CLINDAMYCIN LU clindamycin (as hydrochloride) 150 mg hard capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

clindamycin hydrochloride, Quantity: 162.868 mg

Available from:

Luminarie Pty Ltd

INN (International Name):

clindamycin hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: lactose; purified talc; microcrystalline cellulose; povidone; magnesium stearate; sodium starch glycollate; titanium dioxide; brilliant blue FCF; purified water; Gelatin; sodium lauryl sulfate; tartrazine; propylene glycol; ethanol; isopropyl alcohol; Shellac; tert-butyl alcohol; sodium hydroxide

Administration route:

Oral

Units in package:

100, 50, 24

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CLINDAMYCIN LU (clindamycin hydrochloride) capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.,CLINDAMYCIN LU capsules are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci and staphylococci.,Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate.,Anaerobes:,Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and skin structure infections; septicaemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic cellulitis and post-surgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and skin structure infections, septicaemia,Staphylococci: Serious respiratory tract infections; serious skin and skin structure infections; septicaemia; acute haematogenous osteomyelitis,Pneumococci: Serious respiratory tract infections,Adjunctive Therapy: In the surgical treatment of chronic bone and joint infections due to susceptible organisms. Indicated surgical procedures should be performed in conjunction with antibiotic therapy.,Bacteriological studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

Product summary:

Visual Identification: No. 2 apple green capsule and imprinted with CLD 150; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2014-08-18

Patient Information leaflet

                                CLINDAMYCIN LU capsules
Clindamycin hydrochloride
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CLINDAMYCIN LU
capsules. 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
CLINDAMYCIN LU capsules against the benefits this medicine is expected
to have for
you.
If you have any concerns about using this medicine, ask your doctor or
pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT CLINDAMYCIN LU CAPSULES ARE USED FOR
CLINDAMYCIN LU capsule is an antibiotic. It is used to treat
infections in different
parts of the body caused by bacteria.
CLINDAMYCIN LU capsules works by killing or stopping the growth of the
bacteria
causing your infection.
CLINDAMYCIN LU capsules will not work against viral infections such as
colds or flu.
CLINDAMYCIN LU capsules are recommended for patients who are allergic
to
penicillin or patients for whom penicillin is not suitable.
Your doctor may have prescribed CLINDAMYCIN LU capsules for another
reason. Ask
your doctor if you have any questions about why CLINDAMYCIN LU
capsules have
been prescribed for you.
This medicine is available only with a doctor's prescription.
CLINDAMYCIN LU capsule is not addictive.
BEFORE TAKING CLINDAMYCIN LU CAPSULES
When you must not take CLINDAMYCIN LU capsules
Do not take CLINDAMYCIN LU capsules:
1. if you have an allergy to:
• clindamycin or lincomycin
• lactose or any of the other ingredients listed at the end of this
leaflet
• Symptoms of an allergic reaction may include skin rash, itching or
difficulty in
breathing.
2. if the packaging is torn or shows signs of tampering
3. after the expiry date (EXP) printed on the label.
If you take it after the expiry date, it may have no effect at all, or
worse, an entirely
unexpected effect.
If you are not sure whether you should start taking CLINDAMYCIN LU
capsules, t
                                
                                Read the complete document
                                
                            

Summary of Product characteristics

                                AUSTRALIAN PRODUCT INFORMATION - CLINDAMYCIN LU
(Clindamycin
hydrochloride)
1 NAME OF THE MEDICINE
Clindamycin hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
CLINDAMYCIN LU capsules contain clindamycin hydrochloride, equivalent
to 150 mg of
clindamycin. Clindamycin hydrochloride is a white or almost white
crystalline powder that is
very soluble in water and slightly soluble in ethanol (96%).
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Capsule, hard. The capsules are No.2 apple green in color and
imprinted with CLD 150.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CLINDAMYCIN LU (clindamycin hydrochloride) capsules are indicated in
the treatment of
serious infections caused by susceptible anaerobic bacteria.
CLINDAMYCIN LU capsules are also indicated in the treatment of serious
infections due to
susceptible strains of
_streptococci_
,
_pneumococci _
and
_staphylococci_
.
Its use should be reserved for penicillin-allergic patients or other
patients for whom, in the
judgement of the physician, a penicillin is inappropriate.
ANAEROBES
Serious respiratory tract infections such as empyema, anaerobic
pneumonitis and lung
abscess; serious skin and skin structure infections; septicaemia;
intra-abdominal infections
such as peritonitis and intra-abdominal abscess (typically resulting
from anaerobic organisms
resident in the normal gastrointestinal tract); infections of the
female pelvis and genital tract
such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic
cellulitis and post-surgical
vaginal cuff infection.
STREPTOCOCCI
Serious respiratory tract infections; serious skin and skin structure
infections, septicaemia
STAPHYLOCOCCI
Serious respiratory tract infections; serious skin and skin structure
infections; septicaemia;
acute haematogenous osteomyelitis
PNEUMOCOCCI
Serious respiratory tract infections
ADJUNCTIVE THERAPY
In the surgical treatment of chronic bone and joint infections due to
susceptible organisms.
Indicated surgical procedures should b
                                
                                Read the complete document