Azithromycin (Azithromycin)

Trade Name : Azithromycin

Teva Pharmaceuticals USA, Inc.

POWDER, FOR SUSPENSION

Strength 200 mg/5mL

AZITHROMYCIN MONOHYDRATE Macrolide Antimicrobial [EPC],Macrolides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azithromycin (Azithromycin) which is also known as Azithromycin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 200 mg/5mL per ml. Read more

Azithromycin (Azithromycin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Azithromycin for oral suspension is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications n n
  • Azithromycin for oral suspension is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
  • Limitation of Use:
  • Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. ()
  • 1.4
  • 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 patientsu00a0(6 months of age and older) ()
  • Community-acquired pneumonia in adults and pediatric patientsu00a0(6 months of age and older) (, )
  • Pharyngitis/tonsillitis in adults and pediatric patientsu00a0(2 years of age and older) (, )
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  • Azithromycin For Oral Suspension USP after constitution contains a flavored suspension.
  • Azithromycin For Oral Suspension USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles.
  • Azithromycin for oral suspension 100 mg/5 mL and 200 mg/5 mL ()
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  • Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. (4.1)
  • Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. ()
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  • Serious (including fatal) allergic and skin reactions: Discontinue azithromycin if reaction occurs. (5.1)
  • Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. ()
  • Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. ()
  • 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 of torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. ()
  • Clostridium difficile
  • Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis. ()
  • Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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  • Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. (7.1)
  • Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. ()
  • No data
  • Pediatric use: Safety and effectiveness in the treatment of patients under 6 months of age have not been established. ()
  • Geriatric use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. ()
  • Adverse reactions experienced at higher than recommended doses were similar to those seen at normal doses particularly nausea, diarrhea, and vomiting. In the event of overdosage, general symptomatic and supportive measures are indicated as required.
  • Azithromycin For Oral Suspension USP contains the active ingredient azithromycin, USP, a macrolide antibacterial drug, for oral administration. Azithromycin, USP has the chemical name (2,3,4,5,8,10,11,12,13,14)-13-[(2,6-dideoxy-3--methyl-3--methyl-u03b1-L--hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-u03b2-D--hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin, USP is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
  • Azithromycin, USP has the following structural formula:
  • CHNOM.W. 749
  • Azithromycin, USP, as the monohydrate, is a white crystalline powder with a molecular formula of CHNOu2022HO and a molecular weight of 767.
  • Azithromycin For Oral Suspension USP is supplied in bottles containing azithromycin monohydrate powder equivalent to 300 mg, 600 mg, 900 mg or 1200 mg azithromycin, USP per bottle and the following inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin, USP.
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  • Azithromycin For Oral Suspension USP after constitution contains a flavored pink suspension. Azithromycin For Oral Suspension USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows:
  • [see Dosage and Administration ()]
  • Storage: Store dry powder at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • PROTECT FROM FREEZING.
  • Store constituted suspension between 5u00b0 to 25u00b0C (41u00b0 to 77u00b0F) and discard when full dosing is completed.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • General Patient Counseling
  • Azithromycin tablets and oral suspension can be taken with or without food.
  • Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.
  • The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.
  • Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.
  • Patients should be counseled that antibacterial drugs including azithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When azithromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by azithromycin or other antibacterial drugs in the future.
  • Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
  • Manufactured In Croatia By:n Zagreb, Croatia
  • Manufactured For:n North Wales, PA 19454
  • Rev. L 4/2019
  • Azithromycin (ay zithu2033 roe myeu2032 sin)
  • For Oral Suspension
  • Read this Patient Information leaflet before you start taking azithromycin for oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • What is azithromycin for oral suspension?
  • Azithromycin for oral suspension is a macrolide antibiotic prescription medicine used in adults 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
  • Azithromycin for oral suspension is also used in children to treat:
  • Azithromycin should not be taken by people who cannot tolerate oral medications because they are very ill or have certain other risk factors including:
  • Azithromycin for oral suspension is not for viral infections such as the common cold.
  • It is not known if azithromycin for oral suspension is safe and effective for genital ulcers in women.
  • It is not known if azithromycin for oral suspension is safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age.
  • It is not known if azithromycin for oral suspension is safe and effective for infected throat or tonsils in children under 2 years of age.
  • Who should not take azithromycin for oral suspension?
  • Do not take azithromycin for oral suspension if you:
  • What should I tell my healthcare provider before taking azithromycin for oral suspension?
  • Before you take azithromycin for oral suspension, tell your healthcare provider if you:
  • Contact your healthcare provider immediately if you are giving azithromycin for oral suspension to a young child (less than 6 weeks of age) and he or she vomits or becomes irritable when fed.
  • Tell your healthcare provider about all the medicines you take,
  • Azithromycin for oral suspension and other medicines may affect each other causing side effects. Azithromycin for oral suspension may affect the way other medicines work, and other medicines may affect how azithromycin for oral suspension works.
  • Especially tell your healthcare provider if you take:
  • Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I take azithromycin for oral suspension?
  • What are the possible side effects of azithromycin for oral suspension?
  • Azithromycin for oral suspension can cause serious side effects, including:
  • Stop taking azithromycin for oral suspension at the first sign of a skin rash and call your healthcare provider.Skin rash may be a sign of a more serious reaction to azithromycin for oral suspension.
  • Stop taking azithromycin for oral suspension and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to azithromycin for oral suspension (a liver problem).
  • These are not all the possible side effects of azithromycin for oral suspension. Tell your healthcare provider about any side effect that bothers you or that does not go away.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store azithromycin for oral suspension?
  • Keep azithromycin for oral suspension and all medicines out of the reach of children.
  • General information about the safe and effective use of azithromycin for oral suspension.
  • Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use azithromycin for oral suspension for a condition for which it was not prescribed. Do not give azithromycin for oral suspension to other people, even if they have the same symptoms you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about azithromycin for oral suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azithromycin for oral suspension that is written for health professionals.
  • For more information, call 1-888-838-2872.
  • What are the ingredients in azithromycin for oral suspension?
  • Active ingredient: azithromycin monohydrate
  • Inactive ingredients: ammonio methacrylate copolymer, banana flavor, cherry flavor, colloidal silicon dioxide, FD&C Red No. 40, hydroxypropyl cellulose, sucrose, tribasic sodium phosphate anhydrous, vanilla flavor, and xanthan gum.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Croatia By:n Zagreb, Croatia
  • Manufactured For:n North Wales, PA 19454
  • Rev. F 4/2019
  • No data
  • No data

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