Odazyth 500mg

Tablet
Azithromycin
ACI Pharmaceuticals

Other Strength:

Alternative:
- Azithrocin 500mg
- Zimax 500mg
- Rozith 500mg
- Zibac 500mg
- Azithromax 500mg
- Verizith 500mg
- Odaz 500mg
- Alzith 500mg
- Zinex 500mg
- Amzith 500mg
- AZ 500mg
- Azithro 500mg
- Benzith 500mg



Odazyth
Description:
Odazyth®is a preparation of Azithromycin, which is an azalide antibiotic, a subclass of macrolide antibiotic.Azithromycin is active against wide range of Gram-positive and Gram-negative organisms. It acts by binding to the 50s ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis.

Indications and Uses:
Odazyth®tablet and suspension is indicated for the treatment of patients with infections caused by susceptible organisms in:

Adults:
Acute bacterial exacerbations of chronic obstructive pulmonary diseasedue to Haemophilus influenzae, Moraxellacatarrhalis or Streptococcuspneumoniae.Acute bacterial sinusitisdue to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.Community-acquired pneumoniadue to Chlamydiapneumoniae, Haemophilus influenzae, Mycoplasmapneumoniae or Streptococcus pneumoniaein patients appropriate for oral therapy. Pharyngitis/Tonsillitiscaused by Streptococcus pyogenesas an alternative to first-line therapy in individuals who cannot use first-line therapy.Uncomplicated skin and skin structure infectionsdue to Staphylococcusaureus, Streptococcus pyogenes,or Streptococcus agalactiae. Abscesses usually require surgical drainage.Urethritis and cervicitis due to Chlamydia trachomatisor NeisseriagonorrhoeaeGenital ulcer diseasein men due to Haemophilus ducreyi(chancroid).

Children:
Acute otitis mediacaused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.Community-acquired pneumoniadue to Chlamydia pneumoniae, Haemophilus influenzae,Mycoplasma pneumoniae or Streptococcus pneumoniaein patients appropriate for oral therapy.Pharyngitis/Tonsillitiscaused by Streptococcus pyogenesas an alternative to first-line therapy in individuals who cannot use first-line therapy.

Dosage and Administration:
Odazyth® tabletand capsulefor adult
Infection: Community-acquired pneumonia (mild severity)Pharyngitis/Tonsillitis (second line therapy) Skin/skin structure (uncomplicated) Acute bacterial exacerbations of chronic obstructive pulmonary disease (mild to moderate) Acute bacterial sinusitis Genital ulcer disease (chancroid) Non-gonoccocal urethritis and cervicitis Gonococcal urethritis and cervicitis
Recommendeddoseand duration of therapy: 500 mg as a single dose on day 1, followed by 250 mg once daily on days 2 through 5. 500 mg once daily for 3 days or500 mg as a single dose on Day 1, followed by250 mg once daily on Days 2 through 5. 500 mg once daily for 3 days 1 gas a singledose 1 gas a single dose 2 gas a single dose

Odazyth® oral suspension for children
Infection: Acute otitis media Acute bacterial sinusitis Community-acquired pneumonia Pharyngitis/Tonsillitis
Recommended dose and duration of therapy: 30 mg/kg (0.75ml/kg) given as a single dose or10 mg/kg (0.25ml/kg) once daily for 3 days or 10 mg/kg (0.25ml/kg) as a single dose on the first day followed by 5 mg/kg/day (0.125ml/kg/day) on days 2 through 5 10 mg/kg (0.25ml/kg) once daily for 3 days 10 mg/kg (0.25ml/kg) as a single dose on the first day followed by 5 mg/kg (0.125ml/kg) on days 2 through 5 12 mg/kg (0.3ml/kg) once daily for 5 days

Directions for Reconstitution of Suspension
Shake the bottle well before mixing the water. 15 mlsuspension:Add 10 ml boiled and cooled water for 15 ml; 30 mlsuspension:Add 20 ml boiled and cooled water for 30 ml; 50 ml suspension:Add 33.5 ml boiled and cooled water for 50 ml to the dry powder of the bottle. Use the supplied dropper or spoon for water measurement. Shake till powder is completely mixed with water. Keep the prepared suspension in cool dry place and consume within 5 days of preparation. Shake the bottle well before use.

Use in Pregnancy and Lactation:
Azithromycin should be used during pregnancy only if clearly needed.Recent clinical studies have recommended that Azithromycin should be considered for the initial treatment of chlamydial cervicitisin pregnancy. It is not known whether Azithromycin is excreted in human milk. Caution should be exercised when Azithromycin is administered to a nursing woman.

Contraindications
Azithromycin is contra-indicated in patients with a known hypersensitivity to Azithromycin or any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be co-administered.As liver is the principal route of excretion of Azithromycin, it should not be used in patients with hepatic disease.

Precautions
Azithromycin is eliminated via liver; caution should be taken in patient with impaired hepatic function. Caution should be taken in sever renal impairment. As with any antibiotic, observation for signs of super infection with non-susceptible organisms, including fungi, is recommended. Azithromycin should not be concomitantly used with astemizole or terfenadine.

Side Effects:
Azithromycin is well tolerated with a low incidence of side effects. Most side effects observed were mild to moderate in severity.The majority of side effects were gastro intestinal in origin with nausea, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhea and loose stools being occasionally observed. Allergic reactions such as rash have occurred which are reversible upon discontinuation of therapy.

Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to Azithromycin has not been established.

Drug Interactions
Azithromycin absorption is reduced in presence of food and antacid. So, Azithromycin should be administered at least 1 hour before or 2 hours after the antacid and food taken. Macrolides have been known to increase the plasma concentration of digoxin and cyclosporine. Therefore if co-administration is necessary caution should be exercised and serum levels of digoxin and cyclosporine checked. There have been no pharmacokinetic drug interactions between Azithromycin and warfarin, theophyline, carbamazepine, methylprednisolone and cimetidine.

Over dosage
There are 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.

Pharmaceutical Precautions:
Odazyth®tablet , capsule and powder for suspensions should be stored in a cool dry place. The reconstituted suspension should be stored at room temperature and any used suspension discarded after 5 days.

Presentation:
Odazyth®250 mg capsule: Each capsule contains Azithromycin 250 mg as Dihydrate USP.

Odazyth®500 mg tablet: Each tablet contains Azithromycin 500 mg as DihydrateUSP.

Odazyth®15 ml, 30 ml& 50 mlpowder for suspension: After reconstitution each 5 ml suspension contains Azithromycin 200 mg as Dihydrate USP.

Package Quantities:
Odazyth®250 mg capsule: Carton of 6’s capsules in blister (for export only).
Odazyth®500 mg tablet: Carton of 3’s, 6’s & 9’s tablets in blister (for export only).
Odazyth®500 mg tablet: Carton of 12’stablets in blister.
Odazyth®powder for suspension: Bottle of 15 ml, 30 ml& 50 ml.

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