ROZEX metronidazole 7.5mg/g cream tube

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

metronidazole, Quantity: 7.5 mg/g

থেকে পাওয়া:

Galderma Australia Pty Ltd

INN (আন্তর্জাতিক নাম):

Metronidazole

ফার্মাসিউটিকাল ফর্ম:

Cream

রচনা:

Excipient Ingredients: benzyl alcohol; isopropyl palmitate; glycerol; sorbitol solution (70 per cent) (non-crystallising); emulsifying wax; lactic acid; purified water

প্রশাসন রুট:

Topical

প্যাকেজ ইউনিট:

5g, 3g, 15g, 50g, 30g

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Rozex cream is indicated for the treatment of inflammatory papules and pustules of rosacea.

পণ্য সারাংশ:

Visual Identification: White to beige shiny cream; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Licence status A

অনুমোদন তারিখ:

2002-02-27

তথ্য লিফলেট

ROZEX
®
CREAM
_METRONIDAZOLE 0.75%_
CONSUMER MEDICINE INFORMATION
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ROZEX CREAM. Please
read this leaflet
carefully before you start using the cream. It does not contain all
the information available on
this medicine. 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 using ROZEX
CREAM against the benefits it might have for you. If you have concerns
about using this
medicine ask your doctor or pharmacist.
Keep this leaflet with your tube. You may wish to read it again later.
WHAT ROZEX CREAM IS USED FOR
ROZEX CREAM is used for the treatment of inflammatory papules and
pustules of rosacea.
Skin affected by rosacea has one or more of the following features: a
redness that looks like a
blush; pimples; small knobbly lumps on the nose and / or thin red
lines due to enlarged blood
vessels.
The active ingredient in ROZEX CREAM is metronidazole which belongs to
the class of
medicines known as antiprotozoals and antibacterials.
It is not clear how ROZEX CREAM works however it may have
antibacterial and anti-
inflammatory action.
Preparations which are applied to the skin such as ROZEX CREAM can be
used in
combination with other oral medications prescribed by your doctor.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ROZEX CREAM HAS
BEEN
PRESCRIBED FOR YOU. Your doctor may have prescribed it for another
reason.
BEFORE YOU USE ROZEX CREAM
_WHEN YOU MUST NOT USE IT _
_ _
Do not use ROZEX CREAM:
•
if you have an allergy to metronidazole or any of the inactive
ingredients in the cream
•
if you have or ever have had a blood disorder
•
to treat your child’s skin problem. ROZEX CREAM has not been studied
for use in
children.
•
if you are pregnant. There are no well controlled studies of therapy
with ROZEX
CREAM in pregnant women.
Symptoms of an allergic reaction may include:
•
swelling of the face, lips, tongue or other parts of the body
•

পণ্য বৈশিষ্ট্য

1
PRODUCT INFORMATION
ROZEX CREAM
_(metronidazole)_
NAME OFTHE MEDICINE:
ROZEX cream (metronidazole 7.5 mg/g)
AAN:
Metronidazole
CHEMICAL NAME:
2-methyl-5-nitroimidazole-1-ethanol
MOLECULAR FORMULA:
C
6
H
9
N
3
O
3
CAS REGISTRY NUMBER:
443-48-1
MOLECULAR WEIGHT:
171.16
CHEMICAL CLASS:
Antiprotozoal and antibacterial agent.
CHEMICAL STRUCTURE:
N
N
C H
2
C H
2
O H
O
2
N
C H
3
C
6
H
9
N
3
O
3
; _M_ r 1 7 1 .1 6
DESCRIPTION
Contains 0.75% w/w metronidazole as the active ingredient in an
oil-in-water cream base containing
benzyl alcohol, isopropyl palmitate, glycerol, sorbitol 70%
(non-crystallising), emulsifying wax, lactic
acid or sodium hydroxide solutions to adjust pH and purified water.
PHARMACOLOGY
Metronidazole is an antiprotozoal (trichomoniasis, amoebiasis,
giardiasis) and anaerobic antibacterial
agent. However the mechanisms by which Rozex acts in reducing
inflammatory lesions of rosacea
are unknown.
_Pharmacokinetics_.
Following a single topical 1 gram application of Rozex cream to the
face of twelve normal human
subjects, a mean maximum serum metronidazole concentration of
32.9ng.ml
-1
was reported (range:
14.8 to 54.4 ng.ml
-1
). This is less than 0.5% of the mean maximum metronidazole
concentration
reported in the same subjects administered a single oral 250 mg tablet
of metronidazole (mean C
max
=
7248 ng.ml
-1
, range:4270 to 13970 ng.ml
-1
). The T
lag
and T
max
for metronidazole after topical
administration of the cream formulation were significantly (p<0.05)
prolonged when compared with
oral administration. In comparison to the oral tablet the mean T
max
for the topical formulation occurred
7.0 hours later (95% confidence interval: 2.7 to 11.3 hours).
The hydroxymetabolite (2-hydroxymethylmetronidazole) C
max
after the 250 mg oral dose ranged from
626 to 1788 ng. ml
-1
and peaked betweem 4 and 12 hours. Following topical application of
Rozex
cream the hydroxymetabolite serum concentrations were below the
quantifiable limit of the assay
(<9.6 ng. ml
-1
) at the majority of time points. The hydroxymet