MAYNE PHARMA DOXYCYCLINE 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

INN (International Name):

doxycycline hyclate (hydrochloride)

Pharmaceutical form:

Capsule, modified release

Composition:

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

Administration route:

Oral

Units in package:

7, 21

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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. MAYNE PHARMA Doxycycline Capsules are 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. MAYNE PHARMA Doxycycline Capsules are 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 Capsules alone, or in combination with topical agents. MAYNE PHARMA Doxycycline 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 drug in the treatment of infections due to: Treponema pallidum: syphilis. Treponema pertenue: yaws. Neisseria gonorrhoea: gonorrhoea (see Dosage and Administration). MAYNE PHARMA Doxycycline Capsules is not the drug of choice in the treatment of any type of Staphylococcal infection or infections caused by 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. Doxycycline should not be used in these infections unless the organism has been shown to be sensitive. For upper respiratory tract infections due to group A beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. Doxycycline is active against both pre-erythroycitic and asexual bloodstages of Plasmodium falciparum. The tetracyclines are only partially active against the pre-erythrocytic stages of Plasmodium vivax and protection depends on drug suppression of the blood stages. Doxycycline has no activity against the relapsing forms (hypnozoites) of Plasmodium vivax. 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. In acute intestinal amoebiasis MAYNE PHARMA Doxycycline Capsules may be a useful adjunct to amoebicides. In severe acne MAYNE PHARMA Doxycycline Capsules may be a useful adjunctive therapy.

Product summary:

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

Authorization status:

Registered

Authorization date:

2004-09-14

Patient Information leaflet

MAYNE PHARMA DOXYCYCLINE CAPSULES
1
MAYNE PHARMA
DOXYCYCLINE CAPSULES
_doxycycline hyclate (hydrochloride) (dox-I-SYE-kleen) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Mayne Pharma
Doxycycline Capsules. 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 Mayne
Pharma Doxycycline Capsules
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 DOXYCYCLINE
CAPSULES ARE USED FOR
This medicine 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
DOXYCYCLINE CAPSULES
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DOXYCYCLINE CAPSULES
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
E

Summary of Product characteristics

v 5.0
1
AUSTRALIAN PRODUCT INFORMATON
MAYNE PHARMA DOXYCYCLINE (DOXYCYCLINE HYCLATE
(HYDROCHLORIDE)) CAPSULES
1.
NAME OF THE MEDICINE
Doxycycline hyclate (hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mayne Pharma Doxycycline Capsules contain either 50 mg or 100 mg of
doxycycline (as
doxycycline hyclate (hydrochloride)).
Mayne Pharma Doxycycline Capsules also contain lactose and wheat
starch. For the full
list of excipients see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Mayne Pharma Doxycycline 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.
Mayne Pharma Doxycycline Capsules 50 mg are clear capsules marked doxy
50,
containing yellow pellets.
Mayne Pharma Doxycycline Capsules 100 mg are clear capsules marked
doxy 100,
containing yellow pellets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
NOTE: THE 50 mg CAPSULE IS NOT A PAEDIATRIC FORMULATION.
Mayne Pharma Doxycycline Capsules are 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
v 5.0
2
Borreliae: relapsing fever
_Chlamydia trachomatis_
Mayne Pharma Doxycycline Capsules are 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 Capsules
alone, or in
combination with topical agents.
Mayne Pharma Doxycycline Capsules are 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_
: B