CLARITHROMYCIN SANDOZ clarithromycin 500 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

clarithromycin, Quantity: 500 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Clarithromycin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; croscarmellose sodium; macrogol 4000; hypromellose; titanium dioxide; microcrystalline cellulose; powdered cellulose

Administration route:

Oral

Units in package:

100, 14, 42

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CLARITHROMYCIN SANDOZ 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: Acute streptococcal pharyngitis; Community acquired pneumonia due to Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophilia and Streptococcus pneumoniae;Uncomplicated skin and skin structure infections due to Staphylococcus aureus or Streptococcus pyogenes;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 anti mycobacterial agents.Prevention of disseminated Mycobacterium avium complex infection in HIV infected adults with CD4 lymphocyte counts <75 cells/mm 3 (See Precautions). Disseminated infection due to Mycobacterium avium complex should be excluded by a negative blood culture prior to commencement of prophylaxis.Acute bacterial exacerbation of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae;Combination therapy for the treatment of peptic ulcer disease associated with Helicobacter pylori infection. CLARITHROMYCIN SANDOZ 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:Acute streptococcal pharyngitis and tonsillitis caused by Streptococcus pyogenes; Community acquired pneumonia including infections due to Chlamydia pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila; Skin and skin structure infections (eg impetigo); Disseminated or localised infections due to Mycobacterium avium or Mycobacterium intracellulare in immunocompromised children, including those with HIV Infection or AIDS. 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.

Product summary:

Visual Identification: White, oblong, convex tablets, scored on both faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2005-08-29

Patient Information leaflet

Clarithromycin Sandoz®
1
CLARITHROMYCIN SANDOZ®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CLARITHROMYCIN SANDOZ?
Clarithromycin Sandoz contains the active ingredient clarithromycin.
Clarithromycin Sandoz is used to treat certain bacterial
infections including respiratory tract infections, ear infections,
skin infections and peptic ulcer. Clarithromycin Sandoz is used
to prevent a specific bacterial infection associated with HIV
infection. For more information, see Section
1. Why am I using
Clarithromycin Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CLARITHROMYCIN SANDOZ?
Do not use 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 use
Clarithromycin Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Clarithromycin Sandoz and affect how
it works or may be affected by Clarithromycin
Sandoz. A list of these medicines is in Section 3. What if I am taking
other medicines?
in the full CMI.
4.
HOW DO I USE CLARITHROMYCIN SANDOZ?
Your doctor will tell you how much to take and when to take it. Take
Clarithromycin Sandoz exactly as directed by your doctor.
More instructions can be found in Section 4. How do I use
Clarithromycin Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CLARITHROMYCIN SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist that you visit that you are
using Clarithromycin Sandoz.
•
Tell your doctor if you are taking Clarithromycin Sandoz for an
infection and your symptoms do not
improve within a few days, or they become worse, you become

Summary of Product characteristics

_Product Information _
_ _
_Page_
1
_Clarithromycin Sandoz 250mg, 500mg tablets _
_11/2017 _
_ _
_Sandoz Pty Ltd_
PRODUCT INFORMATION CLARITHROMYCIN SANDOZ 250MG AND 500MG TABLETS
NAME OF THE MEDICINE
Generic name: Clarithromycin.
Chemical
name:
(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)–4-[(2,6-Dideoxy-3-C-methyl-3-O-
methyl-

-L-ribo-hexopyranosyl)oxy]-14-ethyl-12,13-dihydroxy-7-methoxy-3,5,7,9,11,13-
hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione
Other names
6-O-methylerythromycin A
Chemical structure:
CAS number
81103-11-9
C
38
H
69
NO
13
MW:747.95 g/mol
DESCRIPTION
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.
In addition to clarithromycin, Clarithromycin Sandoz tablets contain:
cellulose-microcrystalline,
magnesium
stearate,
croscarmellose
sodium,
cellulose-powdered,
silica-colloidal
anhydrous,
lactose
monohydrate,
hypromellose,
macrogol
4000
and
titanium
dioxide.
_Product Information _
_ _
_Page_
2
_Clarithromycin Sandoz 250mg, 500mg tablets _
_11/2017 _
_ _
_Sandoz Pty Ltd_
PHARMACOLOGY
Clarithromycin is a semi-synthetic macrolide antibiotic.
Hepatotoxicity, atrophy of lymphatic tissues (lymph, thymus) and
adverse reproductive toxicity
were seen in several species at exposures less than those which might
be expected clinically at
proposed doses. The clinical significance of these observations is not
known. There are no data
from long term animal carcinogenicity studies.
_CLINICAL PHARMACOLOGY_
_Helicobacter pylori_
is strongly associated with peptic ulcer disease. Ninety to 100% of
patients
with peptic ulcers are infected with this pathogen. Eradication of
_H. pylori _
is associated with a
reduction in the rate of duodenal ulcer recurrence, thereby reducing
the need for maintenance
anti-secretory therapy.
The
development
of
antimicrobial
resistance
may
have
an
adverse
effect
on
eradication
regimens. The clinical impact