APO-CLARITHROMYCIN clarithromycin 250mg tablet bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

clarithromycin, Quantity: 250 mg

제공처:

Arrotex Pharmaceuticals Pty Ltd

INN (국제 이름):

Clarithromycin

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: magnesium stearate; hypromellose; iron oxide yellow; macrogol 8000; microcrystalline cellulose; colloidal anhydrous silica; croscarmellose sodium; titanium dioxide

관리 경로:

Oral

패키지 단위:

14's, 28's, 100's

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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 pneumophilia 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 < 75 cells/mm3 (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. Clarithromycin is indicated for use in children 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 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 (e.g. 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 clarithromycin 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.

제품 요약:

Visual Identification: pale yellow, oval, film-coated tablets engraved "CLA250" on one side, "APO" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

승인 상태:

Registered

승인 날짜:

2007-11-22

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION
APO- CLARITHROMYCIN (CLARITHROMYCIN) TABLETS
1
NAME OF THE MEDICINE
Clarithromycin.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg or 500 mg of clarithromycin as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
250 MG TABLETS
Pale yellow, oval, film-coated tablets engraved “CLA250” on one
side, “APO” on the other
side.
500 MG TABLETS
Pale yellow, capsule-shaped, film-coated tablets engraved “CLA500”
on one side, “APO” on
the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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:

Acute streptococcal pharyngitis;

Community
acquired
pneumonia
due
to
_Chlamydia _
_pneumoniae, _
_Mycoplasma _
_pneumoniae, Legionella pneumophila _and _Streptococcus pneumoniae_;
(see section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

Uncomplicated skin and skin structure infections due to _
Staphylococcus aureus _ or
_Streptococcus pyogenes_; (see section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR
USE).

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;

Prevention of disseminated _Mycobacterium avium _complex infection in
HIV-infected
adults with CD
4
lymphocyte counts < 75 cells/mm
3
(see section 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE). Disseminated infection due to _
Mycobacterium avium _
complex should be excluded by a negative blood culture prior to
commencement of
2
prophylaxis;

Acute bacterial exacerbation of chronic bronchitis due to _
Haemophilus influenzae, _
_Moraxella catarrhalis _or _Streptococcus pneumoni