Azyth 250 mg/ 5 ml Powder for Suspension

Pharmacology

Azyth 250 mg/ 5 ml Powder for Suspension is an azalide antibiotic, a subclass of the macrolide class. It binds to the 50s ribosomal subunit of susceptible organisms and thus interferes with microbial protein synthesis. It demonstrated activity in vitro against a wide range of gram-positive and gram-negative bacteria, including Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes (Group A), and other Streptococcal species, Haemophilus influenza and poronfluenzar Moraxella catarrhalis, anaerobes including Bacteroides fragilis, Escherichia col Bordetella pertussis, Bordetella parapertussis. Borrelia burgdorferi Haemophilus ducrey Neisseria gonorrhoeae and Chlamydia trachomatis. Azithromycin also demonstrates activity in vitro against Legionella pneumophila, Mycoplasma pneumonia, and hominis: Campylobacter sp Toxoplasma gondii and Treponema pallidum.

Microbiology: Azithromycin is active against most isolates of the following microorganisms, both in vitro and in clinical infections:

• Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.
• Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae.
• Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, and Beta-lactamase production should not affect azithromycin activity.
• Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C, F, G), Viridans group streptococci.
• Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila.
• Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia. 

Uses Of Azyth 250 mg/ 5 ml

Azithromycin Dihydrate is indicated for: 

• Respiratory tract infections: For treating bacterial infections of the respiratory tract, such as bronchitis, pneumonia, and sinusitis.
• Skin and soft tissue infections: Used to treat skin and soft tissue infections such as impetigo, cellulitis, and erysipelas.
• Sexually transmitted infections: Certain sexually transmitted infections, such as chlamydia and gonorrhea.
• Ear infections: Bacterial ear infections, such as otitis media.
• Mycobacterial infections: Sometimes used with other drugs to treat mycobacterial infections such as tuberculosis and Mycobacterium avium complex (MAC) infection.
• Gastrointestinal infections: Can treat gastrointestinal tract bacterial infections, such as traveler’s diarrhea.

Dosage of Azithromycin Dihydrate

Consult a doctor before taking any medicine. Azithromycin Dihydrate can be taken orally and via injection.

Oral Dosage for Adults: 

• 500 mg for the first day or 3 days – Once a Day
• Then 250 mg Once a Day or 2 – 5 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 the next 2 days may also be given.

Children:

• 10 mg/kg body weight once daily for 3 days for children 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) is given once daily for 7-10 days.

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 daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course. The timing of the switch to oral therapy should be done at the physician’s discretion and in accordance with clinical response.
• The recommended dose of Azithromycin for treating 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 daily dose of 250 mg to complete a 7-day course. The timing of the switch to oral therapy should be done at the physician’s discretion 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 with Azithromycin.
• The safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Administration 

For Making the suspension suitable for the child, you should follow the given Preparation method of suspension-

• Step 01: Shake the bottle well to loosen the powder. Otherwise, it will not mix with water properly. 
• Step 02: Mix boiled but cold water with the power according to the given mark of the bottle. 
• Step 03: Shake until powder is thoroughly mixed with water.

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

Azyth 250 mg/ 5 ml Price in Bangladesh

Interaction 

Antacid: If the patient takes antacid and Azithromycin at the same time, then he should take Azithromycin Dihydrate at least 1 hour before or 1 hour after taking the antacid.

• Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite.
• Cyclosporin: Some of the related macrolide antibiotics interfere with the metabolism of cyclosporin. In the absence of conclusive data from pharmacokinetic studies or clinical data investigating potential interactions between Azithromycin Dihydrate and cyclosporine, caution should be exercised before the co-administration of these two drugs. Cyclosporin levels should be monitored, and the dose adjusted accordingly if coadministration is necessary.
• Digoxin: Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin (in the gut) in some patients. Therefore, in patients receiving concomitant Azithromycin and digoxin, the possibility of raised digoxin levels should be borne in mind, and digoxin levels should be monitored.
• Ergot derivatives: Because of the theoretical possibility of ergotism, azithromycin, and ergot derivatives should not be co-administered.
• Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.
• Theophylline: There is no evidence of pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers. In general, however, theophylline levels should be monitored.
• Warfarin: In a pharmacodynamic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Azithromycin and warfarin may be co-administered, but the prothrombin time should be monitored as routinely performed.
• Terfenadine: Azithromycin Dihydrate did not affect the pharmacokinetics of terfenadine administered at the recommended dose of 60 mg every 12 hours. Adding azithromycin did not result in any significant changes in cardiac repolarisation (QTc interval) measured during the steady-state dosing of terfenadine.

Contradictions 

Azithromycin Dihydrate is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin Dihydrate is contraindicated in patients with hepatic diseases.

Side Effects of Azyth 250 mg/ 5 ml

Azithromycin Dihydrate is known as well tolerated drug but some minor side effects may appear. Most side effects observed were mild to moderate in severity. The majority of side effects were: 

• Gastrointestinal in origin, with nausea
• Abdominal discomfort (pain/cramps)
• Vomiting
• Flatulence
• Diarrhea
• And loose stools are occasionally observed. 

Allergic reactions such as rash or photosensitivity have occurred, and there have also been rare reports of serious hypersensitivity reactions. 

Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. 

Rarely cases of cholestatic jaundice have been observed. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to azithromycin has not been established. 

Hearing impairment: In investigational studies where higher doses were used for prolonged periods of time, reversible hearing impairment was seen in some patients.

Precautions & Warnings

As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic edema and anaphylaxis, have been reported. Some of these reactions with Azithromycin Dihydrate have resulted in recurrent symptoms and required a long period of observation and treatment.

Pregnancy and Lactation

The pregnancy Category of Azithromycin is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well-controlled studies on pregnant women. Since animal reproduction studies are not always predictive of human response, They should be used during pregnancy only if adequate alternatives are unavailable. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Use in Special Populations

• Use in renal impairment: No dose adjustment is needed in patients with mild renal impairment (creatinine clearance >40 ml/min), but there are no data regarding azithromycin in patients with more severe renal impairment; thus, caution should be exercised in using azithromycin in these patients.
• Use in hepatic impairment: As the liver is the principal route of excretion of azithromycin, it should not be used in patients with hepatic disease.
• Effects on ability to drive and use machines: There is no evidence to suggest that azithromycin may have an effect on a patient’s ability to drive or operate machinery.

Overdose Effects

There is no data on overdosage with Azithromycin Dihydrate. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting, and diarrhea. Gastric lavage and general supportive measures are indicated.

Storage

Keep in a dry place away from light and heat. Keep out of the reach of children.