ATORHAB 20

Uses / indications

• Atorvastatin 20 mg is a statin (HMG-CoA reductase inhibitor) indicated for:
• - Hypercholesterolaemia — to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides.
• - Mixed dyslipidaemia — as an adjunct to diet when lipid levels remain inadequately controlled.
• - Primary prevention of cardiovascular events in appropriate patients at increased cardiovascular risk.
• - Secondary prevention of cardiovascular events in patients with established coronary heart disease or other atherosclerotic cardiovascular disease.
• - Familial hypercholesterolaemia, including appropriate adult patients and selected paediatric patients as directed by a physician.

Product information

ATORHAB 20

Atorvastatin Calcium IP

Equivalent to Atorvastatin 20 mg

Pack Size: 10 × 10 Tablets
Manufactured/Marketed by: Haibo India

1. COMPOSITION

Each film-coated tablet contains:

Atorvastatin Calcium IP
Equivalent to Atorvastatin 20 mg

Excipients: q.s.

Colour: As approved.

2. THERAPEUTIC INDICATIONS

ATORHAB 20 is indicated as an adjunct to diet and lifestyle modification for:

Treatment of hypercholesterolaemia.

Reduction of elevated LDL-cholesterol, total cholesterol, apolipoprotein B and triglycerides.

Treatment of mixed dyslipidaemia.

Management of familial hypercholesterolaemia, as appropriate.

Reduction of the risk of cardiovascular events in appropriate patients with established cardiovascular disease or multiple cardiovascular risk factors.

Atorvastatin should be used along with an appropriate lipid-lowering diet and other lifestyle modifications.

3. DOSAGE AND ADMINISTRATION

The dosage should be individualized according to the patient's treatment goals, baseline lipid levels and response to therapy.

Adults

The usual starting dose is 10 mg or 20 mg once daily.

The dosage may be adjusted according to therapeutic response. The usual dosage range is 10 mg to 80 mg once daily.

ATORHAB 20 provides 20 mg of atorvastatin per tablet.

The tablet may be taken once daily, with or without food, preferably at the same time each day.

Patients should continue an appropriate cholesterol-lowering diet and lifestyle measures during treatment.

4. CONTRAINDICATIONS

Atorvastatin is contraindicated in patients with:

Hypersensitivity to atorvastatin or any component of the formulation.

Acute liver failure or decompensated cirrhosis.

Pregnancy.

Breastfeeding.

5. WARNINGS AND PRECAUTIONS

Hepatic Effects

Liver function should be assessed as clinically indicated. Atorvastatin should be used with caution in patients with a history of liver disease or substantial alcohol consumption.

Myopathy and Rhabdomyolysis

Patients should be advised to report unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever or malaise.

The risk of myopathy and rhabdomyolysis may be increased with higher doses, advanced age, renal impairment, uncontrolled hypothyroidism and certain concomitant medicines.

Drug Interactions

Certain medicines, including some macrolide antibiotics, azole antifungals, antiviral medicines and other CYP3A4 inhibitors, can increase atorvastatin exposure and may increase the risk of muscle toxicity.

The prescriber should review concomitant medicines before initiating or increasing the dose.

6. ADVERSE EFFECTS

Commonly reported adverse reactions include:

Headache

Nausea

Diarrhoea

Dyspepsia

Muscle pain

Joint pain

Increased liver enzymes

Rare but potentially serious adverse effects include myopathy and rhabdomyolysis and clinically significant hepatic injury.

7. USE IN PREGNANCY AND LACTATION

Atorvastatin should not be used during pregnancy because treatment is not expected to provide benefit during pregnancy and may pose a risk to the fetus.

Breastfeeding is not recommended during treatment with atorvastatin.

8. STORAGE

Store below 30°C.

Protect from light and moisture.

Keep out of reach and sight of children.

Store in the original package.

9. PRESENTATION

ATORHAB 20

Atorvastatin Calcium IP
Equivalent to Atorvastatin 20 mg

Pack Size: 10 × 10 Tablets

HAIBO INDIA