APO-PRAVASTATIN pravastatin sodium 80 mg tablet bottle

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

pravastatin sodium, Quantity: 80 mg

Tilgængelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

pravastatin sodium

Lægemiddelform:

Tablet, uncoated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

100 tablets, 500 tablets, 30 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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. Pravastatin is indicated in patients: with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels; with unstable angina pectoris (see ACTIONS, 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 ACTIONS, CLINICAL TRIALS).

Produkt oversigt:

Visual Identification: Off-white to light yellow, round, unscored tablet, imprinted 'APO' on one side and 'PRA' over '80' on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2008-09-24

Produktets egenskaber

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