Azee (Generic Azithromycin Dihydrate Tablets)

Azee (Generic Azithromycin Dihydrate Tablets)
© The Swiss Pharmacy

Azee (Generic Azithromycin Dihydrate Tablets) is a macrolide
antibacterial drug indicated for the treatment of patients with mild-
to-moderate infections caused by susceptible strains of the
designated susceptible bacteria in the specific conditions.
They include acute bacterial exacerbations of chronic bronchitis in
adults, acute bacterial sinusitis in adults, uncomplicated skin and
skin structure infections in adults, urethritis and cervicitis in adults,
genital ulcer disease in men, acute otitis media in pediatric patients
(6 months of age and older) , community-acquired pneumonia in
adults and pediatric patients (6 months of age and older) and
pharyngitis/tonsillitis in adults and pediatric patients (2 years of age
and older).

Azee Tablets are manufactured by Cipla
Limited, India in the strengths of 250 mg and
500 mg.

Chemical Structure

The active ingredient contained in Azee
tablets is Azithromycin Dihydrate .
Each film-coated Azee tablet contains
Azithromycin Dihydrate equivalent to 250 mg
or 500 mg of Azithromycin.

Uses of Azee 250 mg and 500 mg Tablets:
Azee (Generic Azithromycin Dihydrate Tablets) is used to treat a wide variety of
bacterial infections. It is a macrolide-type antibiotic. It works by stopping the
growth of bacteria. This medication will not work for viral infections (such as
common cold, flu). Azithromycin tablets can be used for the treatment of the
following infections, when caused by microorganisms sensitive to Azithromycin. It
includes the following indications:
- acute bacterial sinusitis (adequately diagnosed)
- acute bacterial otitis media (adequately diagnosed)
- pharyngitis, tonsillitis
- acute exacerbation of chronic bronchitis (adequately diagnosed)
- mild to moderately severe community acquired pneumonia
- skin and soft tissue infections
- uncomplicated Chlamydia trachomatis urethritis and cervicitis.

Recommended Adult Dosage
The dose of Azee (Generic Azithromycin Dihydrate Tablets) for various
indications is given below:
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 days 2 through 5.
Acute bacterial exacerbations of chronic obstructive pulmonary disease
(mild to moderate): 500 mg daily × 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 daily × 3 days
Genital ulcer disease (chancroid): One single 1 gm dose
Non-gonoccocal urethritis and cervicitis: One single 1 gm dose
Gonococcal urethritis and cervicitis: One single 2 gm dose

Recommended Dosage
Children from 6 months and above:
Acute otitis media:
1-Day Regimen: 30 mg/kg single dose
3-Day Regimen: 10 mg/kg once daily
5-Day Regimen: Day 1: 10 mg/kg single dose Days 2-5: 5 mg/kg/day
Acute bacterial sinusitis:
Community-acquired pneumonia/ Acute bronchitis:

Recommended Dosage
Children from 6 months and above:
Uncomplicated Skin and soft tissue infections:
Children from 1 year to 2 years:
Pharyngitis/ Tonsillitis:
3-Day Regimen: 10 or 20 mg/kg with maximum daily dose of 500 mg
Children from 2 years and above:
Pharyngitis/ Tonsillitis:
3-Day Regimen: 10 or 20 mg/kg with maximum daily dose of 500 mg

Recommended Dosage
Adolescents and older children (weighing above 45 kg):
Uncomplicated genital infections:
A single 1 gm dose
Children above 45 kg weight:
All above given indications:
As per adult dosage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Azithromycin (Azee tablets) and other antibacterial drugs,
azithromycin should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be
considered in selecting or modifying antibacterial therapy.

Contraindications
➔
Azee tablets are contraindicated in patients with a known
hypersensitivity to Azithromycin Dihydrate, Erythromycin, any
Macrolide or Ketolide drug or any component of the tablet.
➔
Azee (Azithromycin Dihydrate Tablets) is contraindicated in
patients with a history of cholestatic jaundice/hepatic
dysfunction associated with prior use of Azithromycin.

Storage Instructions
Azee (Azithromycin Dihydrate Tablets)
have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to
77°F) with excursions permitted between
15° to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

Warnings
Serious (including fatal) allergic and skin reactions: Discontinue
Azee (Azithromycin Dihydrate Tablets) if reaction occurs.
Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has
been reported. Discontinue Azee tablets immediately if signs and
symptoms of hepatitis occur.
Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use
of Azithromycin in neonates (treatment up to 42 days of life), IHPS
has been reported. Direct parents and caregivers to contact their
physician if vomiting or irritability with feeding occurs.

Warnings
Prolongation of QT interval and cases of torsades de pointes have
been reported. This risk which can be fatal should be considered in
patients with certain cardiovascular disorders including known QT
prolongation or history torsades de pointes, those with
proarrhythmic conditions, and with other drugs that prolong the QT
interval.
Clostridium difficile-Associated Diarrhea: Evaluate patients if
diarrhea occurs.
Azee (Azithromycin Dihydrate Tablets) may exacerbate muscle
weakness in persons with myasthenia gravis.

Warnings
Azithromycin at the recommended dose should not be relied upon to treat syphilis.
Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the
symptoms of incubating syphilis. All patients with sexually transmitted urethritis or
cervicitis should have a serologic test for syphilis and appropriate testing for gonorrhea
performed at the time of diagnosis.
Prescribing azithromycin in the absence of a proven or strongly suspected bacterial
infection is unlikely to provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
As with any antibiotic preparation, observation for signs of superinfection with non-
susceptible organisms including fungi is recommended.
Penicillin is usually the first choice for treatment of pharyngitis/tonsillitis due to
Streptococcus pyogenes and also for prophylaxis of acute rheumatic fever. Azithromycin is
in general effective against streptococcus in the oropharynx, but no data are available that
demonstrate the efficacy of azithromycin in preventing acute rheumatic fever.

Effects On Ability To Drive And Use Machines
There is no evidence to suggest that Azithromycin (Azee
tablets) may have an effect on a patient's ability to drive or
operate machinery. Visual impairment and vision blurred may
have an effect on a patient's ability to drive or operate
machinery.

Possible Side Effects
Most common Azithromycin Dihydrate (Azee Tablets)
side effects are diarrhea (5 to 14%), nausea (3 to
18%), abdominal pain (3 to 7%), or vomiting (2 to 7%).

Possible Side Effects
No other treatment-related side effects occurred in patients on the
multiple-dose regimens of Azithromycin (Azee Tablets) with a frequency
greater than 1%. Azithromycin Side effects that occurred with a frequency
of 1% or less included the following:
Cardiovascular: Palpitations, chest pain.
Gastrointestinal: Dyspepsia, flatulence, vomiting, melaena and cholestatic
jaundice.
Genitourinary: Monilia, vaginitis and nephritis.
Nervous System: Dizziness, headache, vertigo and somnolence.
General: Fatigue.
Allergic: Rash, pruritus, photosensitivity and angio-oedema.

Azee Tablets Overdosage
Adverse events experienced in higher than recommended doses were
similar to those seen at normal doses. The typical symptoms of an
overdose with macrolide antibiotics include reversible loss of hearing,
severe nausea, vomiting and diarrhoea.
In the event of overdose, the administration of medicinal charcoal and
general symptomatic treatment and supportive measures are indicated
as required.

Azee Tablets During Pregnancy
Azithromycin Dihydrate (Azee Tablets) has been classified by the US FDA
as Pregnancy Category B.
Available data from published observational studies, case series, and case
reports over several decades do not suggest an increased risk for major birth
defects, miscarriage, or adverse maternal or fetal outcomes with
azithromycin use in pregnant women. Limitations of these data include the
lack of randomization and inability to control for confounders such as
underlying maternal disease and maternal use of concomitant medications.
There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human
response, Azithromycin should be used during pregnancy only if clearly
needed.

Azee Tablets are manufactured by Cipla Limited,
India.
For More details Click Here

Azee (Generic Azithromycin Dihydrate Tablets)

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Azee (Generic Azithromycin Dihydrate Tablets)

Similar to Azee (Generic Azithromycin Dihydrate Tablets) (20)

More from The Swiss Pharmacy

More from The Swiss Pharmacy (20)

Recently uploaded

Recently uploaded (20)

Azee (Generic Azithromycin Dihydrate Tablets)