DOXYCYCLINE AN doxycycline 100mg (as hydrochloride) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

01-12-2017

Summary of Product characteristics (SPC)

01-12-2017

Public Assessment Report (PAR)

25-10-2017

Active ingredient:

doxycycline hyclate, Quantity: 115.4 mg (Equivalent: doxycycline, Qty 100 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

doxycycline hyclate (hydrochloride)

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; macrogol 4000

Administration route:

Oral

Units in package:

7 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OTHER CONDITIONS: Protect from moisture. INDICATIONS: Infections caused by the following organisms; Mycoplasma pneumoniae (primary atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic typhus fever, Q fever, murine endemic typhus fever, Australo-Pacific endemic scrub typhus); Chlamydia psittaci (psittacosis); Chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral doxycycline alone, or in combination with topical agents). Borreliae (relapsing fever). Calymmatobacterium (Donovania) granulomatis (granuloma inguinale). Infections caused by the following Gram- negative microorganisms: Vibrio species (chlorea), Brucella sp. (Brucellosis; in conjuction with streptomycin), Haemophilus ducreyi (chancroid), Yersinia pestis (plague), Francisella turarenis (tularaemia), Bartonella bacilliformis (Bartonellosis), Bacteroides sp. When penicillin is contraindicated, Doxy-100 is an alternative drug in the treatment of infections due to: Treponema pallidum (syphilis); Treponema pertenue (yaws); Neisseria gonorrhoea (see Dosage and Administration). Doxy-100 is not the drug of choice in the treatment of any type of staphylococcal infection or infections due to Streptococcus pneumoniae, Haemophilus infuenzae, Streptococcus pyogenes, Streptococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. Doxy-100 should not be used in these infections unless the organism has been shown to be sensitive. For upper respiratory infections due to group A beta-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual drug of choice. In acute intestinal amoebiasis, doxycycline may be a useful adjunct to amoebicides. In severe acne, doxycycline may be useful adjunctive therapy. Doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by Plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by Plasmodium vivax. Doxycycline is only able to suppress malaria caused by P. vivax. As there are relatively few locations where P. vivax does not co-exist to some extent with P. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example, chloroquine.

Product summary:

Visual Identification: White, film-coated, biconvex tablet scored on one side for oral use, diameter 9.1mm; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-06-24

Patient Information leaflet

_Doxycycline AN tablets – Consumer Medicine Information _
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_Doxycycline AN CMI v 3.0 _
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_Page 1 _
DOXYCYCLINE AN TABLETS
_Doxycycline hydrochloride 50 mg & 100 mg tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Doxycycline AN.
It
does
not
contain
all
of
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
Doxycycline
AN
against
the
benefits they expect it will have
for 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 DOXYCYCLINE AN
IS USED FOR
Doxycycline AN is an antibiotic
used to
•
Treat certain infections
•
Control acne
•
Prevent malaria
Doxycyline AN tablets belong to
a
class
of
medicines
called
tetracyclines.
These medicines work by killing
or
stopping
the
growth
of
bacteria which cause infections
or make acne worse. They also
work
against
parasites
which
cause malaria.
Tetracyclines
will
not
work
against viral infections such as
colds or the ‘flu’.
Your
doctor,
however,
may
prescribe
Doxycycline
AN
for
another
purpose.
Ask
your
doctor if you have any questions
about why Doxycycline AN has
been prescribed for you.
This medicine is only available
with a doctor’s prescription.
There
is
no
evidence
that
Doxycycline AN is addictive.
BEFORE YOU TAKE
DOXYCYCLINE AN
_WHEN YOU MUST NOT TAKE _
_DOXYCYCLINE AN _
DO NOT TAKE DOXYCYCLINE AN IF:
1.
You
have
ever
had
an
ALLERGIC REACTION to
•
Medicines
containing
doxycycline,
or
doxycycline
hydrochloride
•
Medicines
containing
other tetracyclines
•
Any
of
the
ingredients
listed at the end of this
leaflet
Some of the symptoms of an
allergic
reaction
to
tetracyclines
may
include:
rash, itching or hives of the
skin,
swelling
of
the
face,
lops
and
tongue
or
other
parts of the body, shortness
of
breath,
wheezing
or
troubled breathing
2.
You

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Summary of Product characteristics

_Doxycycline AN tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Doxycycline AN PI v4
Page 1
DOXYCYCLINE AN
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_(DOXYCYCLINE TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of the medicine is doxycycline hyclate (hydrochloride)
CHEMICAL NAME
:
hydrochloride hemiethanolate hemihydrate of
(4S,4aR,5S,5aR,6R,12aS)-4-(dimethylamino)-
3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-
2-
carboxamide
MOLECULAR FORMULA
: C
22
H
25
ClN
2
0
8
MOLECULAR WEIGHT:
512.9
CAS NUMBER:
[
_24390-14-5_
]
DESCRIPTION
Doxycycline is a broad spectrum antibiotic synthetically derived from
oxytetracycline.
Chemical
name:
6-deoxy-5-oxytetracycline.
It is a light yellow crystalline powder which has a high lipid
solubility and a
low affinity for calcium binding. It is highly stable in normal human
serum. It will
not degrade into an
epianhydro form.
Doxycycline AN 100 mg and Doxycycline AN 50 mg tablets also contain:
microcrystalline
cellulose, maize starch, colloidal
anhydrous silica, magnesium stearate and Opadry white Y-1-
7000B.
PHARMACOLOGY
_Microbiology_
Doxycycline is primarily bacteriostatic and is thought to exert its
anti-microbial effect by the
inhibition of
protein synthesis. It is active against a wide range of Gram-positive
and Gram-
negative organisms
(see indications).
_Doxycycline AN tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Doxycycline AN PI v4
Page 2
Disc
Susceptibility
Test:
“Dilution
or
diffusion
techniques
–
either
quantitative
(MIC)
or
breakpoint,
should be used following a regularly updated, recognised and
standardized method
(eg.
Clinical and
Laboratory
Standards
Institute
[CLSI
formely
NCCLS]).
Standardised
susceptibility test procedures
require the use of laboratory control microorganisms to control the
technical aspects of the laboratory
procedures.
•
A report of “Susceptible” indicates that the pathogen is likely to
be inhibited if the
antimicrobial
compound in the blood reaches the concentrations usual

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