Mayne Pharma Doxycycline

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

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Download Bijsluiter (PIL)
12-06-2024
Download Productkenmerken (SPC)
12-06-2024

Werkstoffen:

Doxycycline hydrochloride

Beschikbaar vanaf:

Mayne Pharma International Pty Ltd

klasse:

Medicine Registered

Bijsluiter

                                MAYNE PHARMA DOXYCYCLINE 
CAPSULES
 
_ _
doxycycline hydrochloride _(dox-I-SYE-kleen)_
 
 
 
CONSUMER MEDICINE INFORMATION
 
 
_Date of Dispensing_
 
_Consumer Name _
_   Pharmacist Name _
_Consumer Address _
_  Pharmacist Address _
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 benefits and 
risks. 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 sympto
                                
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Productkenmerken

                                Product Information - Australia 
 
MAYNE PHARMA DOXYCYCLINE CAPSULES 
 
 
NAME OF DRUG 
Doxycycline hydrochloride 
 
 
DESCRIPTION 
Doxycycline is a broad spectrum antibiotic synthetically derived from
oxytetracycline.  The 
chemical designation of this light-yellow crystalline powder is
6-deoxy-5-oxytetracycline.  
Doxycycline has a high degree of lipid solubility and a low affinity
for calcium binding.  It is 
highly stable in normal human serum.  Doxycycline will not degrade
into an epianhydro form. 
 
The chemical structure of doxycycline hydrochloride is shown below: 
Molecular formula: C
22
H
24
N
2
O
8
.HCl,½[C
2
H
5
OH.H
2
O]
 
  
MW: 512.9 
 
OH
O
OH
O
OH
CONH
2
Me
H
H
OH
NMe
2
OH
H
H
.HCl .½
C
2
H
5
OH. ½H
2
O 
 
CAS No: 24390-14-5 
 
Mayne Pharma Doxycycline Capsules contain modified-release pellets of
doxycycline 
hydrochloride.  The capsule contains pellets which are coated so as
to retard but not prevent 
release in acid media.  Excipients include lactose, cellulose,
povidone, hydroxypropyl 
methylcellulose phthalate, hypromellose, diethyl phthalate, gelatin,
shellac, carbon black, 
wheat starch, magnesium stearate and hydroxypropylcellulose. 
 
 
PHARMACOLOGY 
Doxycycline is virtually completely absorbed after oral
administration.  Its absorption is not 
significantly affected by the presence of food or milk.  Following a
200 mg dose, normal adult 
volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at
2 hours decreasing 
to 1.45 mcg/mL at 24 hours.  Excretion of doxycycline by the kidney
is about 40 percent /72 
hours in individuals with normal renal function (creatinine clearance
above 75 mL/min).  This 
percentage may fall as low as 1-5 percent/72 hours in individuals with
severe renal 
insufficiency (creatinine clearance below 10 mL/min).  Studies have
shown no significant 
difference in serum half-life of doxycycline range (18-22 hours) in
individuals with normal 
and impaired renal function. 
 
The proportion of drug that
                                
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