Consumer medicine information

1. Why am I using APO-ATORVASTATIN?

APO-ATORVASTATIN contains the active ingredient atorvastatin. APO-ATORVASTATIN is used to lower high cholesterol levels.
APO-ATORVASTATIN is also used to help reduce the risk of having a heart attack or stroke in people who have high blood pressure and coronary heart disease (CHD) or who are at risk of CHD.
For more information, see Section 1. Why am I using APO-ATORVASTATIN? in the full CMI.

2. What should I know before I use APO-ATORVASTATIN?

Do not use if you have ever had an allergic reaction to APO-ATORVASTATIN 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, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use APO-ATORVASTATIN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-ATORVASTATIN 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 use APO-ATORVASTATIN?

• The usual dose of APO-ATORVASTATIN is between 10-80 mg taken once a day.

• Swallow the tablets whole with a full glass of water. Do not chew or crush the tablets.

5. What should I know while using APO-ATORVASTATIN?

6. Are there any side effects?

Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Tell your doctor or pharmacist if you notice any of the following and they worry you: muscle and joint pain, muscle weakness, especially in the forearms, thighs, hips, shoulders, neck, and back, difficulty climbing stairs or standing up from a chair, difficulty lifting arms over the head.
This is not a complete list of all possible side effects. 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

Atorvastatin as calcium trihydrate.

2 Qualitative and Quantitative Composition

Each tablet contains atorvastatin calcium trihydrate equivalent to 10 mg, 20 mg, 40 mg and 80 mg atorvastatin.
Excipients with known effect. Contains sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

10 mg tablets. White to off-white, elliptical, film-coated tablets debossed 'AS10' on one side and plain on the other side.
20 mg tablets. White to off-white, elliptical, film-coated tablets debossed 'AS20' on one side and plain on the other side.
40 mg tablets. White to off-white, elliptical, film-coated tablets debossed 'AS40' on one side and plain on the other side.
80 mg tablets. White to off-white, elliptical, film-coated tablets debossed 'AS80' on one side and plain on the other side.

4 Clinical Particulars

4.9 Overdose

There is no specific treatment for atorvastatin overdosage. Should an overdose occur, the patient should be treated symptomatically, and supportive measures instituted as required. In symptomatic patients, monitor serum creatinine, BUN, creatinine phosphokinase, and urine myoglobin for indications of renal impairment secondary to rhabdomyolysis. Liver function tests should be performed in symptomatic patients.
If there has been significant ingestion, consider administration of activated charcoal. Activated charcoal is most effective when administered within 1-hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected. For rhabdomyolysis, administer sufficient 0.9% saline to maintain urine output of 2 to 3 mL/kg/hr. Diuretics may be necessary to maintain urine output. Urinary alkalinisation is not routinely recommended. Due to extensive drug binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
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. Atorvastatin did not demonstrate mutagenic or clastogenic potential in an appropriate battery of assays. It was negative in the Ames test with Salmonella typhimurium and Escherichia coli, and in the in vitro hypoxanthine-guanine phosphoribosyltransferase (HGPRT) forward mutation assay in Chinese hamster lung cells.
Atorvastatin did not produce significant increases in chromosomal aberrations in the in vitro Chinese hamster lung cell assay and was negative in the in vivo mouse micronucleus test.
Carcinogenicity. In a 2-year study in rats given 10 mg 30 mg or 100 mg/kg/day, the incidence of hepatocellular adenoma was marginally, although not significantly, increased in females at 100 mg/kg/day.
The maximum dose used was 11 times higher than the highest human dose (80 mg/kg) based on AUC_(0-24) values. In a 2-year study in mice given 100 mg, 200 mg, or 400 mg/kg, incidences of hepatocellular adenoma in males and hepatocellular carcinoma in females were increased at 400 mg/kg. The maximum dose used was 14 times higher than the highest human dose (80 mg/kg) based on AUC_(0-24) values. Other HMG-CoA reductase inhibitors have been reported to induce hepatocellular tumours in mice and rats.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Atorvastatin calcium trihydrate is a white to off-white crystalline powder. It is insoluble in aqueous solutions of pH 4 and below, insoluble in water, very slightly soluble in pH 7.4 phosphate buffer, insoluble in acetonitrile, slightly soluble in alcohol and freely soluble in methanol. pKa of atorvastatin calcium is approximately 4.4.
Chemical name: Calcium (3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)- 1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate trihydrate.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSATOCAT.gif Molecular formula: C₆₆H₆₈CaF₂N₄O₁₀.3H₂O.
Molecular weight: 1209.42.
CAS number. 344423-98-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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