দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
azithromycin dihydrate, Quantity: 524 mg
Arrotex Pharmaceuticals Pty Ltd
azithromycin dihydrate
Tablet, film coated
Excipient Ingredients: lactose monohydrate; hypromellose; triacetin; calcium hydrogen phosphate; titanium dioxide; pregelatinised maize starch; crospovidone; sodium lauryl sulfate; magnesium stearate
Oral
15, 2, 3
(S4) Prescription Only Medicine
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 influenza 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.,Azithromycin is also indicated for the treatment of Chlamydia trachomatis conjunctivitis and trachoma.,Azithromycin is also indicated for the prevention of infection due to Mycobacterium avium-intracellulare Complex (MAC) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with HIV infection and CD4 cell count less than or equal to 75 cells/?L (see Precautions). Disseminated infection due to Mycobacterium avium-intracellulare complex should be excluded by a negative blood culture prior to commencement of therapy.,Azithromycin is indicated for use in children for the treatment of the following infections:,1. Acute streptococcal pharyngitis/tonsillitis:,Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. The 20 mg/kg azithromycin dose appears to be as effective as penicillin 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. Chlamydia trachomatis conjunctivitis and trachoma in children 12 months or older.
Visual Identification: White, oblong, biconvex, film-coated tablet, scored on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-05-30
ZITHRO _Azithromycin dihydrate (a-zithro-my-sin)_ _ _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Zithro. 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 taking Zithro 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 YOUR MEDICINE. You may need to read it again. WHAT ZITHRO IS USED FOR Zithro is used to treat infections in different parts of the body caused by bacteria. It is commonly used to treat Chlamydia. Zithro is also used to prevent infections by a bacterium called Mycobacterium Avium- intracellulare Complex (MAC) in some people. Zithro is an antibiotic, which belongs to a group of medicines called azalides. The azalides are a sub-class of a group of antibiotics called macrolides. Zithro works by killing or stopping the growth of bacteria causing your infection. Zithro will not work against viral infections such as colds or flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZITHRO HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Zithro is only available with a doctor's prescription. This medicine is not addictive. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE ZITHRO _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ZITHRO IF YOU ARE ALLERGIC TO: • azithromycin • any other macrolide or ketolide antibiotics (e.g., clarithromycin, erythromycin, roxithromycin, telithromycin) • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF THE EXPIRY DATE (EXP) PRINTED ON THE সম্পূর্ণ নথি পড়ুন
1 AUSTRALIAN PRODUCT INFORMATION – ZITHRO (AZITHROMYCIN DIHYDRATE) TABLETS 1 NAME OF THE MEDICINE Azithromycin dihydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ZITHRO tablets contain azithromycin dihydrate equivalent to 500 mg of azithromycin. Excipients with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ZITHRO tablets are white, oblong, biconvex, film coated tablets, scored on one side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 _ _influenza _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. 2 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_. Abscess সম্পূর্ণ নথি পড়ুন