IPCA-HYDROXYCHLOROQUINE hydroxychloroquine sulfate 200 mg tablets bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

hydroxychloroquine sulfate, Quantity: 200 mg

제공처:

Ipca Pharma (Australia) Pty Ltd

INN (International Name):

Hydroxychloroquine sulfate

약제 형태:

Tablet

구성:

Excipient Ingredients: colloidal anhydrous silica; calcium hydrogen phosphate; magnesium stearate; hypromellose; polysorbate 80; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

관리 경로:

Oral

패키지 단위:

100

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

제품 요약:

Visual Identification: White to off white capsule shaped tablets embossed HCQS on one side plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2012-04-13

제품 특성 요약

IPCA-HYDROXYCHLOROQUINE TABLETS 200 MG
NAME OF THE MEDICINE
Hydroxychloroquine sulfate 200 mg
Chemical Name:
(_RS_)-2-N-[4-(7-chloro-4-quinolylamino)pentyl]-_N_-ethylaminoethanol
sulfate
Structural Formula:
Molecular Formula: C
18
H
26
ClN
3
O.H
2
SO
4
Molecular Weight: 433.95
CAS Registry Number: 747-36-4
DESCRIPTION
Hydroxychloroquine sulfate is a colourless crystalline solid, soluble
in water to at least 20%. Each tablet contains
200 mg hydroxychloroquine sulfate, which is equivalent to 155 mg base.
In addition, each tablet contains the
following
inactive
ingredients:
anhydrous
calcium
hydrogen
phosphate,
pregelatinised
maize
starch,
hypromellose, magnesium stearate, polysorbate 80, colloidal anhydrous
silica and Proprietary Ingredient Opadry
II White 85F18422.
PHARMACOLOGY
Hydroxychloroquine is an anti-malarial. It also exerts a beneficial
effect in mild systemic and discoid lupus
erythematosus and rheumatoid arthritis. The precise mechanism of
action is not known.
Like chloroquine phosphate, hydroxychloroquine is highly active
against the erythrocytic forms of _Plasmodium _
_vivax _and _P. malariae _and most strains of _P. falciparum _(but not
the gametocytes of _P. falciparum_).
Hydroxychloroquine does not prevent relapses in patients with vivax or
malariae malaria because it is not
effective against exo-erythrocytic forms of the parasite, nor will it
prevent vivax or malariae infection when
administered as a prophylactic. It is highly effective as a
suppressive agent in patients with vivax or malariae
malaria, in terminating acute attacks and significantly lengthening
the interval between treatment and relapse. In
patients with falciparum malaria, it abolishes the acute attack and
effects complete cure of the infection, unless
due to a resistant strain of _P. falciparum_.
INDICATIONS
Rheumatoid arthritis; mild systemic and discoid lupus erythematosus;
the suppression and treatment of malaria.
CONTRAINDICATIONS
Hydroxychloroquine is contraindicated in:
•
patients with pre-existing maculopathy of the eye;