DORYX Doxycycline 100mg capsules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

doxycycline hyclate, Quantity: 116.3 mg (Equivalent: doxycycline, Qty 100 mg)

Available from:

Mayne Pharma International Pty Ltd

Pharmaceutical form:

Capsule, modified release

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate; purified water; hypromellose phthalate; hyprolose; wheat starch; diethyl phthalate; hypromellose; Gelatin; povidone; ethanol; Shellac; Pharmaceutical glaze; carbon black

Administration route:

Oral

Units in package:

7 capsules, 21 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 24 March 2004: Doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. Doxycycline is active against a wide range of gram positive and gram negative organisms. NOTE: THE 50 mg CAPSULE IS NOT A PAEDIATRIC FORMULATION. Doryx is indicated in the treatment of infections caused by the following micro-organisms: Mycoplasma pneumoniae: primary atypical pneumonia. Rickettsiae: Queensland tick typhus, typhus fever and Q fever Agents of psittacosis. Calymmatobacterium (Donovania) granulomitis: granuloma inguinale. Agents of lymphogranuloma venereum. Borreliae: relapsing fever. Chlamydia trachomatis. Doryx 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 Doryx alone, or in combination with topical agents. Doryx is indicated in the treatment of infections caused by the following gram negative micro-or

Product summary:

Visual Identification: Hard gelatin capsules, size 2, printed Doryx 100 in black and filled with yellow spheroidal pellets.; Container Type: Bottle; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-25

Patient Information leaflet

DORYX
®
1
DORYX
®
(DOR-IX)
_doxycycline hyclate (hydrochloride) (dox-I-SYE-kleen) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DORYX. 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 DORYX
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 DORYX IS USED
FOR
DORYX is an antibiotic used to:
•
treat certain types of infections
•
control acne
•
prevent some forms of malaria,
sometimes in combination with
another antimalarial medicine.
This medicine belongs to a group of
medicines called tetracyclines.
It works by killing or stopping the
growth of bacteria which cause
infections or make acne worse. It
also works against parasites that
cause malaria.
Tetracyclines will not work against
viral infections such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE
DORYX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DORYX IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
doxycycline
•
other tetracyclines
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or troubled breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING PREPARATIONS CONTAINING
VITAMIN A, ISOTRETINOIN OR
ETRETINATE. ASK YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT SURE IF
YOU ARE TAKING ONE OF THESE
MEDICINES.
DO NOT TAKE THIS MEDICINE IF YOU
ARE MORE THAN 1

Summary of Product characteristics

v 10.0
1
AUSTRALIAN PRODUCT INFORMATON
DORYX
® (DOXYCYCLINE HYCLATE (HYDROCHLORIDE))
CAPSULES
1.
NAME OF THE MEDICINE
Doxycycline hyclate (hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Doryx Capsules contain either 50 mg or 100 mg of doxycycline (as
doxycycline hyclate
(hydrochloride)).
Doryx Capsules also contain lactose and wheat starch. For the full
list of excipients see
Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Doryx capsules contain modified release pellets of doxycycline hyclate
(hydrochloride).
The capsule contains pellets which are coated so as to retard but not
prevent release in
acid media.
Doryx 50 mg capsules are clear capsules marked Doryx 50, containing
yellow pellets.
Doryx 100 mg capsules are clear capsules marked Doryx 100, containing
yellow pellets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NOTE: THE 50 mg CAPSULE IS NOT A PAEDIATRIC FORMULATION.
Doryx is indicated in the treatment of infections caused by the
following micro-
organisms:
_Mycoplasma pneumoniae_
:
primary atypical pneumonia
Rickettsiae: Queensland tick typhus, typhus fever and Q fever
Agents of psittacosis
_Calymmatobacterium (Donovania) granulomitis_
: granuloma inguinale
Agents of lymphogranuloma venereum
Borreliae: relapsing fever
v 10.0
2
_Chlamydia trachomatis_
Doryx 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 Doryx alone, or in combination with topical agents.
Doryx is indicated in the treatment of infections caused by the
following gram negative
micro-organisms:
_Vibrio_
species:
cholera
_Brucella_
species:
brucellosis (in conjunction with streptomycin)
_Yersinia pestis_
:
plague
_Francisella tularensis_
:
tularemia
_Bartonella bacilliformis_
: Bartonellosis
_Bacteroides_
species
When penicillin is contraindicated, doxycycline is an alternative
medicine in the
treatment of infections due to:
_Treponema pallidum_
:
syphilis
_Treponema pertenue_
:
yaws