Azrotek 500

Azrotek 500
26 May

Azrotek 500

Antibiotics & Antibacterial

 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

Indecation

Azrotek®  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 cannot use first –line therapy.( penicillin by IM).                                                    
- Uncomplicated skin and skin structure infections: due to staphylococcus aureas , streptococcus 
 pyogenes ,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.

Dosage & Administration

-Each dose should be taken at least 1hour before or 2hours after the main meals.
In adult and elderly : The recommended dose of Azrotek®  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 is10 mg /kg as a single daily dose for 3 days , Azrotek®  suspension should be administered by using the standard spoon according to the following guidance (known that the duration of the therapeutic is 3 days.)    
 Over dose :
 If you take too much of Azrotek® ,and you may get an upset stomach ,diarrhea or skin rash 
 immediately telephone your doctor  for advice or you need urgent medical  attention .

- Each Capsule of  Azrotek®  500  mg  contains: 
   Azithromycin 500 mg  (as Azithromycin  dihydrate)
- Each Capsule of  Azrotek®  250 mg  contains: 
   Azithromycin 250 mg  (as Azithromycin  dihydrate )
- Each 5 ml of  Azrotek®  200  mg  for oral suspension contains: 
   Azithromycin 200 mg (as Azithromycin   dihydrate ).

- Azrotek®  is contraindicated in patient with known hypersensitivity to Azithromycin or any of  macrolide antibiotic.
- Azrotek® should not be used in hepatic disease.
- Azrotek® and ergot derivatives should not be Co-administered 

-Patients should be cautioned not to take aluminum and magnesium containing antacids and  
 Azrotek®  simultaneously. Only take it one hour before  or two hour after Azrotek®  dose .
-The prothrombin time should be monitored in all patients administrated with Azrotek®   and warfarin concomitantly.
-The plasma theophylline levels should be monitored in patients receiving Azrotek® and theophylline concomitantly. 
- Some drug may interfere with Azithromycin and  may these drugs are used concomitantly(digoxin, 
 triazolam, phenytoin ,carbamazepine, terfenadine or astemizole ,lomotil and ergot derivatives ).
- No clinically significant interactions have been observed  between Azrotek®  and theophyllin, 
 methylprednisolone or carbamazepine, however , with other macrolides interactions were observed.

Azrotek®   should  not   be used during pregnancy or lactation women . where adequate alternatives 
 are not available,  only the doctor determine   if used or no .

- 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 . 

-The patient should be directed to discontinue Azrotek®  immediately  and contact a  physician if any  
 sign of an allergic  reactions occur  .                                                                                                         
-Tell your doctor before you start  taking Azrotek®  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 Azrotek®, 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 Azrotek®   
 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  well closed in a dry place , at a temperature below 30oC. 
- protect from light.