Expiration date: 01/2025
The composition and form of issue:
Tablets, film-coated. 1 tablet contains active substance:
atorvastatin calcium of 10.36 mg
(based on atorvastatin — 10 mg)
excipients: alpha-tocopherol succinate macrogol — 3 mg Eudragit (E100) (butylmethacrylate, dimethylaminoethylmethacrylate and methyl methacrylate copolymer (1:2:1) and 1.5 mg of croscarmellose sodium, 5 mg lactose monohydrate — 94,94 mg of sodium fumarate — 1.2 mg povidone — 4 mg
shell film: Opadry YS-1R-7003 (titanium dioxide — of 0.9375 g of hypromellose 2910 3BR (E464) — 0,8963 g hypromellose 2910 5 SP (E464) — 0,8963 g macrogol 4000 — 0,24 mg of Polysorbate 80 — 0,03 mg
active substance:
atorvastatin calcium of 20.72 mg
(based on atorvastatin — 20 mg)
excipients: alpha-tocopherol macrogol succinate — 6 mg Eudragit (E100) (butylmethacrylate, dimethylaminoethylmethacrylate and methyl methacrylate copolymer (1:2:1) 3 mg croscarmellose sodium 10 mg lactose monohydrate — 189,88 mg of sodium fumarate — 2.4 mg povidone — 8 mg
shell film: Opadry YS-1R-7003 (titanium dioxide — 1,875 g of hypromellose 2910 3BR (?464) — 1,7926 g hypromellose 2910 5 SP (?464) — 1,7926 g macrogol 400 — 0,48 mg Polysorbate 80 — 0,06 mg
active substance:
atorvastatin calcium 41,44 mg
(based on atorvastatin — 40 mg)
excipients: alpha-tocopherol succinate macrogol — 12 mg Eudragit (E100) (butylmethacrylate, dimethylaminoethylmethacrylate and methyl methacrylate copolymer (1:2:1) 6 mg croscarmellose sodium — 20 mg lactose monohydrate — 379,76 mg of sodium fumarate and 4.8 mg povidone — 16 mg
shell film: Opadry YS-1R-7003 (titanium dioxide 3.75 g hypromellose 2910 3BR (?464) — 3,5852 g hypromellose 2910 5 cP (?464) — 3,5852 g macrogol 400 — oil 0.960 mg Polysorbate 80 and 0.12 mg
active substance:
atorvastatin calcium 82,88 mg
(based on atorvastatin — 80 mg)
excipients: alpha-tocopherol succinate macrogol — 24 mg Eudragit (E100) (butylmethacrylate, dimethylaminoethylmethacrylate and methyl methacrylate copolymer (1:2:1) 12 mg croscarmellose sodium 40 mg lactose monohydrate — 759,52 mg of sodium fumarate and 9.6 mg of povidone — 16 mg
shell film: Opadry YS-1R-7003 (titanium dioxide and 7.5 g of hypromellose 2910 3 CP (E464) — 7,1704 g hypromellose 2910 5 SP (E464) — 7,1704 g macrogol 400 — 1,192 mg of Polysorbate 80 — 0,24 mg
in blister PVC/aluminum foil 10 PCs. in cardboard pack 3 blisters.
Method of application and dose:
Inside.
The usual starting dose is 10 mg 1 time per day. Dose ranges from 10 to 80 mg/day. The drug can be taken at any time of day 1 time per day regardless of the meal. The dose should be individualized based on the initial level of LDL cholesterol, the goal of therapy and patient response to treatment. At the beginning and/or at the time of dosage increase Atorvastatin-Teva to every 2-4 week control lipid levels in plasma and accordingly to correct the dose.
Adjusting the doses should be at intervals of not less than 4 weeks. The maximum daily dose is 80 mg.
For patients with established coronary artery disease and other patients having a high risk of cardiovascular complications, it is recommended that the formulation of the following objectives correction of lipid levels: LDL cholesterol less than 3 mmol/l (or less than 115 mg/DL) and total cholesterol less than 5 mmol/l (or less than 190 mg/DL).
Primary hypercholesterolemia and combined (mixed) hyperlipidemia
Most patients required control lipid levels is provided by receiving 10 mg of Atorvastatin-Teva 1 per day. Significant therapeutic effect is usually observed after 4 weeks. With prolonged treatment, this effect persists.
Heterozygous familial hypercholesterolemia
Treatment patients should start with the appointment of 10 mg of Atorvastatin-Teva a day. By implementing an individual correction dose every 4 weeks should bring it up to 40 mg/day. Then you can increase the dose to the maximum level, equal to 80 mg/day, or to use combined assignment and 40 mg of Atorvastatin-Teva and sequestrant of bile acids.
Homozygous familial hypercholesterolemia
The drug is administered at a dose of 80 mg 1 time per day.
In patients with renal insufficiency
Kidney disease did not affect the concentration of atorvastatin in plasma and the degree of reduction of lipids in its application in this regard, any dose adjustment in patients with kidney disease is not required.
In patients with hepatic insufficiency
When liver failure may require dose reduction or withdrawal of the drug.
