DOXYLIN 100 doxycycline 100mg (as hyclate) tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

doxycycline hyclate, Quantity: 115 mg (Equivalent: doxycycline, Qty 100 mg)

Dostupné s:

Alphapharm Pty Ltd

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; pregelatinised maize starch; titanium dioxide; lactose monohydrate; hypromellose; indigo carmine; sunset yellow FCF; quinoline yellow; macrogol 4000

Podání:

Oral

Jednotky v balení:

21 tablets, 7 tablets

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Doxycycline is indicated in the treatment of 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; Calymmatobacterium (Donovania) granulomatis: granuloma inguinale; 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.); Doxycycline is indicated in the treatment of infections caused by the following Gram-negative microorganisms: Vibrio species: Cholera; Brucella species: Brucellosis (in conjunction with streptomycin); Yersinia pestis: plague; Francisella tularensis: tularaemia; Bartonella bacilliformis: Bartonellosis; Bacteroides species. Doxycycline is active against both pre-erythrocytic 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, eg. chloroquine. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: Treponema pallidum: syphilis; Treponema pertenue: yaws; Neisseria gonorrhoeae: gonorrhoea. Doxycycline may be a useful adjunct to amoebicides in the treatment of acute intestinal amoebiasis. In the treatment of severe acne, doxycycline may be a useful adjunctive therapy. Doxycycline is not the drug of choice in the following: Any type of staphylococcal infection or infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Enterococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. Doxylin should not be used for these infections unless the organism has been shown to be sensitive. For upper respiratory infections due to group A B-haemolytic streptococci, (including prophylaxis of rheumatic fever), penicillin is the usual drug of choice.

Přehled produktů:

Visual Identification: 8.5mm normal convex, yellow film coated tablet, debossed DE over 100 on one side, G on the reverse.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius

Stav Autorizace:

Registered

Datum autorizace:

1998-05-22

Informace pro uživatele

DOXYLIN
_doxycycline hyclate (as hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about DOXYLIN. 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 DOXYLIN
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 DOXYLIN IS
USED FOR
DOXYLIN is an antibiotic used to:
•
treat certain infections caused by
bacteria
•
control acne
•
prevent certain types of malaria
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.
DOXYLIN also works against
parasites that cause malaria. It is
sometimes used in combination with
other anti-malarial medicines.
Tetracyclines will not work against
infections caused by viruses, 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.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
DOXYLIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DOXYLIN IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
doxycycline
•
any medicines containing 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 difficulty 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 OTHER MEDICINES
CONTAINING VITAMIN A, ISOTRETINOIN
OR ETRETINATE.
DOXYLIN SHOULD NOT BE TAKEN IF
YOU ARE MORE THAN 18 WEEKS
PREGNANT OR ARE BREASTFEEDING.

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION
DOXYLIN
_doxycycline hyclate (as hydrochloride) film coated tablet _
1
NAME OF THE MEDICINE
Doxycycline hyclate (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains doxycycline hyclate hydrochloride equivalent to
50 mg or 100 mg of doxycycline.
Excipients with known effect: lactose monohydrate and trace amounts of
sulfites.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
DOXYLIN 50 mg tablet: round, yellow film coated, marked “DE” over
“50” on one side, “G” on the reverse.
DOXYLIN 100 mg tablet: round, yellow film coated, marked “DE” over
“100” on one side “G” on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NOTE: THE 50 MG TABLET IS NOT A PAEDIATRIC FORMULATION.
Doxycycline is indicated in the treatment of 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
_Calymmatobacterium (Donovania) granulomatis_
: granuloma inguinale
_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.)
Doxycycline
is
indicated
in
the
treatment
of
infections
caused
by
the
following
Gram-negative
microorganisms:
_Vibrio_
species: cholera
_Brucella_
species: Brucellosis (in conjunction with streptomycin)
_Yersinia pestis_
: plague
DOXYLIN – PRODUCT INFORMATION
2
_Francisella tularensis_
: tularaemia
_Bartonella bacilliformis_
: Bartonellosis
_Bacteroides_
species.
Doxycycline is indicated, in adults and children older than 10 years,
as chemoprophylaxis for malaria caused
by
_Plasmodium falcipa