Azithromycin by Mylan
Azithromycin by Mylan Uses, Dosage, Side Effects, Food Interaction and all others data.
Azithromycin by Mylan is an azalide antibiotic, a subclass of macrolide antibiotic. It acts by binding to the 50s ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis. Azithromycin by Mylan has been shown to be active against most strains in the following microorganisms, both In vitro and in clinical infections:
Gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.
Gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Escherichia coli.
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Bacteroides fragilis, Legionella pneumophila, oxoplasma gondii.
Macrolides stop bacterial growth by inhibiting protein synthesis and translation, treating bacterial infections .Azithromycin by Mylan has additional immunomodulatory effects and has been used in chronic respiratory inflammatory diseases for this purpose .
Trade Name | Azithromycin by Mylan |
Availability | Prescription only |
Generic | Azithromycin |
Azithromycin Other Names | Azithromycin, Azithromycine, Azithromycinum, Azitromicina |
Related Drugs | amoxicillin, prednisone, albuterol, doxycycline, ciprofloxacin, cephalexin, metronidazole, clindamycin, ceftriaxone, levofloxacin |
Type | |
Formula | C38H72N2O12 |
Weight | Average: 748.9845 Monoisotopic: 748.508525778 |
Protein binding | The serum protein binding of azithromycin varies in humans, decreasing from 51% at 0.02 g/mL to 7% at 2 g/mL . |
Groups | Approved |
Therapeutic Class | Macrolides |
Manufacturer | |
Available Country | United States |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Azithromycin by Mylan is used for infections caused by susceptible organisms in-
Upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis
Lower respiratory tract infections including bronchitis, acute bacterial exacerbations of chronic obstructive pulmonary
disease (COPD)
Otitis media
Skin and soft tissue infections including cellulitis, pyoderma, erysipelas, wound infections
Diarrhea, Shigellosis
Sexually transmitted diseases, especially in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
Mild or moderate typhoid due to multiple-antibacterial resistant organisms
Prophylaxis against a-hemolytic (viridans group) streptococcal bacterial endocarditis
Other infections including odontogenic infections, bartonella infections, toxoplasmosis, babesiosis
Azithromycin by Mylan is also used to associated treatment for these conditions: Acute Bacterial Sinusitis (ABS), Acute Otitis Media, Acute bacterial exacerbation of COPD caused by Haemophilus Influenza Infections, Moraxella Catarrhalis Infection, Streptococcus Pneumoniae Infections, Bacterial Conjunctivitis, Bacterial Sinusitis, Cervicitis, Chancroid, Community Acquired Pneumonia (CAP), Genital Ulcer Disease (GUD), Pelvic Inflammatory Disease (PID), Pharyngitis, Streptococcal Pharyngitis, Streptococcal tonsillitis, Tonsillitis bacterial, Traveler's Diarrhea, Uncomplicated Skin and Skin Structure Infections, Urethritis
How Azithromycin by Mylan works
In order to replicate, bacteria require a specific process of protein synthesis, enabled by ribosomal proteins . Azithromycin by Mylan binds to the 23S rRNA of the bacterial 50S ribosomal subunit. It stops bacterial protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis and by inhibiting the assembly of the 50S ribosomal subunit , . This results in the control of various bacterial infections , . The strong affinity of macrolides, including azithromycin, for bacterial ribosomes, is consistent with their broad‐spectrum antibacterial activities .
Azithromycin by Mylan is highly stable at a low pH, giving it a longer serum half-life and increasing its concentrations in tissues compared to erythromycin .
Dosage
Azithromycin by Mylan dosage
Azithromycin by Mylan tablet can be taken with or without food. Azithromycin by Mylan suspension should be taken at least 1 hour before or 2 hours after meal.
Oral:
Adult:
For respiratory tract infections, otitis media and skin & soft tissue infections: 500 mg once daily for 3 days or an alternative to this as 500 mg once on day 1, followed by 250 mg once daily for next 4 days. For sexually transmitted diseases like genital ulcer, non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis : a single 1 gm (1000 mg) dose. For the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae : a single 2 gm (2000 mg) dose. In typhoid, 500 mg once daily for 7 days. In Cholera, a single 1 gm (1000 mg) dose. In Shigellosis, 500 mg once on day 1, followed by 250 mg once daily for next 4 days.
Azithromycin by Mylan can be taken with or without food.
To reconstitute Azithromycin by Mylan 15 ml powder for suspension: Add 10 ml or 2 tea spoonfuls of just boiled and cooled water to the content of the bottle and shake well to mix uniformly.
To reconstitute Azithromycin by Mylan 30 ml powder for suspension: Add 20 ml or 4 tea spoonfuls of just boiled and cooled water to the content of the bottle and shake well to mix uniformly.
To reconstitute Azithromycin by Mylan 50 ml powder for suspension: Add 35 ml or 7 tea spoonfuls of just boiled and cooled water to the content of the bottle and shake well to mix uniformly.
Side Effects
Azithromycin by Mylan is well tolerated with a low incidence of side efects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy. Reversible elevations in liver transaminases have been observed occasionally. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although causal relationship to Azithromycin by Mylan has not been established.
Toxicity
Rat Oral LD50: >2000 mk/kg
Possible major adverse effects include cardiovascular arrhythmias and hearing loss. Macrolide resistance is also an ongoing issue. Hepatotoxicity has been observed in rare cases.
A note on the risk of liver toxicity:
Due to the act that azithromycin is mainly eliminated by the liver, caution should be observed when azithromycin is given to patients with decreased hepatic function .
A note on potential renal toxicity:
Because limited data in patients with renal GFR Label.
Use in Pregnancy:
This drug is categorized as a pregnancy category B drug. Reproduction studies have been done in rats and mice at doses up to moderately maternally toxic doses (for example, 200 mg/kg/day). These doses, based on a mg/m2 basis, are approximately 4 and 2 times, respectively, the human daily dose of 500 mg. In the animal studies, no harmful effects to the fetus due to azithromycin were observed. There are, at this time, no conclusive and well-controlled studies that have been done in pregnant women. Because animal reproduction studies do not always predict human response, azithromycin should be used during pregnancy only if clearly needed .
Nursing Mothers:
It is unknown at this time whether azithromycin is excreted in human milk. Because many other drugs are excreted in human milk, caution should be observed when azithromycin is given to a nursing woman .
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term studies in animals have not been performed to study carcinogenic potential. Azithromycin by Mylan has demonstrated no potential to be mutagenic in standard laboratory tests. No evidence of negative effects on fertility due to azithromycin was found .
Precaution
As with any antibiotic, observation for signs of super infection with non-susceptable organisms, including fungi, is recommended. Precaution should be taken in patients with more severe renal impairment.
Interaction
Antacids: Peak serum levels but not the total extent of absorption are reduced by aluminium and magnesium containing antacids in the stomach. Azithromycin by Mylan should therefore be taken at least 1 hour before or 2 hours after taking these antacids.
Ergot Derivatives: Because of the theoretical possibility of ergotism, concomitant administration of ergot derivatives and Azithromycin by Mylan should be avoided. Digoxin & Cyclosporin: Macrolides have been known to increase the plasma concentration of Digoxin & Cyclosporin and so caution should be exercised while co-administration is necessary.
Anti-Histamines: A potentially life threatening interaction between erythromycin and terfenadine or astemizole have been reported. Although such an interaction with Azithromycin by Mylan is not established yet, it is wise to avoid concomitant use of Azithromycin by Mylan and terfenadine or astemizole.
Food Interaction
- Take on an empty stomach. Take at least 1 hour before or 2 hours after meals.
Azithromycin by Mylan Drug Interaction
Moderate: albuterol, albuterolUnknown: diphenhydramine, diphenhydramine, fluticasone nasal, fluticasone nasal, guaifenesin, guaifenesin, montelukast, montelukast, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, cetirizine, cetirizine
Azithromycin by Mylan Disease Interaction
Major: colitis, QT prolongationModerate: liver disease, myasthenia gravis
Volume of Distribution
After oral administration, azithromycin is widely distributed in tissues with an apparent steady-state volume of distribution of 31.1 L/kg . Significantly greater azithromycin concentrations have been measured in the tissues rather than in plasma or serum , . The lung, tonsils and prostate are organs have shown a particularly high rate of azithromycin uptake .
This drug is concentrated within macrophages and polymorphonucleocytes, allowing for effective activity against Chlamydia trachomatis . In addition, azithromycin is found to be concentrated in phagocytes and fibroblasts, shown by in vitro incubation techniques. In vivo studies demonstrate that concentration in phagocytes may contribute to azithromycin distribution to inflamed tissues .
Elimination Route
Bioavailability of azithromycin is 37% following oral administration. Absorption is not affected by food. Macrolide absorption in the intestines is believed to be mediated by P-glycoprotein (ABCB1) efflux transporters, which are known to be encoded by the ABCB1 gene .
Half Life
Terminal elimination half-life: 68 hours
Clearance
Mean apparent plasma cl=630 mL/min (following single 500 mg oral and i.v. dose)
Elimination Route
Biliary excretion of azithromycin, primarily as unchanged drug, is a major route of elimination. Over a 1 week period, approximately 6% of the administered dose is found as unchanged drug in urine .
Pregnancy & Breastfeeding use
Pregnancy: US FDA pregnancy category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin by Mylan was found. Because animal reproduction studies are not always predictive of human response, Azithromycin by Mylan should be used during pregnancy only if clearly needed.
Lactation: It is not known whether Azithromycin by Mylan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin by Mylan is administered to nursing mother.
Contraindication
Azithromycin by Mylan is contraindicated in patients hypersensitive to Azithromycin by Mylan or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin by Mylan is contraindicated. Azithromycin by Mylan is contraindicated in patients with hepatic diseases.
Special Warning
Pediatric Use: Azithromycin by Mylan oral dosage forms can be administered to pediatric patients from 6 months of age. Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.
Acute Overdose
There are no data available on overdose with Azithromycin by Mylan. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.
Interaction with other Medicine
Peak serum levels but not the total extent of absorption were reduced by the presence of magnesium and aluminum-containing antacids. Azithromycin by Mylan should be taken at least 1 hr before or 2 hrs after these antacids. In patients receiving ergot alkaloids, Azithromycin by Mylan should be avoided concurrently because of the possibilty of ergotism result in from interaction of Azithromycin by Mylan 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 cyclosporine. Therefore, if co-administration is necessary caution should be exercised and serum levels of digoxin and cyclosporine should be checked. There have been no pharmacokinetic drug interactions between Azithromycin by Mylan and warfarin, theophylline, carbamazepine, methylprednisolone and cimetidine.
Storage Condition
Azithromycin by Mylan IV infusion: When diluted according to the instructions, azithromycin for injection is stable for 24 hours at or below room temperature 30° C, or for 7 days if stored under refrigeration 5° C.
Azithromycin by Mylan capsule, tablet and dry powder for suspension: should be stored at room temperature (below 30° C). Any unused portion of reconstituted Azithromycin by Mylan suspension should be discarded after 5 days.
Azithromycin by Mylan eye drops: Store unopened bottle under refrigeration at 2°C to 8°C. Once the bottle is opened, store at 2°C to 25°C for up to 14 days. Discard after the 14 days.
Innovators Monograph
You find simplified version here Azithromycin by Mylan
Azithromycin by Mylan contains Azithromycin see full prescribing information from innovator Azithromycin by Mylan Monograph, Azithromycin by Mylan MSDS, Azithromycin by Mylan FDA label
FAQ
What is Azithromycin by Mylan used to treat?
Azithromycin by Mylan is an antibiotic. It's widely used to treat chest infections such as pneumonia, infections of the nose and throat such as sinus infection (sinusitis), skin infections, Lyme disease, and some sexually transmitted infections.
Is Azithromycin by Mylan a steroid or antibiotic?
Azithromycin by Mylan is an antibiotic medication used for the treatment of a number of bacterial infections.
What is the side effect of Azithromycin by Mylan?
Stomach upset, diarrhea/loose stools, nausea, vomiting, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
How quickly does Azithromycin by Mylan work?
Azithromycin by Mylan typically takes at least five days to fully work, but it can start to relieve your sore throat and other symptoms on the first day you take it. If your doctor prescribes a generic version of Azithromycin by Mylan, your treatment may only last three days.
Who should not take Azithromycin by Mylan?
The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:
Conditions:
- diarrhea from an infection with Clostridium difficile bacteria
- low amount of magnesium in the blood
- low amount of potassium in the blood
- myasthenia gravis, a skeletal muscle disorder
- hearing loss
- torsades de pointes, a type of abnormal heart rhythm
- slow heartbeat
- prolonged QT interval on EKG
- abnormal EKG with QT changes from birth
- a narrowing of the opening between the stomach and the small intestine
- liver problems
- abnormal liver function tests
- inflammation of the liver with stoppage of bile flow
- a yellowing of the eyes or skin from buildup of bilirubin called jaundice
Does Azithromycin by Mylan kill gut bacteria?
Like all broad-spectrum antibiotics, Azithromycin by Mylan does not discriminate between pathogenic bacteria and healthy bacteria. Hence, when you take antibiotics to fight an infection, many of the bacteria in your gut are killed too (think of it as collateral damage).
Does Azithromycin by Mylan make me tired?
Azithromycin by Mylan oral tablet doesn't cause drowsiness, but it can cause other side effects.
How safe is Azithromycin by Mylan?
The U.S. Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. source
Can Azithromycin by Mylan treat cold?
Azithromycin by Mylan 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).
Can I take Azithromycin by Mylan during pregnancy?
The safety of Azithromycin by Mylan during pregnancy is yet to establish. Azithromycin by Mylan is not recommendable in pregnancy. Ask your doctor before taking this medicine.
Can I take Azithromycin by Mylan while breastfeeding?
Azithromycin by Mylan partially passes into human breast milk. If you are taking Azithromycin by Mylan then stop breastfeeding your baby. It is advised to discard the milk during treatment and until two days after discontinuation of treatment. You can restart breastfeeding thereafter.
Can I drive if I have consumed Azithromycin by Mylan?
You may drive, but be sure you are not experiencing dizziness before you start driving.
How Does Azithromycin by Mylan Work?
Azithromycin by Mylan prevents the growth of bacteria by interfering with their protein synthesis. It binds to a specific part of the bacterial nucleus and inhibits the process required for bacterial growth. Thereby, bacteria are killed, or their growth is stalled depending on the organism and the medicine concentration.