1 Name of Medicine
Pravastatin sodium.
2 Qualitative and Quantitative Composition
Each Pravastatin Sandoz 10 mg tablets contains 10 mg pravastatin sodium.
Each Pravastatin Sandoz 20 mg tablets contains 20 mg pravastatin sodium.
Each Pravastatin Sandoz 40 mg tablets contains 40 mg pravastatin sodium.
Each Pravastatin Sandoz 80 mg tablets contains 80 mg pravastatin sodium.
Not all strengths may be marketed in Australia.
Excipient with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.
3 Pharmaceutical Form
Pravastatin Sandoz 10 mg tablet is a light brown, mottled, oval tablet, scored on both sides and debossed "P 10" on one side.
Pravastatin Sandoz 20 mg tablet is a light brown, mottled, oval tablet, scored on both sides and debossed "P 20" on one side.
Pravastatin Sandoz 40 mg tablet is a light brown, mottled, oval tablet, scored on both sides and debossed "P 40" on one side.
Pravastatin Sandoz 80 mg tablet is a light brown, mottled, oval tablet, debossed "HLP 80" on one side.
4 Clinical Particulars
4.9 Overdose
There has been limited experience with over dosage 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 pravastatin 3 g; the other ingested pravastatin 280 mg 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 Poison Information Centre on 131126 (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 two-year oral study of rats, a statistically significant increase in the incidence of hepatocellular carcinomas was observed in male rats given pravastatin 100 mg/kg/day. 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/day. Increased incidences of hepatocellular carcinomas were also observed in male and female mice dosed with pravastatin at 250 and 500 mg/kg/day, 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 pravastatin 80 mg/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 soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform and ether.
Chemical structure. The chemical name of pravastatin sodium is sodium (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. Its empirical formula is C23H35NaO7 (MW: 446.52) and its chemical structure is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPRASOD.gif CAS number. 81131-70-6.
7 Medicine Schedule (Poisons Standard)
S4 - Prescription Only Medicine.
Summary Table of Changes
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PRVSANST.gif
