Azithromycin Tablets IP 500 mg | Azifon-500 tablet

Darshan Singh
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Azithromycin Tablets IP 500 mg | Azifon-500 tablet 

Introduction: 

Azithromycin tablets are antibiotics that contain Azithromycin Dihydrate IP equivalent to Azithromycin 500mg in each tablet. Generally, Azithromycin tablets are used to treat bacterial infections of the nose, throat infections, and tonsils. It is also used in the treatment of ear infections. Lung infections can also be cured by Azithromycin. 

Azithromycin blocks the further formation of proteins that is required for bacterial growth. Therefore, it can stop the further growth of bacteria and their multiplication. 

Azithromycin Tablets IP 500 mg are manufactured according to the parameters given in Indian Pharmacopeia (IP). The word "IP" denotes here that this product is manufactured according to the IP monograph, and the product's quality parameters should comply with IP. 
According to IP 2010 Vol-II, Page no. 861, "Azithromycin Tablets contain not less than 90.0 percent and not more than 110.0 percent of the stated amount of azithromycin, C38H72N2Ol2,"

In this article, we are providing information only for knowledge not for medical advice or diagnostic purpose. For medical advice and the use of Azithromycin tablets, you should consult with a doctor. Here, we will cover all pharmaceutical concepts of Azithromycin tablets. 



Azithromycin Tablets IP 500 mg | Azifon-500 tablet

Understanding Azithromycin

To understand Azithromycin as a drug we have to go through the history and the development phase of Azithromycin

History and Development of Azithromycin

Azithromycin was discovered by Pliva Pharmaceutical company headquartered in Zagreb in 1980.  It was approved in 1988 for medical use under the brand name Sumamed

In starting, its developing company Pliva got a patent in Yugoslavia in 1981. After some time US drug manufacturer, Pfizer done an agreement with Pliva for sale in the United States and worldwide except in Central and East Europe. 

Pfizer sold Azithromycin under its own brand Zithromax. It was the best-selling branded antibiotic in the US and worldwide. In 2005. the total sales of Zithromax reached US$ 2 billion. 

Mechanism of action of Azithromycin tablet

Azithromycin is an azalide macrolide antibiotic. It decreases the production of the protein that is responsible for bacterial growth in infections. As it stops the protein production, the further growth of bacteria stops.[3

Different forms and Strengths available

Azithromycin is available in various forms and strengths. It is available as tablets of Azithromycin Tablets IP 250 mg and Azithromycin Tablets IP 500 mg

Oral suspension of 100 mg or 200 mg per 5 mL for pediatric use, and injection of 500 mg in a 10 mL vial is also available.


Azithromycin Tablets IP 500 mg

Azithromycin tablets IP 500mg comes under the brand name Azifon-500. This is available in a blister pack in a mono carton with a drip-off outer box. It is manufactured by WHO-GMP certified company to meet all compliances made in the IP monograph

Azithromycin Tablets IP 500mg Uses:

Azithromycin tablets IP 500mg i.e. Azifon-500 is an antibiotic commonly used in the treatment of a large number of bacterial infections. The most common are:-
  • Middle ear infections
  • Strep throat
  • Pneumonia
  • Diarrhea
  • Intestinal disorders
  • Respiratory tract infections [4
  • Skin and soft tissue infections

Azifon-500 is also used in sexually transmitted infections, chlamydia, and gonorrhea infections commonly in the summer season.

Side effects of Azithromycin Tablets 500 mg:

This medication has some side effects which may be nausea, vomiting, diarrhea, and stomach pain. It may have some allergic reactions such as anaphylaxis and QT prolongation. [7]

Dosage and Administration

It is highly recommended to consult your doctor before taking any medicine including Azithromycin. You should let your doctor decide the dose and method of administration. The dosage of Azithromycin may vary as per the type of infection being treated. The dosage and administration of azithromycin can vary depending on the type of infection being treated. 

The prescribed dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia is a single dose by the intravenous route for a minimum of two days.[5]

For oral use tablets and suspension, the recommended dose is 500mg per day for 3 to 10 days for adult patients. The dose may be lower as your doctor prescribes depends on the age of the patient (Children) [6

Safety and Precautions

Drug interaction with Azithromycin tablet:

Azifon-500 may have interactions with dronedarone, hydroxychloroquine, ibutilide, pimozide, procainamide, quinidine, sotalol, disopyramide, dofetilide, amiodarone and chloroquine.

Special considerations for certain patient groups:

The dose of Azithromycin will be changed if the patient has any kidney disease. Tell your doctor if you have any kidney-related problems, and your doctor will decide on a new dose keeping in mind your kidney status. 

Pregnancy and breastfeeding:

There are some Clinical trials where some data found that if a woman takes Azithromycin, some traces of azithromycin passes into the breast milk. However, it is a very low quantity that passes to milk and reaches breastfeeding babies. But you must tell your doctor that you are a breastfeeding mother before taking the Azithromycin tablet.
Similarly, ask your doctor if you are a pregnant woman before taking Azithromycin.


Pharmacokinetics of Azithromycin

Azithromycin is an acid-stable antibiotic. When it is taken orally no need for protection from gastric acid problems. It is readily absorbed after meals, but on an empty stomach, the absorption of this drug is more excellent. Time to peak concentration (Tmax) in adults is 2.1 to 3.2 hours for oral dosage forms of Azithromycin.

SHORT DESCRIPTION

AZITHROMYCIN TABLETS IP

BRAND NAME: AZIFON-500

DOSAGE FORM: TABLETS

COMPOSITION:

Each film-coated tablet contains:

Azithromycin IP eq. to Azithromycin (Anhydrous) 500mg

PACKING: 10*1*3 BLISTER

MRP: 71.34/-

Azithromycin tablets IP 500mg price

In India, Azithromycin tablets are covered under DPCO 2013, as per NPPA current ceiling price of Azithromycin tablets IP 500 mg is Rs. 23.56/- per tablet. The GST is extra in this price. After adding GST the maximum allowed MRP is 26.38 per tablet. 


ALSO AVAILABLE:

AZIFON-250 (Azithromycin tablets IP 250mg)

Ceffon-200 Tablet (Cefixime 200 mg and Lactic Acid Bacillus Tablets)

Pantafon-40 Inj. (Pantoprazole Soium 40 mg Inj. )

Pantafon-DSR Capsules (Pantoprazole 40mg+Domperidone 10 mg tablets)


References:

  1. Azithromycin Tablets, IP 2010 Vol-II, Page no. 861, 
  2. Azithromycin: A world best-selling Antibiotic [WIPO]
  3. Azithromycin - Mechanism of Action [National Library of Medicines -NIH]
  4. Azithromycin in lower respiratory tract infections: Review-Scand J Infect Dis Suppl- 1992;83:26-33. [Pubmed]
  5. Azithromycin dosage and administration; by C. Michael Gibson, M.S., M.D. [Wikidoc.org]
  6. How and when to take azithromycin [NHS(.uk)]
  7. 6 Side Effects of Azithromycin You Should Know About [GOODRx Health]

Disclaimer:

Disclaimer: All the information and articles available on this site are for educational purposes only. The information given here should not be used for the diagnosis or treatment of any health problem or disease without expert advice. The advice of a qualified medical practitioner should always be sought for medical examination and treatment.


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