STOCRIN efavirenz 300mg tablet bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

efavirenz, Quantity: 300 mg

Disponible desde:

Merck Sharp & Dohme (Australia) Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; hyprolose; lactose monohydrate; magnesium stearate; Carnauba Wax; titanium dioxide; hypromellose; macrogol 400; propylene glycol; indigo carmine; purified water; isopropyl alcohol; cochineal

Vía de administración:

Oral

Unidades en paquete:

60 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

STOCRIN is indicated for use in combination with other antiviral agents for the treatment of HIV-1 infection in adults and children. (See Clinical Trails; Use in Children)

Resumen del producto:

Visual Identification: WHITE CAPSULAR FILM-COATED TABLETS WITH "224" IN PURPLE INK ON BOTH SIDES.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2002-08-29

Ficha técnica

AUSTRALIAN PRODUCT INFORMATION
STOCRIN
®
(efavirenz) Tablets
1 NAME OF THE MEDICINE
Efavirenz
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Efavirenz is a white to slightly pink crystalline powder.
STOCRIN is available as tablets for oral administration. Each STOCRIN
tablet contains 50, 200, 300 or
600 mg of efavirenz.
List of excipients with known effect: contains sugars (as lactose).
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
STOCRIN 50mg tablets are yellow, round shaped tablets with "113" on
one side and plain on the other.
STOCRIN 200mg tablets are yellow, round shaped tablets with "223" on
one side and plain on the
other.
STOCRIN 300mg tablets are white, capsular film-coated tablets with
"224" in purple ink on both sides.
STOCRIN 600mg tablets are yellow, capsular film-coated tablets with
"225" in purple ink on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
STOCRIN is indicated for use in combination with other antiviral
agents for the treatment of HIV-1
infection in adults and children (See section 5.1 Pharmacodynamic
properties Use in Children).
4.2 DOSE AND METHOD OF ADMINISTRATION
STOCRIN should be taken in the fasted state, preferably at bedtime.
Food increases the bioavailability
of STOCRIN and this may be associated with a higher frequency of side
effects.
In order to improve the tolerability of nervous system side effects,
bedtime dosing is recommended
during the first two to four weeks of therapy and in patients who
continue to experience these symptoms
(see section 4.8 Adverse effects (undesirable effects)).
Concomitant Antiretroviral Therapy:
STOCRIN must be given in combination with other antiretroviral
medications (see section 4.5
Interactions with other medicines and other forms of interactions).
Adults:
The recommended dosage of STOCRIN in combination with a protease
inhibitor and/or nucleoside
analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally,
once daily.
Adolescents and Children (17 years and under):
The recommend