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Ranzith®
250 mg Capsule & 500 mg Tablet
Granules for 15 ml & 30 ml Suspension
Description
Ranzith® (Azithromycin) is an azalide compound, a subclass of macrolide antibiotics
with enhanced spectrum of activity against Gram-positive and Gram-negative bacteria
including: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogens
(Group A) and other Streptococcal species, Haemophilus influenzae, Parainfluenzae;
Neisseria gonorrhoeae and Chlamydia trachomatis. Azithromycin also demonstrates in
vitro activity against Mycoplasma pneumoniae and hominis; Campylobacter sp and
Treponema pallidum.
Ranzith® (Azithromycin), the first member of azalide, is derived by the incorporation of a
nitrogen atom in the lactone ring of the macrolide nucleus. This structural modification
confers several desirable properties in clinical practices.
Composition
Ranzith® 250 Capsule: Each capsule contains Azithromycin Dihydrate USP equivalent to
250 mg Azithromycin.
Ranzith® 500 Tablet: Each film-coated tablet contains Azithromycin Dihydrate USP
equivalent to 500 mg Azithromycin.
Ranzith® Granules for 15 ml Suspension: After reconstitution, each 5 ml suspension will
contain Azithromycin Dihydrate USP equivalent to 200 mg Azithromycin.
Ranzith® Granules for 30 ml Suspension: After reconstitution, each 5 ml suspension will
contain Azithromycin Dihydrate USP equivalent to 200 mg Azithromycin.
Mechanism of action:
Azithromycin acts by binding to the 50S ribosomal subunit of susceptible
microorganisms and thus, interfering with microbial protein synthesis. In vitro techniques
suggest that Azithromycin concentrates in phagocytes and fibroblasts may contribute to
drug distribution to inflamed tissues.
Pharmacokinetics:
Absorption:
Following oral administration of a single 500 mg dose to 36 fasted healthy male
volunteers, the mean (SD) pharmacokinetic parameters wereCmax : 0.5 mcg/ml
Tmax : 2.2 hours
Bioavailability: 34-52%
Azithromycin absorption is not altered in presence of food
Distribution:
Following oral administration, Azithromycin is widely distributed throughout the body
with an apparent steady-state volume of distribution of 31.1 L/kg preferably high
concentration in Poly morphonuclear leukocytes, monocytes, alveoler macrophages,
fibrolasts.
Greater Azithromycin concentrations in tissues than in plasma or serum were observed.
The extensive tissue distribution was confirmed by examination of additional tissues and
fluids (bone, ejaculum, prostate, ovary, uterus, salpinx, stomach, liver, and gallbladder).
Metabolism:
Liver; CYP450: unknown
Elimination:
Terminal elimination half life (T1/2): 68 hours.The prolonged terminal half-life is
thought to be due to extensive uptake and subsequent release of drug from tissues.
Route of elimination: Biliary excretion of Azithromycin, predominantly as unchanged
drug, is a major route of elimination.
Indication and Use
Ranzith® (Azithromycin) is indicated for following infections caused by susceptible
organisms.
Lower respiratory tract infections: Bronchitis and Pneumonia
Skin and soft tissue infections
ENT: Otitis media
Upper respiratory tract infections: Sinusitis, Pharyngitis and Tonsillitis.
STD: For sexually transmitted diseases both in men and women caused by Chlamydia
trachomatis.
Dosage and Administration
Adult: Ranzith® (Azithromycin) should be given as 500 mg once daily orally for 3 days
or as an alternative, given 500 mg on day 1, then 250 mg on days 2-5. For sexually
transmitted diseases caused by Chlamydia trachomatis in adult, the dose is 1 gm as single
dose.
Elderly: Normal adult dose is recommended.
Children: The dose of Ranzith® in Children is given as follows
Age
> 6 months
3 - 7 Years
8 - 11 Years
12 - 14
Years
>15 Years
Weight
(Kg)
<15
15 - 25
26 - 35
Dose/Day
10 mg/kg
200 mg
300 mg
Course time
(Days)
3
3
3
36 - 45
>45
400 mg
500 mg
3
3
Contraindication
It is contraindicated in patients with known hypersensitivity to Azithromycin or any of
the macrolide or ketolide antibiotics. Co-administration of ergot derivatives and
Azithromycin is contraindicated.
Use in Pregnancy and Lactation
Pregnancy: Pregnancy category B. Recommendation: Limited Human Data-Animal Data
Suggest Low Risk.
Lactation: Recommendation: Limited Human Data-Probably Compatible
* A reference guide to fetal and neonatal risk Drugs in Pregnancy and Lactation, 7th
edition.
Side Effect
Azithromycin is well tolerated with a low incidence of side effects.
Gastro-intestinal: Nausea, abdominal discomfort, vomiting, flatulence, diarrhea, and
loose stools.
Allergic reactions: Rash and serious hypersensitivity reactions occur rarely.
Others: Reversible elevation in liver transaminases, transient and mild reduction in
neutrophil counts.
Precaution
Avoid concomitant administration with terfenadine or astemazole. Precaution should be
taken in patients with severe renal impairment.
Overdosage
There is no data on over dosage with Azithromycin. Typical symptoms of over dosage
with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhea.
Gastric lavage and general supportive measures are indicated.
Drug Interaction
Azithromycin should be administered 1 hour before or 2 hours after taking antacid. In
patients receiving ergot alkaloids Azithromycin should be avoided concurrently because
of the possibility of ergotism resulting from interaction of Azithromycin with the
cytochrome P-450 system. However, no cases of such interaction have been reported.
Macrolides have been known to increase the plasma concentration of digoxin and
cyclosporin. Therefore, if co-administration is necessary caution should be exercised and
serum level of digoxin and cyclosporin should be checked. There has been no
pharmacokinetic drug interaction between Azithromycin and warfarin, theophylline,
carbamazepine, methylprednisolone and cimetidine.
Storage Condition
Tablet & capsule: Store at room temperature (25°- 30° C).
Suspension: Prior to reconstitution-store at room temperature (25°- 30° C). After
reconstitution- The product may be stored for 7 days at room temperature or for 14 days
in a refrigerator (2°- 8° C)
Direction for suspension reconstitution
15 ml Granules for Suspension: Add 7.5 ml of boiled and cooled water to the bottle and
shake well to mix uniformly.
30 ml Granules for Suspension: Add 15 ml of boiled and cooled water to the bottle and
shake well to mix uniformly.
Packaging Quantity
Ranzith® 250 Capsule: Box containing 2 x 3 capsules in Alu-Alu pack.
Ranzith® 500 Tablet: Box containing 2 x 3 & 4 x 3 tablets in Alu-Alu pack.
Ranzith® Granules for 15 ml Suspension: Bottle containing granules sufficient to produce
15 ml suspension.
Ranzith® Granules for 30 ml Suspension: Bottle containing granules sufficient to produce
30 ml suspension.