KLACID clarithromycin 250mg/5mL powder for oral liquid bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

clarithromycin, Quantity: 50 mg/mL

Boleh didapati daripada:

Viatris Pty Ltd

Borang farmaseutikal:

Oral Liquid, powder for

Komposisi:

Excipient Ingredients: potassium sorbate; Castor Oil; titanium dioxide; hypromellose phthalate; maltodextrin; carbomer 934; citric acid; silicon dioxide; xanthan gum; sucrose; povidone; Flavour

Laluan pentadbiran:

Oral

Unit dalam pakej:

1 x 100mL, 1 x 70mL, 1 x 50mL bottle

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Klacid (clarithromycin) is indicated for use in adults and children older than 12 years for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. Acute streptococcal pharyngitis; 2. Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila and Streptococcus pneumoniae; 3. Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes; 4. Disseminated or localised mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare and skin and skin structure infections due to Mycobacterium chelonae. Clarithromycin should be used in combination with other antimycobacterial agents. 5. Prevention of disseminated Mycobacterium avium complex infection in HIV-infected adults with CD4 lymphocyte counts of < 75 cells/cubic mm. (See Precautions) Disseminated infection due to Mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis. 6. Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae; 7. Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. Klacid (clarithromycin) is indicated for use in children for the treatment of mild to moderately severe infections caused by susceptible strains of the designated micro-organisms in the conditions listed below: 1. Acute streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes; 2. Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila; 3. Skin and skin structure infections (eg impetigo); 4. Disseminated or localised infections due to Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV Infection or AIDS. 5. Acute otitis media. NOTE: 1. Penicillins are the drug of first choice in the treatment of acute otitis media. 2. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections including prophylaxis of rheumatic fever. Clarithromycin appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx, however substantial data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not available at present. 3. There is insufficient evidence of efficacy to support the use of Klacid in acute bronchitis in young children. 4. The data presented on infections of skin and skin structure were confined largely to mild to moderate infections such as impetigo.

Ringkasan produk:

Visual Identification: White to pale yellow granules; Container Type: Bottle; Container Material: HDPE; Container Life Time: 42 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status kebenaran:

Licence status A

Tarikh kebenaran:

1996-08-22

Risalah maklumat

KLACID
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING KLACID?
KLACID contains the active ingredient clarithromycin. KLACID is used
to treat certain bacterial infections including respiratory tract
infections, ear infections, skin infections and peptic ulcer. KLACID
is also used to prevent a specific bacterial infection associated
with HIV infection. For more information, see Section 1. Why am I
taking KLACID? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE KLACID?
Do not take if you have ever had an allergic reaction to
clarithromycin, other antibiotics from the macrolide family or any of
the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
KLACID? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KLACID and affect how it works or
may be affected by KLACID.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE KLACID?
Your doctor will tell you how much to take and when to take it. Take
KLACID exactly as directed by your doctor. More instructions
can be found in Section 4. How do I take KLACID? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING KLACID?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
KLACID.
•
Tell your doctor if you are taking KLACID for an infection and your
symptoms do not improve within a
few days, or they become worse, you become pregnant, you get severe
diarrhoea, you experience heart
palpitations, changes in heartbeat, dizziness or fainting or you are
having urine tests.
THINGS YOU
SHOULD NOT DO
•
Do not take KLACID to treat any other complaints unless your doct

Ciri produk

AUSTRALIAN PRODUCT INFORMATION
KLACID
®
_Clarithromycin film coated tablets and powder for oral liquid _
1
NAME OF THE MEDICINE
Clarithromycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KLACID (clarithromycin) is a semi-synthetic macrolide antibiotic.
Clarithromycin is a white to off-white
crystalline powder. It is soluble in acetone, slightly soluble in
methanol, ethanol and acetonitrile and
practically insoluble in water.
KLACID tablets contain sorbates. KLACID powder for oral liquid
contains sugars, sorbates and sulfites. For
the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The KLACID 250 mg tablet is yellow, oval and film-coated, containing
250 mg clarithromycin.
The KLACID 500 mg tablet is pale yellow, oval and film-coated,
containing 500 mg clarithromycin.
KLACID Powder for Oral Liquid consists of a granulation of
clarithromycin and carbomer 934 coated with
hypromellose phthalate. Water is added to reconstitute the suspension
prior to use. After mixing, each 5 mL
contains 250 mg of clarithromycin.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KLACID (clarithromycin) is indicated for use in adults and children
older than 12 years for the treatment of
mild to moderately severe infections caused by susceptible strains of
the designated microorganisms in the
conditions listed below:
1.
Acute streptococcal pharyngitis;
2.
Community
acquired
pneumonia
due
to
_Chlamydia _
_pneumoniae_
,
_Mycoplasma _
_pneumoniae_
,
_Legionella pneumophila_
and
_Streptococcus pneumoniae_
(see section 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE regarding sensitivity testing);
3.
Uncomplicated skin and skin structure infections due to
_Staphylococcus aureus_
or
_Streptococcus _
_pyogenes_
(see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE regarding
sensitivity testing);
4.
Disseminated or localised mycobacterial infections due to
_Mycobacterium avium_
or
_Mycobacterium _
_intracellulare_
and skin and skin structure infections due to
_Mycobacterium chelonae_
. Clarithromycin
should b