APO-PRAVASTATIN pravastatin sodium 10 mg tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pravastatin sodium, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

pravastatin sodium

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

30 tablets, 100 tablets, 500 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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 heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older.

Product summary:

Visual Identification: Light pink, round, unscored tablets, imprinted "APO" on one side and "PRA" over "10" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-01-11

Summary of Product characteristics

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