Apo-Atorvastatin

Apo-Atorvastatin Dosage/Direction for Use

atorvastatin

Manufacturer:

Apotex

Distributor:

Pharmaforte
Full Prescribing Info
Dosage/Direction for Use
General: Before instituting therapy with Atorvastatin, an attempt should be made to control hypercholesterolemia with appropriate diet, exercise and weight reduction in obese patients, and to treat underlying medical problems. The patient should continue on a standard cholesterol-lowering diet during treatment with Atorvastatin. The recommended starting dose of Atorvastatin is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range is 10 to 80 mg once daily.
Atorvastatin can be administered as a single dose at any time of the day, with or without food. The doses should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response. After initiation and/or upon titration of Atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and dosage adjusted accordingly.
Prevention of Cardiovascular Disease: For primary prevention, the recommended dose is 10 mg once daily. For secondary prevention, optimal dosing may range from 10 mg to 80 mg Atorvastatin once daily, to be given at the discretion of the prescriber, taking into account the expected benefit and safety considerations relevant to the patient to be treated (see Pharmacology: Pharmacodynamics: Secondary Prevention of Cardiovascular Events under Actions).
Primary Hypercholesterolemia and Combined (Mixed) Hyperlipidemia: The majority of patients are controlled with 10 mg Atorvastatin once a day. A therapeutic response is evident within two weeks, and the maximum response is usually achieved within four weeks. The response is maintained during chronic therapy.
Homozygous Familial Hypercholesterolemia: In a compassionate-use study of patients with homozygous familial Hypercholesterolemia, most patients responded to 80 mg of Atorvastatin with a greater than 15% reduction in LDL-C (18%-45%).
Use in Patients with Hepatic Insufficiency: (See Contraindications and Precautions).
Use in Patients with Renal Insufficiency: Renal disease has no influence on the plasma concentrations or on the LDL-C reduction of Atorvastatin. Thus, no adjustment of the dose is required. (See Precautions).
Paediatric use, Hypercholesterolaemia: Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress. For patients aged 10 years and above, the recommended starting dose of Atorvastatin is 10 mg per day with titration up to 20 mg per day. Titration should be conducted according to the individual response and tolerability in paediatric patients. Safety information for paediatric patients treated with doses above 20 mg, corresponding to about 0.5 mg/kg, is limited.
There is limited experience in children between 6-10 years of age (See Pharmacology: Pharmacodynamics under Actions). Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Treatment experience in a pediatric population is limited to doses of Atorvastatin up to 80 mg/day for one year in 8 patients with homozygous FH. No clinical or biochemical abnormalities were reported in these patients.
Use in the Elderly - No differences in safety, efficacy or lipid treatment goal attainment were observed between elderly patients and the overall population (see Pharmacology: Pharmacokinetics: Special Populations under Actions).
Use in Combination with Other Medicinal Compounds: In cases where co-administration of Atorvastatin with cyclosporine, telaprevir, or the combination tipranavir/ritonavir is necessary, the dose of Atorvastatin should not exceed 10 mg. In patients taking clarithromycin or in patients with HIV taking a combination of ritonavir plus saquinavir or lopinavir plus ritonavir, for doses of Atorvastatin exceeding 20 mg appropriate clinical assessment is recommended to ensure that the lowest dose necessary of Atorvastatin is employed.
THE FOLLOWING TREATMENT GUIDELINES MAY BE USED TO ESTABLISH TREATMENT GOALS: (See Table 6.)

Click on icon to see table/diagram/image

After the LDL-C goal has been achieved, if the TG is still ≥200 mg/dL (2.2 mmol/L), non HDL-C (total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL (0.8 mmol/L) higher than LDL-C goals for each risk category.
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