Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
hydroxychloroquine sulfate, Quantity: 200 mg
Ipca Pharma (Australia) Pty Ltd
Hydroxychloroquine sulfate
Tablet
Excipient Ingredients: colloidal anhydrous silica; calcium hydrogen phosphate; magnesium stearate; hypromellose; polysorbate 80; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Oral
100
(S4) Prescription Only Medicine
Rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.
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
Licence status A
2012-04-13
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; Lire le document complet