ATORHAB-40

Uses / indications

• - Hypercholesterolaemia
• - Mixed dyslipidaemia
• - Familial hypercholesterolaemia
• - Prevention of cardiovascular events
• - Secondary prevention of cardiovascular disease
• - Reduction of elevated LDL-cholesterol
• - Reduction of elevated triglycerides

Product information

ATORHAB 40

Atorvastatin Calcium IP

Equivalent to Atorvastatin 40 mg

Pack Size: 10 × 10 Tablets
Marketed by: HAIBO PRIME

1. COMPOSITION

Each film-coated tablet contains:

Atorvastatin Calcium IP
Equivalent to Atorvastatin 40 mg

Excipients: q.s.

2. INDICATIONS

ATORHAB 40 is indicated as an adjunct to diet and lifestyle modification for:

Hypercholesterolaemia

Mixed dyslipidaemia

Primary hyperlipidaemia

Familial hypercholesterolaemia

Hypertriglyceridaemia

Reduction of elevated LDL-cholesterol

Reduction of cardiovascular risk in appropriate patients

3. DOSAGE AND ADMINISTRATION

Adults:
The usual dosage range is 10 mg to 80 mg once daily.

A dose of 40 mg once daily may be used in patients requiring a substantial reduction in LDL-cholesterol, as determined by the physician.

ATORHAB 40 should be taken orally once daily, with or without food.

The dosage should be individualized according to the patient's treatment goals, baseline lipid levels and response to therapy. Lipid levels may be assessed approximately 4 weeks after initiation or dosage adjustment.

4. CONTRAINDICATIONS

ATORHAB 40 is contraindicated in patients with:

Hypersensitivity to atorvastatin or any component of the formulation.

Acute liver failure.

Decompensated cirrhosis.

5. WARNINGS AND PRECAUTIONS

Use with caution in patients with a history of liver disease.

Liver enzyme abnormalities may occur during treatment.

Patients should report unexplained muscle pain, tenderness or weakness.

The risk of myopathy and rhabdomyolysis may be increased with higher doses and certain concomitant medicines.

Use with caution in patients with renal impairment or uncontrolled hypothyroidism.

The prescriber should review concomitant medicines for potential drug interactions.

6. ADVERSE EFFECTS

Commonly reported adverse effects include:

Headache

Nausea

Diarrhoea

Dyspepsia

Muscle pain

Joint pain

Increased liver enzymes

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

7. DRUG INTERACTIONS

Atorvastatin exposure may increase when used with certain medicines, including some:

Macrolide antibiotics

Azole antifungals

Antiviral medicines

Other CYP3A4 inhibitors

Appropriate dosage adjustments may be required when atorvastatin is administered with interacting medicines.

8. USE IN PREGNANCY AND LACTATION

ATORHAB 40 should not be used during pregnancy.

Breastfeeding is not recommended during treatment with atorvastatin.

9. OVERDOSAGE

There is no specific antidote for atorvastatin overdose. Treatment is supportive and symptomatic.

Medical attention should be sought in cases of suspected overdose.

10. STORAGE

Store below 30°C.

Protect from light and moisture.

Keep out of reach and sight of children.

Store in the original package.

11. PRESENTATION

ATORHAB 40

Atorvastatin Calcium IP
Equivalent to Atorvastatin 40 mg

10 × 10 Tablets

Marketed by:

HAIBO INDIA