumoniae.
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Sinusitis caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae .

Lower respiratory tract infections (LRTIs)

Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
Acute bronchitis caused by Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae.

Uncomplicated skin and soft tissue infections (SSTIs)

Furunculosis, pyoderma and impetigo due to Staphylococcus aureus, Streptococcus pyogenes and Streptococcus agalactiae.

Uncomplicated genital infections (in adolescents and older children)

Urethritis and cervicitis due to Chlamydia trachomatis.

DOSAGE AND ADMINISTRATION

Adults

Oral Tablets

Dosage

Infection*	Recommended Dose/Duration of Therapy
Community-acquired pneumonia (mild severity) 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 day 2 through day 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate)	500 mg o.d. × 3 days OR 500 mg as a single dose on day 1, followed by 250 mg once daily on day 2 through day 5
Acute bacterial sinusitis	500 mg o.d. × 3 days

*Due to the indicated organisms

AZISEN tablets can be taken with or without food.

Paediatric Use
Rediuse Oral suspension and DT

Age	Indications	1-day Regimen	3-days Regimen	5-days Regimen
From 6 months and above	Acute otitis media	30 mg/kg single dose	10 mg/kg once daily	*Day 1:10 mg/kg single dose Days 2–5:* 5 mg/kg/day
	Acute bacterial sinusitis		10 mg/kg once daily
	Community-acquired pneumonia/Acute bronchitis		10 mg/kg once daily	*Day 1:10 mg/kg single dose Days 2–5:* 5 mg/kg/day
	Uncomplicated SSTIs		10 mg/kg once daily	*Day 1:10 mg/kg single dose Days 2–5:* 5 mg/kg/day
From 2 years and above	Pharyngitis/Tonsillitis		12 mg/kg once daily

Effectiveness of the 1-day regimen in paediatric patients with community-acquired pneumonia has not been established. Effectiveness of the 5-day or 1-day regimen in paediatric patients with acute bacterial sinusitis has not been established.The safety of re-dosing azithromycin in paediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose.

AZISEN ( for rediuse oral suspension/DT) can be taken with or without food.

CONTRAINDICATIONS

Azithromycin is contraindicated in patients with a known hypersensitivity to azithromycin, erythromycin, and any macrolide or ketolide antibiotic.

PACKAGING INFORMATION

Azisen -500 Tablets .................................................... Blister pack of 3 tablets
Azisen -250 Tablets .....................................................Blister pack of 6 tablets
Azisen -200 Rediuse Oral Suspension .................15 ml bottle