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Azithromycin (Azithromycin Dihydrate)

Trade Name : Azithromycin Dihydrate

Major Pharmaceuticals

TABLET, FILM COATED

Strength 250 mg/1

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

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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Disclaimer

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 Dihydrate) which is also known as Azithromycin Dihydrate and Manufactured by Major Pharmaceuticals. It is available in strength of 250 mg/1 per ml. Read more

Azithromycin (Azithromycin Dihydrate) 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 () 02/2016
  • 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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • Azithromycin tablets, are 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.
  • u00a0
  • Azithromycin 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. ()
  • 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 are supplied as white, oval, biconvex film coated tablets engraved u201cAPOu201d on one side and u201cAZ250u201d on the other side.
  • Azithromycin Tablets, USP 500 mg are supplied as white, oval, biconvex film coated tablets engraved u201cAPOu201d on one side and u201cAZ500u201d on the other side.
  • u00a0
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  • Clostridiumu00a0difficile
  • 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 Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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  • Adverseu00a0reactionsu00a0experiencedu00a0atu00a0higheru00a0thanu00a0recommendedu00a0dosesu00a0wereu00a0similaru00a0tou00a0thoseu00a0seenu00a0atu00a0normalu00a0dosesu00a0particularlyu00a0nausea,u00a0diarrhea, 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 ()-u201113-[(2,6-dideoxy-3--methyl-3--methyl-u03b1--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 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 dihydrate, is a white to almost white crystalline powder, with a molecular formula of CHNOu20222HO and a molecular weight of 785.02. u00a0
  • Azithromycin tablets, USP are supplied for oral administration as film-coated, white, oval, biconvex tabletsu00a0 containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate and Opadry II white (Opadry II white contains the following components: hypromellose, lactose monohydrate, titanium dioxide and triacetin).
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  • Azithromycin Tablets, USP 250 mg are supplied as white, oval, biconvex film coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin.u00a0
  • Azithromycin Tablets, USP 250 mg are engraved u201cAPOu201d on one side and u201cAZ250u201d on the other side. These are packaged in bottles and blister cards of 6 tablets as follows:
  • Carton of 50 tablets (10 tablets each blister pack x 5) , NDC 0904-6405-06
  • Carton of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6405-61
  • Storage: Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted from 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature].
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  • Azithromycin Tablets
  • Read this Patientu00a0Informationu00a0leafletu00a0before youu00a0startu00a0takingu00a0azithromycin tablets andu00a0each time youu00a0getu00a0au00a0refill.u00a0There mayu00a0be newu00a0information.u00a0This informationu00a0does notu00a0take the place ofu00a0talkingu00a0tou00a0youru00a0healthcare provideru00a0aboutu00a0youru00a0medicalu00a0conditionu00a0oru00a0youru00a0treatment.
  • What aren- azithromycin tablets?
  • Azithromycin tabletsareu00a0au00a0macrolide antibioticu00a0prescriptionu00a0medicine usedu00a0inu00a0adults 18u00a0years oru00a0olderu00a0tou00a0treatu00a0certainu00a0infections causedu00a0byu00a0certainu00a0germs calledu00a0bacteria.u00a0These bacterialu00a0infectionsu00a0include:
  • Azithromycintablets are also used in childrenu00a0to treat:
  • Azithromycinu00a0shouldu00a0notu00a0be takenu00a0byu00a0peopleu00a0who cannotu00a0tolerateu00a0oralu00a0medications because theyu00a0are veryu00a0illu00a0oru00a0have certainu00a0otheru00a0risku00a0factors including:
  • Azithromycintablets are notu00a0foru00a0viralu00a0infections suchu00a0as the commonu00a0cold.
  • It is notu00a0knownu00a0ifu00a0azithromycintablets are safe andu00a0effective foru00a0genitalu00a0ulcers in women.
  • It is notu00a0knownu00a0if azithromycintablets are safe andu00a0effective foru00a0childrenu00a0withu00a0earu00a0infections,u00a0sinusu00a0infections,u00a0andu00a0community-acquiredu00a0pneumoniau00a0underu00a06 monthsu00a0ofu00a0age.
  • It is notu00a0knownu00a0ifu00a0azithromycintablets are safe andu00a0effective foru00a0infectedu00a0throatu00a0oru00a0tonsilsu00a0in childrenu00a0underu00a02u00a0years ofu00a0age.
  • Whou00a0shouldu00a0not takeu00a0azithromycin tablets?
  • Dou00a0not takeu00a0azithromycin tablets if you:
  • Whatu00a0shouldu00a0Iu00a0tellu00a0my healthcareu00a0provider beforeu00a0takingu00a0azithromycin tablets?
  • Beforeu00a0youn- takeu00a0azithromycin tablets,u00a0tellu00a0youru00a0healthcareu00a0provideru00a0if you:
  • Tellu00a0youru00a0healthcareu00a0provider about all theu00a0medicinesu00a0youu00a0take,u00a0
  • Azithromycin tablets andu00a0otheru00a0medicines mayu00a0affectu00a0eachu00a0otheru00a0causingu00a0side effects. Azithromycin tablets mayu00a0affectu00a0the wayu00a0otheru00a0medicines work,u00a0andu00a0otheru00a0medicines mayu00a0affectu00a0howu00a0azithromycin tablets work.
  • Especiallyu00a0tellu00a0youru00a0healthcare provideru00a0if youu00a0take:
  • Knowu00a0the medicinesu00a0youu00a0take.u00a0Keepu00a0au00a0listu00a0ofu00a0youru00a0medicines andu00a0show it to youru00a0healthcareu00a0provideru00a0andu00a0pharmacistu00a0whenu00a0youu00a0getu00a0au00a0newu00a0medicine.
  • Howu00a0shouldn- Iu00a0takeu00a0azithromycin tablets?
  • What aren- then- possibleu00a0sideu00a0effectsu00a0of azithromycin tablets?
  • Azithromycin tablets canu00a0causeu00a0seriousu00a0sideu00a0effects, including:
  • Stopu00a0takingu00a0azithromycin tablets atu00a0the firstu00a0signu00a0ofu00a0au00a0skinu00a0rashu00a0andu00a0callu00a0youru00a0healthcare provider.u00a0Skinu00a0rashu00a0mayu00a0be au00a0signu00a0ofu00a0au00a0more serious reactionu00a0to 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. These can be signs of a serious reaction to azithromycin tablets (a liver problem).
  • The mostu00a0commonu00a0side effects ofu00a0azithromycin tablets include:
  • These are notu00a0allu00a0theu00a0possible side effects ofu00a0azithromycin tablets. Tellu00a0your healthcare provideru00a0aboutu00a0anyu00a0side effectu00a0thatu00a0bothers youu00a0oru00a0thatu00a0does notu00a0go away.
  • Callu00a0youru00a0doctoru00a0foru00a0medicalu00a0advice aboutu00a0side effects. Youu00a0mayu00a0reportu00a0side effects to FDA at 1-800-FDA-1088.
  • Howu00a0shouldu00a0Iu00a0storeu00a0azithromycin tablets?
  • Keepu00a0azithromycin tablets and all medicinesu00a0out of the reachu00a0of children.
  • Generalu00a0informationu00a0about theu00a0safe and effectiveu00a0useu00a0of azithromycin tablets.
  • Medicines are sometimes prescribedu00a0foru00a0purposes otheru00a0thanu00a0those listedu00a0in the Patientu00a0Informationu00a0leaflet. Do notu00a0use azithromycin tablets foru00a0au00a0conditionu00a0foru00a0whichu00a0itu00a0was notu00a0prescribed.u00a0Do not giveu00a0azithromycin tablets to otheru00a0people,u00a0even ifu00a0theyu00a0have the same symptoms youu00a0have.u00a0Itu00a0mayu00a0harmu00a0them.
  • This Patientu00a0Informationu00a0leafletu00a0summarizes the mostu00a0importantu00a0informationu00a0aboutu00a0azithromycin tablets.u00a0Ifu00a0youu00a0wouldu00a0like more information,u00a0talku00a0withu00a0youru00a0healthcare provider. You canu00a0asku00a0youru00a0pharmacistu00a0oru00a0healthcare provideru00a0foru00a0informationu00a0aboutu00a0azithromycin tablets that is writtenu00a0for healthu00a0professionals.
  • For more information, go to or call 1-800-706-5575.
  • What areu00a0theu00a0ingredientsu00a0inu00a0azithromycin tablets?
  • Activeu00a0ingredient: azithromycinu00a0dihydrate
  • Inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate and Opadry II white (Opadry II white contains the following components: hypromellose, lactose monohydrate, titanium dioxide and triacetin).
  • Thisu00a0Patientu00a0Informationu00a0hasu00a0beenu00a0approvedu00a0by theu00a0U.S.u00a0Foodu00a0andu00a0Drugu00a0Administration.
  • APOTEX CORP.n- AZITHROMYCIN TABLETS, USPn- 250 mg and 500 mg
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152
  • Revised: July 2016Rev. 13a
  • Azithromycin Tablets, USP
  • 250 mg
  • 50 Tablets

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