DOXSIG doxycycline 100mg (as hydrochloride) tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

24-08-2020

Summary of Product characteristics (SPC)

24-08-2020

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, 21 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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). Infection caused by the following Gram-negative microorganisms: Vibrio species (chlorea), Brucella sp. (Brucellosis; in conjunction 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 influenzae, 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 tablets with a breakline on one face, for oral use, diameter 9.1mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-06-24

Patient Information leaflet

_DOXSIG tablets – Consumer Medicine Information _
_ _
_DOXSIG CMI July 2019 _
_ _
_ _
_Page 1 _
DOXSIG TABLETS
_doxycycline hyclate (hydrochloride) _
_ 50 mg & 100 mg tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
DOXSIG.
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 DOXSIG
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 DOXSIG IS USED
FOR
DOXSIG is an antibiotic used to
•
Treat certain infections
•
Control acne
•
Prevent malaria
DOXSIG
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
DOXSIG
for
another
purpose. Ask your doctor if you
have any questions about why
DOXSIG
has
been
prescribed
for you.
This medicine is only available
with a doctor’s prescription.
There
is
no
evidence
that
DOXSIG is addictive.
BEFORE YOU TAKE
DOXSIG
_WHEN YOU MUST NOT TAKE _
_DOXSIG _
DO NOT TAKE DOXSIG 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
are
TAKING
PREPARATIONS
CONTAINING
VITAMIN A, ISOTRETINOIN OR
ETRETINATE
Ask
your
doctor
or

Read the complete document

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – DOXSIG (DOXYCYCLINE
HYCLATE (HYDROCHLORIDE)) TABLETS
1
NAME OF THE MEDICINE
Doxycycline hyclate (hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxycycline is a broad spectrum antibiotic synthetically derived from
oxytetracycline.
DOXSIG tablets contain doxycycline 5 0 m g o r 100mg as doxycycline
hyclate ( hydrochloride).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DOXSIG 50 mg tablets: White film-coated
circular biconvex tablet having a diameter of 6.3 mm.
DOXSIG 100 mg tablets: White film-coated, biconvex tablet, with a
breakline on one face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Infections caused by the following microorganisms: 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 sp. (cholera); Brucella sp.
(Brucellosis; in conjunction with streptomycin); Haemophilus ducreyi
(chancroid); Yersinia
pestis (plague); Francisella tularensis (tularaemia); Bartonella
bacilliformis (Bartonellosis);
Bacteroides sp.
When penicillin is contraindicated, doxycycline is an alternative drug
in the
treatment of infections due
to: Treponema pallidum (syphilis); Treponema perenue (yaws);
Neisseria gonorrhoea (see section 4.2 DOSE AND METHOD OF
ADMINISTRATION).
Doxycycline is not the drug of choice in the treatment of any type of
staphylococcal infection

Read the complete document