Klacid

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clarithromycin 250mg;  ; Clarithromycin 250mg

Available from:

Viatris Limited

INN (International Name):

Clarithromycin 250 mg

Dosage:

250 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Clarithromycin 250mg   Excipient: Croscarmellose sodium Hydrated silica Hyprolose Hypromellose Magnesium stearate Microcrystalline cellulose Povidone Propylene glycol Purified talc Quinoline yellow   Sorbic acid Sorbitan oleate Starch Stearic acid Titanium dioxide Vanillin Active: Clarithromycin 250mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Ethanol   Hyprolose Hypromellose Magnesium stearate Microcrystalline cellulose Povidone Propylene glycol Purified talc Purified water Quinoline yellow   Sorbic acid Sorbitan oleate Starch Stearic acid Titanium dioxide Vanillin

Units in package:

Blister pack, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Abbott Healthcare (Puerto Rico) Ltd

Therapeutic indications:

Klacid tablets are indicated for treatment of infections caused by susceptible organisms. Such infections include: · Respiratory tract infections including bronchitis, pneumonia, tonsillitis, sinusitis and pharyngitis. · Skin and soft tissue infections such as folliculitis, cellulitis and erysipelas. · Disseminated or localized mycobacterial infections due to Mycobacterium avium or Mycobacterium intracellulare. Localized infections due to Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii. · Prevention of disseminated Mycobacterium avium complex infection in HIV-infected patients with CD4 lymphocyte counts less than or equal to 100/mm3. · Clarithromycin in the presence of acid suppression is indicated for the treatment of duodenal ulcer and in reducing the rate of ulcer recurrence.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 10 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, - 14 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture

Authorization date:

1991-02-20

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
KLACID
®
, KLACID
®
IV
_CLARITHROMYCIN POWDER FOR ORAL LIQUID 250 MG/5 ML_
_FILM COATED TABLETS 250 MG AND 500 MG_
_POWDER FOR INJECTION 500 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Klacid.
This leaflet answers some common
questions about this medicine.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Klacid against
the benefits they expect it will have
on you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to read it
again.
WHAT KLACID IS USED
FOR
Klacid is used to treat certain
bacterial infections, including the
following:
•
respiratory tract infections
•
skin infections
•
ear infections
•
peptic ulcer
•
certain types of bacterial
infections
Klacid is also used to prevent a
specific bacterial infection
associated with HIV infection.
Klacid is an antibiotic that belongs
to the group of medicines called
macrolides. These medicines work
by killing or stopping the growth of
bacteria which cause infections.
Klacid will not work against
infections caused by viruses, such
as colds or flu.
Klacid is available only with a
doctor's prescription.
_KLACID TO TREAT PEPTIC _
_ULCER_
Peptic ulcers are associated with an
infection in the intestine and
stomach caused by a bacteria
called Helicobacter pylori (H. pylori).
Nearly all patients with peptic ulcers
are infected with this bacterium.
The H. pylori infection can be
treated with a combination of Klacid
(clarithromycin) and other
appropriate antibiotic and stomach
acid control treatments. Your
doctor will determine the best
combination for you.
If your symptoms return, consult
your doctor. It is possible that Klacid
may no longer be effective in killing
the H. pylori infection and a different
antibiotic may be needed.

Summary of Product characteristics

Page 1 of 33
NEW ZEALAND DATA SHEET
KLACID
®
, KLACID
® IV
1. PRODUCT NAME
Klacid, 250 mg and 500 mg, film coated tablet.
Klacid, 125 mg/5 mL and 250 mg/5 mL, granules for oral suspension.
Klacid IV, 500 mg, powder for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Klacid 250 mg: Each film coated tablet contains 250 mg of
clarithromycin.
Klacid 500 mg: Each film coated tablet contains 500 mg of
clarithromycin.
Klacid 125 mg/5 ml: Each 5 ml of the granules for suspension contains
125 mg of clarithromycin.
Klacid 250 mg/5 ml: Each 5 ml of the granules for suspension contains
250 mg of clarithromycin.
Klacid IV: Each vial contains 739.5 mg clarithromycin lactobionate,
corresponding to 500 mg of
clarithromycin.
For the full list of excipients, see section 6.1.
Klacid Suspension: Contains sugars and sorbates.
Klacid Tablet: Contains sorbates
3. PHARMACEUTICAL FORM
Klacid 250 mg – yellow, ovaloid, film coated tablets.
Klacid 500 mg – pale yellow, ovaloid, film coated tablets.
Klacid 125 mg/5 ml: white to off-white granules.
Klacid 250 mg/5 ml: white to off-white granules.
Klacid IV: white to off-white caked, lyophilized powder.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Klacid
I.V.
is
indicated
whenever
parenteral
therapy
is
required
for
treatment
of
sensitive
microorganisms in the following conditions:
Page 2 of 33

Upper respiratory tract infections.

Lower respiratory tract infections (see section 4.4 and 5.1 regarding
Sensitivity testing).

Skin and soft tissue infections (see section 4.4 and 5.1 regarding
Sensitivity testing).
Klacid Suspension is indicated for treatment of infections caused by
susceptible organisms. Such
infections include:

Upper respiratory infections (e.g. streptococcal pharyngitis).

Lower respiratory infections (e.g. bronchitis, pneumonia) (see section
4.4 and 5.1 regarding
Sensitivity testing).

Acute otitis media.

Skin and skin structure infections (e.g. impetigo, folliculitis,
cellulitis, abscesses) (see section
4.4 and 5.1 regarding Sensi