Rozith Suspention 200 mg/5 ml (15ml)

Indications of Rozith 15 ml Powder For Suspension

Rozith 15 ml Powder For Suspension is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, upper respiratory tract infections including sinusitis and pharyngitis/ tonsillitis, in otitis media and skin and soft tissue infections. In sexually transmitted diseases in men and women, Azithromycin is indicated for the treatment of non-gonococcal urethritis and cervicitis caused by Chlamydia trachomatis.

Pharmacology of Rozith 15 ml Powder For Suspension

Azithromycin is acid stable and can therefore be taken orally without protection against stomach acid. It is easily absorbed; Its absorption is greater on an empty stomach. The time to maximum concentration in adults is 2.1 to 3.2 hours for the oral dosage form. Due to its high concentration in phagocytic cells, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in tissue can be up to 50 times higher than in plasma. This is due to the trapping of ions and the high solubility of lipids.

The half-life of azithromycin allows a large single dose to be delivered while maintaining bacteriostatic levels in infected tissue for several days. After a single 500 mg dose, plasma azithromycin concentrations decreased in a polyphasic fashion with a mean apparent plasma clearance of 630 ml / min and a terminal elimination half-life of 68 hours. The prolonged terminal half-life is believed to be due to the extensive absorption and subsequent release of the drug from the tissues. The predominantly unchanged excretion of azithromycin is the major route of elimination. Within a week, approximately 6% of the administered dose appeared unchanged in the urine.

Microbiology: Azithromycin works by binding to the 50S ribosomal subunit of sensitive microorganisms and thereby interfering with microbial protein synthesis. The synthesis of nucleic acids is not affected. Azithromycin has been shown to be active against most of the following isolates, both in vitro and in clinical infections:

• Aerobic and readily cultured Gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis producing, Mycoplasma pneumoniae, Betalactamase is not expected to affect the activity of azithromycin.
• Aerobic and aerobic gram-positive microorganisms: Streptococci (Groups C, F, G), Streptococci belonging to the group Viridans
• Aerobic and easy-to-cultivate Gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
• Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

Rozith 15 ml Powder For Suspension Dosage & Administration

Oral-

Adult:

• 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days.
• For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for child over 6 months
• 200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
• 300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.

In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

• 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
• The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
• Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Administration of Rozith 15 ml Powder For Suspension

Reconstitution procedure of suspension-

• Step 01: Shake the bottle well to loosen the powder.
• Step 02: Add boiled and cooled water up to the watermark of the bottle label.
• Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Interaction of Rozith 15 ml Powder For Suspension

Azithromycin absorption was reduced in presence of food & antacid. So, azithromycin should be administered 1 hour before or 2 hour after taking food & antacid. Careful monitoring of patients is advised if azithromycin is concurrently used with digoxin & ergot derivatives, as there is possibility of increased concentration of digoxin and theoretical possibility of ergotism. There have been no pharmacokinetic drug interactions between azithromycin and warfarin, theophylline, carbamazepine, methylprednisolone and cimetidine.

Contraindications of Rozith 15 ml Powder For Suspension

Rozith® is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic.

Rozith 15 ml Powder For Suspension Side Effects

Azithromycin is well tolerated with a low incidence of side effects. Most frequently reported side effects are related to Gastrointestinal system with diarrhoea, nausea, abdominal pain, flatulence, melena. Allergic reactions such as rash, edema, urticria have occured and there have also been rare reports of serious hypersensitivity reactions. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to azithromycin has not been established.

Pregnancy & Lactation

Pregnancy: Pregnancy Category B. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. Animal reproduction studies are not always predictive of human response; azithromycin should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

Precautions & Warnings

Liver is the principle route of elimination of azithromycin, caution should be exercised when azithromycin is administered to patients with impaired hepatic function. If any allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.

Therapeutic Class of Rozith 15 ml Powder For Suspension

Macrolides

Storage Conditions of Rozith 15 ml Powder For Suspension

For Rozith® Tablet : Store at temperature not exceeding 30 ºC in a dry place, protect from light.

For Rozith® PFS: Store at 5-30 ºC in a dry place, protect from light.