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Azithromycin (Azithromycin)

Trade Name : Azithromycin

Sandoz Inc

TABLET, FILM COATED

Strength 250 mg/1

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 Sandoz Inc. It is available in strength of 250 mg/1 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

Packaging and Delivery

Validated Cold Chain Shipment

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.

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About GNH

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 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
  • Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
  • Limitation of Use:
  • Azithromycin tablets 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. ()
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. ()
  • 1.1n- 1.2
  • 1.1n- 1.2
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  • Azithromycin tablets, USP 250 mg (debossed GG D6 on one side and plain on the reverse side) are supplied as white, oval-shaped, unscored, film-coated tablets.
  • Azithromycin tablets, USP 500 mg (debossed GG D8 on one side and plain on the reverse side) are white, oval-shaped, unscored, film-coated tablets.
  • u2022
  • 3
  • No data
  • No data
  • torsades de pointesn- torsades de pointes
  • Clostridium difficile
  • 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n
  • No data
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  • torsades de pointes
  • 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 tablets, USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (234581011121314)u2011 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]-1u2011oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is CHNO, and its molecular weight is 749. Azithromycin has the following structural formula:
  • Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of CHNOu2022HO and a molecular weight of 767.
  • Each azithromycin tablet, intended for oral administration, contains azithromycin monohydrate equivalent to either 250 mg or 500 mg of azithromycin. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and xanthan gum.
  • No data
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  • Azithromycin tablets, USP, equivalent to 250 mg azithromycin, are white, oval-shaped, unscored, film-coated tablets, debossed GG D6 on one side and plain on the reverse side, and are supplied as follows:
  • NDC 0781-5776-31 in bottles of 30 tablets
  • NDC 0781-5776-69 Unit Dose Package of 50 tablets
  • NDC 0781-5776-26 Package of 6 unit-of-use blisters
  • Azithromycin tablets, USP, equivalent to 500 mg azithromycin, are white, oval-shaped, unscored, film-coated tablets, debossed GG D8 on one side and plain on the reverse side, and are supplied as follows:
  • NDC 0781-5789-31 in bottles of 30 tablets
  • NDC 0781-5789-03 Package of 3 unit-of-use blisters
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Dispense in a tight container.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • General Patient Counseling
  • Azithromycin tablets 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.
  • Read this Patient Information leaflet before you start taking azithromycin 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?
  • Azithromycin 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 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 is not for viral infections such as the common cold.
  • It is not known if azithromycin is safe and effective for genital ulcers in women.
  • It is not known if azithromycin 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 is safe and effective for infected throat or tonsils in children under 2 years of age.
  • Who should not take azithromycin?
  • Do not take azithromycin if you:
  • What should I tell my healthcare provider before taking azithromycin?
  • Before you take azithromycin, tell your healthcare provider if you:
  • Contact your healthcare provider immediately if you are giving azithromycin 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 and other medicines may affect each other causing side effects. Azithromycin may affect the way other medicines work, and other medicines may affect how azithromycin 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?
  • What are the possible side effects of azithromycin?
  • Azithromycin can cause serious side effects, including:
  • These are not all the possible side effects of azithromycin. 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?
  • Keep azithromycin and all medicines out of the reach of children.
  • General information about the safe and effective use of azithromycin.
  • Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use azithromycin for a condition for which it was not prescribed. Do not give azithromycin 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. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azithromycin that is written for health professionals.
  • What are the ingredients in azithromycin tablets?
  • Active ingredient: azithromycin monohydrate
  • Inactive ingredients: colloidal silicon dioxide, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide and xanthan gum.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • For Patient Information sheets, please call 1-800-507-2130.
  • Manufactured in Romania by S.C. Sandoz S.R.L. for
  • Sandoz Inc., Princeton, NJ 08540
  • Rev. April 2019
  • 8125
  • NDC 0781-5776-31
  • Azithromycin
  • Tablets, USP
  • 250 mg
  • Rx Only
  • 30 Tablets
  • SANDOZ
  • NDC 0781-5789-31
  • Azithromycin
  • Tablets, USP
  • 500 mg
  • Rx only
  • 30 Tablets
  • SANDOZ

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