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Azithromycin for Injection

December 13,2022

composition

The main ingredient of this product is azithromycin.

Chemical name: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14r)-13-[(2,6-dideoxy -3-C- methyl -3-O- methyl -α-L- nuclear-hexopyranosyl) oxygen]-2

character

This product is white to nearly white block powder.

As a generic drug supplier in China, Feiyue Pharmaceutical can provide finished drugs such as Azithromycin for Injection

Packaging: 7ml tubular vial with filp-off, 1's/box, 10's/box50's/box

FEIYUE recruits agents worldwide, we can provide complete registration documents.

indication

This product is suitable for the following infections caused by sensitive pathogenic bacteria

Community acquired pneumonia

It is caused by pathogenic bacteria such as Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus or Streptococcus pneumoniae, etc., and patients who need intravenous administration at the beginning of treatment.

Pelvic inflammatory disease

It is caused by Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis, and patients who need intravenous administration are initially treated. If it is suspected that it may be complicated with anaerobic infection, it is necessary to add an anti-anaerobic drug in combination with this drug.

When it is necessary, when you stop using Histamine injection (azithromycin for injection), you can take Histamine orally for sequential treatment.

adverse effect

In the clinical trial of azithromycin intravenous preparation in the treatment of community-acquired pneumonia, 2-5 doses were given intravenously, and most of the reported adverse reactions were mild to moderate, which could be recovered after drug withdrawal. In these clinical trials, most patients have more than one complication and need to use other drugs. About 1.2% of the patients who used Histamine intravenous preparation stopped taking drugs, and 2.4% of the patients who used intravenous or oral azithromycin stopped taking drugs because of adverse reaction symptoms or abnormal laboratory tests.

In the clinical trials of patients with pelvic inflammatory disease, after 1-2 doses of azithromycin were administered intravenously to women, 2% of the patients stopped taking the medicine because of clinical adverse reactions, and 4% of the patients who were combined with azithromycin and metronidazole stopped the treatment because of adverse reactions.

In the above studies, the most common adverse reactions leading to drug withdrawal are gastrointestinal reactions (abdominal pain, nausea, vomiting, diarrhea, etc.) and skin rash. The abnormal laboratory examination leading to drug withdrawal is mainly the increase of serum transaminase and/or alkaline phosphatase.

Clinical aspects:

In the study of community-acquired pneumonia, the most common adverse reactions of adult patients after receiving intravenous/oral preparation of Histamine [sup] [/sup] are gastrointestinal reactions, including diarrhea or loose stool (4.3%), nausea (3.9%), abdominal pain (2.7%) and vomiting (1.4%). About 12% of patients had adverse reactions related to intravenous injection, the most common of which were injection site pain (6.5%) and local inflammatory reaction (3.1%).

In clinical trials of patients with pelvic inflammatory disease, adult female patients were treated with intravenous/oral preparation of Histamine [sup] [/sup], and the most common adverse reactions related to the treatment were gastrointestinal reactions, including diarrhea (8.5%), nausea (6.6%), vaginitis (2.8%), abdominal pain (1.9%), anorexia (1.9%) In these studies, when azithromycin is combined with metronidazole, the incidence of adverse reactions such as nausea (10.3%), abdominal pain (3.7%), vomiting (2.8%), site reaction, gastritis, dizziness and dyspnea (1.9% in total) is higher.

Other adverse reactions caused by the intravenous/oral multi-dose regimen of sumatrix [sup] [/sup] did not exceed 1%.Adverse reactions with an incidence of less than 1% include:

Gastrointestinal reaction: indigestion, abdominal distension, mucositis, oral candidiasis and gastritis.

Nervous system: headache, lethargy.

Allergic reaction: bronchospasm.

Special sensation: abnormal taste.

Experience of post-marketing application:

Oral azithromycin preparation has been applied to adult and/or child patients after marketing. The following adverse events have been reported, but it is not certain whether it is caused by azithromycin:

Allergic reaction: arthralgia, edema, urticaria, angioneurotic edema.

Cardiovascular: Arrhythmias include ventricular tachycardia and hypotension.

Gastrointestinal tract: anorexia, constipation, indigestion, abdominal distension, vomiting/diarrhea but rarely cause dehydration, pseudomembranous enteritis, pancreatitis, oral candidiasis and rare tongue discoloration.

Systemic reaction: fatigue, paresthesia and allergy (life threatening is rare).

Genital system: interstitial nephritis, acute renal insufficiency, candidiasis, vaginitis.

Hematopoietic system: thrombocytopenia.

Liver/gallbladder: Liver dysfunction includes hepatitis and cholestatic jaundice, as well as hepatocyte necrosis and liver failure, some cases of which may be fatal.

Nervous system: convulsion, dizziness/vertigo, headache, lethargy, hyperactivity, nervousness and mental excitement.

Spirit: Aggressive reaction and anxiety.

Skin accessories: pruritus, severe skin reactions including erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis are rare.

Special sensation: Hearing impairment includes hearing loss, deafness and/or tinnitus, with occasional reports of abnormal taste.

Abnormal laboratory inspection:

Laboratory examination of significant abnormalities seen in clinical trials (whether related to drugs or not) are:

Incidence rate was 4-6%: ALT (SGPT), AST (SGOT) and creatinine increased.

Incidence rate is 1-3%: LDH and bilirubin increase.

The incidence rate is less than 1%: leukopenia, thrombocytopenia, and elevated serum alkaline phosphatase.

Follow-up showed that the above laboratory abnormalities were reversible.

In more than 750 clinical trials of intravenous/oral multi-dose administration of this drug, no more than 2% of patients stopped using azithromycin for the treatment of drug-related liver enzyme abnormalities.

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