APO-PRAVASTATIN pravastatin sodium 40 mg tablets bottle

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

pravastatin sodium, Quantity: 40 mg

Commercializzato da:

Arrotex Pharmaceuticals Pty Ltd

INN (Nome Internazionale):

pravastatin sodium

Forma farmaceutica:

Tablet, uncoated

Composizione:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; iron oxide yellow; brilliant blue FCF

Via di somministrazione:

Oral

Confezione:

30 tablets, 100 tablets, 500 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephritic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol / L) serum cholesterol levels. Patients with unstable angina pectoris. As an adjunct to diet and lifestyle modification for the treatment of heterozygenous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older.

Dettagli prodotto:

Visual Identification: Light green, round, unscored tablets, imprinted "APO" on one side and "PRA" over "40" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2010-01-11

Scheda tecnica

1
AUSTRALIAN PRODUCT INFORMATION
APO-PRAVASTATIN
(PRAVASTATIN SODIUM) TABLET
1
NAME OF THE MEDICINE
Pravastatin sodium.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg, 20 mg, 40 mg or 80 mg of pravastatin
sodium, as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
10 MG TABLETS:
Light pink, round, unscored tablets, imprinted “APO” on one side
and “PRA” over “10” on the
other side.
20 MG TABLETS:
Off-white to light yellow, round, unscored tablets, imprinted
“APO” on one side and “PRA” over
“20” on the other side.
40 MG TABLETS:
Light green, round, unscored tablets, imprinted “APO” on one side
and “PRA” over “40” on the
other side.
80 MG TABLETS:
Off-white to light yellow, round, unscored tablets, imprinted
“APO” on one side and “PRA” over
“80” on the other side.
2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pravastatin is indicated:
•
as an adjunct to diet for the treatment of hypercholesterolaemia.
Prior to initiating therapy
with pravastatin, secondary causes of hypercholesterolaemia (e.g.
poorly controlled
diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinaemias, obstructive
liver disease, other drug therapy, alcoholism) should be identified
and treated.
•
in patients with previous myocardial infarction including those who
have normal (4.0 to 5.5
mmol/L) serum cholesterol levels.
•
in patients with unstable angina pectoris (see section 5.1
PHARMACODYNAMIC PROPERTIES
- CLINICAL TRIALS).
•
as an adjunct to diet and lifestyle modification for the treatment of
heterozygous familial
hypercholesterolaemia in children and adolescent patients aged 8 years
and older (see
section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Pravastatin tablets are intended for oral administration
DOSAGE
Prior to initiating pravastatin, the patient should be placed on a
standard ch