Consumer medicine information

1. Why am I taking LORSTAT?

LORSTAT contains the active ingredient atorvastatin (as calcium trihydrate). LORSTAT is used to treat lowers high cholesterol levels and to 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 taking LORSTAT? in the full CMI.

2. What should I know before I take LORSTAT?

Do not use if you have ever had an allergic reaction to LORSTAT 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 take LORSTAT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with LORSTAT 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 LORSTAT?

• The usual dose of LORSTAT 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 taking LORSTAT?

6. Are there any side effects?

Speak to your doctor or pharmacist if you have any of these: 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; falling and difficulty getting up from a fall; constipation, diarrhoea; stomach or belly pain, nausea (feeling sick); heartburn, indigestion or wind; urine infection; headache; stuffy or runny nose; nose bleeds; rash. Tell your doctor as soon as possible if you have any of these: yellowing of the skin and eyes and dark coloured urine; feeling weak and tired, excessively thirsty and passing more urine; problems with breathing, including shortness of breath, persistent cough and fever. Tell your doctor immediately or go straight to the Emergency Department at your nearest hospital if you have any of these: symptoms of allergy such as skin rash, itching, swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing or breathing; chest pain; unexpected muscle pain, tenderness or weakness not caused by exercise, particularly if you also feel unwell or have a fever; sudden severe headache, which may be accompanied by nausea, vomiting, loss of sensation, tingling in any part of the body or ringing in the ears; severe blisters and bleeding of the lips, eyes, mouth, nose or genitals.
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 calcium trihydrate.

2 Qualitative and Quantitative Composition

Each Lorstat tablet contains either 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin as the active ingredient.
Excipients with known effect. Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Lorstat 10 mg tablets. White, oval, biconvex, film coated tablet plain on one side and debossed '10' on the other side.
Lorstat 20 mg tablets. White, oval, biconvex, film coated tablet with break line on one side and debossed '20' on the other side.
Lorstat 40 mg tablets. White, oval, biconvex, film coated tablet with break line on one side and debossed '40' on the other side.
Lorstat 80 mg tablets. White, oval, biconvex, film coated tablet with break line on one side and debossed '80' on the other side.

4 Clinical Particulars

4.9 Overdose

There is no specific treatment for Lorstat 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 alkalinization 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 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, 30 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, 200 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 powder that is practically insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium trihydrate is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile, slightly soluble in ethanol and freely soluble in methanol.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSATOCAT.gif CAS number. 344423-98-9.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/LORSTAST.gif