LINCOCIN lincomycin 600 mg/2 mL (as hydrochloride) injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lincomycin hydrochloride monohydrate, Quantity: 340.26 mg/mL (Equivalent: lincomycin, Qty 300 mg/mL)

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: benzyl alcohol; water for injections

Administration route:

Intravenous, Intramuscular, Subconjunctival

Units in package:

5 X 2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 22 SEPTEMBER 1994: LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of gram positive aerobes such as 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. Because of the risk of colitis (see PRECAUTIONS), before selecting lincomycin the physician should consider the nature of infection and the suitability of less toxic alternatives (e.g.erythromycin). LINCOCIN has been demonstrated to be effective in the treatment of staphylococcal infections resistant to other antibiotics and susceptible to lincomycin. Staphylococcal strains resistant to LINCOCIN have been recovered; culture and susceptibility studies should be done in conjunction with LINCOCIN therapy. In the case of macrolides, partial but not complete cross resistance may occur. The drug may be administered concomitantly with other antimicrobial agents with which it is compatible when indicated (see PRECAUTIONS). The specific infections for which LINCOCIN is indicated are as follows: - Upper respiratory infections including tonsillitis, pharyngitis, otitis media, sinusitis, scarlet fever and as adjuvant therapy for diphtheria. Effectiveness in the treatment of mastoiditis would be anticipated. - Lower respiratory infections including acute and chronic bronchitis and pneumonia. - Skin and skin structure infections including cellulitis, furuncles, abscesses, impetigo, acne and wound infections. Conditions such as erysipelas, lymphadenitis, paronychia (panaritium), mastitis and cutaneous gangrene should, if caused by susceptible organisms, respond to lincomycin therapy. - Bone and joint infections including osteomyelitis and septic arthritis. - Septicaemia and endocarditis. Selected cases of septicaemia and/or endocarditis due to susceptible organisms have responded well to lincomycin. However, bactericidal drugs are often preferred for these infections. - Bacillary Dysentery. Although Shigella is resistant to lincomycin in vitro (MIC approximately 200-400 micrograms/mL), lincomycin has been effective in its treatment due to the very high levels of lincomycin attained in the bowel (approximately 3000-7000 micrograms/gram of stool).

Product summary:

Visual Identification: Clear colourless liquid; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

LINCOCIN
®
_lincomycin hydrochloride monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using LINCOCIN
Injection. This leaflet answers some
common questions about LINCOCIN
Injection. 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 using LINCOCIN
against the benefits it is expected to
have for you. Use LINCOCIN as
instructed and follow the advice
given in this leaflet.
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 LINCOCIN IS
USED FOR
LINCOCIN is an antibiotic used to
treat serious infections in different
parts of the body caused by certain
bacteria. LINCOCIN works by
killing or stopping the growth of
bacteria causing your infection.
The specific infections for which
LINCOCIN is used include: ear,
throat and lung infections; skin
infections; bone and joint infections;
and infections of the blood.
LINCOCIN will not work against
viral infections such as colds or flu.
Your doctor may have prescribed
LINCOCIN for another reason.
Ask your doctor if you have any
questions about why LINCOCIN has
been prescribed for you.
This medicine is available only with
a doctor's prescription.
LINCOCIN is not addictive.
BEFORE YOU USE
LINCOCIN
Some information is provided below.
However, always talk to your doctor
if you have concerns or questions
about your treatment.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LINCOCIN IF YOU
HAVE AN ALLERGY TO:
•
clindamycin or lincomycin
•
any of the other ingredients listed
at the end of this leaflet
(see 'Product Description')
Symptoms of an allergic reaction
may include:
Symptoms of an allergic reaction
may include skin rash, itching or
difficulty in breathing, wheezing or
coughing (anaphylactic reactions). If
you are not sure if you have or have
had an allergic reacti

Summary of Product characteristics

Version: pfplinci10320
Supersedes: pfplinci10918
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION -
LINCOCIN LINCOMYCIN
600MG/2ML (AS HYDROCHLORIDE MONOHYDRATE) INJECTION VIAL
1. NAME OF THE MEDICINE
Lincomycin hydrochloride monohydrate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains lincomycin hydrochloride monohydrate equivalent to
lincomycin base
300 mg;
Excipients with known effect
•
benzyl alcohol, 9.45 mg
For the full list of excipients, see section 6.1, List of Excipients.
3. PHARMACEUTICAL FORM
LINCOCIN Injection is a clear, colourless or almost colourless
solution, practically free from
particles.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
LINCOCIN is indicated in the treatment of serious infections due to
susceptible strains of
gram-positive aerobes such as 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. Because of
the risk of colitis (see
section 4.4, Special Warnings and Precautions for Use), before
selecting lincomycin the
physician should consider the nature of infection and the suitability
of less toxic alternatives
(e.g. erythromycin).
LINCOCIN has been demonstrated to be effective in the treatment of
staphylococcal infections
resistant to other antibiotics and susceptible to lincomycin.
Staphylococcal strains resistant to
LINCOCIN
have
been
recovered;
culture
and
susceptibility
studies
should
be
done
in
conjunction with LINCOCIN therapy. In the case of macrolides, partial
but not complete cross
resistance may occur. The drug may be administered concomitantly with
other antimicrobial
agents with which it is compatible when indicated (see section 4.4,
Special Warnings and
Precautions for Use).
The specific infections for which LINCOCIN is indicated are as
follows:
*
Upper respiratory infections including tonsillitis, pharyngitis,
otitis media, sinusitis,
scarlet fever and as adjuvant therapy for diphtheria. Effectiveness in
the tre