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Azithromycin (Azithromycin)

Trade Name : Azithromycin

Proficient Rx LP

TABLET, FILM COATED

Strength 250 mg/1

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

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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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 Proficient Rx LP. 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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  • Warnings and Precautions, Hypersensitivity ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 3/2017
  • Warnings and Precautions, Infantile Hypertrophic Pyloric Stenosis ()u00a0u00a0u00a0 2/2017
  • 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 n
  • Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
  • Limitation of Use:
  • 1.1n- 1.2
  • 1.1n- 1.2
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  • Azithromycin Tablets USP, 250 mg are white to off-white, modified capsule shaped, film-coated biconvex tablets, debossed with u201c66u201d on one side and u201cDu201d on other side. These are packaged in bottles and blister packs.n Azithromycin Tablets USP, 500 mg are white to off-white, oval shaped, film-coated biconvex tablets, debossed with u201c67u201d on one side and u201cDu201d on other side. These are packaged in bottles and blister packs.
  • u2022
  • 3
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  • 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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or n
  • 6.1
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  • 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 (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-u03b1-L-ribo-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-xylo-hexopyranosyl]oxy]-1-oxa-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 749.00. Azithromycin has the following structural formula:
  • Azithromycin, as the dihydrate, is a white or almost white powder with a molecular formula of CHNO2HO and a molecular weight of 785.0.n Azithromycin is supplied as tablets containing azithromycin dihydrate USP equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, pregelatinized starch (maize), magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin.
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  • Azithromycin Tablets USP, 250 mg
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  • Azithromycin Tablets USPn- (ay zith'' roe mye' sin)
  • Read this Patient Information leaflet before you start taking azithromycin tablets and each time you get a refill. There may be new information.u00a0 This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • What are azithromycin tablets?
  • Azithromycin tablets are 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 tablets are 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 tablets are not for viral infections such as the common cold.
  • It is not known if azithromycin tablets are safe and effective for genital ulcers in women.
  • It is not known if azithromycin tablets are 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 tablets are safe and effective for infected throat or tonsils in children under 2 years of age.
  • Who should not take azithromycin tablets?
  • Do not take azithromycin tablets if you:
  • What should I tell my healthcare provider before taking azithromycin tablets?
  • Before you take azithromycin tablets, tell your healthcare provider if you:
  • Contact your healthcare provider immediately if you are giving azithromycin tablets to a young child (less than 6 weeks of age) and he or she vomits or becomes irritable when fed.n
  • Tell your healthcare provider about all the medicines you take,
  • Azithromycin tablets and other medicines may affect each other causing side effects.u00a0 Azithromycin tablets may affect the way other medicines work, and other medicines may affect how azithromycin tablets work.
  • Especially tell your healthcare provider if you take:
  • Know the medicines you take.u00a0 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 tablets?
  • What are the possible side effects of azithromycin tablets?
  • Azithromycin tablets can cause serious side effects, including:
  • Stop taking azithromycin tablets 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 tablets.
  • Stop taking azithromycin tablets 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.u00a0 These can be signs of a serious reaction to azithromycin tablets (a liver problem).
  • Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel faint and dizzy.u00a0 Azithromycin tablets may cause a rare heart problem known as prolongation of the QT interval.u00a0 This condition can cause an abnormal heartbeat and can be very dangerous.u00a0 The chances of this happening are higher in people:
  • Certain antibiotics like azithromycin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
  • The most common side effects of azithromycin tablets include:
  • These are not all the possible side effects of azithromycin tablets.u00a0 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.u00a0 You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store azithromycin tablets?
  • Keep azithromycin tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of azithromycin tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use azithromycin tablets for a condition for which it was not prescribed. Do not give azithromycin tablets to other people, even if they have the same symptoms you have. They may harm them.
  • This Patient Information leaflet summarizes the most important information about azithromycin tablets. If you would like more information, talk with your healthcare provider.u00a0 You can ask your pharmacist or healthcare provider for information about azithromycin tablets that is written for health professionals.
  • For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.
  • What are the ingredients in azithromycin tablets?
  • Active ingredient:
  • Inactive ingredients:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Distributed by:n n 279 Princeton-Hightstown RoadEast Windsor, NJ 08520n Manufactured by:n n Hyderabad - 500 038, India
  • Repackaged & Relabeled by:n n Thousand Oaks, CA 91320n Revised:u00a008/2018
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