PRO-CID probenecid 500mg tablet bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

製品の特徴 製品の特徴 (SPC)
24-08-2020
公開評価報告書 公開評価報告書 (PAR)
13-05-2019

有効成分:

probenecid, Quantity: 500 mg

から入手可能:

Phebra Pty Ltd

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: colloidal anhydrous silica; sodium starch glycollate; stearic acid; magnesium stearate; maize starch; microcrystalline cellulose; povidone; macrogol 8000; hypromellose; macrogol 400; titanium dioxide; sunset yellow FCF; polysorbate 80; quinoline yellow

投与経路:

Oral

パッケージ内のユニット:

100 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

INDICATIONS AS AT 25 MAY 2000 : Gout - Probenecid is a uricosuric agent for the treatment of hyperuricaemia in all stages of gout and gouty arthritis except an acute attack. Asymptomatic hyperuricaemia seems to occur in a significant percentage of relatives of gouty patients. Probenecid may be given prophylactically to these people to forestall gouty attacks and urate deposition in tissues. By virtue of its effective uricosuric activity, probenecid may be used to control the hyperuricaemia induced or aggravated by many diuretics employed for the treatment of oedema and hypertension (e.g. thiazides and smiliar diuretics). B-Lactam Antibiotic Therapy - Probenecid is indicated for the elevation and prolongation of plasma levels by whatever route the antibiotic is given. A two-to-fourfold increase in plasma levels has been demonstrated for benzylpenicillin, phenoxymethylpenicillin, the synthetic penicillins, ampicillin, methicillin, oxacillin, cloxacillin, nafcillin, carbenicillin, and for the cephamycin, MEFOXIN (cefoxitin sodium, MSD), and the cephalosporins, cephalothin, cephalexin and cephaloglycin. Because of its mechanisim of action, probenecid is not recommended in conjunction with a B-lactam antibiotic in the presence of known renal impairment. Concurrent Treatment with Cidofovir for CMV retinitis in HIV patients. Probenecid is recommended to be administered concomitantly with cidofovir, as the combination reduces the potential for nephrotoxicity associated with cidofovir.

製品概要:

Visual Identification: A capsule-shaped, yellow, film-coated tablet, bisected on one side and plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

認証ステータス:

Registered

承認日:

2000-06-05

情報リーフレット

                                PRO-CID™
Page 1 of 4
_Version 02 _
PRO-CID™
_Probenecid_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRO-CID. 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 PRO-CID 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 PRO-CID IS USED
FOR
PRO-CID is used to prevent gout or
gouty arthritis. It is not used to treat an
acute attack of gout.
PRO-CID helps remove excess uric
acid from the body which helps prevent
uric acid crystals forming deposits in
some joints. This will help prevent
joints becoming swollen and painful.
PRO-CID can also help increase the
level of certain antibiotics in the blood
which helps increase the effectiveness
of the antibiotics to treat an infection.
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.
BEFORE YOU TAKE
PRO-CID
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PRO-CID IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
probenecid
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction are:
•
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 HAVE
CERTAIN BLOOD DISORDERS.
Your doctor
will advise you.
DO NOT TAKE THIS MEDICINE IF YOU
CURRENTLY HAVE, OR ARE PRONE TO,
KIDNEY STONES.
DO NOT TAKE THIS MEDICINE IF YOU ARE
TAKING ASPIRIN OR ANY MEDICINES
CONTAINING ASPIRIN.
DO NOT START TO TAKE THIS MEDICINE IF
YOU HAVE AN ACUTE ATTACK OF GOUT.
Other medication may be needed to
relieve the symptoms of an acute attack
of gou
                                
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製品の特徴

                                PRODUCT INFORMATION
Australian Product Information- PRO-CID™
Page 1 of 9
Version 02
PRO-CID
TM
(PROBENECID TABLETS 500 MG)
1
NAME OF THE MEDICINE
Probenecid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PRO-CID tablet contains 500 mg probenecid.
Probenecid is a white or nearly white, fine, crystalline powder. It is
slightly bitter with a pleasant aftertaste.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
PRO-CID 500 mg tablets are a yellow capsule-shaped film coated tablet,
bisected on one side, with no embossing.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PRO-CID is indicated for:
GOUT
Probenecid is a uricosuric agent for the treatment of hyperuricaemia
in all stages of gout and gouty arthritis except
an acute attack.
Asymptomatic hyperuricaemia seems to occur in a significant percentage
of relatives of gouty patients. Probenecid
may be given prophylactically to these people to forestall gouty
attacks and urate deposition in tissues.
By virtue of its effective uricosuric activity, probenecid may be used
to control the hyperuricaemia induced or
aggravated by many diuretics employed for the treatment of oedema and
hypertension (eg thiazides and similar
diuretics).
Β-LACTAM ANTIBIOTIC THERAPY
Probenecid is indicated for the elevation and prolongation of plasma
levels by whatever route the antibiotic is given.
A two-to-fourfold increase in plasma levels has been demonstrated for
benzylpenicillin, phenoxymethylpencillin,
the synthetic penicillins, ampicillin, methicillin, oxacillin,
cloxacillin, nafcillin, carbenicillin, and for the cephamycin,
Mefoxin
TM
(cefoxitin sodium, MSD), and the cephalosporins, cephalothin,
cephalexin and cephaloglycin.
Because of its mechanism of action, probenecid is not recommended in
conjunction with a Β-lactam antibiotic in
the presence of known renal impairment.
CONCURRENT TREATMENT WITH CIDOFOVIR FOR CMV RETINITIS IN HIV PATIENTS
PRODUCT INFORMATION
PRO-CID™
(PROBENECID TABLETS 500 MG)
Australian Product Information- PRO-CID
                                
                                完全なドキュメントを読む