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Normostat (20) (Atorvastatin 20mg)
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Formula
Each film-coated tablet contains atorvastatin calcium equivalent to atorvastatin 20 mg and excipients q.s. (anhydrous dibasic calcium phosphate, lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, film coating excipients).
Dosage form
Film-coated tablets
Presentation
Box of 1 bottle x 30 film-coated tablets
Box of 2 blisters x 7 film-coated tablets
Indications
Atorvastatin is indicated:
- As an adjunct to diet to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglyceride levels in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson type IIa and IIb).
- To reduce total cholesterol and LDL cholesterol in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments or if such treatments are unavailable.
Contra-indications
Hypersensitivity to atorvastatin; active liver disease or unexplained persistent elevations of serum transaminases; pregnancy and lactation.
Precautions
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 other underlying medical problems.
Warnings
Effects on liver function
HMG-CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function.
It is recommended that the liver function tests should be performed before the initiation of treatment, at 6 and 12 weeks after initiation of therapy or elevation in dose, and periodically (eg. semiannually) thereafter. Liver enzyme changes generally occur in the first 3 months of treatment with atorvastatin. Patients who develop increased transaminase levels should be monitored until the abnormalities resolved. Should an increase in ALT or AST of >= 3 times ULN persist, reduction of dose or withdrawal of atorvastatin is recommended.
Atorvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Effects on skeletal muscle
Rhabdomyolysis with acute failure secondary to myoglobulinurea has been reported with other drugs in this class. Uncomplicated myalgia has been reported in patients treated with atorvastatin. Myopathy, defined as muscle aches or muscle weakness in conjunction with increase in creatine phosphokinase (CPK) value > 10 times ULN, should be considered in any patient with diffuse myalgias, muscle tenderness, and/or marked elevation of CPK. Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly accompanied by malaise or fever. Atorvastatin should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Atorvastatin therapy should be temporarily withheld or discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (eg. severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).
Side effects
Side effects have usually been mild and transient, manifested as abdominal pain, constipation, flatulence, dyspepsia, diarrhea, asthenia, sinusitis, pharyngitis, rash, arthralgia, myalgia.
Inform the physician any side-effect occurs during the therapy.
Drug interactions
Risk of myopathy during treatment with other drugs of this class is increased with concurrent administration of cyclosporine, fibric acid derivatives, niacin (nicotinic acid) erythromycin, azole antifungals.
When multiple doses of atorvastatin and digoxin were coadministered, steady-state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.
Plasma concentration of atorvastatin increased approximately 40% with coadministration of atorvastatin and erythromycin.
Coadministration of atorvastatin and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol by approximately 30% and 20%. These increases should be considered when selecting an oral contraceptive for woman taking atorvastatin.
Dosage and administration
Hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredickson type IIa and IIb): The recommended starting dose is 10 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. Therapy should be individualized according to the goal of therapy and response. After initiation and/or upon titration of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly. Since the goal of treatment is to lower LDL cholesterol, it is recommended that LDL cholesterol levels be used to initiate and assess treatment response. Only if LDL cholesterol levels are not available, should total cholesterol be used to monitor the therapy.
Homozygous familial hypercholesterolemia: The recommended dosage is 10 to 80 mg daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments in these patients or if such treatments are unavailable.
The patients should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin.
Concomitant therapy: Atorvastatin 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.
Shelf-life
36 months.
Storage
Store in a dry and cool place(<25 C). Keep out of reach of children. |
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