MINOMYCIN 50 minocycline 50mg (as hydrochloride) tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

minocycline hydrochloride dihydrate, Quantity: 53.985 mg (Equivalent: minocycline, Qty 50 mg)

Διαθέσιμο από:

Aspen Pharma Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: lactose monohydrate; sodium starch glycollate; povidone; sorbitol; microcrystalline cellulose; stearic acid; magnesium stearate; titanium dioxide; hypromellose; sunset yellow FCF; quinoline yellow; light liquid paraffin; sodium lauryl sulfate

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

4 tablets, 60 tablets

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

INDICATIONS AS AT 12 NOVEMBER 2003 : Minocycline may be used for the treatment of infections caused by any of the following organisms provided that they have been shown by bacteriological testing to be susceptible to minocycline: Escherichia coli, Enterobacter aerogenes, Haemophilus influenzae, Klebsiella and Proteus. It may also be used in the treatment of infections due to Streptococcus pyogenes (group A Beta-haemolytic) and Streptococcus faecalis but because a large proportion of these organisms are resistant to tetracyclines, minocycline should be used only if the orgaisms have been shown to be definitely sensitive. Tetracyclines, including minocycline, are not the drugs of choice in the treatment of staphylococcal infections. Minocycline may be considered for the treatment of such infections only if other suitable agents are not available and the organism has been shown to be sensitive to minocycline. Minocycline may be used in the treatment of tetracycline-resistant acne.

Περίληψη προϊόντος:

Visual Identification: Round, convex, orange film coated tablet with a scoreline on one side, and plain on the other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1993-12-07

Φύλλο οδηγιών χρήσης

MINOMYCIN- Consumer Medicine Information
Page 1 of 4
MINOMYCIN
_minocycline _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MINOMYCIN.
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
MINOMYCIN against the benefits
this medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT MINOMYCIN IS
USED FOR
The name of your medicine is
MINOMYCIN. It contains the
active ingredient minocycline
hydrochloride.
MINOMYCIN is used to treat
acne, which is resistant to other
antibiotics. It is also used to treat
various other infections.
MINOMYCIN belongs to a group
of antibiotics called tetracyclines.
They work by stopping the growth
of bacteria.
Your doctor may have prescribed
MINOMYCIN for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Tetracyclines will not work
against infections caused by
viruses such as colds or flu.
This medicine is available only
with a doctor's prescription.
MINOMYCIN is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MINOMYCIN IF:
1.
YOU HAVE EVER HAD AN
ALLERGIC REACTION TO:
•
MINOCYCLINE, OR ANY OTHER
TETRACYCLINE ANTIBIOTICS
•
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET
Some of the symptoms of an
allergic reaction to a
tetracycline may include rash,
itching or hives on the skin;
swelling of the face, lips,
tongue or other parts of the
body; shortness of breath,
wheezing or difficulty
breathing.
2.
YOU ARE PREGNANT OR
BREASTFEEDING.
As with many medicines,
tetracyclines may harm the
developing or breastfeeding
baby. This may include
enamel loss and staining of the
child's teeth.
High doses of tetracyclines
may also cause liver problems
in pregnant women.

Αρχείο Π.Χ.Π.

Minomycin-PI
1
AUSTRALIAN PRODUCT INFORMATION
MINOMYCIN (MINOCYCLINE HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Minocycline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
MINOMYCIN
50
mg
tablet
contains
minocycline
hydrochloride
equivalent
to
50
mg
of
minocycline
Excipients of known effect: lactose monohydrate and sorbitol
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
MINOMYCIN 50 minocycline 50mg (as hydrochloride) blister packs are
presented as round, convex,
orange film coated tablet, engraved "M50" on one side, the other
plain.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Minocycline may be used for the treatment of infections caused by any
of the following organisms
provided that they have been shown by bacteriological testing to be
susceptible to minocycline:
Escherichia coli, Enterobacter aerogenes, Haemophilus influenzae,
Klebsiella and Proteus.
It may also be used in the treatment of infections due to
Streptococcus pyogenes (group A
β
-
haemolytic) and Streptococcus faecalis but because a large proportion
of these organisms is resistant
to tetracyclines, minocycline should be used only if the organisms
have been shown to be definitely
sensitive.
Tetracyclines, including minocycline, are not the drugs of choice in
the treatment of staphylococcal
infections. Minocycline may be considered for the treatment of such
infections only if other suitable
agents are not available and the organism has been shown to be
sensitive to minocycline.
Minocycline may be used in the treatment of tetracycline-resistant
acne.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The usual dosage of minocycline for adults is 200 mg initially,
followed by 100 mg every 12 hours.
Therapy should be continued for at least 24 to 48 hours after symptoms
and fever have subsided.
In tetracycline resistant acne, the dosage is 100 mg daily given
preferably as 50 mg twice daily. Most
cases are likely to resolve within 3 months.
Minomycin-PI
2
RENAL IMPAIRMENT
Patients with renal impai