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Azithromycin (Azithromycin)

Trade Name : Azithromycin

Aidarex Pharmaceuticals LLC

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 Aidarex Pharmaceuticals LLC. 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 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 n
  • Azithromycin tablets are 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 tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strongly suspected to be caused by 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 (, )
  • Pharyngitis/tonsillitis in adults and pediatric patients (, )
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  • Azithromycin tablets USP, 250 mg are supplied as white, oval, biconvex, unscored, film-coated tablets, debossed with u201c787u201d on one side and u201cPLIVAu201d on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin, USP.
  • Azithromycin tablets USP 250 mg and 500 mg ()
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  • Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. ()
  • 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. ()
  • 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 1-866-832-8537 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. ()
  • 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 tablets USP contain 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:
  • CHNO M.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 tablets USP are supplied for oral administration as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin, USP and the following inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide.
  • The 500 mg tablets also contain FD&C blue #2.
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  • Azithromycin tablets USP, 250 mg are supplied as white, oval, biconvex, unscored, film-coated tablets, debossed with u201c787u201d on one side and u201cPLIVAu201d on the other, containing azithromycin monohydrate equivalent to 250 mg of azithromycin, USP.
  • Store at 20u00ba to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • 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.
  • See FDA-approved Patient Labeling
  • Repackaged by:
  • Aidarex Pharmaceuticals, LLC
  • Corona, CA 92880
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. L 4/2017
  • Azithromycin (a ZITH roe MYE sin)
  • Tablets
  • Read this Patient Information leaflet before you start taking azithromycin tablets 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 are azithromycin tablets?
  • Azithromycin tablets are 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 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.
  • Tell your healthcare provider about all the medicines you take,
  • Azithromycin tablets and other medicines may affect each other causing side effects. 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. 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:
  • These are not all the possible side effects of azithromycin tablets. 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 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 they were not prescribed. Do not give azithromycin tablets 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 tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azithromycin tablets that is written for health professionals.
  • For more information, call 1-888-838-2872.
  • What are the ingredients in azithromycin tablets?
  • Active ingredient: azithromycin monohydrate
  • Inactive ingredients: corn starch, dibasic calcium phosphate anhydrous, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium citrate, sodium lauryl sulfate, and titanium dioxide.
  • The 500 mg tablets also contain FD&C blue #2.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Repackaged by:
  • Aidarex Pharmaceuticals, LLC
  • Corona, CA 92880
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. K 2/2017
  • No data

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