Consumer medicine information

1. Why am I taking CHOLSTAT?

CHOLSTAT contains the active ingredient pravastatin sodium. CHOLSTAT is used to lower cholesterol levels in your blood and reduce the risk of further heart disease or having a heart attack or stroke. It is more effective if it is taken with a diet low in fat.
For more information, see Section 1. Why am I taking CHOLSTAT? in the full CMI.

2. What should I know before I take CHOLSTAT?

Do not take if you have ever had an allergic reaction to pravastatin sodium or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take CHOLSTAT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CHOLSTAT and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take CHOLSTAT?

• Your doctor will decide on the right dose for you after taking into consideration a number of factors including your cholesterol level and any other medicines that you are taking.

• Follow all directions given to you by your doctor and pharmacist carefully.

5. What should I know while taking CHOLSTAT?

6. Are there any side effects?

Common side effects include: headache, dizziness, nausea, vomiting, upset stomach, wind, constipation, diarrhoea, blurred or double vision, ringing in the ears, nervousness, sleep disturbance, tiredness, scalp and hair problems and passing urine too often.
Serious side effects include: skin rash, itching or hives, symptoms of an allergic reaction including swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath, unexplained muscle pain, cramping tenderness and/or weakness (including eye and facial muscle) and joint pain.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Pravastatin sodium.

2 Qualitative and Quantitative Composition

Each tablet contains 10 mg, 20 mg or 40 mg of pravastatin sodium as the active ingredient.
Excipients with known effect. Soya bean products and sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cholstat 10: Pravastatin 10 mg tablets; white to off-white, capsule shaped, biconvex tablets with "G/G" on one side and "PR/10" on the other side.
Cholstat 20: Pravastatin 20 mg tablets; white to off-white, capsule shaped, biconvex tablets with "G/G" on one side and "PR/20" on the other side.
Cholstat 40: Pravastatin 40 mg tablets; white to off-white, capsules shaped, biconvex tablets with "G" on one side and "PR 40" on the other side.

4 Clinical Particulars

4.9 Overdose

Symptoms. There has been limited experience with overdosage of pravastatin. To date, there are two reported cases, both of which were asymptomatic and not associated with clinical laboratory test abnormalities. Of these two cases, one occurred in a clinical trial patient who ingested 3 g pravastatin; the other ingested 280 mg pravastatin, as marketed tablets. Both cases also involved overdose of concomitant medications.
Treatment. Should overdose occur, treat symptomatically and institute supportive measures as required.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. In six genetic toxicology studies performed with pravastatin, there was no evidence of mutagenic potential at the chromosomal or gene level.
Carcinogenicity. In a 2 year oral study of rats, a statistically significant increase in the incidence of hepatocellular carcinomas was observed in male rats given 100 mg/kg daily of pravastatin. This change was not seen in male rats given 40 mg/kg or less, or in female rats at doses up to 100 mg/kg daily. Increased incidences of hepatocellular carcinomas were also observed in male and female mice dosed with pravastatin at 250 and 500 mg/kg daily, but not at 100 mg/kg/day or less. An increased incidence of pulmonary adenomas was seen in female mice dosed at 250 mg/kg/day. The AUC value for the serum concentration of pravastatin at the no effect dose level of 100 mg/kg/day in mice was 2 times higher than that in humans receiving 80 mg pravastatin per day.
The hepatocarcinogenic effect of pravastatin in rats is associated with proliferation of hepatic peroxisomes. Other HMG-CoA reductase inhibitors (simvastatin and lovastatin) also induce hepatic peroxisome proliferation and hepatocellular carcinomas in rats and mice. The clinical significance of these findings is unclear.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Pravastatin sodium is an odourless, white to off white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/water) of 0.59 at a pH of 7.0. It is freely soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform and ether.
Chemical structure. (3R,5R)-7- [(1S,2S,6S,8S,8aR)- 1,2,6,7,8,8a- hexahydro-6-hydroxy- 2-methyl-8-[(S)-2- methylbutyryloxy- 1-naphthyl]]-3,5 -dihydroxyheptanoic acid, sodium salt.
Structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPRASOD.gif Molecular formula: C₂₃H₃₅NaO₇.
Molecular weight: 446.52.
CAS number. 81131-70-6.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

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