Atherox Tablet 10 mg
Composition:

Each film-coated tablet contains:
Active substance: 10 mg of atorvastatin (equivalent to 10.85 mg, 21.70 mg, or 43.40 mg of atorvastatin calcium, depending on the formulation).
Excipients: lactose monohydrate, calcium carbonate, Avicel PH 101, sodium croscarmellose, HPC, Tween 80, magnesium stearate, Opadry-31K 28462 white (lactose monohydrate, hypromellose, titanium dioxide, triacetin).

Indications:

Hypercholesterolemia:
In combination with diet to reduce elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo-B), and triglycerides (TG) in adults, adolescents, and children aged 10 years and older with primary hypercholesterolemia (heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia – Type IIa and IIb per Fredrickson classification) when response to diet and other non-pharmacological interventions is inadequate.

Homozygous Familial Hypercholesterolemia:
To reduce TC, LDL-C, and Apo-B levels in adult patients when diet and other lipid-lowering therapies are not effective.

Cardiovascular Prevention:
To reduce the risk of serious cardiovascular events in patients at high risk, as an addition to the correction of other risk factors.

Dosage and Administration:

Atherox tablets are administered orally once daily, at any time of the day, with or without food.
It is recommended that patients follow a standard hypolipidemic diet during treatment.
The initial and maintenance dose should be individualized according to baseline LDL-C levels, therapeutic goals, and patient response.

Lipid levels should be assessed within 2–4 weeks of initiation or dose adjustment, and dosage may be adjusted accordingly.
The usual dose is 10–80 mg once daily. Adjustments may be made every 4 weeks up to a maximum of 40 mg or 80 mg daily if needed.

Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia:
Most patients are controlled with 10 mg once daily.
Therapeutic response is seen within 2 weeks and usually reaches a maximum in 4 weeks.
Long-term use maintains effectiveness.

Heterozygous Familial Hypercholesterolemia:
Recommended starting dose is 10 mg once daily. The dose may be adjusted every 4 weeks up to 40 mg/day.
Thereafter, the dose may be increased to a maximum of 80 mg/day or combined with bile acid sequestrants.

Homozygous Familial Hypercholesterolemia:
Limited data available. The dose is 10–80 mg once daily.
Atherox should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are unavailable.

Cardiovascular Disease Prevention:
For primary prevention, the recommended dose is 10 mg/day.
Higher doses may be required to reach target LDL-C levels as per clinical guidelines.

Special Populations:

Patients with Renal Impairment:
No dose adjustment is needed as renal impairment does not affect plasma levels or efficacy.

Pediatric Patients (Aged 10–17) with Heterozygous Familial Hypercholesterolemia:
Starting dose is 10 mg once daily; maximum dose is 20 mg/day.
Doses above 20 mg or use in combination therapy in this group has not been studied.

Elderly Patients:
No differences in safety or effectiveness have been observed compared to the general population.

Use with Other Lipid-Lowering Therapies:

Atherox can be combined with bile acid sequestrants for additional effect.
Avoid concurrent use with other HMG-CoA reductase inhibitors and fibrates (e.g., gemfibrozil, fenofibrate).

Dosage Adjustment with Specific Interactions:

• Avoid Atheroxin patients taking:

• Cyclosporine

• HIV protease inhibitors (tipranavir + ritonavir)

• Hepatitis C protease inhibitors (telaprevir)

• Do not exceed 20 mg/dayin patients taking:

• Clarithromycin, itraconazole

• Saquinavir + ritonavir, darunavir + ritonavir

• Fosamprenavir or fosamprenavir + ritonavir

• HIV protease inhibitor nelfinavir

• Hepatitis C protease inhibitor boceprevir

Storage Conditions:

Store at temperatures not exceeding 25°C, in the original packaging, out of reach of children.