Azithromycin Monohydrate (Azasite)

Trade Name : AzaSITE

Akorn, Inc.

SOLUTION/ DROPS

Strength 10 mg/mL

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 Monohydrate (Azasite) which is also known as AzaSITE and Manufactured by Akorn, Inc.. It is available in strength of 10 mg/mL per ml. Read more

Azithromycin Monohydrate (Azasite) 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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About GNH

No data

AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:n
AzaSite is a macrolide antibiotic indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G, group, and ()n

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:n
Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days.n
Instill 1 drop in the affected eye(s) twice daily, eight to twelve hours apart for the first two days and then instill 1 drop in the affected eye(s) once daily for the next five days. ()n

2.5 mL of a 1% sterile topical ophthalmic solution.n
2.5 mL of 1% sterile topical ophthalmic solution. ()n

Hypersensitivity ()n

No data

For topical ophthalmic use only. ()n
Anaphylaxis and hypersensitivity have been reported with systemic use of azithromycin. ()n
Growth of resistant organisms may occur with prolonged use. ()n
Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ()n

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.n
The data described below reflect exposure to AzaSite in 698 patients. The population was between 1 and 87 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction reported in patients receiving AzaSite was eye irritation. This reaction occurred in approximately 1-2% of patients. Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and non-ocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).n
Most common adverse reaction reported in patients was eye irritation (1-2% of patients). ()n

No data

AzaSite (azithromycin ophthalmic solution) is a 1% sterile aqueous topical ophthalmic solution of azithromycin formulated in DuraSite (polycarbophil, edetate disodium, sodium chloride). AzaSite is an off-white, viscous liquid with an osmolality of approximately 290 mOsm/kg.n
Preservative:n- Inactives:
Azithromycin is a macrolide antibiotic with a 15-membered ring. Its chemical name is (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-u03b1-L-ribohexopyranosyl)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-aza-cyclopentadecan-15-one, and the structural formula is:n
Azithromycin has a molecular weight of 749, and its empirical formula is CHNO.n

No data

No data

In a randomized, vehicle-controlled, double-blind, multicenter clinical study in which patients were dosed twice daily for the first two days, then once daily on days 3, 4, and 5, AzaSite solution was superior to vehicle on days 6-7 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis. Clinical resolution was achieved in 63% (82/130) of patients treated with AzaSite versus 50% (74/149) of patients treated with vehicle. The p-value for the comparison was 0.03 and the 95% confidence interval around the 13% (63%-50%) difference was 2% to 25%. The microbiological success rate for the eradication of the baseline pathogens was approximately 88% compared to 66% of patients treated with vehicle (p<0.001, confidence interval around the 22% difference was 13% to 31%). Microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.n

AzaSite is a sterile aqueous topical ophthalmic formulation of 1% azithromycin.n
NDC 17478-307-03: 2.5 mL in 5 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided.n
NDC 17478-307-04: 2.5 mL in 4 mL bottle containing a total of 25 mg of azithromycin in a white, round, low-density polyethylene (LDPE) bottle, with a clear LDPE dropper tip, and a tan colored high density polyethylene (HDPE) eyedropper cap. A white tamper evident over-cap is provided.n
Storage and Handling:
Store unopened bottle under refrigeration at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F). Once the bottle is opened, store at 2u00b0 to 25u00b0C (36u00b0 to 77u00b0F) for up to 14 days. Discard after the 14 days.n

See FDA-Approved Patient Labeling ().n
Patients should be advised to avoid contaminating the applicator tip by allowing it to touch the eye, fingers or other sources.n
Patients should be directed to discontinue use and contact a physician if any signs of an allergic reaction occur.n
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 AzaSite (azithromycin ophthalmic solution) or other antibacterial drugs in the future.n
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.n
Patients should be advised to thoroughly wash hands prior to using AzaSite.n
Patients should be advised to invert the closed bottle (upside down) and shake once before each use. Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s).n
AKORNn n- Akorn, Inc.n
U.S. Patent Nos.: 6,159,458; 6,239,113; 6,569,443; 6,861,411; 7,056,893; and Patents Pendingn
AzaSite is a registered trademark of InSite Vision Inc.n
OPZT00N u00a0 u00a0 u00a0Rev. 06/17n

PATIENT INFORMATION
AzaSiten- Array
(azithromycin ophthalmic solution) 1%n
Read this Patient Information before you start using AzaSite and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.n
What is AzaSite?
AzaSite is a prescription sterile eye drop solution. AzaSite is used to treat bacterial conjunctivitis which is an infection of the eye caused by certain bacteria.n
It is not known if AzaSite is safe and effective in children less than 1 year of age.n
Information about bacterial conjunctivitis.
Bacterial conjunctivitis is a bacterial infection of the mucous membranes which line the inside of the eyelids. Symptoms may include redness of the eye and discharge. The infection can be spread to other people and to both eyes.n
Who should not use AzaSite?
Do not
What should I tell my doctor before using AzaSite?
Before you use AzaSite, tell your doctor if you:
Tell your doctor about all the medicines you take,
Know the medicines you take. Keep a list of them to show your doctors and pharmacist when you get a new medicine.n
How should I use AzaSite?
What should I be aware of while using AzaSite?
Do not
Only your doctor can tell you if you have bacterial conjunctivitis.n
Severe allergic reactions have been reported rarely when azithromycin has been taken by mouth.
Increased risk of other infections caused by bacteria or fungi.
What are the possible side effects of AzaSite?
The most common side effect of AzaSite is eye irritation.n
Other side effects seen with AzaSite include:n
Tell your doctor about any side effect that bothers you or that does not go away.n
These are not all of the possible side effects of AzaSite. For more information, ask your doctor or pharmacist.n
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 AzaSite?
Keep AzaSite and all medicines out of reach of children.
General information about the safe and effective use of AzaSite
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use AzaSite for a condition for which it was not prescribed. Do not give AzaSite to other people, even if they have the same symptoms that you have. It may harm them.n
This Patient Information summarizes the most important information about AzaSite. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about AzaSite that is written for health professionals.n
For more information, go to or call 1-800-932-5676.n
What are the ingredients in AzaSite?
Active ingredient:
Inactive ingredients:

Instructions for Use
AzaSiten- Array
(azithromycin ophthalmic solution) 1%n
Read this Instructions for Use for AzaSite before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.n
Important:
The checklist below tells you when to use your medicine for each eye that has bacterial conjunctivitis:n
This is a total of 9 drops of AzaSite for each infected eye.n
Before using a new bottle of AzaSite:
Wash your hands each time you use AzaSite.
To use AzaSite:
Step 1. Turn the closed bottle upside down. n
Step 2.n- See n
Step 3. Hold the bottle upside down and take off the tan cap. n
Step 4. Hold the bottle over your eye and gently squeeze the bottle to let 1 drop into each eye that has bacterial conjunctivitis. Put the tan cap back on the bottle and close tightly. n
If a drop does not come out of the bottle, repeat steps one to four.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.
AKORNn n- Akorn, Inc.n
U.S. Patent Nos.: 6,159,458; 6,239,113; 6,569,443; 6,861,411; 7,056,893; and Patents Pendingn
AzaSite is a registered trademark of InSite Vision Inc.n
OPZTA0N Rev. 06/17n

Principal Display Panel Text for Container Label:n
NDC 17478-307-03n
AzaSITEn
(azithromycin ophthalmic solution) 1%n
Rx Only Sterile 2.5 mLn

Principal Display Panel Text for Carton Label:n
NDC 17478-307-03n
AzaSITEn
(azithromycin ophthalmic solution) 1%n
Sterile 2.5 mLn
Rx Onlyn
FOR OPHTHALMIC USE ONLYn

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Azithromycin Monohydrate (Azasite)

Trade Name : AzaSITE

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Azithromycin Monohydrate (Azasite)

Trade Name : AzaSITE

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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Can’t find what you’re looking for?

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