Atorvastatin Calcium Trihydrate USP
Brand name: SB-Ator
Generic name with specification: Atorvastatin Calcium Trihydrate USP
Strength: 10 mg, 20 mg.
Composition: Each Film Coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 10 mg.
Each Film Coated tablet contains Atorvastatin Calcium Trihydrate USP equivalent to Atorvastatin 20 mg.
Indications: SB-Ator is indicated-
- As an adjunct to diet to reduce elevated total cholesterol, LDL-C, apolipoprotein B, and triglycerides (TG) levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia;
- As an adjunct to diet for the treatment of patients with elevated serum triglycerides (TG) levels;
- For the treatment of patients with primary dysbetalipoproteinemia who do not respond adequately to diet;
- To reduce total cholesterol and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid lowering treatments;
- As an adjunct to diet reduce total cholesterol, LDL-C and apolipoprotein B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia.
Dosage & Administration:
The patient should be placed on a standard cholesterol-lowering diet before receiving SB-Ator and should continue on this diet during treatment with SB-Ator. The recommended starting doses are 10 mg, 20 mg or 40 mg. The 40 mg dose is recommended for patients who require a reduction in LDL-cholesterol of more than 45 percent. Therapy for patients requiring further reductions can be adjusted up to the 80 mg dose. Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia: The recommended starting dose of SB-Ator is 10 mg once daily. The dosage range is 10 to 80 mg once daily. SB-Ator can be administered as a single dose at any time of the day, with or without food. Therapy should be individualized according to goal of therapy and response. After initiation and/or upon titration of SB-Ator, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Since the goal of treatment is to lower LDL-C, the LDL-C levels should be used to initiate and assess treatment response. Only if LDL-C levels are not available, should total-C be used to monitor therapy. Homozygous Familial Hypercholesterolemia: The dosage of SB-Ator in patients with homozygous FH is 10 to 80 mg daily. SB-Ator should be used as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) in these patients or if such treatments are unavailable.
Concomitant Therapy: SB-Ator may be used in combination with a bile acid binding resin for additive effect.The combination of HMG-CoA reductase inhibitors and fibrates should generally be avoided. Dosage in Patients With Renal Insufficiency: Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary.
Pediatric Use: Treatment experience in a pediatric population is limited to doses of SB-Ator up to 80 mg/day for 1 year in 8 patients with homozygous FH. No clinical or biochemical abnormalities were reported in these patients. None of these patients was below 9 years of age.
Geriatric Use: Treatment experience in adults age 70 years with doses of SB-Ator up to 80 mg/day has been evaluated in 221 patients. The safety and efficacy of SB-Ator in this population were similar to those of patients <70 years of age.
Atorvastatin is generally well tolerated.The most frequent adverse events thought to be related to atorvastatin were constipation, flatulence, dyspepsia and abdominal pain.
Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases.
Pregnancy category: X
Since HMG-Co A reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women.Therefore,HMG-Co A reductase inhibitors are contraindicated during pregnancy and in nursing mothers. Atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, therapy should be discontinued and the patient apprised of the potential hazard to the fetus. Because of the potential for adverse reactions in nursing infants, women taking atorvastatin should not breast-feed.
Available packaging: 50’S, 30’S.
Price: 12 tk, 20 tk.