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Azithromycin Tablets 250MG 500MG Antibiotic Medicines BP / USP

Azithromycin Tablets 250MG 500MG Antibiotic Medicines BP / USP

Brand Name : ZMC/SENA
Model Number : 250MG 500MG
Certification : GMP
Place of Origin : China
MOQ : 200,000 tablets
Price : Negotiation
Payment Terms : T/T, L/C, D/A, Western Union
Supply Ability : 10,000,000 tablets per month
Delivery Time : Negotiation
Packaging Details : 3*1TABLETS/BOX*200/CATON
Product Name : Azithromycin Tablets
Composition : Each tablet contains:Azithromycin 250MG/500MG
Standard : BP/USP
Package : 3*1TABLETS/BOX*200/CATON
Indications : A macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria
Storage Instructions : Store below 25℃,Protect from light
Expiration Date : 3 Years
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Azithromycin Tablets 500MG

COMPOSITION.
Each Azithromycin Tablets contains azithromycin 500mg.


PHARMACOLOGICAL ACTION:

Based on animal models of infection, the antibacterial activity of azithromycin appears to correlate with the ratio of area under the concentration- time curve to minimum inhibitory concentration (AUC/MIC) for certain pathogens (S. pneumoniae and S. aureus). The principal pharmacokinetic/pharmacodynamic parameter best associated with clinical and microbiological cure has not been elucidated in clinical trials with azithromycin.


INDICATIONS:

Zithromax is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:

Acute bacterial exacerbations of chronic bronchitis in adults

Acute bacterial sinusitis in adults

Uncomplicated skin and skin structure infections in adults

Urethritis and cervicitis in adults

Genital ulcer disease in men

Acute otitis media in pediatric patients

Community-acquired pneumonia in adults and pediatric patients


CONTRA-INDICATIONS:

Patients with known hypersensitivity to azithromycin,erythromycin,any other macrolide or ketolide antibiotic,or to any component of the product.


WARNINGS:

Serious (including fatal) allergic and skin reactions: Discontinue azithromycin if reaction occurs.

Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported, Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.

Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval.

Clostridium difficile-associated diarrhea: Evaluate patients if diarrhea occurs.

Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis.

Azithromycin has been reported to be excreted in human breast milk in small amounts. Caution should be exercised when azithromycin is administered to a nursing woman.


DOSAGE AND DIRECTIONS FOR USE:

Adult Patients

Infection

Recommended Dose/Duration of Therapy

Community- acquired pneumonia (mild severity)

Pharyngitis/ tonsillitis (second-line therapy) Skin/skin structure(uncomplicated)

500 mg as a single dose on Day 1,

followed by 250 mg once daily on Days 2 through 5.

Acute bacterial exacerbations of chronic bronchitis

(mild to moderate)

500 mg as a single dose on Day 1,

followed by 250 mg once daily on Days 2 through 5

or 500 mg once daily for 3 days.

Acute bacterial sinusitis

500 mg once daily for 3 days.

Genital ulcer disease (chancroid) Non-gonococcal urethritis and cervicitis

One single 1 gram dose.

Gonococcal urethritis and cervicitis

One single 2 gram dose.


Pediatric Patients

Infection

Recommended Dose/Duration of Therapy


Acute otitis media

30 mg/kg as a single dose or 10 mg/kg once daily for 3 days

or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day

on days 2 through 5.

Acute bacterial sinusitis

10 mg/kg once daily for 3 days.

Community-acquired pneumonia

10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily

on Days 2 through 5.

Pharyngitis/tonsillitis

12 mg/kg once daily for 5 days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal system with diarrhea/loose stools (4 to 5%), nausea (3%), and abdominal pain (2 to 3%) being the most frequently reported.

Adverse reactions that occurred with a frequency of 1% or less included the following:

Cardiovascular: Palpitations, chest pain. Gastrointestinal: Dyspepsia, flatulence, vomiting, melena, and cholestatic jaundice. Genitourinary: Monilia, vaginitis, and nephritis. Nervous System: Dizziness, headache, vertigo, and somnolence. General: Fatigue. Allergic: Rash, pruritus, photosensitivity, and angioedema.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Keep out of reach of children.



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