Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
azithromycin dihydrate, Quantity: 524.05 mg (Equivalent: azithromycin, Qty 500 mg)
Arrotex Pharmaceuticals Pty Ltd
azithromycin dihydrate
Tablet, film coated
Excipient Ingredients: calcium hydrogen phosphate dihydrate; hyprolose; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin
Oral
2, 3, 15, 1
(S4) Prescription Only Medicine
APO-Azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity:,1. Lower respiratory tract infections:,? Acute bacterial bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis. ? Community acquired pneumonia due to Streptococcus pneumoniae or Haemophilus influenzae in patients suitable for outpatient oral treatment. ? Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.,2. Upper respiratory tract infections:,? Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae. ? Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. However, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,3. Uncomplicated skin and skin structure infections:,? Uncomplicated infections due to Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae. Abscesses usually require surgical drainage.,4. Sexually transmitted diseases: Uncomplicated urethritis and cervicitis due to Chlamydia trachomatis.,? Note: At the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. As with other drugs for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. Appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required. ? APO-Azithromycin is also indicated for the treatment of Chlamydia trachomatis conjunctivitis and trachoma.
Visual Identification: White, oval, biconvex film coated tablets engraved "APO" on one side and "AZ500" on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2012-12-13
APO-AZITHROMYCIN TABLETS _Azithromycin dihydrate_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about azithromycin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Azithromycin is used to treat infections in different parts of the body caused by bacteria, such as chlamydia. Azithromycin belongs to a group of medicines called macrolide antibiotics. _HOW IT WORKS_ Azithromycin works by killing or stopping the growth of bacteria causing your infection. Azithromycin will not work against viral infections such as colds or flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of azithromycin tablets in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • azithromycin • macrolide antibiotics (e.g. clarithromycin, erythromycin, roxithromycin, telithromycin) • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION APO-AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Azithromycin dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg Azithromycin (as dihydrate) For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM White, oval, biconvex film coated tablets engraved “APO” on one side and “AZ500” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AZITHROMYCIN IS INDICATED FOR USE IN ADULTS FOR THE TREATMENT OF THE FOLLOWING INFECTIONS OF MILD TO MODERATE SEVERITY: 1. Lower respiratory tract infections: Acute bacterial bronchitis due to _ Streptococcus pneumoniae, Haemophilus influenzae_ or _Moraxella catarrhalis._ Community acquired pneumonia due to _Streptococcus _ _pneumoniae_ or _Haemophilus _ _influenzae_ in patients suitable for outpatient oral treatment. Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against _Chlamydia _ _pneumoniae, _ _Haemophilus _ _influenzae, _ _Legionella _ _pneumophilia, _ _Moraxella _ _catarrhalis, _ _Mycoplasma _ _pneumoniae, _ _Staphylococcus _ _aureus_ and _Streptococcus _ _pneumoniae_. 2. Upper respiratory tract infections: Acute sinusitis due to _Streptococcus pneumoniae_ or _Haemophilus influenzae_. Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. However, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present. 2 3. Uncomplicated skin and skin structure infections: Uncomplicated infections due to _Staphylococcus _ _aureus, _ _Streptococcus _ _pyogenes_ or _Streptococcus agalactiae_. Abscesses usually require surgical drainage. 4. Sexually Read the complete document