This injection is used to treat bacterial infections in many different parts of the body.
This medicine is also used to prevent Mycobacterium avium complex diseases in patients who have HIV (human immunodeficiency virus).
It works by killing the bacteria or preventing their growth. However, it will not work for colds, flu, or other virus infections. Azithromycin injection may be used for other problems as determined by your doctor.
Azithromycin is available only with a prescription from your doctor.
Once a drug has been approved for marketing for a particular use, experience may show that it is helpful for other medical problems as well.
Although these uses are not listed on the product labeling, azithromycin is used in certain patients with the following medical condition:
- Trachoma (treatment).
Indications of azitrocin
Azithromycin extended-release granules are indicated for treating patients with mild to moderate infections caused by susceptible strains of designated microorganisms under the specific conditions listed below.
The following bacteria cause uncomplicated acute bacterial sinusitis:
- Moraxella catarrhalis.
- Streptococcus pneumonia.
- Haemophilus influenzae.
Tonsillitis or pharyngitis, caused by Streptococcus pyogenes bacteria, is an alternative treatment in patients unable to use first-line therapy. Penicillin is generally the usual drug in the treatment of this infection.
There are susceptibility tests that must be carried out in patients treated with this drug since some strains are resistant.
Mild to moderate community-acquired pneumonia in pediatric patients six months of age and older due to:
- Mycoplasma pneumonia.
- Haemophilus influenzae
- Streptococcus pneumonia.
- Chlamydophila pneumoniae.
In patients suitable for oral treatment, pediatric use in this indication is based on extrapolation of efficacy from the adult.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should only be used to treat infections that are known or suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered when selecting or modifying antibacterial therapy.
Before determining the causative organism, appropriate susceptibility and culture tests should be performed.
Azithromycin therapy can be started before the results of these tests are known; once results are available, antimicrobial therapy should be adjusted accordingly.
How should azithromycin be used?
Use azithromycin as directed by your doctor and check the label on the medication package for use.
- An additional booklet is available for the azithromycin patient. Talk to your pharmacist if you have questions about this information.
- Azithromycin is for use in the eye only. Do not swallow it.
- Wash your hands immediately before using Azitrocin.
- To use azithromycin, turn the bottle upside down and shake it once before use. Remove the cap while the bottle is still upside down. Tilt your head back. Pull the lower eyelid away from the eye to form a pocket with your index finger.
- Repeat these steps if a drop does not come out of the bottle when you use your dose.
- To prevent germs from contaminating your medicine, do not touch the applicator tip on any surface, including the eye. Keep the container closed.
- Do not wear contact lenses while using azithromycin. Take care of your contact lenses according to the manufacturer’s directions. Check with your doctor before using them.
- To completely clear up your infection, use azithromycin throughout treatment. Keep using it even if you feel better in a few days.
Description of azitrocin
Each capsule contains Azitrocin dihydrate 262.05 mg, equivalent to Azitrocin base 250 mg. It contains cornstarch, magnesium stearate, anhydrous lactose, and sodium lauryl sulfate as excipients. The capsule shell contains gelatin, titanium dioxide (E171), and 1,000 ppm sulfur dioxide.
Each tablet contains Azitrocin dihydrate 262.05 mg, equivalent to Azitrocin base 250 mg. As excipients, it contains anhydrous dibasic calcium phosphate, pregelatinized starch, magnesium stearate, croscarmellose sodium, and sodium lauryl sulfate.
The film coating contains hydroxypropyl cellulose, triacetin, and titanium dioxide (E171).
Every 5 ml of powder contains Azitrocin dihydrate 209.64 mg equivalent to Azitrocin base 200 mg for oral suspension.
It also contains sucrose (1.94 g / 100 mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, vanilla cream, and banana flavors as excipients.
Each sachet contains Azitrocin dihydrate 100.16 mg equivalent to Azitrocin base 100 mg.
It also contains sucrose (1.85 g / azithromycin 100 mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, vanilla cream, and banana flavors as excipients.
It also contains a dry powder that produces, when added to water, a white to off-white cherry/banana suspension with a slight vanilla odor.
Each vial contains azithromycin dihydrate 524.1 mg, equivalent to Azitrocin base 500 mg. It also contains anhydrous citric acid and sodium hydroxide as excipients. It is supplied in the lyophilized form under vacuum in a 10 ml vial for intravenous administration.
After reconstitution, the azithromycin powder produces a solution containing 100 mg/ml of azithromycin.
Azithromycin is 9-deoxy-9a-aza-9a-methyl-9a-homoerythromycin A. The molecular weight is 749.
It is recommended to take azithromycin extended-release granules at least 1 hour before or 2 hours after eating.
The recommended dose for adults is a single dose of 2.0 g of azithromycin extended-release granules. In Phase 3 studies, no patient vomited within 5 minutes of dosing the azithromycin extended-release granules.
If a patient vomits within 5 minutes after administration, additional antibiotic treatment may be considered as there will be minimal absorption of azithromycin. In patients with delayed gastric emptying, alternative therapy should be considered.
Azithromycin should be taken as a single dose of 60 mg/kg (equivalent to 27 mg/lb) of body weight for pediatric patients six months and older. The azithromycin dose in mL equals the child’s weight (1 mL/lb dose, see Table 7) for less than 75 lb (34 kg).
Pediatric patients weighing 75 lbs. (34 kg) should receive the adult dose (2 g).
The drug’s safety and effectiveness in pediatric patients younger than six months have not yet been established.
Additional treatment after vomiting with azitrocin: If a patient vomits within 5 minutes after administration, the doctor should consider other antibiotic treatments as there will be minimal absorption of azitrocin.
In patients with delayed gastric emptying, alternative therapy should be considered.
Elderly: no dose adjustment is necessary for elderly patients requiring azithromycin therapy. Elderly patients may be more susceptible to the development of torsades de pointes arrhythmias.
In patients with renal insufficiency: it is not recommended to adjust the dose from mild to moderate (glomerular filtration rate of 10-80 ml/min). Caution should be exercised when administering azitrocin prolonged-release granules to patients with severe renal impairment (GFR <10 ml/min).
In patients with hepatic impairment: The pharmacokinetics of azithromycin in patients with hepatic impairment have not been established for azithromycin prolonged-release granules.
Based on studies with immediate-release formulations, adjusting the dose from mild to moderate is not recommended. Azithromycin should be used with caution in patients with severe hepatic impairment.
The drugs should not be taken simultaneously in patients receiving azithromycin and antacids.
Azithromycin does not interact significantly with the hepatic cytochrome P450 system.
The frequency of monitoring prothrombin time should be considered when using azithromycin in people receiving oral anticoagulants (coumarin-type), even if a causal relationship has not yet been established.
Great care should be taken before giving a patient a combination of some of these drugs with azithromycin. Cyclosporine levels should be regulated and the doses of cyclosporine adjusted if the administration of these drugs is necessary for the patient.
Concomitant administration of a single 1,200 mg dose of azithromycin had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for five days.
Azithromycin side effects
Clinical trial experience
Because clinical trials are conducted under widely varying conditions, the rates of adverse reactions seen in clinical trials of one drug cannot be directly compared to clinical trials of another drug. They may not reflect the rates seen in the medicine. Practice.
All patients received a single 2 g oral dose of azitrocin. The population studied had acute bacterial sinusitis and community-acquired pneumonia.
Most reported treatment-related adverse reactions were gastrointestinal and mild to moderate intensity in controlled clinical trials with azithromycin.
Overall, the most common treatment-related adverse reactions in adult patients receiving a single 2-g dose of azithromycin were diarrhea / loose stools (12%), nausea (4%), abdominal pain (3%), and abdominal pain. Head (1%). And they were vomiting (1%).
Treatment-related gastrointestinal adverse reactions were 17% for azithromycin and 10% for the combined comparators.
Treatment-related adverse reactions after azithromycin treatment that occurred with a frequency of <1% included the following:
- Cardiovascular: palpitations, chest pain.
- Gastrointestinal: constipation, dyspepsia, flatulence, gastritis, oral moniliasis.
- Genitourinary: vaginitis.
- Nervous system: dizziness, vertigo.
- General: asthenia.
- Allergic: rash, itching, hives.
- Special senses: the perversion of taste.
The data described below reflect exposure to azithromycin in 907 pediatric patients. The population was between 3 months and 12 years old. All patients received a single oral dose of 60 mg/kg of azitrocin.
As in adults, the most common treatment-related adverse reactions in pediatric patients were gastrointestinal. All pediatric subjects received a single 60 mg/kg dose (equivalent to 27 mg/lb) of azithromycin.
In a trial of 450 pediatric subjects (ages three months to 48 months), vomiting (11%), diarrhea (10%), loose stools (9%), and abdominal pain (2%) were treatment-related gastrointestinal reported more often.
Many treatment-related gastrointestinal adverse reactions with an incidence greater than 1% began on the day of administration in these subjects [43% (68/160)] and the majority [53% (84/160)] resolved within 48 hours after the start.
Treatment-related adverse events that were not gastrointestinal and that occurred with a frequency of ≥ 1% were: rash (5%), anorexia (2%), fever (2%), and dermatitis (2%).
In the second trial of 337 pediatric subjects aged two years to 12 years, the most frequently reported treatment-related adverse reactions also included vomiting (14%), diarrhea (7%), loose stools (2%), nausea ( 4%), and abdominal pain (4%).
A third trial investigated the tolerability of two different concentrations of azithromycin oral suspension in 120 pediatric subjects (3 months to 48 months), all of whom were treated with azithromycin.
The study tested the hypothesis that a more dilute and less viscous formulation (the recommended concentration of 27 mg/ml azithromycin) is less likely to induce vomiting in young children than a more concentrated suspension used in other pediatric studies.
The vomiting rate in subjects taking the diluted concentration of azithromycin was 3% (2/61). The pace was numerically lower but not statistically different from vomiting for the more concentrated suspension.
In both treatment groups, the only treatment-related adverse events with a frequency of ≥ 1% were vomiting (6%, 7/120) and diarrhea (2%, 2/120).
Treatment-related adverse reactions with a frequency <1% after azitrocin treatment in the 907 pediatric patients in phase 3 studies were:
- Body in general: chills, fever, flu syndrome, headache.
- Lymphatic and hematological: leukopenia.
- Digestive: gas, constipation, abnormal stools, dyspepsia, gastritis, hepatitis. And gastrointestinal disorder.
- Nervous system: agitation, emotional responsibility, hostility, hyperkinesia, insomnia, irritability, paraesthesia, drowsiness.
- Respiratory: rhinitis, cough, asthma, cough, dyspnea, bronchitis, pharyngitis.
- Skin and appendages: dermatitis, fungal dermatitis, maculopapular rash, pruritus, urticaria.
- Special senses: taste changes, otitis media.
- Urogenital: dysuria.
Post-marketing experience with other azithromycin products
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship with drug exposure.
Adverse events reported with azithromycin immediate-release formulations during the post-marketing period for which a causal relationship cannot be established include:
- Allergic: arthralgia, edema, urticaria, and angioedema.
- Cardiovascular: arrhythmias and palpitations (including hypotension and ventricular tachycardia).
- There have been reports of QT prolongation and torsades de pointes.
- Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration.
- General: asthenia, paraesthesia, fatigue, malaise, and anaphylaxis.
- Genitourinary: vaginitis, interstitial nephritis, renal insufficiency.
- Hematopoyético: neutropenia leve, trombocitopenia.
- Liver / Biliary: Adverse reactions related to liver dysfunction have been reported in post-marketing experience with azitrocin.
- Nervous system: seizures, headaches, hyperactivity, drowsiness, hyperactivity, nervousness, syncope, agitation, vertigo, and dizziness.
- Psychiatric: anxiety and aggressive reactions.
- Skin / Appendages: Itching, rash, photosensitivity, severe skin reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
- Special Senses: Hearing disorders including hearing loss, deafness, tinnitus, and reports of perversion/loss of taste/odor.
In subjects with average baseline values, the following clinically significant laboratory abnormalities (regardless of drug relationship) were reported in clinical trials with azithromycin in adults and pediatric patients:
Laboratory abnormalities with an incidence greater than or equal to 1%: decreased lymphocytes and increased eosinophils; reduced bicarbonate. Laboratory abnormalities with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, and potassium disturbances.
Laboratory abnormalities with an incidence greater than or equal to 1%: elevated eosinophils, BUN, and potassium; decreased lymphocytes; and changes in neutrophils; with an incidence of less than 1%: elevation of SGOT, SGPT, and creatinine; decreased potassium; and alterations in sodium and glucose.
Contraindications of azithromycin
Azithromycin tablets are contraindicated in patients with known hypersensitivity to administering azithromycin, erythromycin, macrolide, or ketolide.
Azithromycin tablets are contraindicated in patients with a history of cholestatic jaundice/liver dysfunction associated with previous use of azithromycin.