Azirox® 500mg
Broad Spectrum & long Acting
  • Azithromycin is an antibiotic, which belongs to a group of medicines called Azalides, which are a subclass of a group of antibiotics called macrolides. It acts by binding to the 50S ribosomal subunit of susceptible organisms and thus inhibiting microbial protein synthesis.
  • Azithromycin has a broad antibacterial spectrum, and following oral administration, Azithromycin is readily and rapidly absorbed and widely distributed throughout the body, and the peak plasma levels are reached approximately in 2- 3 hours, since food decreases the absorption of drug, Azithromycin should not be taken with food. Pharmacokinetic studies have shown higher Azithromycin levels in the tissue than in plasma (up to 50 times) that was confirmed by examination of following tissues such as lung, tonsil, bone, prostate, ovary, uterus, stomach, liver and gallbladder.                              
  • Azithromycin bioavailability is 37 %. Biliary excretion of Azithromycin, predominantly as unchanged drug, is a major route of elimination, plasma terminal elimination half life is 2- 4 days.
  • Azithromycin  has been shown to be active against many Gram-positive and Gram-negative microorganisms, as well as other organisms including Mycoplasma pneumonia and Chlamydia pneumonia.

Each Capsule of  Azirox®  500  mg  contains: 

  • Azithromycin 500 mg  (as Azithromycin  dihydrate)

Each Capsule of  Azirox®  250 mg  contains: 

  • Azithromycin 250 mg  (as Azithromycin  dihydrate )

Each 5 ml of  Azirox®  200  mg  for oral suspension contains: 

  • Azithromycin 200 mg (as Azithromycin   dihydrate ).

¤ Azirox® is indicated for the treatment of moderate infections caused by susceptible strains of  microorganisms in the specific conditions listed below: 

  • Acute bacterial sinusitis and Acute otitis media.
  •  Acute bacterial exacerbations of chronic obstructive pulmonary disease: due to Heamophilus influenzae, Moraxella catarrhalis or Streptococcus pneumonia.
  • Acute community pneumonia :due to Mycoplasma  pneumonia, Chlamydia pneumonia, Heamophilus influenza or Streptococcus pneumonia in patients appropriate for oral therapy.
  • Pharyngitis, tonsillitis: caused by Streptococcus pyogenes as an alternative to first –line therapy in individuals who can not use first –line therapy.( penicillin by IM).
  • Uncomplicated skin and skin structure infections: due to Staphylococcus aureas, Streptococcuspyogenes, or Streptococcus agalactiae.
  • Urethritis and cervicitis: due to Chlamydia trachomatis or Neisseria gonorrhoe.
  • Genital ulcer disease in men: due to Heamophilus ducreyl (chancroid).
  • Odontostomatological infections.
  • Azirox® is contraindicated in patient with known hypersensitivity to Azithromycin or any of macrolide antibiotic.
  • Azirox® should not be used in hepatic disease.
  • Azirox® and ergot derivatives should not be Co-administered.
  • Patients should be cautioned not to take aluminum and magnesium containing antacids and Azirox® simultaneously. Only take it one hour before or two hour after Azirox® dose.
  • The prothrombin time should be monitored in all patients administrated with Azirox® and warfarin concomitantly.
  • The plasma theophylline levels should be monitored in patients receiving Azirox® and theophylline concomitantly.
  • Some drugs may interfere with Azithromycin when these drugs are used concomitantly (digoxin, triazolam, phenytoin, carbamazepine, terfenadine or astemizole, lomotil and ergot derivatives ).
  • No clinically significant interactions have been observed between Azirox® and theophyllin, methylprednisolone or carbamazepine; however, with other macrolides interactions were observed.
  • Azirox® should not be used during pregnancy or lactation. Where adequate alternatives are not available, only the doctor determine if it is used or not.

Common  Side Effects

  • Stomach upset, stomach cramps, feeling or being sick or diarrhea.

Uncommon  Side Effects 

  • Loss of appetite or taste disturbances, loose stools, wind or indigestion, soreness or itching of the vagina, skin rash and/or itching, joint pains, dizziness, fatigue, headache, sleepiness, or fainting.

Rare  Serious  Side Effects 

  • Numbness or spins and needles, skin more sensitive to light than normal, sever skin rash causing redness and flaking, fast or irregular heartbeat, low blood pressure, constipation, inflammation of the bowel, tiredness or weakness, tongue discoloration, yeast infection of the mouth and vagina (thrush), pancreatitis, hepatitis and changes in liver enzymes, inflammation of kidney or kidney failure,  jaundice or liver failure, feeling nervous, angry, irritable or anxious, insomnia, feeling hyperactive, poor hearing, temporary deafness or ringing in the ears, and reductions in white blood cells, bruising or prolonged bleeding after injury.

Very  rare and  can be severe Side effects:

  • Sudden wheezing, difficulty in breathing, swelling of eyelids, face or lips, rash or itching of whole body. 

¤ Each dose should be taken at least 1 hour before or 2 hours after the main meals.

In adult and elderly: 

  • The recommended dose of Azirox® for treatment of individual 16 years  and older is (one capsule 500 mg) as a single dose daily for 3 days, or 500 mg initially followed by 250 mg daily for 4 days.

Sexually transmitted disease:

  • 1 g taken as (as a single oral dose)

In Children:

  • The usual dose for children is 10 mg /kg as a single daily dose for 3 days,
  • The usual dose for children is 10 mg /kg as a single daily dose for 3 days, Azirox® suspension should be administered by using the standard spoon According to the body weight (known that the duration of the therapeutic is 3 days).
  • Or as directed by the physician.
  • The patient should be directed to discontinue Azirox® immediately and contact a physician if any sign of an allergic reactions occu.
  • Tell your doctor before you start taking Azirox® if you have any health problem, including: liver, kidney, heart, diabetes, hereditary fructose intolerance, glucose –galactose mal-absorption or saccharine–isomaltase deficiency and cystic fibrosis.
  • Also tell your doctor if there is pregnancy or lactation or planning for pregnancy.
  • If you get a sore, white mouth, or tongue, vaginal itching or discharge after stopping Azirox®, tell  your doctor because you have a yeast infection called thrush because of Azithromycin.
  • If you get severe diarrhea, tell your doctor.
  • Protect your skin when you are in the sun, especially between 10 am and 3pm, because Azirox® may cause your skin to be rash, itching, redness or sever sunburn. 
  • Capsules  500 mg: Blister of 3 capsules, Pack of 1 Blister )
  • Capsules  250 mg: Blister of 6 capsules, Pack of 1 Blister ).
  • Oral suspension 200 mg: ( Bottle of 15ml or 30 ml after reconstitution ).  
  • Store the drug in a dry place, at a temperature below 25ºC, protect from light.