Doxine
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
02-01-2024
Summary of Product characteristics
(SPC)
31-01-2024
Active ingredient:
Doxycycline hyclate 115mg equivalent to Doxycycline 100 mg; ; ; ; Doxycycline hyclate 115mg equivalent to Doxycycline 100 mg; Doxycycline hyclate 115mg equivalent to 100 mg doxycycline
Available from:
Viatris Limited
INN (International Name):
Doxycycline hyclate 115 mg (=Doxycycline 100 mg)
Dosage:
100 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Doxycycline hyclate 115mg equivalent to Doxycycline 100 mg Excipient: Carnauba wax Colloidal silicon dioxide Colour film coat 5511 Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Active: Doxycycline hyclate 115mg equivalent to Doxycycline 100 mg Excipient: Carnauba wax Colloidal silicon dioxide Diethyl phthalate Ethanol Hypromellose Magnesium stearate Microcrystalline cellulose Opaspray yellow K-1F-6012B Pregelatinised maize starch Purified water Active: Doxycycline hyclate 115mg equivalent to 100 mg doxycycline Excipient: Colloidal silicon dioxide Magnesium stearate Microcrystalline cellulose Opadry yellow OY-LS-32814 Pregelatinised maize starch
Units in package:
Bottle, plastic, HDPE, 250 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Hovione PharmaScience Limited
Therapeutic indications:
Doxycycline is indicated in the treatment of uncomplicated chest, urethral, endocervical or rectal infections in adults caused by susceptible organisms (see Actions) as shown by culture and sensitivity testing. It may also be a useful adjunct to amoebicides in acute intestinal amoebiasis and has a place as adjunctive therapy in severe acne.
Product summary:
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 250 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 500 tablets - 24 months from date of manufacture stored at or below 25°C
Authorization date:
1982-12-17
Patient Information leaflet
Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DOXINE
_DOXYCYCLINE FILM COATED TABLET 100 MG _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking DOXINE.
This leaflet answers some common
questions about DOXINE.
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 DOXINE
against the benefits they expect it
will 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 DOXINE IS
TAKEN FOR
DOXINE is taken to treat infections
of the chest, urethra, womb and
rectum.
DOXINE may be used in
combination with amoebicides,
which are used to treat parasites.
DOXINE may also be used to treat
severe acne.
DOXINE contains the active
ingredient doxycycline. It is a broad
spectrum antibiotic. This means it
can be used to treat a wide range of
organisms.
Doxycycline belongs 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.
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 available only with
a doctor’s prescription.
BEFORE YOU TAKE
DOXINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DOXINE IF YOU HAVE
AN ALLERGY TO:
•
doxycycline
•
other tetracycline antibiotics
(e.g. minocycline)
•
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 DOXINE IF YOU ARE
TAKING PREPARATIONS CONTAINING
VITAMIN A (E.G. VESANOID),
ISOTRETINOIN (E.G. ISOTANE,
ORATANE) OR ETRETINATE.
DO NOT GIVE THIS MEDICIN
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Summary of Product characteristics
Page 1 of 10
NEW ZEALAND DATA SHEET
DOXINE
1. PRODUCT NAME
DOXINE, 100 mg, film-coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains doxycycline hyclate 115 mg,
equivalent to 100 mg doxycycline.
Excipients with known effect: Microcrystalline Cellulose,
Pregelatinised Maize Starch and Opadry II
Yellow.
Allergen Declaration: Lactose and sulfites.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Yellow, film-coated, normal convex tablets, 8.5 mm diameter, debossed
‘DE’ over ‘100’ on one side,
‘G’ on the reverse.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Doxycycline is indicated in the treatment of uncomplicated chest,
urethral, endocervical or rectal
infections in adults caused by susceptible organisms (see section 5.1)
as shown by culture and
sensitivity testing. It may also be a useful adjunct to amoebicides in
acute intestinal amoebiasis and
has a place as adjunctive therapy in severe acne.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
The usual dose in adults is 200 mg on the first day of treatment
followed by a maintenance dose of
100 mg/day. This may be given as either a single dose or divided doses
administered every 12
hours.
In the management of more severe infections, 200 mg daily should be
given throughout the treatment
period. Therapy should be continued at least 24 - 48 hours after
symptoms and fever has subsided.
If used in streptococcal infections, therapy should be continued for
10 days to prevent the
development of rheumatic fever or glomerulonephritis.
For children over 12 years of age, the recommended dosage schedule for
those under 50 kg is 4
mg/kg on the first day and 2 mg/kg daily subsequently. For children
over 50 kg the usual adult dose
is used.
In the treatment of acute gonococcal anterior urethreitus in males,
administer either: 200 mg stat
and 100 mg at bedtime on the first day followed by 100 mg twice daily
for 3-7 days, or 300 mg stat
followed by 300 mg one hour later. For acute gonococcal infections in
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