VIBRAMYCIN TABLET 100MG

国家: 马来西亚

语言: 英文

来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

有效成分:

DOXYCYCLINE HYDROCHLORIDE/HYCLATE

可用日期:

PFIZER (MALAYSIA) SDN. BHD.

INN（国际名称）:

DOXYCYCLINE HYDROCHLORIDE/HYCLATE

每包单位数:

100Tablet Tablets

厂商:

PFIZER PHARMACEUTICALS LIMITED

资料单张

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
VIBRAMYCIN
®
TABLET
Doxycycline Hydrochloride (100 mg)
1
WHAT IS IN THIS LEAFLET
1.
What VIBRAMYCIN is used for
2.
How VIBRAMYCIN works
3.
Before you use VIBRAMYCIN
4.
How to use VIBRAMYCIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
VIBRAMYCIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT VIBRAMYCIN IS USED FOR
VIBRAMYCIN is an antibiotic. It is
used to treat many bacterial infections
such as:
- Fever associated with louse or tick bites
(typhus fever)
- Chest, lung or nasal infections e.g.
pneumonia
- Sexually transmitted diseases e.g.
gonorrhoea, syphilis, chlamydia
- Urinary tract infections (the passage
through which urine passes) e.g.
urethritis
It is also used for the prevention and
treatment of malaria (when chloroquine
is not effective), leptospirosis (a bacteria
carried by animals and found in soil and
water), and cholera.
It is used with other medicines to treat
acne and intestinal parasites. It is also
used to prevent scrub typhus and
traveler's diarrhea.
HOW VIBRAMYCIN WORKS
VIBRAMYCIN kills or prevents bacteria
from growing.
BEFORE YOU USE VIBRAMYCIN
-
_When you must not use it_
Do not use VIBRAMYCIN if you are
allergic to doxycycline or any of its
other ingredients or any other
tetracycline.
_Pregnancy and lactation_
Do not take VIBRAMYCIN if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take VIBRAMYCIN if you are
breast-feeding. Doxycycline is present in
the milk of breastfeeding women. Ask
your doctor or pharmacist for advice
before taking any medicine.
-
_Before you start to use it_
Tell your doctor if
- you are in the last half of pregnancy
or the medicine has been prescribed
for a child under the age of 8 years as
it may cause permanent
discolouration of teeth (yellow-gray-
brown).
- you have diarrhoea or usually get
diarrhoea when you take antibiotics.
If you develop severe diarrhoea
during or after

产品特点

Pfizer Confidential
1
VIBRAMYCIN
Doxycycline Hydrochloride
1. NAME OF THE MEDICINAL PRODUCT
VIBRAMYCIN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxycycline is a broad-spectrum antibiotic synthetically derived from
oxytetracycline and is available
as doxycycline hyclate (hydrochloride hemiethanolate hemihydrate). The
chemical designation of this
light-yellow crystalline powder is alpha-6-deoxy-5-oxytetracycline.
Doxycycline has a high degree of
lipoid solubility and a low affinity for calcium binding. It is highly
stable in normal human serum.
Doxycycline will not degrade into an epianhydro form.
3. PHARMACEUTICAL FORM
Doxycycline is available as:
Film-coated tablets containing 100 mg of doxycycline as the hyclate
salt.
DESCRIPTION
Doxycycline film-coated tablets are a smooth, well formed, round
biconvex, white film-coated tablet,
8.1 mm in diameter, debossed with “PT” and “097” on one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT:
Doxycycline is indicated for treatment of the following infections:
Rocky Mountain spotted fever, typhus fever and the typhus group;
Q fever, rickettsial pox and tick fevers caused by _Rickettsiae_;
Respiratory infections caused by _Mycoplasma pneumoniae_;
Psittacosis caused by _Chlamydia psittaci_;
Lymphogranuloma venereum, caused by _Chlamydia trachomatis_;
Uncomplicated urethral, endocervical or rectal infections in adults
caused by _ Chlamydia _
_trachomatis_;
Trachoma caused by _ Chlamydia trachomatis _ although the infectious
agent is not always
eliminated, as judged by immunofluorescence;
Pfizer Confidential
2
Inclusion conjunctivitis caused by _Chlamydia trachomatis _may be
treated with oral doxycycline
alone or with a combination of topical agents;
Granuloma inguinale (donovanosis) caused by _Calymmatobacterium
granulomatis_;
Early (Stage 1) Lyme disease caused by _Borrelia burgdorferi_;
Louse-borne relapsing fever caused by _Borrelia recurrentis_;
Tick-borne relapsing fever caused by _Borrelia duttonii_;
Non-gonococcal urethritis (NGU) caused b